Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 1R21AG057586-01A1 | U.S. NIH Grant/Contract | View source |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| National Institute on Aging (NIA) | NIH |
Not provided
Not provided
Not provided
Not provided
Dancing is a complex sensorimotor rhythmic activity that integrates cognitive, physical, and social components and is applicable to seniors with various fitness levels. Despite its popularity, there is a paucity of studies that have systematically examined the role of dancing in preventing or delaying cognitive decline in older adults at high risk for Alzheimer's disease and related dementias. This preliminary randomized clinical trial will help provide the evidence base to develop a definitive full-scale trial to support or refute prescription of social dancing to prevent further cognitive decline in older adults at high risk of Alzheimer's disease and related dementia.
Social dancing is a complex sensorimotor rhythmic activity integrating physical, cognitive and social elements with the potential to ameliorate a wide range of physical and cognitive impairments in older individuals at risk of Alzheimer's disease (AD) and related dementias. The few extant studies report that dancing stimulates multiple cognitive processes, including attention, processing speed, and executive function, but these discoveries were made in small samples, lacking control conditions, and did not investigate the underlying biological mechanisms.
Executive function (EF) is an umbrella term for the management of cognitive processes, including working memory, reasoning, task flexibility, and problem solving that are central to planning, goal-directed action, and coordination of daily activities. Impairment of EF and related processes such as processing speed and attention is seen in normal aging as well as early in dementia, and is associated with difficulty in performing daily activities and increased risk of adverse events such as falls. Encouragingly, aerobic exercise is reported to enhance cognition, especially EF. Cognitively impaired seniors fall more, and have higher prevalence and severity of balance and gait problems than cognitively intact fallers. Given social dancing's multimodal cognitive and physical benefits; it may help maintain mobility and reduce falls in individuals at risk for dementia. In support, the investigators reported that older social dancers had better balance and gait than non-dancers.
The investigators propose a 6-month pilot single blind, randomized clinical trial (RCT) comparing social dancing (ballroom dancing) versus active control (walking) in 32 older adults at high risk of dementia. The overall hypothesis is that social dancing in cognitively vulnerable seniors will induce neuroplasticity that will enhance cognitive processes and improving everyday behaviors. The objective for this pilot trial is to obtain preliminary data on intervention effects (trajectory and asymptote) on EF to design a full-scale RCT.
Social dancing appeals to older adults, has intrinsic value, is enjoyable, and has high potential for sustainability. This trial is novel and high risk, but will provide the evidence base to develop a definitive full-scale RCT to support or refute prescription of social dancing to prevent cognitive decline in older adults at high risk of AD and related dementias.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Social Dancing | Experimental | The program includes Fox-trot, Waltz, and Latin dances. |
|
| Treadmill Walking | Active Comparator | The treadmill walking training protocol is based on the recommendations of the American College of Sports Medicine (ACSM) and American Heart Association (AHA) for older adults. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Social Dancing | Behavioral | 90-min dance sessions twice weekly for 6-months. The session includes warm-up, dance and cool down. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Executive Function (EF). | Improvement in EF will be measured through a composite score from 3 tests. (1) The Digit Symbol Substitution test is a measure of attention and speed of processing. Scoring is based on the total number of correct responses generated over 90 seconds. Higher values reflect better outcome. (2) Flanker Test is a measure of speed of processing, attention and inhibitory control. Scoring is based on accuracy and reaction time. Lower values reflect better outcome. (3) Walking While Talking (repeating alternating letters of the alphabet) gait speed (centimeters/second) will be measured using a electronic walkway system. Higher values reflect better outcome. The scores on the 3 tests are standardized and summed to obtain a single z-score. The Z-score indicates the number of standard deviations away from the mean of the study population and a value of 0 is equal to the mean. Negative numbers indicate values lower than the mean and positive numbers indicate values higher than the mean. | Baseline, 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Neuroplasticity. | Functional Magnetic Resonance Imaging will be used to investigate neuroplasticity under three conditions: 'imagined Walking While Talking' task, Digit Symbol Substitution test and Flanker interference tests. Functional activation/deactivation patterns recorded by Functional Magnetic Resonance Imaging in response to the three tests will be examined within each participant before and after the intervention. The values measured as factor scores reflect change in functional activation/deactivation covariance patterns from pre to post intervention as a function intervention (social dancing vs. treadmill walking). Larger absolute values reflect more change in functional activation/deactivation covariance patterns from pre to post intervention on each of the three tasks. There is no set minimum and maximum values of the scale. |
| Measure | Description | Time Frame |
|---|---|---|
| Lifestyle Changes. | Lifestyle changes will be measured at baseline and post-intervention through the Community Healthy Activities Model Program for Seniors (CHAMPS) questionnaire. CHAMPS scale measures weekly frequency/week of moderate-intensity exercise-related activities. Scores range from 0 to 133 with higher score indicating more exercise | Baseline, 6 months |
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Joe Verghese, MBBS | Albert Einstein College of Medicine | Principal Investigator |
| Helena Blumen, PhD | Albert Einstein College of Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Albert Einstein College of Medicine | The Bronx | New York | 10461 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32741240 | Background | Blumen HM, Ayers E, Wang C, Ambrose AF, Verghese J. A social dancing pilot intervention for older adults at high risk for Alzheimer's disease and related dementias. Neurodegener Dis Manag. 2020 Aug;10(4):183-194. doi: 10.2217/nmt-2020-0002. Epub 2020 Aug 3. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Social Dancing | The program includes Fox-trot, Waltz, and Latin dances. Social Dancing: 90-min dance sessions twice weekly for 6-months. The session includes warm-up, dance and cool down. |
| FG001 | Treadmill Walking | The treadmill walking training protocol is based on the recommendations of the American College of Sports Medicine (ACSM) and American Heart Association (AHA) for older adults. Treadmill Walking: Each session starts with 5-10 minutes of warm-up walking at comfortable speed. Speed is gradually increased to the level at which participants felt it is 'somewhat hard' for two 35 minute sessions with breaks in between followed by 5-10 minute cool down period (total 90 min to match dance group). |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 6 Month Intervention |
|
| |||||||||||||||||||||
| 9 Months |
|
Includes all participants who were randomized.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Social Dancing | The program includes Fox-trot, Waltz, and Latin dances. Social Dancing: 90-min dance sessions twice weekly for 6-months. The session includes warm-up, dance and cool down. |
| BG001 | Treadmill Walking |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| 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 | Executive Function (EF). | Improvement in EF will be measured through a composite score from 3 tests. (1) The Digit Symbol Substitution test is a measure of attention and speed of processing. Scoring is based on the total number of correct responses generated over 90 seconds. Higher values reflect better outcome. (2) Flanker Test is a measure of speed of processing, attention and inhibitory control. Scoring is based on accuracy and reaction time. Lower values reflect better outcome. (3) Walking While Talking (repeating alternating letters of the alphabet) gait speed (centimeters/second) will be measured using a electronic walkway system. Higher values reflect better outcome. The scores on the 3 tests are standardized and summed to obtain a single z-score. The Z-score indicates the number of standard deviations away from the mean of the study population and a value of 0 is equal to the mean. Negative numbers indicate values lower than the mean and positive numbers indicate values higher than the mean. | Includes all participants who were randomized except 3 participants in the Treadmill walking group who were missing 1 or more of the 3 composite score tests. | Posted | Mean | Standard Error | z score | Baseline, 6 months |
9 months
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Social Dancing | The program includes Fox-trot, Waltz, and Latin dances. Social Dancing: 90-min dance sessions twice weekly for 6-months. The session includes warm-up, dance and cool down. |
Not provided
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Falls | Musculoskeletal and connective tissue disorders | Systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Joe Verghese | Albert Einstein College of Medicine | 718-430-3877 | joe.verghese@einsteinmed.org |
Not provided
| 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 | Sep 24, 2018 | May 3, 2021 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Jan 24, 2020 | May 3, 2021 | ICF_001.pdf |
Not provided
| ID | Term |
|---|---|
| D000544 | Alzheimer Disease |
| D003704 | Dementia |
| D060825 | Cognitive Dysfunction |
| ID | Term |
|---|---|
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D024801 | Tauopathies |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Treadmill Walking | Behavioral | Each session starts with 5-10 minutes of warm-up walking at comfortable speed. Speed is gradually increased to the level at which participants felt it is 'somewhat hard' for two 35 minute sessions with breaks in between followed by 5-10 minute cool down period (total 90 min to match dance group). |
|
| Baseline, 6 months |
| Gait. | Changes in gait speed will be measured at baseline and post-intervention through a quantitative gait mat. Gait is measured in centimeters per second and higher values indicate faster walking speed. | Baseline, 6 months |
| Balance | Changes in balance will be measures at baseline and post-intervention using the Unipedal stance (measured in seconds). Higher time indicates better balance. | Baseline, 6 months |
| Modified Katz Disability Scale. | Changes in function assessed by 4 key activities of daily living tasks-bathing, dressing, walking, and transferring. Scores range from 0 to 8 with higher scores indicating worse outcome. | Baseline, 6 months |
| The Geriatric Depression Scale (GDS). | Changes in depressive symptoms assessed using the 30 item GDS, scores range from 0 (not depressed) to 30 (depressed). | Baseline, 6 months |
| Study stopped due to COVID pandemic |
|
| NOT COMPLETED |
|
|
The treadmill walking training protocol is based on the recommendations of the American College of Sports Medicine (ACSM) and American Heart Association (AHA) for older adults.
Treadmill Walking: Each session starts with 5-10 minutes of warm-up walking at comfortable speed. Speed is gradually increased to the level at which participants felt it is 'somewhat hard' for two 35 minute sessions with breaks in between followed by 5-10 minute cool down period (total 90 min to match dance group).
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Years of education | Mean | Standard Deviation | years |
|
| ID | Title | Description |
|---|
| OG000 | Social Dancing | The program includes Fox-trot, Waltz, and Latin dances. Social Dancing: 90-min dance sessions twice weekly for 6-months. The session includes warm-up, dance and cool down. |
| OG001 | Treadmill Walking | The treadmill walking training protocol is based on the recommendations of the American College of Sports Medicine (ACSM) and American Heart Association (AHA) for older adults. Treadmill Walking: Each session starts with 5-10 minutes of warm-up walking at comfortable speed. Speed is gradually increased to the level at which participants felt it is 'somewhat hard' for two 35 minute sessions with breaks in between followed by 5-10 minute cool down period (total 90 min to match dance group). |
|
|
|
| Secondary | Neuroplasticity. | Functional Magnetic Resonance Imaging will be used to investigate neuroplasticity under three conditions: 'imagined Walking While Talking' task, Digit Symbol Substitution test and Flanker interference tests. Functional activation/deactivation patterns recorded by Functional Magnetic Resonance Imaging in response to the three tests will be examined within each participant before and after the intervention. The values measured as factor scores reflect change in functional activation/deactivation covariance patterns from pre to post intervention as a function intervention (social dancing vs. treadmill walking). Larger absolute values reflect more change in functional activation/deactivation covariance patterns from pre to post intervention on each of the three tasks. There is no set minimum and maximum values of the scale. | Includes all participants who completed the baseline MRI session and was randomized, except 3 participants in the Social Dancing group and 2 participants in the Treadmill Walking group with incomplete tasks/session or corrupted data files. | Posted | Mean | Standard Error | units on a scale (factor scores) | Baseline, 6 months |
|
|
|
|
| Other Pre-specified | Lifestyle Changes. | Lifestyle changes will be measured at baseline and post-intervention through the Community Healthy Activities Model Program for Seniors (CHAMPS) questionnaire. CHAMPS scale measures weekly frequency/week of moderate-intensity exercise-related activities. Scores range from 0 to 133 with higher score indicating more exercise | Posted | Mean | Standard Error | score on a scale | Baseline, 6 months |
|
|
|
|
| Other Pre-specified | Gait. | Changes in gait speed will be measured at baseline and post-intervention through a quantitative gait mat. Gait is measured in centimeters per second and higher values indicate faster walking speed. | Posted | Mean | Standard Error | centimeters per second | Baseline, 6 months |
|
|
|
|
| Other Pre-specified | Balance | Changes in balance will be measures at baseline and post-intervention using the Unipedal stance (measured in seconds). Higher time indicates better balance. | Includes all randomized participants, but excludes 8 participants in the experimental group who were unable to do the assessment. | Posted | Mean | Standard Error | seconds | Baseline, 6 months |
|
|
|
|
| Other Pre-specified | Modified Katz Disability Scale. | Changes in function assessed by 4 key activities of daily living tasks-bathing, dressing, walking, and transferring. Scores range from 0 to 8 with higher scores indicating worse outcome. | This measure was not completed; therefore, no outcome data is included. | Posted | Baseline, 6 months |
|
|
| Other Pre-specified | The Geriatric Depression Scale (GDS). | Changes in depressive symptoms assessed using the 30 item GDS, scores range from 0 (not depressed) to 30 (depressed). | Posted | Mean | Standard Error | score on a scale | Baseline, 6 months |
|
|
|
|
| 0 |
| 13 |
| 0 |
| 13 |
| 5 |
| 13 |
| EG001 | Treadmill Walking | The treadmill walking training protocol is based on the recommendations of the American College of Sports Medicine (ACSM) and American Heart Association (AHA) for older adults. Treadmill Walking: Each session starts with 5-10 minutes of warm-up walking at comfortable speed. Speed is gradually increased to the level at which participants felt it is 'somewhat hard' for two 35 minute sessions with breaks in between followed by 5-10 minute cool down period (total 90 min to match dance group). | 0 | 12 | 0 | 12 | 4 | 12 |
| Leg pain | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Shortness of breath | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| High blood pressure | Vascular disorders | Systematic Assessment |
|
Not provided
Not provided
Not provided
| D019636 |
| Neurodegenerative Diseases |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |
| D003072 | Cognition Disorders |
| functional activation/deactivation covariance patterns during imagined Walking While Talking |
|
| Estimates with standard errors (SE) and p-values are from linear mixed effect models used to examine the difference in change in functional activation/deactivation covariance patterns during the Flanker interference test at post intervention from pre intervention between the social dancing and treadmill walking group. | Mean Difference (Net) | 24.60 | Standard Error of the Mean | 28.47 | 2-Sided | 95 | -31.20 | 80.40 | The estimate parameter reflects change in functional activation/deactivation pattern from pre to post intervention as a function intervention (social dancing vs. treadmill walking). | Superiority |
| Estimates with standard errors (SE) are from linear mixed effect models used to examine the difference in functional activation/deactivation covariance patterns during the Imagery of Walking-While Talking task at post intervention from pre intervention between the social dancing and treadmill walking group. | Mean Difference (Net) | 58.22 | Standard Error of the Mean | 51.20 | 2-Sided | 95 | -42.14 | 158.58 | The estimate parameter reflects change in functional activation/deactivation pattern from pre to post intervention as a function intervention (social dancing vs. treadmill walking). | Superiority |