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| ID | Type | Description | Link |
|---|---|---|---|
| R01AT009444 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Center for Complementary and Integrative Health (NCCIH) | NIH |
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Dementia is a progressive decline in cognition that impairs a person's ability to perform activities of daily living. Changes in mood, gait, and balance are prominent secondary symptoms of Alzheimer's dementia that can dramatically decrease quality of life for the person with dementia and increase caregiver burden. The overall aim of this study is to determine the independent and combined effects of dance movement and social engagement on quality of life in people with early-stage dementia, and test the neural mechanisms of these effects.
Dementia is a progressive decline in cognition that impairs a person's ability to perform activities of daily living. Alzheimer's disease is the most common form of dementia, the most common neurodegenerative disease in older adults, and the 6th leading cause of death in the US. Neuropsychiatric symptoms (apathy, depression, anxiety) and altered gait and balance are prominent secondary symptoms of Alzheimer's disease that increase medical costs and decrease quality of life for both the person with dementia and their caregiver.
In a report from the Secretariat (Executive Board, 134th Session, December 20th, 2013), the World Health Organization identified a need to integrate evidence-based palliative care services into the continuum of care for serious chronic diseases, including Alzheimer's disease. However, two recent NIH workshops identified major gaps in the evidence supporting the wider use of non-pharmacologic activities to ameliorate secondary symptoms of chronic disease. Arts-based activities were identified as particularly understudied for symptom management, given growing evidence that various arts-based activities can improve quality of life, relieve symptoms, and reduce reliance on medications. It is important that these benefits can be achieved without adding medications. Dance is an arts-based activity that can improve quality of life, decrease symptoms of depression, and improve balance in healthy older adults, those with Parkinson disease, and Alzheimer's disease. Thus, dance is a non-pharmacological intervention that simultaneously addresses two sets of prominent secondary symptoms in Alzheimer's disease: 1) gait and balance and 2) neuropsychiatric symptoms. However, the mechanisms through which dance exerts these effects are unknown.
Pilot data from the investigators' laboratory suggest that participating in a group improvisational movement class twice weekly improved balance and connectivity in motor-related brain regions, as well as improving mood and connectivity in brain regions associated with social engagement. Improvisation is the ability to create new gestures and movements spontaneously. Improvisation can be a part of many different art forms. However, improvisational movement can also be practiced as a specific dance form. The objective in improvisational movement is that choreographed movement is replaced by a cue or prompt that allows the possibility for multiple responses. This unique form of dance is especially well-suited for people with dementia because it: 1) does not rely heavily on memory of repeated movements; 2) can be seamlessly adapted to include sitting, standing, or moving around the room; 3) is cognitively challenging; and 4) fosters a social, playful atmosphere. Participants seemed to benefit from both the social nature of the class and the movement. Therefore, the overall aim of this proposal is to experimentally determine the independent and combined effects of dance movement and social engagement on quality of life in people with early stage dementia, and test the neural mechanisms of these effects.
To accomplish this goal, the investigators will use a 2x2 factorial design and randomize 120 community-dwelling older adults adjudicated as having early-stage dementia of the presumed Alzheimer's type to one of four 3-month interventions: 1) Dance Group, 2) Non-group Dance, 3) Social Group, or 4) No Contact Control.
It is not hypothesized that dance affects the underlying disease course, and therefore no improvement is expected in cognition.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Dance Group | Active Comparator | The Dance Group will participate in 1-hour group improvisational dance lessons 2x/week for 12 weeks. Improvisational dance classes are grounded in 4 principles that shape the tone of the class and result in a sense of social belonging: non-judgment, non-competitiveness, curiosity, and playfulness. The following training strategies are used to maintain: active imagination, variability, and pacing. |
|
| Non-group Dance | Active Comparator | The Non-group dance intervention is designed to capture the same dance movement and auditory stimuli as the group class without social interaction. Recordings of the dance instructor teaching a dance class will be played. This will ensure participants hear comparable music and receive comparable verbal auditory cues to prompt dance movements that students in the group class will hear, without interacting with other people. Improvisational dance is particularly suited for this means of delivery because the primary method of instruction is verbal auditory cueing. Participants will be asked to follow the same schedule as participants in the Dance Group arm and complete 2 one-hour dance sessions each week. |
|
| Social Group | Active Comparator | The social group will consist of improvisational party games to foster curiosity and playfulness, use imagery, and encourage non-judgment. Games that may be used include 'Balderdash', 'Wise and Otherwise', 'Charades', 'Pictionary', and 'Tell Me A Story' cards. These games will also use the same core strategies as the dance group. Games will be varied within an hour-long session to incorporate pacing and variability into the social group, akin to the dance group. The social group will occur 2x/week for 1 hour each time and be led by the same instructors who lead the Dance Group, to control for effects of personality of the group leader. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dance Group | Behavioral | Active imagination refers to working with imagery and is crucial in improvisatory practice. Verbal auditory cues are used to create movement scenarios that cue or activate the motor imagination. Variability means the improvisational method does not aim to learn a specific movement pattern and habituate to it. Cues are delivered quickly, one after another. Within an average of two minutes, tasks requiring quicker decision-making are introduced. Pacing is the rate at which new movement prompts are presented. Quick changes in pace avoid defaulting to habitual responses, thereby facilitating new movement options. Participants cannot rely on copying another, memory, or anticipation to address the motor problem. |
| Measure | Description | Time Frame |
|---|---|---|
| Quality of Life in Alzheimer's Disease (QOL-AD)--Participants With Dementia (PWD) | Self-reported quality of life in the person with dementia is the primary outcome and will be measured using the QOL-AD . The QOL-AD is validated for use in people with Mini Mental State Exam scores as low as 10.The QOL_AD contains 13 items.Points are assigned to each item as follows: poor = 1, fair = 2, good = 3, excellent = 4.The total score is the sum of all 13 item (range 13- 52) higher scores represent better outcomes. | Baseline |
| QOL-AD--PWD | Self-reported quality of life in the person with dementia is the primary outcome and will be measured using the QOL-AD . The QOL-AD is validated for use in people with Mini Mental State Exam scores as low as 10.The QOL_AD contains 13 items.Points are assigned to each item as follows: poor = 1, fair = 2, good = 3, excellent = 4.The total score is the sum of all 13 item (range 13- 52) higher scores represent better outcomes. | Week 12 |
| Measure | Description | Time Frame |
|---|---|---|
| Community Structure--PWD | This is a brain imaging variable derived from fMRI images. Modularity (Q) ranges from 0 (no community structure) to 1 (perfectly modular network). One Q-value is generated for each person and group averages are shown. | Baseline |
| Community Structure--PWD |
| Measure | Description | Time Frame |
|---|---|---|
| Body Mass Index (BMI) | a measure of body fat based on height and weight that applies to adult men and women--PWD only | Baseline, Week 12 |
| Blood Pressure | PWD only |
Inclusion Criteria:
Age 60-85 years
Adjudicated as having mild cognitive impairment or early-stage dementia of Alzheimer's, vascular, or mixed Alzheimer's/vascular type
MRI compatible
English speaking
Have study partner who is around the person with dementia approximately 10 hours/week and is willing to be an active study partner.
Able to attend bi-weekly intervention classes or come to study visits for no-contact control.
Not enrolled in another interventional study for at least 3 months prior to beginning this study.
Exclusion Criteria:
Untreated depression
Other causes of dementia (for example, frontotemporal, early onset, Lewy body or Parkinsonian dementia)
Current cancer treatment or other major medical problems that might independently affect cognition or movement
Other neurological disorders (e.g., Parkinson disease, multiple sclerosis)
Taking medication that could negatively influence safety during intervention
Planned extensive travel during the study period
Any reason for which the study doctor or personal physician feels the intervention is contraindicated for the participant
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| Name | Affiliation | Role |
|---|---|---|
| Christina Hugenschmidt, PhD | Assistant Professor Gerontology and Geriatric Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Wake Forest Baptist Health | Winston-Salem | North Carolina | 27104 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23507120 | Background | Alzheimer's Association. 2013 Alzheimer's disease facts and figures. Alzheimers Dement. 2013 Mar;9(2):208-45. doi: 10.1016/j.jalz.2013.02.003. | |
| 19169120 | Background | Gaugler JE, Yu F, Krichbaum K, Wyman JF. Predictors of nursing home admission for persons with dementia. Med Care. 2009 Feb;47(2):191-8. doi: 10.1097/MLR.0b013e31818457ce. |
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Participants were enrolled in dyads consisting of one person with dementia (PWD) and one caregiver (CG). Participant flow section includes numbers as dyad since both were considered enrolled. Elsewhere in the record, numbers include either participants with dementia or caregivers as indicated in baseline analysis population description and in outcome titles or descriptions.
All Persons With Dementia (PWDs) were enrolled with one caregiver each. There was never a time when one was enrolled without the other, so these two people are represented in the participant flow as a dyad.
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| ID | Title | Description |
|---|---|---|
| FG000 | Dance Group | The Dance Group will participate in 1-hour group improvisational dance lessons 2x/week for 12 weeks. Improvisational dance classes are grounded in 4 principles that shape the tone of the class and result in a sense of social belonging: non-judgment, non-competitiveness, curiosity, and playfulness. The following training strategies are used to maintain: active imagination, variability, and pacing. Dance Group: Active imagination refers to working with imagery and is crucial in improvisatory practice. Verbal auditory cues are used to create movement scenarios that cue or activate the motor imagination. Variability means the improvisational method does not aim to learn a specific movement pattern and habituate to it. Cues are delivered quickly, one after another. Within an average of two minutes, tasks requiring quicker decision-making are introduced. Pacing is the rate at which new movement prompts are presented. Quick changes in pace avoid defaulting to habitual responses, thereby facilitating new movement options. Participants cannot rely on copying another, memory, or anticipation to address the motor problem. |
| FG001 | Non-group Dance | The Non-group dance intervention is designed to capture the same dance movement and auditory stimuli as the group class without social interaction. Recordings of the dance instructor teaching a dance class will be played. This will ensure participants hear comparable music and receive comparable verbal auditory cues to prompt dance movements that students in the group class will hear, without interacting with other people. Improvisational dance is particularly suited for this means of delivery because the primary method of instruction is verbal auditory cueing. Participants will be asked to follow the same schedule as participants in the Dance Group arm and complete 2 one-hour dance sessions each week. Non-Group Dance: The caregiver will be asked to stay in the area while the subject is dancing. A video camera will be affixed in an upper corner of the room to record individual dance sessions. This recording will yield data that a trained student or staff member can view and code to document movement fidelity (e.g., that the person has responded to the dance prompts and for the purpose of comparing the amount of quality of movements that occur in individual vs. group dance settings). For the first two sessions, study staff would observe the full dance session from outside the room to be sure that instruction was clear and adherence was attained, and that no safety issues arise. |
| FG002 | Social Group | The social group will consist of improvisational party games to foster curiosity and playfulness, use imagery, and encourage non-judgment. Games that may be used include 'Balderdash', 'Wise and Otherwise', 'Charades', 'Pictionary', and 'Tell Me A Story' cards. These games will also use the same core strategies as the dance group. Games will be varied within an hour-long session to incorporate pacing and variability into the social group, akin to the dance group. The social group will occur 2x/week for 1 hour each time and be led by the same instructors who lead the Dance Group, to control for effects of personality of the group leader. Social Group: The social group will consist of improvisational party games to foster curiosity and playfulness, use imagery, and encourage non-judgment. Games that may be used include 'Balderdash', 'Wise and Otherwise', 'Charades', 'Pictionary', and 'Tell Me A Story' cards. These games will also use the same core strategies as the dance group. Games will be varied within an hour-long session to incorporate pacing and variability into the social group, akin to the dance group. The social group will occur 2x/week for 1 hour each time and be led by the same instructors who lead the Dance Group, to control for effects of personality of the group leader. |
| FG003 | No Contact | A No Contact condition captures the condition of no added social contact and no added dance movement. Participants randomized to the No Contact condition will be asked to continue their current disease management and lifestyle for 12 weeks No Contact: The condition of not receiving an intervention can have ethical implications and reduce retention rates. Therefore, these participants will be invited to join in a weekly community improvisational dance class after they complete the study, for as many sessions as they would like. |
| FG004 | Never Randomized | Subject dyads who signed consent but withdrew prior to randomization. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Baseline Analysis population included only the PWD portion of the dyad. No data for baseline analysis for caregivers was collected so it is not represented in this section.
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| ID | Title | Description |
|---|---|---|
| BG000 | Dance Group | The Dance Group will participate in 1-hour group improvisational dance lessons 2x/week for 12 weeks. Improvisational dance classes are grounded in 4 principles that shape the tone of the class and result in a sense of social belonging: non-judgment, non-competitiveness, curiosity, and playfulness. The following training strategies are used to maintain: active imagination, variability, and pacing. Dance Group: Active imagination refers to working with imagery and is crucial in improvisatory practice. Verbal auditory cues are used to create movement scenarios that cue or activate the motor imagination. Variability means the improvisational method does not aim to learn a specific movement pattern and habituate to it. Cues are delivered quickly, one after another. Within an average of two minutes, tasks requiring quicker decision-making are introduced. Pacing is the rate at which new movement prompts are presented. Quick changes in pace avoid defaulting to habitual responses, thereby facilitating new movement options. Participants cannot rely on copying another, memory, or anticipation to address the motor problem. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Quality of Life in Alzheimer's Disease (QOL-AD)--Participants With Dementia (PWD) | Self-reported quality of life in the person with dementia is the primary outcome and will be measured using the QOL-AD . The QOL-AD is validated for use in people with Mini Mental State Exam scores as low as 10.The QOL_AD contains 13 items.Points are assigned to each item as follows: poor = 1, fair = 2, good = 3, excellent = 4.The total score is the sum of all 13 item (range 13- 52) higher scores represent better outcomes. | Results at baseline for this outcome represent all PWD who were randomized. | Posted | Mean | Standard Deviation | score on a scale | Baseline |
|
Baseline through Week 12
Persons with dementia (PWDs) and caregivers make up participant dyads for this study. The National Institutes for Health (NIH) requires adverse events to be collected on both participants within the dyad, so AEs for both are reported here.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Dance Group--PWD | The Dance Group will participate in 1-hour group improvisational dance lessons 2x/week for 12 weeks. Improvisational dance classes are grounded in 4 principles that shape the tone of the class and result in a sense of social belonging: non-judgment, non-competitiveness, curiosity, and playfulness. The following training strategies are used to maintain: active imagination, variability, and pacing. Dance Group: Active imagination refers to working with imagery and is crucial in improvisatory practice. Verbal auditory cues are used to create movement scenarios that cue or activate the motor imagination. Variability means the improvisational method does not aim to learn a specific movement pattern and habituate to it. Cues are delivered quickly, one after another. Within an average of two minutes, tasks requiring quicker decision-making are introduced. Pacing is the rate at which new movement prompts are presented. Quick changes in pace avoid defaulting to habitual responses, thereby facilitating new movement options. Participants cannot rely on copying another, memory, or anticipation to address the motor problem. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Heart attack | Cardiac disorders | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Sprained foot after fall (unrelated to study) | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Christina Hugenschmidt, PhD | Wake Forest University School of Medicine | 336-713-8116 | chugensc@wakehealth.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Nov 18, 2020 | May 26, 2022 | Prot_SAP_003.pdf |
| ICF | No | No | Yes | Informed Consent Form | Jan 4, 2021 | Sep 23, 2021 | ICF_002.pdf |
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| ID | Term |
|---|---|
| D000544 | Alzheimer Disease |
| D003704 | Dementia |
| D060825 | Cognitive Dysfunction |
| D008569 | Memory Disorders |
| ID | Term |
|---|---|
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D024801 | Tauopathies |
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| ID | Term |
|---|---|
| D000092882 | Social Group |
| ID | Term |
|---|---|
| D009938 | Organizations |
| D004472 | Health Care Economics and Organizations |
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Randomized controlled trial. Investigators will use a 2x2 factorial design to test the separate and combined effects of social engagement and dance movement on QoL in 120 community-dwelling older adults adjudicated as having mild cognitive impairment (MCI) or early-stage dementia of the presumed AD or mixed AD/vascular type. Participants will be randomized to one of four 12-week interventions: 1) Dance Group 2) Non-group Dance, 3) Social Group, or 4) No Contact Control.
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All study assessments will be conducted by experienced staff certified annually on the proper conduct of study assessments and blinded to group assignment.
|
| No Contact | Sham Comparator | A No Contact condition captures the condition of no added social contact and no added dance movement. Participants randomized to the No Contact condition will be asked to continue their current disease management and lifestyle for 12 weeks |
|
|
| Non-Group Dance | Behavioral | The caregiver will be asked to stay in the area while the subject is dancing. A video camera will be affixed in an upper corner of the room to record individual dance sessions. This recording will yield data that a trained student or staff member can view and code to document movement fidelity (e.g., that the person has responded to the dance prompts and for the purpose of comparing the amount of quality of movements that occur in individual vs. group dance settings). For the first two sessions, study staff would observe the full dance session from outside the room to be sure that instruction was clear and adherence was attained, and that no safety issues arise. |
|
| Social Group | Behavioral | The social group will consist of improvisational party games to foster curiosity and playfulness, use imagery, and encourage non-judgment. Games that may be used include 'Balderdash', 'Wise and Otherwise', 'Charades', 'Pictionary', and 'Tell Me A Story' cards. These games will also use the same core strategies as the dance group. Games will be varied within an hour-long session to incorporate pacing and variability into the social group, akin to the dance group. The social group will occur 2x/week for 1 hour each time and be led by the same instructors who lead the Dance Group, to control for effects of personality of the group leader. |
|
| No Contact | Behavioral | The condition of not receiving an intervention can have ethical implications and reduce retention rates. Therefore, these participants will be invited to join in a weekly community improvisational dance class after they complete the study, for as many sessions as they would like. |
|
This is a brain imaging variable derived from fMRI images. Modularity (Q) ranges from 0 (no community structure) to 1 (perfectly modular network). One Q-value is generated for each person and group averages are shown. |
| Week 12 |
| Global Efficiency (eGlob)--PWD | This is a brain imaging variable derived from fMRI images.Scale ranges from 0 (no long-range information processing) to 1 (maximal distributed processing). Decreased Eglob has been associated with aging, cognitive impairment, and depression. | Baseline |
| Global Efficiency (eGlob)--PWD | This is a brain imaging variable derived from fMRI images.Scale ranges from 0 (no long-range information processing) to 1 (maximal distributed processing). Decreased Eglob has been associated with aging, cognitive impairment, and depression. | Week 12 |
| Local Efficiency (eLoc)--PWD | Scale ranges from 0 (no local connectivity) to 1 (maximal local connectivity - all connections are local) and has been observed to change with cognitive impairment and depression. | Baseline |
| Local Efficiency (eLoc)--PWD | Scale ranges from 0 (no local connectivity) to 1 (maximal local connectivity - all connections are local) and has been observed to change with cognitive impairment and depression. | Week 12 |
| Path Length--PWD | Refers to the number of edges that must be crossed to get from one node to another. Longer path length in people with AD has been associated with slower cognitive performance, beta amyloid deposition, and depression. | Baseline |
| Path Length--PWD | Refers to the number of edges that must be crossed to get from one node to another. Longer path length in people with AD has been associated with slower cognitive performance, beta amyloid deposition, and depression. | Week 12 |
| Fullerton Advanced Balance Scale (Overall Balance) PWD | Fullerton Advanced Balance Scale (FAB) measures balance using 10 different performance-based tests (scored 0 worst - 4 best), including; standing with feet together and eyes closed, standing on a foam pad with eyes closed, walking while turning the head from side to side rhythmically, functional standing reach, turning around to the left and right, stepping up and over a 6-inch box, standing on one leg, and a test for postural reaction. The scale goes from 0-40 with 40 being the best outcome and a cutoff of <=25 for risk of falls. | Baseline |
| Fullerton Advanced Balance Scale (Overall Balance) PWD | Fullerton Advanced Balance Scale (FAB) measures balance using 10 different performance-based tests (scored 0 worst - 4 best), including; standing with feet together and eyes closed, standing on a foam pad with eyes closed, walking while turning the head from side to side rhythmically, functional standing reach, turning around to the left and right, stepping up and over a 6-inch box, standing on one leg, and a test for postural reaction. The scale goes from 0-40 with 40 being the best outcome and a cutoff of <=25 for risk of falls. | Week 12 |
| Falls Efficacy Scale - International (FES) PWD | A 16-item scale to assess fear of falling where higher scores reflect a higher fear and risk of falling. Out of a total score of 100, a score of 70 or above indicates the individual has a fear of falling. | Baseline |
| Falls Efficacy Scale - International (FES) PWD | A 16-item scale to assess fear of falling where higher scores reflect a higher fear and risk of falling. Out of a total score of 100, a score of 70 or above indicates the individual has a fear of falling. | Week 12 |
| Neuropsychiatric Inventory Questionnaire (NPI-Q) | The NPI is a reliable and valid structured interview designed to assess neuropsychiatric symptoms in person with dementia through a structured interview with the caregiver. The NPI includes questions about 12 domains of symptoms: delusions, hallucinations, agitation/aggression, depression, anxiety, elation/ euphoria, apathy, disinhibition, irritability, aberrant motor activity, sleep, and eating. For each, symptom severity is scored on a scale of 0-4, with 4 being the worst outcome and caregiver distress is scored on a scale from 0-5, with 5 being the worst outcome. The sum of all 12 domains is calculated. Severity scores are reported here with a range from 0-36 with a higher score reflecting greater symptom severity. | Baseline |
| NPI-Q | The NPI is a reliable and valid structured interview designed to assess neuropsychiatric symptoms in person with dementia through a structured interview with the caregiver. The NPI includes questions about 12 domains of symptoms: delusions, hallucinations, agitation/aggression, depression, anxiety, elation/ euphoria, apathy, disinhibition, irritability, aberrant motor activity, sleep, and eating. For each, symptom severity is scored on a scale of 0-4, with 4 being the worst outcome and caregiver distress is scored on a scale from 0-5, with 5 being the worst outcome. The sum of all 12 domains is calculated. Severity scores are reported here with a range from 0-36 with a higher score reflecting greater symptom severity. | Week 12 |
| Geriatric Depression Scale | The person with dementia will be asked to complete a screening tool for assessing depression. This test has 15 yes/no questions with a yes receiving 1 point for a depressive answer. A total score is calculated and will be on a scale from 0-15 with 0-4 indicating no depression, 5-10 suggestive of a mild depression, and 11+ suggestive of severe depression. | Baseline |
| Geriatric Depression Scale | The person with dementia will be asked to complete a screening tool for assessing depression. This test has 15 yes/no questions with a yes receiving 1 point for a depressive answer. A total score is calculated and will be on a scale from 0-15 with 0-4 indicating no depression, 5-10 suggestive of a mild depression, and 11+ suggestive of severe depression. | Week 12 |
| Geriatric Anxiety Scale | The Geriatric Anxiety Scale measures symptoms of anxiety in older adults. A single total score ranges from 0 (low anxiety) to 63 (high anxiety). Four cutoff scores have been provided by authors in the manuals: 0-7 (normal anxiety), 8-15 (mild-moderate anxiety), 16-25 (moderate-severe anxiety), and 26-63 (severe anxiety). | Baseline |
| Geriatric Anxiety Scale | The Geriatric Anxiety Scale measures symptoms of anxiety in older adults. A single total score ranges from 0 (low anxiety) to 63 (high anxiety). Four cutoff scores have been provided by authors in the manuals: 0-7 (normal anxiety), 8-15 (mild-moderate anxiety), 16-25 (moderate-severe anxiety), and 26-63 (severe anxiety). | Week 12 |
| Apathy Evaluation Scale--PWD | The Apathy Evaluation Scale (AES) addresses characteristics of goal directed behavior that reflect apathy including behavioral, cognitive, and emotional indicators. A short form will be used that has been modified for use with people with dementia. This shortened version has 10 questions scored 1-4 with 4 being the positive outcome answer. The total score is calculated and on a scale of 10-40 with lower scores reflecting less apathy and thus a better outcome. | Baseline |
| Apathy Evaluation Scale--PWD | The Apathy Evaluation Scale (AES) addresses characteristics of goal directed behavior that reflect apathy including behavioral, cognitive, and emotional indicators. A short form will be used that has been modified for use with people with dementia. This shortened version has 10 questions scored 1-4 with 4 being the positive outcome answer. The total score is calculated and on a scale of 10-40 with lower scores reflecting less apathy and thus a better outcome. | Week 12 |
| Expanded Short Physical Performance Battery (eSPPB) | The eSPPB is a brief test of global mobility function with excellent test-retest and inter-examiner reliability; is sensitive to change; is safe, and is a robust predictor of future physical disability and death. To avoid ceiling effects, investigators will use an expanded version (eSPPB) that increases the difficulty of the standing balance task by asking participants to hold postures for 30 instead of 10 seconds, adds a one-leg stand, and adds a narrow walk. The resulting score is normally distributed, continuous, and shows greater sensitivity to change. Dementia patients have lower scores on the SPPB so a favorable outcome for this outcome measure would be a significantly higher score post treatment. The eSPPB is scored as a continuous measure with a minimum score of 0 and a maximum score of 3.0 where 3 is the best possible outcome. | Baseline |
| Expanded Short Physical Performance Battery (eSPPB) | The eSPPB is a brief test of global mobility function with excellent test-retest and inter-examiner reliability; is sensitive to change; is safe, and is a robust predictor of future physical disability and death. To avoid ceiling effects, investigators will use an expanded version (eSPPB) that increases the difficulty of the standing balance task by asking participants to hold postures for 30 instead of 10 seconds, adds a one-leg stand, and adds a narrow walk. The resulting score is normally distributed, continuous, and shows greater sensitivity to change. Dementia patients have lower scores on the SPPB so a favorable outcome for this outcome measure would be a significantly higher score post treatment. The eSPPB is scored as a continuous measure with a minimum score of 0 and a maximum score of 3.0 where 3 is the best possible outcome. | Week 12 |
| Postural Sway--PWD | Center of pressure displacement (area of the 95% confidence ellipse) using an AccuSway forceplate. Center of pressure displacement is one way to characterize postural sway. Increased postural sway is correlated with decreased balance in older adults and increased fall risk. Center of pressure displacement was measured using the area of the 95% confidence ellipse using an AccuSway forceplate. Higher numbers indicate greater levels of postural sway. | Baseline |
| Postural Sway--PWD | Center of pressure displacement (area of the 95% confidence ellipse) using an AccuSway forceplate. Center of pressure displacement is one way to characterize postural sway. Increased postural sway is correlated with decreased balance in older adults and increased fall risk. Center of pressure displacement was measured using the area of the 95% confidence ellipse using an AccuSway forceplate. Higher numbers indicate greater levels of postural sway. | Week 12 |
| Gait Speed--PWD | The time one takes to walk a specified distance on level surfaces over a short distance. 4m usual gait speed was measured as part of the eSPPB. | Baseline |
| Gait Speed--PWD | The time one takes to walk a specified distance on level surfaces over a short distance. 4m usual gait speed was measured as part of the eSPPB. | Week 12 |
| Gait Variability--PWD | Stride time variability, which is calculated out of the mean and standard deviation of stride time, reflects the change in time elapsed between the first two contacts of two consecutive footfalls of the same foot over a number of gait cycles. Increased gait variability is associated with increased fall risk in older adults. | Baseline |
| Gait Variability--PWD | Stride time variability, which is calculated out of the mean and standard deviation of stride time, reflects the change in time elapsed between the first two contacts of two consecutive footfalls of the same foot over a number of gait cycles. Increased gait variability is associated with increased fall risk in older adults. | Week 12 |
| Baseline, Week12 |
| Neuroticism-Extraversion-Openness Five-Factor Inventory (NEO-FFI) | A measure of five domains of personality (neuroticism, extraversion, openness, agreeableness, and conscientiousness). A higher score on any scale indicates stronger presence of that trait. PWD only | Baseline |
| White Matter Lesion Burden | The volume of white matter lesions is calculated using the Lesion Segmentation Toolbox. PWD only. | Baseline, Week 12 |
| Blood-based Stress Biomarkers (Covariate or Alternative Hypothesis) | Social engagement may change biomarkers of stress relevant for interpreting outcomes. These stress biomarkers include cortisol and allostatic load, a composite measure of blood-based biomarkers associated with chronically elevated stress. PWD only | Baseline, Week 12 |
| Caregiver Quality of Life With the 36-item Short-Form Health (SF-36)--Covariate or Alternative Hypothesis | The SF-36 consists of 36 questions assessing physical functioning, role functioning difficulties caused by physical problems, bodily pain, general health, vitality, social functioning, role functioning difficulties caused by emotional problems, and mental health. High scores are representative of a great health status and better outcomes, while low scores are representative of a poor health status. | Baseline, Week 12 |
| Caregiver Burden With Zarit Caregiver Burden Scale--Covariate or Alternative Hypothesis | The Zarit Caregiver Burden Scale is administered in interview form to the caregiver. It consists of 22 questions scored 0-4 with 0=Never, 1=Rarely, 2=Sometimes, 3=Quite Frequently, 4=Nearly Always. The total score range is 0-88 with 88 being the worst possible outcome. 0-20 represents little or no burden on the caregiver, 21-40 represents mild to moderate burden, 41-60 represents moderate to severe burden, and 61-88 represents severe burden. | Baseline, Week 12 |
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| 18187399 | Background | Cardaciotto L, Herbert JD, Forman EM, Moitra E, Farrow V. The assessment of present-moment awareness and acceptance: the Philadelphia Mindfulness Scale. Assessment. 2008 Jun;15(2):204-23. doi: 10.1177/1073191107311467. Epub 2008 Jan 9. |
| 20725636 | Background | Kattenstroth JC, Kolankowska I, Kalisch T, Dinse HR. Superior sensory, motor, and cognitive performance in elderly individuals with multi-year dancing activities. Front Aging Neurosci. 2010 Jul 21;2:31. doi: 10.3389/fnagi.2010.00031. eCollection 2010. |
| 23447455 | Background | Kattenstroth JC, Kalisch T, Holt S, Tegenthoff M, Dinse HR. Six months of dance intervention enhances postural, sensorimotor, and cognitive performance in elderly without affecting cardio-respiratory functions. Front Aging Neurosci. 2013 Feb 26;5:5. doi: 10.3389/fnagi.2013.00005. eCollection 2013. |
| Background | Kattenstroth, J.C., et al., Dance Therapy for Cognitive Enhancement in the Elderly. Journal of Psychophysiology, 2011. 25: p. 17-17. |
| Background | Bollen, K.A., Structural equations with latent variables. 1989, Hoboken, NJ: Wiley. |
| 24201821 | Background | Bizik G, Picard M, Nijjar R, Tourjman V, McEwen BS, Lupien SJ, Juster RP. Allostatic load as a tool for monitoring physiological dysregulations and comorbidities in patients with severe mental illnesses. Harv Rev Psychiatry. 2013 Nov-Dec;21(6):296-313. doi: 10.1097/HRP.0000000000000012. |
| 23045648 | Background | McEwen BS. Brain on stress: how the social environment gets under the skin. Proc Natl Acad Sci U S A. 2012 Oct 16;109 Suppl 2(Suppl 2):17180-5. doi: 10.1073/pnas.1121254109. Epub 2012 Oct 8. |
| 8379800 | Background | McEwen BS, Stellar E. Stress and the individual. Mechanisms leading to disease. Arch Intern Med. 1993 Sep 27;153(18):2093-101. |
| 18525292 | Background | Wahbeh H, Kishiyama SS, Zajdel D, Oken BS. Salivary cortisol awakening response in mild Alzheimer disease, caregivers, and noncaregivers. Alzheimer Dis Assoc Disord. 2008 Apr-Jun;22(2):181-3. doi: 10.1097/WAD.0b013e31815a9dff. |
| 15939974 | Background | de Vugt ME, Nicolson NA, Aalten P, Lousberg R, Jolle J, Verhey FR. Behavioral problems in dementia patients and salivary cortisol patterns in caregivers. J Neuropsychiatry Clin Neurosci. 2005 Spring;17(2):201-7. doi: 10.1176/jnp.17.2.201. |
| 23690846 | Background | Danucalov MA, Kozasa EH, Ribas KT, Galduroz JC, Garcia MC, Verreschi IT, Oliveira KC, Romani de Oliveira L, Leite JR. A yoga and compassion meditation program reduces stress in familial caregivers of Alzheimer's disease patients. Evid Based Complement Alternat Med. 2013;2013:513149. doi: 10.1155/2013/513149. Epub 2013 Apr 18. |
| 24051140 | Background | Ornish D, Lin J, Chan JM, Epel E, Kemp C, Weidner G, Marlin R, Frenda SJ, Magbanua MJM, Daubenmier J, Estay I, Hills NK, Chainani-Wu N, Carroll PR, Blackburn EH. Effect of comprehensive lifestyle changes on telomerase activity and telomere length in men with biopsy-proven low-risk prostate cancer: 5-year follow-up of a descriptive pilot study. Lancet Oncol. 2013 Oct;14(11):1112-1120. doi: 10.1016/S1470-2045(13)70366-8. Epub 2013 Sep 17. |
| 7203086 | Background | Zarit SH, Reever KE, Bach-Peterson J. Relatives of the impaired elderly: correlates of feelings of burden. Gerontologist. 1980 Dec;20(6):649-55. doi: 10.1093/geront/20.6.649. No abstract available. |
| 35098120 | Derived | Thumuluri D, Lyday R, Babcock P, Ip EH, Kraft RA, Laurienti PJ, Barnstaple R, Soriano CT, Hugenschmidt CE. Improvisational Movement to Improve Quality of Life in Older Adults With Early-Stage Dementia: A Pilot Study. Front Sports Act Living. 2022 Jan 14;3:796101. doi: 10.3389/fspor.2021.796101. eCollection 2021. |
| Caregiver withdrew |
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| Withdrawal by Subject |
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| COVID interrupted enrollment--had to rescreen and didn't qualify |
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| BG001 | Non-group Dance | The Non-group dance intervention is designed to capture the same dance movement and auditory stimuli as the group class without social interaction. Recordings of the dance instructor teaching a dance class will be played. This will ensure participants hear comparable music and receive comparable verbal auditory cues to prompt dance movements that students in the group class will hear, without interacting with other people. Improvisational dance is particularly suited for this means of delivery because the primary method of instruction is verbal auditory cueing. Participants will be asked to follow the same schedule as participants in the Dance Group arm and complete 2 one-hour dance sessions each week. Non-Group Dance: The caregiver will be asked to stay in the area while the subject is dancing. A video camera will be affixed in an upper corner of the room to record individual dance sessions. This recording will yield data that a trained student or staff member can view and code to document movement fidelity (e.g., that the person has responded to the dance prompts and for the purpose of comparing the amount of quality of movements that occur in individual vs. group dance settings). For the first two sessions, study staff would observe the full dance session from outside the room to be sure that instruction was clear and adherence was attained, and that no safety issues arise. |
| BG002 | Social Group | The social group will consist of improvisational party games to foster curiosity and playfulness, use imagery, and encourage non-judgment. Games that may be used include 'Balderdash', 'Wise and Otherwise', 'Charades', 'Pictionary', and 'Tell Me A Story' cards. These games will also use the same core strategies as the dance group. Games will be varied within an hour-long session to incorporate pacing and variability into the social group, akin to the dance group. The social group will occur 2x/week for 1 hour each time and be led by the same instructors who lead the Dance Group, to control for effects of personality of the group leader. Social Group: The social group will consist of improvisational party games to foster curiosity and playfulness, use imagery, and encourage non-judgment. Games that may be used include 'Balderdash', 'Wise and Otherwise', 'Charades', 'Pictionary', and 'Tell Me A Story' cards. These games will also use the same core strategies as the dance group. Games will be varied within an hour-long session to incorporate pacing and variability into the social group, akin to the dance group. The social group will occur 2x/week for 1 hour each time and be led by the same instructors who lead the Dance Group, to control for effects of personality of the group leader. |
| BG003 | No Contact | A No Contact condition captures the condition of no added social contact and no added dance movement. Participants randomized to the No Contact condition will be asked to continue their current disease management and lifestyle for 12 weeks No Contact: The condition of not receiving an intervention can have ethical implications and reduce retention rates. Therefore, these participants will be invited to join in a weekly community improvisational dance class after they complete the study, for as many sessions as they would like. |
| BG004 | Never Randomized | Subject dyads who signed consent but withdrew prior to randomization. |
| BG005 | Total | Total of all reporting groups |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| OG001 | Non-group Dance | The Non-group dance intervention is designed to capture the same dance movement and auditory stimuli as the group class without social interaction. Recordings of the dance instructor teaching a dance class will be played. This will ensure participants hear comparable music and receive comparable verbal auditory cues to prompt dance movements that students in the group class will hear, without interacting with other people. Improvisational dance is particularly suited for this means of delivery because the primary method of instruction is verbal auditory cueing. Participants will be asked to follow the same schedule as participants in the Dance Group arm and complete 2 one-hour dance sessions each week. Non-Group Dance: The caregiver will be asked to stay in the area while the subject is dancing. A video camera will be affixed in an upper corner of the room to record individual dance sessions. This recording will yield data that a trained student or staff member can view and code to document movement fidelity (e.g., that the person has responded to the dance prompts and for the purpose of comparing the amount of quality of movements that occur in individual vs. group dance settings). For the first two sessions, study staff would observe the full dance session from outside the room to be sure that instruction was clear and adherence was attained, and that no safety issues arise. |
| OG002 | Social Group | The social group will consist of improvisational party games to foster curiosity and playfulness, use imagery, and encourage non-judgment. Games that may be used include 'Balderdash', 'Wise and Otherwise', 'Charades', 'Pictionary', and 'Tell Me A Story' cards. These games will also use the same core strategies as the dance group. Games will be varied within an hour-long session to incorporate pacing and variability into the social group, akin to the dance group. The social group will occur 2x/week for 1 hour each time and be led by the same instructors who lead the Dance Group, to control for effects of personality of the group leader. Social Group: The social group will consist of improvisational party games to foster curiosity and playfulness, use imagery, and encourage non-judgment. Games that may be used include 'Balderdash', 'Wise and Otherwise', 'Charades', 'Pictionary', and 'Tell Me A Story' cards. These games will also use the same core strategies as the dance group. Games will be varied within an hour-long session to incorporate pacing and variability into the social group, akin to the dance group. The social group will occur 2x/week for 1 hour each time and be led by the same instructors who lead the Dance Group, to control for effects of personality of the group leader. |
| OG003 | No Contact | A No Contact condition captures the condition of no added social contact and no added dance movement. Participants randomized to the No Contact condition will be asked to continue their current disease management and lifestyle for 12 weeks No Contact: The condition of not receiving an intervention can have ethical implications and reduce retention rates. Therefore, these participants will be invited to join in a weekly community improvisational dance class after they complete the study, for as many sessions as they would like. |
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| Primary | QOL-AD--PWD | Self-reported quality of life in the person with dementia is the primary outcome and will be measured using the QOL-AD . The QOL-AD is validated for use in people with Mini Mental State Exam scores as low as 10.The QOL_AD contains 13 items.Points are assigned to each item as follows: poor = 1, fair = 2, good = 3, excellent = 4.The total score is the sum of all 13 item (range 13- 52) higher scores represent better outcomes. | Overall number of participants analyzed corresponds to the number of participants who completed the study. | Posted | Mean | Standard Deviation | score on a scale | Week 12 |
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| Secondary | Community Structure--PWD | This is a brain imaging variable derived from fMRI images. Modularity (Q) ranges from 0 (no community structure) to 1 (perfectly modular network). One Q-value is generated for each person and group averages are shown. | Participants are missing at baseline imaging data due to an undisclosed contraindicated device, aborting scan, refusing scans, or excessive head motion. | Posted | Mean | Standard Deviation | Q-Value | Baseline |
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| Secondary | Community Structure--PWD | This is a brain imaging variable derived from fMRI images. Modularity (Q) ranges from 0 (no community structure) to 1 (perfectly modular network). One Q-value is generated for each person and group averages are shown. | Numbers at baseline and week 12 differ due to withdrawals, poor data quality, and inability to complete scans. | Posted | Mean | Standard Deviation | Q-Value | Week 12 |
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| Secondary | Global Efficiency (eGlob)--PWD | This is a brain imaging variable derived from fMRI images.Scale ranges from 0 (no long-range information processing) to 1 (maximal distributed processing). Decreased Eglob has been associated with aging, cognitive impairment, and depression. | Participants are missing at baseline imaging data due to an undisclosed contraindicated device, aborting scan, refusing scans, or excessive head motion. | Posted | Mean | Standard Deviation | score on a scale | Baseline |
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| Secondary | Global Efficiency (eGlob)--PWD | This is a brain imaging variable derived from fMRI images.Scale ranges from 0 (no long-range information processing) to 1 (maximal distributed processing). Decreased Eglob has been associated with aging, cognitive impairment, and depression. | Number at baseline and follow-up differ due to withdrawals, poor data quality, participant refusal of procedure, inability to complete scan. | Posted | Mean | Standard Deviation | score on a scale | Week 12 |
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| Secondary | Local Efficiency (eLoc)--PWD | Scale ranges from 0 (no local connectivity) to 1 (maximal local connectivity - all connections are local) and has been observed to change with cognitive impairment and depression. | Participants are missing at baseline imaging data due to an undisclosed contraindicated device, aborting scan, refusing scans, or excessive head motion. | Posted | Mean | Standard Deviation | units on a scale | Baseline |
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| Secondary | Local Efficiency (eLoc)--PWD | Scale ranges from 0 (no local connectivity) to 1 (maximal local connectivity - all connections are local) and has been observed to change with cognitive impairment and depression. | Number at baseline and follow-up differ due to withdrawals, poor data quality, participant refusal of procedure, inability to complete scan. | Posted | Mean | Standard Deviation | units on a scale | Week 12 |
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| Secondary | Path Length--PWD | Refers to the number of edges that must be crossed to get from one node to another. Longer path length in people with AD has been associated with slower cognitive performance, beta amyloid deposition, and depression. | Participants are missing at baseline imaging data due to an undisclosed contraindicated device, aborting scan, refusing scans, or excessive head motion. | Posted | Mean | Standard Deviation | Number of Edges | Baseline |
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| Secondary | Path Length--PWD | Refers to the number of edges that must be crossed to get from one node to another. Longer path length in people with AD has been associated with slower cognitive performance, beta amyloid deposition, and depression. | Number at baseline and follow-up differ due to withdrawals, poor data quality, participant refusal of procedure, inability to complete scan. | Posted | Mean | Standard Deviation | Number of Edges | Week 12 |
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| Secondary | Fullerton Advanced Balance Scale (Overall Balance) PWD | Fullerton Advanced Balance Scale (FAB) measures balance using 10 different performance-based tests (scored 0 worst - 4 best), including; standing with feet together and eyes closed, standing on a foam pad with eyes closed, walking while turning the head from side to side rhythmically, functional standing reach, turning around to the left and right, stepping up and over a 6-inch box, standing on one leg, and a test for postural reaction. The scale goes from 0-40 with 40 being the best outcome and a cutoff of <=25 for risk of falls. | One participant is missing baseline data due to a recording error during data collection. | Posted | Mean | Standard Deviation | score on a scale | Baseline |
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| Secondary | Fullerton Advanced Balance Scale (Overall Balance) PWD | Fullerton Advanced Balance Scale (FAB) measures balance using 10 different performance-based tests (scored 0 worst - 4 best), including; standing with feet together and eyes closed, standing on a foam pad with eyes closed, walking while turning the head from side to side rhythmically, functional standing reach, turning around to the left and right, stepping up and over a 6-inch box, standing on one leg, and a test for postural reaction. The scale goes from 0-40 with 40 being the best outcome and a cutoff of <=25 for risk of falls. | Number at baseline and week 12 differ due to withdrawals. | Posted | Mean | Standard Deviation | score on a scale | Week 12 |
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| Secondary | Falls Efficacy Scale - International (FES) PWD | A 16-item scale to assess fear of falling where higher scores reflect a higher fear and risk of falling. Out of a total score of 100, a score of 70 or above indicates the individual has a fear of falling. | Posted | Mean | Standard Deviation | score on a scale | Baseline |
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| Secondary | Falls Efficacy Scale - International (FES) PWD | A 16-item scale to assess fear of falling where higher scores reflect a higher fear and risk of falling. Out of a total score of 100, a score of 70 or above indicates the individual has a fear of falling. | Overall number of participants analyzed corresponds to the number of participants who completed the study. | Posted | Mean | Standard Deviation | score on a scale | Week 12 |
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| Secondary | Neuropsychiatric Inventory Questionnaire (NPI-Q) | The NPI is a reliable and valid structured interview designed to assess neuropsychiatric symptoms in person with dementia through a structured interview with the caregiver. The NPI includes questions about 12 domains of symptoms: delusions, hallucinations, agitation/aggression, depression, anxiety, elation/ euphoria, apathy, disinhibition, irritability, aberrant motor activity, sleep, and eating. For each, symptom severity is scored on a scale of 0-4, with 4 being the worst outcome and caregiver distress is scored on a scale from 0-5, with 5 being the worst outcome. The sum of all 12 domains is calculated. Severity scores are reported here with a range from 0-36 with a higher score reflecting greater symptom severity. | Posted | Mean | Standard Deviation | score on a scale | Baseline |
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| Secondary | NPI-Q | The NPI is a reliable and valid structured interview designed to assess neuropsychiatric symptoms in person with dementia through a structured interview with the caregiver. The NPI includes questions about 12 domains of symptoms: delusions, hallucinations, agitation/aggression, depression, anxiety, elation/ euphoria, apathy, disinhibition, irritability, aberrant motor activity, sleep, and eating. For each, symptom severity is scored on a scale of 0-4, with 4 being the worst outcome and caregiver distress is scored on a scale from 0-5, with 5 being the worst outcome. The sum of all 12 domains is calculated. Severity scores are reported here with a range from 0-36 with a higher score reflecting greater symptom severity. | Number at baseline and follow-up differ due to withdrawals and due to staff error during data collection. | Posted | Mean | Standard Deviation | score on a scale | Week 12 |
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| Secondary | Geriatric Depression Scale | The person with dementia will be asked to complete a screening tool for assessing depression. This test has 15 yes/no questions with a yes receiving 1 point for a depressive answer. A total score is calculated and will be on a scale from 0-15 with 0-4 indicating no depression, 5-10 suggestive of a mild depression, and 11+ suggestive of severe depression. | Results at baseline for this outcome represent all PWD who were randomized. | Posted | Mean | Standard Deviation | score on a scale | Baseline |
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| Secondary | Geriatric Depression Scale | The person with dementia will be asked to complete a screening tool for assessing depression. This test has 15 yes/no questions with a yes receiving 1 point for a depressive answer. A total score is calculated and will be on a scale from 0-15 with 0-4 indicating no depression, 5-10 suggestive of a mild depression, and 11+ suggestive of severe depression. | Overall number of participants analyzed corresponds to the number of participants who completed the study. | Posted | Mean | Standard Deviation | score on a scale | Week 12 |
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| Secondary | Geriatric Anxiety Scale | The Geriatric Anxiety Scale measures symptoms of anxiety in older adults. A single total score ranges from 0 (low anxiety) to 63 (high anxiety). Four cutoff scores have been provided by authors in the manuals: 0-7 (normal anxiety), 8-15 (mild-moderate anxiety), 16-25 (moderate-severe anxiety), and 26-63 (severe anxiety). | Results at baseline for this outcome represent all PWD who were randomized. | Posted | Mean | Standard Deviation | score on a scale | Baseline |
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| Secondary | Geriatric Anxiety Scale | The Geriatric Anxiety Scale measures symptoms of anxiety in older adults. A single total score ranges from 0 (low anxiety) to 63 (high anxiety). Four cutoff scores have been provided by authors in the manuals: 0-7 (normal anxiety), 8-15 (mild-moderate anxiety), 16-25 (moderate-severe anxiety), and 26-63 (severe anxiety). | Overall number of participants analyzed corresponds to the number of participants who completed the study. | Posted | Mean | Standard Deviation | score on a scale | Week 12 |
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| Secondary | Apathy Evaluation Scale--PWD | The Apathy Evaluation Scale (AES) addresses characteristics of goal directed behavior that reflect apathy including behavioral, cognitive, and emotional indicators. A short form will be used that has been modified for use with people with dementia. This shortened version has 10 questions scored 1-4 with 4 being the positive outcome answer. The total score is calculated and on a scale of 10-40 with lower scores reflecting less apathy and thus a better outcome. | Results at baseline for this outcome represent all PWD who were randomized. | Posted | Mean | Standard Deviation | score on a scale | Baseline |
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| Secondary | Apathy Evaluation Scale--PWD | The Apathy Evaluation Scale (AES) addresses characteristics of goal directed behavior that reflect apathy including behavioral, cognitive, and emotional indicators. A short form will be used that has been modified for use with people with dementia. This shortened version has 10 questions scored 1-4 with 4 being the positive outcome answer. The total score is calculated and on a scale of 10-40 with lower scores reflecting less apathy and thus a better outcome. | One participant is missing follow-up data due to a recording error during data collection. | Posted | Mean | Standard Deviation | score on a scale | Week 12 |
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| Secondary | Expanded Short Physical Performance Battery (eSPPB) | The eSPPB is a brief test of global mobility function with excellent test-retest and inter-examiner reliability; is sensitive to change; is safe, and is a robust predictor of future physical disability and death. To avoid ceiling effects, investigators will use an expanded version (eSPPB) that increases the difficulty of the standing balance task by asking participants to hold postures for 30 instead of 10 seconds, adds a one-leg stand, and adds a narrow walk. The resulting score is normally distributed, continuous, and shows greater sensitivity to change. Dementia patients have lower scores on the SPPB so a favorable outcome for this outcome measure would be a significantly higher score post treatment. The eSPPB is scored as a continuous measure with a minimum score of 0 and a maximum score of 3.0 where 3 is the best possible outcome. | Posted | Mean | Standard Deviation | score on a scale | Baseline |
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| Secondary | Expanded Short Physical Performance Battery (eSPPB) | The eSPPB is a brief test of global mobility function with excellent test-retest and inter-examiner reliability; is sensitive to change; is safe, and is a robust predictor of future physical disability and death. To avoid ceiling effects, investigators will use an expanded version (eSPPB) that increases the difficulty of the standing balance task by asking participants to hold postures for 30 instead of 10 seconds, adds a one-leg stand, and adds a narrow walk. The resulting score is normally distributed, continuous, and shows greater sensitivity to change. Dementia patients have lower scores on the SPPB so a favorable outcome for this outcome measure would be a significantly higher score post treatment. The eSPPB is scored as a continuous measure with a minimum score of 0 and a maximum score of 3.0 where 3 is the best possible outcome. | Number at baseline and follow-up differ due to withdrawals, staff error, participant unwilling to complete, and participant unable to complete test. | Posted | Mean | Standard Deviation | score on a scale | Week 12 |
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| Secondary | Postural Sway--PWD | Center of pressure displacement (area of the 95% confidence ellipse) using an AccuSway forceplate. Center of pressure displacement is one way to characterize postural sway. Increased postural sway is correlated with decreased balance in older adults and increased fall risk. Center of pressure displacement was measured using the area of the 95% confidence ellipse using an AccuSway forceplate. Higher numbers indicate greater levels of postural sway. | Number of participants analyzed at baseline differs due to technical error. | Posted | Mean | Standard Deviation | centimeter squared | Baseline |
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| Secondary | Postural Sway--PWD | Center of pressure displacement (area of the 95% confidence ellipse) using an AccuSway forceplate. Center of pressure displacement is one way to characterize postural sway. Increased postural sway is correlated with decreased balance in older adults and increased fall risk. Center of pressure displacement was measured using the area of the 95% confidence ellipse using an AccuSway forceplate. Higher numbers indicate greater levels of postural sway. | Numbers averaged at baseline and follow-up differ due to withdrawals, technical errors, safety concern, participant unwilling and participant unable to continue. | Posted | Mean | Standard Deviation | centimeter squared | Week 12 |
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| Secondary | Gait Speed--PWD | The time one takes to walk a specified distance on level surfaces over a short distance. 4m usual gait speed was measured as part of the eSPPB. | Posted | Mean | Standard Deviation | seconds | Baseline |
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| Secondary | Gait Speed--PWD | The time one takes to walk a specified distance on level surfaces over a short distance. 4m usual gait speed was measured as part of the eSPPB. | Number at baseline and follow-up differ due to withdrawals, staff error, participant unwilling to complete and participant unable to complete. | Posted | Mean | Standard Deviation | seconds | Week 12 |
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| Secondary | Gait Variability--PWD | Stride time variability, which is calculated out of the mean and standard deviation of stride time, reflects the change in time elapsed between the first two contacts of two consecutive footfalls of the same foot over a number of gait cycles. Increased gait variability is associated with increased fall risk in older adults. | Subject numbers differ due to equipment failure, subjects withdrawing, subject inability to complete task, or lost to follow up. | Posted | Mean | Standard Deviation | percentage of variability | Baseline |
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| Secondary | Gait Variability--PWD | Stride time variability, which is calculated out of the mean and standard deviation of stride time, reflects the change in time elapsed between the first two contacts of two consecutive footfalls of the same foot over a number of gait cycles. Increased gait variability is associated with increased fall risk in older adults. | Subject numbers differ due to equipment failure, technical error, subjects withdrawing, subject inability to complete task, or subject unwilling to complete task. | Posted | Mean | Standard Deviation | percentage of variability | Week 12 |
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| Other Pre-specified | Body Mass Index (BMI) | a measure of body fat based on height and weight that applies to adult men and women--PWD only | Not Posted | Baseline, Week 12 | Participants |
| Other Pre-specified | Blood Pressure | PWD only | Not Posted | Baseline, Week12 | Participants |
| Other Pre-specified | Neuroticism-Extraversion-Openness Five-Factor Inventory (NEO-FFI) | A measure of five domains of personality (neuroticism, extraversion, openness, agreeableness, and conscientiousness). A higher score on any scale indicates stronger presence of that trait. PWD only | Not Posted | Baseline | Participants |
| Other Pre-specified | White Matter Lesion Burden | The volume of white matter lesions is calculated using the Lesion Segmentation Toolbox. PWD only. | Not Posted | Baseline, Week 12 | Participants |
| Other Pre-specified | Blood-based Stress Biomarkers (Covariate or Alternative Hypothesis) | Social engagement may change biomarkers of stress relevant for interpreting outcomes. These stress biomarkers include cortisol and allostatic load, a composite measure of blood-based biomarkers associated with chronically elevated stress. PWD only | Not Posted | Baseline, Week 12 | Participants |
| Other Pre-specified | Caregiver Quality of Life With the 36-item Short-Form Health (SF-36)--Covariate or Alternative Hypothesis | The SF-36 consists of 36 questions assessing physical functioning, role functioning difficulties caused by physical problems, bodily pain, general health, vitality, social functioning, role functioning difficulties caused by emotional problems, and mental health. High scores are representative of a great health status and better outcomes, while low scores are representative of a poor health status. | Not Posted | Baseline, Week 12 | Participants |
| Other Pre-specified | Caregiver Burden With Zarit Caregiver Burden Scale--Covariate or Alternative Hypothesis | The Zarit Caregiver Burden Scale is administered in interview form to the caregiver. It consists of 22 questions scored 0-4 with 0=Never, 1=Rarely, 2=Sometimes, 3=Quite Frequently, 4=Nearly Always. The total score range is 0-88 with 88 being the worst possible outcome. 0-20 represents little or no burden on the caregiver, 21-40 represents mild to moderate burden, 41-60 represents moderate to severe burden, and 61-88 represents severe burden. | Not Posted | Baseline, Week 12 | Participants |
| 0 |
| 24 |
| 1 |
| 24 |
| 15 |
| 24 |
| EG001 | Dance Group--Caregivers | Caregivers of the PWDs in the Dance Group--these participants are part of the dyad mentioned in the participant flow. | 0 | 24 | 4 | 24 | 13 | 24 |
| EG002 | Non-group Dance--PWD | The Non-group dance intervention is designed to capture the same dance movement and auditory stimuli as the group class without social interaction. Recordings of the dance instructor teaching a dance class will be played. This will ensure participants hear comparable music and receive comparable verbal auditory cues to prompt dance movements that students in the group class will hear, without interacting with other people. Improvisational dance is particularly suited for this means of delivery because the primary method of instruction is verbal auditory cueing. Participants will be asked to follow the same schedule as participants in the Dance Group arm and complete 2 one-hour dance sessions each week. Non-Group Dance: The caregiver will be asked to stay in the area while the subject is dancing. A video camera will be affixed in an upper corner of the room to record individual dance sessions. This recording will yield data that a trained student or staff member can view and code to document movement fidelity (e.g., that the person has responded to the dance prompts and for the purpose of comparing the amount of quality of movements that occur in individual vs. group dance settings). For the first two sessions, study staff would observe the full dance session from outside the room to be sure that instruction was clear and adherence was attained, and that no safety issues arise. | 0 | 25 | 0 | 25 | 15 | 25 |
| EG003 | Non-group Dance--Caregivers | Caregivers of the Non-group Dance PWDs--these participants are part of the dyad mentioned in the participant flow. | 0 | 25 | 2 | 25 | 5 | 25 |
| EG004 | Social Group--PWD | The social group will consist of improvisational party games to foster curiosity and playfulness, use imagery, and encourage non-judgment. Games that may be used include 'Balderdash', 'Wise and Otherwise', 'Charades', 'Pictionary', and 'Tell Me A Story' cards. These games will also use the same core strategies as the dance group. Games will be varied within an hour-long session to incorporate pacing and variability into the social group, akin to the dance group. The social group will occur 2x/week for 1 hour each time and be led by the same instructors who lead the Dance Group, to control for effects of personality of the group leader. Social Group: The social group will consist of improvisational party games to foster curiosity and playfulness, use imagery, and encourage non-judgment. Games that may be used include 'Balderdash', 'Wise and Otherwise', 'Charades', 'Pictionary', and 'Tell Me A Story' cards. These games will also use the same core strategies as the dance group. Games will be varied within an hour-long session to incorporate pacing and variability into the social group, akin to the dance group. The social group will occur 2x/week for 1 hour each time and be led by the same instructors who lead the Dance Group, to control for effects of personality of the group leader. | 0 | 27 | 2 | 27 | 11 | 27 |
| EG005 | Social Group--Caregivers | Caregivers of the Social Group PWDs--these participants are part of the dyad mentioned in the participant flow. | 0 | 27 | 4 | 27 | 8 | 27 |
| EG006 | No Contact--PWD | A No Contact condition captures the condition of no added social contact and no added dance movement. Participants randomized to the No Contact condition will be asked to continue their current disease management and lifestyle for 12 weeks No Contact: The condition of not receiving an intervention can have ethical implications and reduce retention rates. Therefore, these participants will be invited to join in a weekly community improvisational dance class after they complete the study, for as many sessions as they would like. | 0 | 25 | 4 | 25 | 17 | 25 |
| EG007 | No Contact--Caregivers | Caregivers of the No Contact PWDs--these participants are part of the dyad mentioned in the participant flow. | 0 | 25 | 2 | 25 | 15 | 25 |
| EG008 | Never Randomized-- PWD | PWD who dropped out before randomization | 1 | 3 | 3 | 3 | 0 | 3 |
| EG009 | Never Randomized--Caregiver | Caregivers of the PWDs who never randomized. | 0 | 3 | 1 | 3 | 0 | 3 |
| Prostate cancer recurrence | Reproductive system and breast disorders | Systematic Assessment |
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| Elective full knee replacement | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| Acute congestive heart failure | Cardiac disorders | Systematic Assessment |
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| Elevated blood pressure | Vascular disorders | Systematic Assessment |
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| Emergency room visit for shortness of breath | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| Acute colitis | Gastrointestinal disorders | Systematic Assessment |
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| Admitted to hospital for suicidal ideation | Psychiatric disorders | Systematic Assessment |
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| New diagnosis of non-small cell lung cancer | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| Pain in hip due to sepsis | Infections and infestations | Systematic Assessment |
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| Emergency room visit due to difficulty swallowing | Gastrointestinal disorders | Systematic Assessment |
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| Fell walking across street and hit chest on sidewalk | Injury, poisoning and procedural complications | Systematic Assessment |
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| Emergency room visit for chest discomfort | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| Accidentally given dilaudid in hospital | Injury, poisoning and procedural complications | Systematic Assessment |
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| Respiratory failure due to COVID | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| Hit head falling backward getting out of bed | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| Upper gastrointestinal bleed | Gastrointestinal disorders | Systematic Assessment |
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| Numbness and lack of coordination in arm | Nervous system disorders | Systematic Assessment |
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| Complications and infection from hernia surgery | Injury, poisoning and procedural complications | Systematic Assessment |
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| Death (prior to randomization) | General disorders | Systematic Assessment |
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| Shoulder pain from arthritis | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| Shingles | Nervous system disorders | Systematic Assessment |
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| Fall outside of study, no treatment needed | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| Fall during data collection visit, no treatment needed | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| Stumbled at home | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| Leg pain | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| Pulled muscle in lower back | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| Chest pain due to gastrointestinal issue | Gastrointestinal disorders | Systematic Assessment |
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| Discontinued atorvastatin | Product Issues | Systematic Assessment |
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| Knee pain | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| Knee and hip pain | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| Back pain | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| Foot pain | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| Urinary tract infection | Renal and urinary disorders | Systematic Assessment |
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| Toothache, swollen jaw | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| Cellulitis | Infections and infestations | Systematic Assessment |
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| Hip pain during intervention | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| Low hemoglobin | Blood and lymphatic system disorders | Systematic Assessment |
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| Side effects from donepezil | Product Issues | Systematic Assessment |
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| Motor vehicle accident | Injury, poisoning and procedural complications | Systematic Assessment |
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| Chest pain and dizziness | Cardiac disorders | Systematic Assessment |
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| Slipped on wet pavement | Injury, poisoning and procedural complications | Systematic Assessment |
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| Leg cramps | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| Exhaustion spell | General disorders | Systematic Assessment |
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| Broken ankle | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| Respiratory infection | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| Recurrent pneumonia | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| Knee arthroscopy | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| Diverticulitis flare | Gastrointestinal disorders | Systematic Assessment |
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| Acute cystitis | Infections and infestations | Systematic Assessment |
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| Aspiration of thyroid nodule | Surgical and medical procedures | Systematic Assessment |
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| Eye surgery | Eye disorders | Systematic Assessment |
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| Headache | General disorders | Systematic Assessment |
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| Abnormal lab results | Blood and lymphatic system disorders | Systematic Assessment |
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| Incidental finding on MRI-space occupying lesion | General disorders | Systematic Assessment |
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| Seen by surgeon for hernia surgery-no treatment | General disorders | Systematic Assessment |
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| Acute gastritis | Gastrointestinal disorders | Systematic Assessment |
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| Ruptured patellar tendon | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| Labored breathing and chest pain when bending over | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| Tooth implants | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| Diarrhea and cough | Gastrointestinal disorders | Systematic Assessment |
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| Laser cytoscopy for bladder stones | Renal and urinary disorders | Systematic Assessment |
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| Basal cell carcinoma removed from arm | Skin and subcutaneous tissue disorders | Systematic Assessment |
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| Admitted to rehabilitation center | General disorders | Systematic Assessment |
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| Bilateral recurrent inguinal hernia repair | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| Sinus infection | Infections and infestations | Systematic Assessment |
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| Infection in finger | Infections and infestations | Systematic Assessment |
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| Swimmer's ear | Ear and labyrinth disorders | Systematic Assessment |
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| Injections for knee pain | Surgical and medical procedures | Systematic Assessment |
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| Dermatology treatment | Surgical and medical procedures | Systematic Assessment |
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| Removal of squamous cell carcinoma | Surgical and medical procedures | Systematic Assessment |
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Not provided
Not provided
| D019636 |
| Neurodegenerative Diseases |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |
| D003072 | Cognition Disorders |
| D019954 | Neurobehavioral Manifestations |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |