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| ID | Type | Description | Link |
|---|---|---|---|
| 1R01AG060741-01 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute on Aging (NIA) | NIH |
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REACT is a randomized intervention to examine the benefits of African Dance as a method to increase physical activity behaviors in older adults. In this 6- month intervention, older African Americans will be randomly assigned to either an African Dance or an Africana Culture class. Both before and at the completion of the intervention, the investigators will collect a comprehensive neuropsychological battery and MRI scans of brain health and function to better study how physical activity influences neurocognitive health in African Americans.
Aim 1: Examine whether the African Dance intervention improves cognitive performance compared to an educational control group. H1: The dance group will show cognitive improvements in a domain-specific fashion such that executive and memory functions will be enhanced more than other cognitive domains; Aim 2. Examine whether African Dance influences brain morphology, task-evoked neural responses, cerebral blood flow, and resting state connectivity. H1: It is predicted that African Dance will increase volume, white matter integrity, perfusion, and functional activation/connectivity in a regionally-specific fashion such that prefrontal and hippocampal areas will be more sensitive to the intervention than other brain regions. Aim 3. Explore potential physiological and socio-emotional mechanisms of the dance intervention. The investigators will collect measures of physical and psychosocial health such as waist circumference, blood pressure, blood glucose and lipid levels, mood, anxiety, depression, and loneliness and examine whether intervention-related changes to these measures mediate improvements in cognitive performance.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| African Dance | Experimental | This is the experimental group. Dance classes will be held 3 times per week for 1 hour. Participants will learn traditional Africana dance moves and sequences. |
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| African Cultural Immersion | Active Comparator | This is the active control group. Participants will participate in a variety of educational activities related to African Culture, including traditional cooking, lectures, crafts, music and films. They will meet 3 times per week for the same duration as the Dance group. However, they will not participate in aerobic activity during the classes, and most activities will be conducted in a seated position. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| African Dance | Behavioral | Basic principles and guidelines for exercise programming will be followed including adequate warm-up and cool-down, progressive and gradual increments in duration, and instruction regarding avoidance of physical activity (PA) related injury. The African dance group will receive moderate intensity dance 1 hour per day, twice per week, for 6 months. The prescribed intensity will begin at light to moderate and progress to a moderate to high intensity level. Frequent assessment of heart rate and ratings of perceived exertion will ensure appropriate levels of intensity during each dance session. Levels of exertion during the dance will be prescribed and monitored based on baseline assessments of heart rate and cardiorespiratory fitness. |
| Measure | Description | Time Frame |
|---|---|---|
| Flanker Performance | A Flanker Inhibitory Control and Attention task will be administered at baseline, and then following the intervention (6 months). The main outcome from this task is the computed score from the NIH Toolbox, which reflects the participant's ability to inhibit responses to irrelevant information while focusing attention on a target stimulus. In each trial, participants make a directional response to a center arrow when the flanking arrows are arranged in congruent vs. incongruent direction from the center stimulus. The computed score combines accuracy and reaction time into a single performance metric, ranging from 0 to 10, with higher values indicating better performance. Group differences will be tested on this outcome. | Changes from baseline to 6-months |
| Measure | Description | Time Frame |
|---|---|---|
| Hippocampal Volume (mm3) | Structural scans will be collected at baseline as well as following the intervention. Hippocampal volume will be calculated in mm3. The investigators will examine group differences in size of the hippocampus following the intervention. | Changes from baseline to 6-months |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Cognitive Function | Investigators are assessing change in cognitive function from baseline to 12 months. A comprehensive neuropsychological battery will be used that assesses 5 domains of cognitive function (Working Memory, Processing Speed, Episodic Memory, Attentional Control, and Visuospatial Function). We will perform a confirmatory factor analysis on the cognitive data and determine whether the exercise intervention influences performance as measured by these factors. There is no min and max values. These are generated from a confirmatory factor analysis that normalizes the scores around 0 (being the mean). As such, positive values reflect better performance and negative values reflect poorer cognitive performance. Since the scores are standardized we can calculate the changes in standard deviations - e.g., a shift of 0.5 would be an improvement of ½ standard deviation in performance based on the sample average. |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Kirk I Erickson, PhD | University of Pittsburgh | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Pittsburgh | Pittsburgh | Pennsylvania | 15260 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | African Dance | This is the experimental group. Dance classes will be held 3 times per week for 1 hour. Participants will learn traditional Africana dance moves and sequences. African Dance: Basic principles and guidelines for exercise programming will be followed including adequate warm-up and cool-down, progressive and gradual increments in duration, and instruction regarding avoidance of physical activity (PA) related injury. The African dance group will receive moderate intensity dance 1 hour per day, twice per week, for 6 months. The prescribed intensity will begin at light to moderate and progress to a moderate to high intensity level. Frequent assessment of heart rate and ratings of perceived exertion will ensure appropriate levels of intensity during each dance session. Levels of exertion during the dance will be prescribed and monitored based on baseline assessments of heart rate and cardiorespiratory fitness. |
| FG001 | African Cultural Immersion | This is the active control group. Participants will participate in a variety of educational activities related to African Culture, including traditional cooking, lectures, crafts, music and films. They will meet 3 times per week for the same duration as the Dance group. However, they will not participate in aerobic activity during the classes, and most activities will be conducted in a seated position. African Cultural Immersion: The Culture group will participate in activities, including cooking, art and games, music, traditional crafts, and lectures and discussions about other aspects of Africana culture and customs. Topics will vary from session to session to maintain interest and engagement. The sessions will be held in a small group format and will be lead my personnel with training in each topic. Participants will meet 1 hour per day, 3 times per week, for 6 months. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | African Dance | This is the experimental group. Dance classes will be held 3 times per week for 1 hour. Participants will learn traditional Africana dance moves and sequences. African Dance: Basic principles and guidelines for exercise programming will be followed including adequate warm-up and cool-down, progressive and gradual increments in duration, and instruction regarding avoidance of physical activity (PA) related injury. The African dance group will receive moderate intensity dance 1 hour per day, twice per week, for 6 months. The prescribed intensity will begin at light to moderate and progress to a moderate to high intensity level. Frequent assessment of heart rate and ratings of perceived exertion will ensure appropriate levels of intensity during each dance session. Levels of exertion during the dance will be prescribed and monitored based on baseline assessments of heart rate and cardiorespiratory fitness. |
| Units | Counts |
|---|---|
| Participants |
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| 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 | Flanker Performance | A Flanker Inhibitory Control and Attention task will be administered at baseline, and then following the intervention (6 months). The main outcome from this task is the computed score from the NIH Toolbox, which reflects the participant's ability to inhibit responses to irrelevant information while focusing attention on a target stimulus. In each trial, participants make a directional response to a center arrow when the flanking arrows are arranged in congruent vs. incongruent direction from the center stimulus. The computed score combines accuracy and reaction time into a single performance metric, ranging from 0 to 10, with higher values indicating better performance. Group differences will be tested on this outcome. | All participants data were included, as we conducted intention-to-treat (ITT) analysis. | Posted | Least Squares Mean | 95% Confidence Interval | score on a scale | Changes from baseline to 6-months |
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6 months
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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 | African Dance | This is the experimental group. Dance classes will be held 3 times per week for 1 hour. Participants will learn traditional Africana dance moves and sequences. African Dance: Basic principles and guidelines for exercise programming will be followed including adequate warm-up and cool-down, progressive and gradual increments in duration, and instruction regarding avoidance of physical activity (PA) related injury. The African dance group will receive moderate intensity dance 1 hour per day, twice per week, for 6 months. The prescribed intensity will begin at light to moderate and progress to a moderate to high intensity level. Frequent assessment of heart rate and ratings of perceived exertion will ensure appropriate levels of intensity during each dance session. Levels of exertion during the dance will be prescribed and monitored based on baseline assessments of heart rate and cardiorespiratory fitness. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nephrolithiasis | Surgical and medical procedures | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| abnormal blood pressure | Vascular disorders | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Kirk I. Erickson | AdventHealth Research Institute | 4125763724 | Kirk.Erickson@adventhealth.com |
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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 | Aug 29, 2023 | Jul 24, 2025 | Prot_SAP_000.pdf |
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180 African American older adults between the ages of 60-80 will be randomly assigned to one of two groups: African Dance or Africana Culture. Both groups will meet 3 times per week for 1 hour over a period of 6-months. Cognitive and brain metrics will be assessed at baseline and following the completion of the intervention.
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Neither the investigator, nor outcomes assessors will know participants' group assignments. Participants will be instructed to refrain from speaking about their group's activities when visiting the lab for follow-up assessment. In addition, special care was taken to ensure that non-blinded laboratory staff (e.g., staff member notifying participants of their group assignments, staff monitoring the intervention classes) are not located in the same proximity in the laboratory, further preventing accidental unblinding.
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| African Cultural Immersion | Behavioral | The Culture group will participate in activities, including cooking, art and games, music, traditional crafts, and lectures and discussions about other aspects of Africana culture and customs. Topics will vary from session to session to maintain interest and engagement. The sessions will be held in a small group format and will be lead my personnel with training in each topic. Participants will meet 1 hour per day, 3 times per week, for 6 months. |
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| Changes from baseline to 6-months |
| Medication Use | We will be recording all prescribed and over-the-counter (OTC) medications that the study participant is currently taking and will examine whether the intervention effects vary as a function of medication use. | Changes from baseline to 6-months |
| Cardiorespiratory Fitness | The investigators will conduct a sub-maximal fitness test before and after the intervention in order to calculate each participant's fitness level (via estimated VO2 max). The investigators will examine group differences in fitness following the intervention. | Changes from baseline to 6-months |
| Functional Fitness | Senior Fitness Test will be used to measure various aspects of fitness - e.g., balance, flexibility, strength. We will examine whether the exercise intervention improves any marker of fitness. | Changes from baseline to 6-months |
| Actigraphy Steps Per Day | The investigators will collect objective physical activity levels via wrist-worn accelerometers every 6 weeks throughout the intervention. Steps per day will be a primary outcome from the actigraphy. The investigators will examine changes in physical activity over the intervention. | Changes from baseline to 6-months |
| Change in Exercise Frequency | Exercise frequency will be measured using Actigraph Link physical activity monitoring device. This device is small and lightweight. It is worn around the non-dominant wrist(touching the skin) for approximately 7 days during all waking and sleeping hours. We will examine whether the intervention altered this measure of daily activity. | Changes from baseline to 6-months |
| Change in Exercise Intensity | Exercise intensity will be measured using the Actigraph Link physical activity monitoring device. This device is small and lightweight. It is worn around the non-dominant wrist (touching the skin) for approximately 7 days during all waking and sleeping hours. We will examine whether the exercise intervention altered amount of time spent in moderate-to-vigorous activities during daily life. | Changes from baseline to 6-months |
| Change in Exercise Duration | Exercise duration will be measured using Actigraph Link physical activity monitoring device. This device is small and lightweight. It is worn around the non-dominant wrist (touching the skin) for approximately 7 days during all waking and sleeping hours.. The duration is measured in minutes. We will examine whether the exercise intervention altered amount of time spent in moderate-to-vigorous activities during daily life. | Changes from baseline to 6-months |
| Weight | Participants will be weighed on a calibrated stadiometer both before and after the intervention. The investigators will examine percent changes in body weight in the groups before and after the intervention. | Changes from baseline to 6-months |
| Change in Hippocampal Subfield Volumes | MRI will be used to measure volumetric changes in hippocampal subfields. | Changes from baseline to 6-months |
| Change in White Matter Lesions | MRI will be used to measure changes in white matter microstructure in relation to the intervention. | Changes from baseline to 6-months |
| Change in White Matter Diffusion Properties | MRI will be used to measure changes in white matter microstructure in relation to the intervention. | Changes from baseline to 6-months |
| Change in Cerebral Blood Flow | MRI will be used to measure changes in cerebral blood flow. Total cerebral blood flow changes over the course of the intervention will be evaluated. | Changes from baseline to 6-months |
| Change in Resting State Brain Activity | MRI will be used to measure changes in resting state brain function. We will examine whether the intervention alters resting state connectivity metrics. | Changes from baseline to 6-months |
| Change in Task-evoked Relational Memory Brain Activity | MRI will be used to measure changes in encoding and retrieval during a relational memory task. | Changes from baseline to 6-months |
| Change in Task-evoked Working Memory Brain Activity | MRI will be used to measure changes in brain activity task-evoked patterns using an N-back working memory task. | Changes from baseline to 6-months |
| Change in Cortical Thickness | MRI will be used to measure average cortical thickness over the course of the intervention. | Changes from baseline to 6-months |
| Changes in Blood Levels of Cholesterol | The investigators are collecting data on changes in blood biomarkers including levels of cholesterol, low-density lipoprotein (LDL), very low-density lipoprotein (VLDL), high-density lipoprotein (HDL), and triglycerides. | Changes from baseline to 6-months |
| Change in Blood Levels of Glucose | The investigators will examine whether changes in markers of insulin resistance change over the course of the intervention and whether these changes mediate neurocognitive outcomes. | Changes from baseline to 6-months |
| Change in Blood Levels of Hemoglobin | The investigators are collecting data on changes in average blood sugar levels (HbA1C) | Changes from baseline to 6-months |
| Socioeconomic Status (SES) Composite | Combining information from the MacArthur questionnaire to develop Social Economic Status of participants, we will examine whether the effectiveness of the intervention varied by SES levels of the participants. The SES composite is generated using a confirmatory factor analysis of various SES indicators - e.g., income, debt, savings, etc. The scores are normalized so that 0 is the average for the sample, higher numbers reflect higher SES, and lower numbers indicate lower SES. | Baseline |
| Health History & Lifestyle Habits | Health History assesses medical history and lifestyle habits such as alcohol and tobacco use. We will examine whether any neurocognitive outcomes vary as a function of these health conditions and behaviors. | Changes from baseline to 6-months |
| Depression | The investigators are collecting a questionnaire measuring depressive symptoms, the Center for Epidemiologic Studies Depression Scale (CES-D). The CES-D is a 20-item measure that asks caregivers to rate how often over the past week they experienced symptoms associated with depression, such as restless sleep, poor appetite, and feeling lonely. Response options range from 0 to 3 for each item (0 = Rarely or None of the Time, 1 = Some or Little of the Time, 2 = Moderately or Much of the time, 3 = Most or Almost All the Time). Scores range from 0 to 60, with high scores indicating greater depressive symptoms. The questionnaire will be administered at baseline as well as at the 6-month followup. | Changes from baseline to 6-months |
| Loneliness | The investigators are collecting a questionnaire measuring self-perceived loneliness, the University of California Loneliness Scale (UCLALS). This is a 20-item scale in which participants rate frequency of feelings of loneliness and social isolation on a 4 point scale ranging from "never" to "often". A total score is computed which can range from 20- 80. Higher scores indicate more loneliness. The questionnaire will be assessed at baseline as well as at the 6-month followup. | Changes from baseline to 6-months |
| Mindfulness | The Mindful Attention Awareness Scale (MAAS) assesses a core characteristic of mindfulness mainly open or receptive awareness of and attention to what is taking place in the present. We will examine whether the exercise intervention altered measures of mindfulness. Score scale runs 15-90 with higher scores reflecting more mindfulness. | Changes from baseline to 6-months |
| Positive and Negative Affect | The Positive and Negative Affect Schedule (PANAS) is used to measure mood and emotion. It is comprised of 20 items, with 10 items measuring positive affect (e.g., excited, inspired) and 10 items measuring negative affect (e.g., upset, afraid). Each item is rated on a five-point Likert scale. Positive affect scores range from 10 to 50, and negative affect scores range from 10 to 50. | Changes from baseline to 6-months |
| State Trait Anxiety Inventory (STAI) | The STAI is a validated 20 item self-report assessment which includes separate measures of state and trait anxiety. The inventory includes 40 items on a 4-point Likert scale. Higher scores indicate higher levels of anxiety. | Changes from baseline to 6-months |
| Perceived Pain | The McGill Pain Questionnaire is used to evaluate a person's perception of pain. It can be used to monitor the pain over time and to determine the effectiveness of any intervention. We will examine whether the intervention alters perceptions of pain in late adulthood. Score scale runs 0-45 with higher values meaning more pain. | Changes from baseline to 6-months |
| Perceived Fatigability | The Pittsburgh Fatigability Scale assesses self-report whole-body physical and mental tiredness related to activities of fixed intensity and duration in adults age ≥60. The scale includes 10 items, each measured on a 5-point Likert scale for a total score of 0-50. Higher scores indicate higher fatigability. | Changes from baseline to 6-months |
| Levels of Inactivity | Sitting Time Questionnaire scores how much time is spent sitting during 5 different events on a weekday and weekend day. We will examine whether participating in the intervention alters amount of time spent sitting. Calculate weekly minutes with higher values in minutes = more sedentary (sitting time) | Changes from baseline to 6-months |
| Lifestyle Physical Activities | The Community Healthy Activities Model Program for Seniors (CHAMPS) questionnaire assesses self-report weekly frequency and duration of a variety of lifestyle physical activities that are meaningful and appropriate for older adults. It includes activities of various intensities (from light to vigorous) such as walking, running, hiking, swimming, bicycling, dancing, tennis, aerobics, yoga/tai chi, gardening, and housework. For each activity, the following measures are scored: frequency per week, hours per week, estimated caloric expenditure per week, and mets/kg/week. | Changes from baseline to 6-months |
| Perceived Sleep Quality | Pittsburgh Sleep Quality Index (PSQI) will be used to assess perceived sleep quality. We will examine whether the exercise intervention alters perceived sleep quality. All components have score range 0-3 with lower number equal to better sleep quality. | Changes from baseline to 6-months |
| Exercise Self-Efficacy | The investigators will use the Exercise Self-Efficacy Scale (EXSE) to assess belief in the ability to continue exercising three times a week at a moderate intensity for 40 plus minutes a session into the future. We will examine whether this measure predicts long-term adherence outcomes. Score scale runs 0-100 with higher values = higher confidence to continue to exercise (3X's week for 40 + minutes) in the future 8 weeks | Changes from baseline to 6-months |
| Barriers to Exercise (BARSE) | BARSE questionnaire assess degrees of confidence that one could exercise despite a variety of limitations such as during bad weather, while on vacation, etc. This scale was designed to tap subjects' perceived capabilities to exercise three times per week for 40 minutes over the next two months in the face of commonly identified barriers to participation. We will examine whether measures of barriers predicts adherence and compliance to the intervention. Scale 1-100, higher values = higher level of perceived capability to overcome barriers to exercise | Changes from baseline to 6-months |
| Social Provisions | Social Provisions Scale (SPS):A 24-item scale assessing six relational provisions: attachment, or emotional support; social integration, or network support; reassurance of worth, or esteem support; reliable alliance, or tangible aid; guidance, or informational support; and the opportunity of nurturance.The items were modified for the exercise setting. For example, one of the statements used to assess social integration was "I feel part of the exercise group". We will examine whether social provisions relates to adherence to the intervention. Each subscale has range of 4 - 16 with total score range 24 - 96, higher values = higher social relationship (ppt. is receiving that provision) | Changes from baseline to 6-months |
| Physical Activity Self-Regulation | Physical Activity Self-Regulation Scale, 12-item version (PASR-12): (PASR-12 FORM) A 12-item version of a popular 43-item self-regulation scale. Participants were asked to rate how often they used each strategy on a scale from 1 (never) to 5 (very often). We will examine whether measures of self-regulation predicts adherence and compliance to the intervention. Each subscale has range of 2 - 10, higher scores = greater use of self-regulation strategies. Summary score has range of 12 - 60 | Changes from baseline to 6-months |
| Perceived Weight Discrimination | Hunger and Major (2015) developed a perceived weight discrimination scale based on a widely-used measure of racial discrimination. Participants respond to five items (e.g., "In the past 12 months, how often other people treated you unfairly because of your weight?") on 0 (never) to 4 (all the time) scales. We will examine whether the exercise intervention modified measures of perceived weight discrimination. | Changes from baseline to 6-months |
| Perceived Health & Quality of Life | The Short Form Health Survey (SF-36) taps into eight health concepts: physical functioning, bodily pain, role limitations due to physical health problems, role limitations due to personal or emotional problems, emotional well-being, social functioning, energy/fatigue, and general health perceptions. It also includes a single item that provides an indication of perceived change in health. We will examine whether the exercise intervention modified measures of health related quality of life. Each concept has a score range of 0-100 with higher scores equal to more favorable health traits. | Changes from baseline to 6-months |
| Life Satisfaction | We will use the Satisfaction with Life Scale (SWLS) as a global cognitive judgement of study participants life satisfaction. We will examine whether the exercise intervention altered SWLS measures. Total score range is 5 -35 with higher scores equal to greater satisfaction with life. | Changes from baseline to 6-months |
| Subjective Cognitive Performance | Everyday Cognition (ECOG)(Short version) measures subjective cognitive performance. We will examine whether the intervention alters this subjective/perceived level of cognitive function. Score range is 1 - 4 with lower scores equal to better daily function. | Changes from baseline to 6-months |
| Perceived Cognitive Abilities | Patient Reported Outcomes Measurement Information System (PROMIS) Applied Cognition: (Abilities) This is a brief self-report of perceived cognitive abilities for daily functioning. We will examine whether the intervention alters this subjective/perceived level of cognitive function. Scale 8-40, assess ppt. perceived functional abilities in regard to cognitive tasks. Higher value = higher self-perceived ability in cognition. | Changes from baseline to 6-months |
| Perceived Cognition for Daily Life | PROMIS Applied Cognition: (General Concerns) This is a brief self-report of perceived difficulties with cognition for daily functioning. We will examine whether the intervention alters this subjective/perceived level of cognitive function. Scale 8-40. Lower score = less cognitive concerns | Changes from baseline to 6-months |
| Black Identity | The Multidimensional Model of Racial Identity (MMRI) is a model that identifies four dimensions of African American racial identity: salience, centrality, regard, and ideology. We will examine whether racial identity acts as mediator to cognitive performance post-intervention. | 6-month post |
| Race-Related Stress | The Index of Race-Related Stress (IRRS) is one of the most commonly used measures to assess race-related stress among Black Americans. We will examine whether racial identity acts as mediator to cognitive performance post-intervention. | 6-month post |
| BG001 | African Cultural Immersion | This is the active control group. Participants will participate in a variety of educational activities related to African Culture, including traditional cooking, lectures, crafts, music and films. They will meet 3 times per week for the same duration as the Dance group. However, they will not participate in aerobic activity during the classes, and most activities will be conducted in a seated position. African Cultural Immersion: The Culture group will participate in activities, including cooking, art and games, music, traditional crafts, and lectures and discussions about other aspects of Africana culture and customs. Topics will vary from session to session to maintain interest and engagement. The sessions will be held in a small group format and will be lead my personnel with training in each topic. Participants will meet 1 hour per day, 3 times per week, for 6 months. |
| BG002 | Total | Total of all reporting groups |
| years |
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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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| Cardiorespiratory fitness (VO2peak) | Mean | Standard Deviation | mL/kg/min |
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This is the experimental group. Dance classes will be held 3 times per week for 1 hour. Participants will learn traditional Africana dance moves and sequences. African Dance: Basic principles and guidelines for exercise programming will be followed including adequate warm-up and cool-down, progressive and gradual increments in duration, and instruction regarding avoidance of physical activity (PA) related injury. The African dance group will receive moderate intensity dance 1 hour per day, twice per week, for 6 months. The prescribed intensity will begin at light to moderate and progress to a moderate to high intensity level. Frequent assessment of heart rate and ratings of perceived exertion will ensure appropriate levels of intensity during each dance session. Levels of exertion during the dance will be prescribed and monitored based on baseline assessments of heart rate and cardiorespiratory fitness. |
| OG001 | African Cultural Immersion | This is the active control group. Participants will participate in a variety of educational activities related to African Culture, including traditional cooking, lectures, crafts, music and films. They will meet 3 times per week for the same duration as the Dance group. However, they will not participate in aerobic activity during the classes, and most activities will be conducted in a seated position. African Cultural Immersion: The Culture group will participate in activities, including cooking, art and games, music, traditional crafts, and lectures and discussions about other aspects of Africana culture and customs. Topics will vary from session to session to maintain interest and engagement. The sessions will be held in a small group format and will be lead my personnel with training in each topic. Participants will meet 1 hour per day, 3 times per week, for 6 months. |
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| Secondary | Hippocampal Volume (mm3) | Structural scans will be collected at baseline as well as following the intervention. Hippocampal volume will be calculated in mm3. The investigators will examine group differences in size of the hippocampus following the intervention. | All participants data were included, as we conducted intention-to-treat (ITT) analysis. | Posted | Least Squares Mean | 95% Confidence Interval | cubic millimeters (mm³) | Changes from baseline to 6-months |
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| Other Pre-specified | Change in Cognitive Function | Investigators are assessing change in cognitive function from baseline to 12 months. A comprehensive neuropsychological battery will be used that assesses 5 domains of cognitive function (Working Memory, Processing Speed, Episodic Memory, Attentional Control, and Visuospatial Function). We will perform a confirmatory factor analysis on the cognitive data and determine whether the exercise intervention influences performance as measured by these factors. There is no min and max values. These are generated from a confirmatory factor analysis that normalizes the scores around 0 (being the mean). As such, positive values reflect better performance and negative values reflect poorer cognitive performance. Since the scores are standardized we can calculate the changes in standard deviations - e.g., a shift of 0.5 would be an improvement of ½ standard deviation in performance based on the sample average. | Not Posted | Changes from baseline to 6-months | Participants |
| Other Pre-specified | Medication Use | We will be recording all prescribed and over-the-counter (OTC) medications that the study participant is currently taking and will examine whether the intervention effects vary as a function of medication use. | Not Posted | Changes from baseline to 6-months | Participants |
| Other Pre-specified | Cardiorespiratory Fitness | The investigators will conduct a sub-maximal fitness test before and after the intervention in order to calculate each participant's fitness level (via estimated VO2 max). The investigators will examine group differences in fitness following the intervention. | Not Posted | Changes from baseline to 6-months | Participants |
| Other Pre-specified | Functional Fitness | Senior Fitness Test will be used to measure various aspects of fitness - e.g., balance, flexibility, strength. We will examine whether the exercise intervention improves any marker of fitness. | Not Posted | Changes from baseline to 6-months | Participants |
| Other Pre-specified | Actigraphy Steps Per Day | The investigators will collect objective physical activity levels via wrist-worn accelerometers every 6 weeks throughout the intervention. Steps per day will be a primary outcome from the actigraphy. The investigators will examine changes in physical activity over the intervention. | Not Posted | Changes from baseline to 6-months | Participants |
| Other Pre-specified | Change in Exercise Frequency | Exercise frequency will be measured using Actigraph Link physical activity monitoring device. This device is small and lightweight. It is worn around the non-dominant wrist(touching the skin) for approximately 7 days during all waking and sleeping hours. We will examine whether the intervention altered this measure of daily activity. | Not Posted | Changes from baseline to 6-months | Participants |
| Other Pre-specified | Change in Exercise Intensity | Exercise intensity will be measured using the Actigraph Link physical activity monitoring device. This device is small and lightweight. It is worn around the non-dominant wrist (touching the skin) for approximately 7 days during all waking and sleeping hours. We will examine whether the exercise intervention altered amount of time spent in moderate-to-vigorous activities during daily life. | Not Posted | Changes from baseline to 6-months | Participants |
| Other Pre-specified | Change in Exercise Duration | Exercise duration will be measured using Actigraph Link physical activity monitoring device. This device is small and lightweight. It is worn around the non-dominant wrist (touching the skin) for approximately 7 days during all waking and sleeping hours.. The duration is measured in minutes. We will examine whether the exercise intervention altered amount of time spent in moderate-to-vigorous activities during daily life. | Not Posted | Changes from baseline to 6-months | Participants |
| Other Pre-specified | Weight | Participants will be weighed on a calibrated stadiometer both before and after the intervention. The investigators will examine percent changes in body weight in the groups before and after the intervention. | Not Posted | Changes from baseline to 6-months | Participants |
| Other Pre-specified | Change in Hippocampal Subfield Volumes | MRI will be used to measure volumetric changes in hippocampal subfields. | Not Posted | Changes from baseline to 6-months | Participants |
| Other Pre-specified | Change in White Matter Lesions | MRI will be used to measure changes in white matter microstructure in relation to the intervention. | Not Posted | Changes from baseline to 6-months | Participants |
| Other Pre-specified | Change in White Matter Diffusion Properties | MRI will be used to measure changes in white matter microstructure in relation to the intervention. | Not Posted | Changes from baseline to 6-months | Participants |
| Other Pre-specified | Change in Cerebral Blood Flow | MRI will be used to measure changes in cerebral blood flow. Total cerebral blood flow changes over the course of the intervention will be evaluated. | Not Posted | Changes from baseline to 6-months | Participants |
| Other Pre-specified | Change in Resting State Brain Activity | MRI will be used to measure changes in resting state brain function. We will examine whether the intervention alters resting state connectivity metrics. | Not Posted | Changes from baseline to 6-months | Participants |
| Other Pre-specified | Change in Task-evoked Relational Memory Brain Activity | MRI will be used to measure changes in encoding and retrieval during a relational memory task. | Not Posted | Changes from baseline to 6-months | Participants |
| Other Pre-specified | Change in Task-evoked Working Memory Brain Activity | MRI will be used to measure changes in brain activity task-evoked patterns using an N-back working memory task. | Not Posted | Changes from baseline to 6-months | Participants |
| Other Pre-specified | Change in Cortical Thickness | MRI will be used to measure average cortical thickness over the course of the intervention. | Not Posted | Changes from baseline to 6-months | Participants |
| Other Pre-specified | Changes in Blood Levels of Cholesterol | The investigators are collecting data on changes in blood biomarkers including levels of cholesterol, low-density lipoprotein (LDL), very low-density lipoprotein (VLDL), high-density lipoprotein (HDL), and triglycerides. | Not Posted | Changes from baseline to 6-months | Participants |
| Other Pre-specified | Change in Blood Levels of Glucose | The investigators will examine whether changes in markers of insulin resistance change over the course of the intervention and whether these changes mediate neurocognitive outcomes. | Not Posted | Changes from baseline to 6-months | Participants |
| Other Pre-specified | Change in Blood Levels of Hemoglobin | The investigators are collecting data on changes in average blood sugar levels (HbA1C) | Not Posted | Changes from baseline to 6-months | Participants |
| Other Pre-specified | Socioeconomic Status (SES) Composite | Combining information from the MacArthur questionnaire to develop Social Economic Status of participants, we will examine whether the effectiveness of the intervention varied by SES levels of the participants. The SES composite is generated using a confirmatory factor analysis of various SES indicators - e.g., income, debt, savings, etc. The scores are normalized so that 0 is the average for the sample, higher numbers reflect higher SES, and lower numbers indicate lower SES. | Not Posted | Baseline | Participants |
| Other Pre-specified | Health History & Lifestyle Habits | Health History assesses medical history and lifestyle habits such as alcohol and tobacco use. We will examine whether any neurocognitive outcomes vary as a function of these health conditions and behaviors. | Not Posted | Changes from baseline to 6-months | Participants |
| Other Pre-specified | Depression | The investigators are collecting a questionnaire measuring depressive symptoms, the Center for Epidemiologic Studies Depression Scale (CES-D). The CES-D is a 20-item measure that asks caregivers to rate how often over the past week they experienced symptoms associated with depression, such as restless sleep, poor appetite, and feeling lonely. Response options range from 0 to 3 for each item (0 = Rarely or None of the Time, 1 = Some or Little of the Time, 2 = Moderately or Much of the time, 3 = Most or Almost All the Time). Scores range from 0 to 60, with high scores indicating greater depressive symptoms. The questionnaire will be administered at baseline as well as at the 6-month followup. | Not Posted | Changes from baseline to 6-months | Participants |
| Other Pre-specified | Loneliness | The investigators are collecting a questionnaire measuring self-perceived loneliness, the University of California Loneliness Scale (UCLALS). This is a 20-item scale in which participants rate frequency of feelings of loneliness and social isolation on a 4 point scale ranging from "never" to "often". A total score is computed which can range from 20- 80. Higher scores indicate more loneliness. The questionnaire will be assessed at baseline as well as at the 6-month followup. | Not Posted | Changes from baseline to 6-months | Participants |
| Other Pre-specified | Mindfulness | The Mindful Attention Awareness Scale (MAAS) assesses a core characteristic of mindfulness mainly open or receptive awareness of and attention to what is taking place in the present. We will examine whether the exercise intervention altered measures of mindfulness. Score scale runs 15-90 with higher scores reflecting more mindfulness. | Not Posted | Changes from baseline to 6-months | Participants |
| Other Pre-specified | Positive and Negative Affect | The Positive and Negative Affect Schedule (PANAS) is used to measure mood and emotion. It is comprised of 20 items, with 10 items measuring positive affect (e.g., excited, inspired) and 10 items measuring negative affect (e.g., upset, afraid). Each item is rated on a five-point Likert scale. Positive affect scores range from 10 to 50, and negative affect scores range from 10 to 50. | Not Posted | Changes from baseline to 6-months | Participants |
| Other Pre-specified | State Trait Anxiety Inventory (STAI) | The STAI is a validated 20 item self-report assessment which includes separate measures of state and trait anxiety. The inventory includes 40 items on a 4-point Likert scale. Higher scores indicate higher levels of anxiety. | Not Posted | Changes from baseline to 6-months | Participants |
| Other Pre-specified | Perceived Pain | The McGill Pain Questionnaire is used to evaluate a person's perception of pain. It can be used to monitor the pain over time and to determine the effectiveness of any intervention. We will examine whether the intervention alters perceptions of pain in late adulthood. Score scale runs 0-45 with higher values meaning more pain. | Not Posted | Changes from baseline to 6-months | Participants |
| Other Pre-specified | Perceived Fatigability | The Pittsburgh Fatigability Scale assesses self-report whole-body physical and mental tiredness related to activities of fixed intensity and duration in adults age ≥60. The scale includes 10 items, each measured on a 5-point Likert scale for a total score of 0-50. Higher scores indicate higher fatigability. | Not Posted | Changes from baseline to 6-months | Participants |
| Other Pre-specified | Levels of Inactivity | Sitting Time Questionnaire scores how much time is spent sitting during 5 different events on a weekday and weekend day. We will examine whether participating in the intervention alters amount of time spent sitting. Calculate weekly minutes with higher values in minutes = more sedentary (sitting time) | Not Posted | Changes from baseline to 6-months | Participants |
| Other Pre-specified | Lifestyle Physical Activities | The Community Healthy Activities Model Program for Seniors (CHAMPS) questionnaire assesses self-report weekly frequency and duration of a variety of lifestyle physical activities that are meaningful and appropriate for older adults. It includes activities of various intensities (from light to vigorous) such as walking, running, hiking, swimming, bicycling, dancing, tennis, aerobics, yoga/tai chi, gardening, and housework. For each activity, the following measures are scored: frequency per week, hours per week, estimated caloric expenditure per week, and mets/kg/week. | Not Posted | Changes from baseline to 6-months | Participants |
| Other Pre-specified | Perceived Sleep Quality | Pittsburgh Sleep Quality Index (PSQI) will be used to assess perceived sleep quality. We will examine whether the exercise intervention alters perceived sleep quality. All components have score range 0-3 with lower number equal to better sleep quality. | Not Posted | Changes from baseline to 6-months | Participants |
| Other Pre-specified | Exercise Self-Efficacy | The investigators will use the Exercise Self-Efficacy Scale (EXSE) to assess belief in the ability to continue exercising three times a week at a moderate intensity for 40 plus minutes a session into the future. We will examine whether this measure predicts long-term adherence outcomes. Score scale runs 0-100 with higher values = higher confidence to continue to exercise (3X's week for 40 + minutes) in the future 8 weeks | Not Posted | Changes from baseline to 6-months | Participants |
| Other Pre-specified | Barriers to Exercise (BARSE) | BARSE questionnaire assess degrees of confidence that one could exercise despite a variety of limitations such as during bad weather, while on vacation, etc. This scale was designed to tap subjects' perceived capabilities to exercise three times per week for 40 minutes over the next two months in the face of commonly identified barriers to participation. We will examine whether measures of barriers predicts adherence and compliance to the intervention. Scale 1-100, higher values = higher level of perceived capability to overcome barriers to exercise | Not Posted | Changes from baseline to 6-months | Participants |
| Other Pre-specified | Social Provisions | Social Provisions Scale (SPS):A 24-item scale assessing six relational provisions: attachment, or emotional support; social integration, or network support; reassurance of worth, or esteem support; reliable alliance, or tangible aid; guidance, or informational support; and the opportunity of nurturance.The items were modified for the exercise setting. For example, one of the statements used to assess social integration was "I feel part of the exercise group". We will examine whether social provisions relates to adherence to the intervention. Each subscale has range of 4 - 16 with total score range 24 - 96, higher values = higher social relationship (ppt. is receiving that provision) | Not Posted | Changes from baseline to 6-months | Participants |
| Other Pre-specified | Physical Activity Self-Regulation | Physical Activity Self-Regulation Scale, 12-item version (PASR-12): (PASR-12 FORM) A 12-item version of a popular 43-item self-regulation scale. Participants were asked to rate how often they used each strategy on a scale from 1 (never) to 5 (very often). We will examine whether measures of self-regulation predicts adherence and compliance to the intervention. Each subscale has range of 2 - 10, higher scores = greater use of self-regulation strategies. Summary score has range of 12 - 60 | Not Posted | Changes from baseline to 6-months | Participants |
| Other Pre-specified | Perceived Weight Discrimination | Hunger and Major (2015) developed a perceived weight discrimination scale based on a widely-used measure of racial discrimination. Participants respond to five items (e.g., "In the past 12 months, how often other people treated you unfairly because of your weight?") on 0 (never) to 4 (all the time) scales. We will examine whether the exercise intervention modified measures of perceived weight discrimination. | Not Posted | Changes from baseline to 6-months | Participants |
| Other Pre-specified | Perceived Health & Quality of Life | The Short Form Health Survey (SF-36) taps into eight health concepts: physical functioning, bodily pain, role limitations due to physical health problems, role limitations due to personal or emotional problems, emotional well-being, social functioning, energy/fatigue, and general health perceptions. It also includes a single item that provides an indication of perceived change in health. We will examine whether the exercise intervention modified measures of health related quality of life. Each concept has a score range of 0-100 with higher scores equal to more favorable health traits. | Not Posted | Changes from baseline to 6-months | Participants |
| Other Pre-specified | Life Satisfaction | We will use the Satisfaction with Life Scale (SWLS) as a global cognitive judgement of study participants life satisfaction. We will examine whether the exercise intervention altered SWLS measures. Total score range is 5 -35 with higher scores equal to greater satisfaction with life. | Not Posted | Changes from baseline to 6-months | Participants |
| Other Pre-specified | Subjective Cognitive Performance | Everyday Cognition (ECOG)(Short version) measures subjective cognitive performance. We will examine whether the intervention alters this subjective/perceived level of cognitive function. Score range is 1 - 4 with lower scores equal to better daily function. | Not Posted | Changes from baseline to 6-months | Participants |
| Other Pre-specified | Perceived Cognitive Abilities | Patient Reported Outcomes Measurement Information System (PROMIS) Applied Cognition: (Abilities) This is a brief self-report of perceived cognitive abilities for daily functioning. We will examine whether the intervention alters this subjective/perceived level of cognitive function. Scale 8-40, assess ppt. perceived functional abilities in regard to cognitive tasks. Higher value = higher self-perceived ability in cognition. | Not Posted | Changes from baseline to 6-months | Participants |
| Other Pre-specified | Perceived Cognition for Daily Life | PROMIS Applied Cognition: (General Concerns) This is a brief self-report of perceived difficulties with cognition for daily functioning. We will examine whether the intervention alters this subjective/perceived level of cognitive function. Scale 8-40. Lower score = less cognitive concerns | Not Posted | Changes from baseline to 6-months | Participants |
| Other Pre-specified | Black Identity | The Multidimensional Model of Racial Identity (MMRI) is a model that identifies four dimensions of African American racial identity: salience, centrality, regard, and ideology. We will examine whether racial identity acts as mediator to cognitive performance post-intervention. | Not Posted | 6-month post | Participants |
| Other Pre-specified | Race-Related Stress | The Index of Race-Related Stress (IRRS) is one of the most commonly used measures to assess race-related stress among Black Americans. We will examine whether racial identity acts as mediator to cognitive performance post-intervention. | Not Posted | 6-month post | Participants |
| 0 |
| 75 |
| 4 |
| 75 |
| 12 |
| 75 |
| EG001 | African Cultural Immersion | This is the active control group. Participants will participate in a variety of educational activities related to African Culture, including traditional cooking, lectures, crafts, music and films. They will meet 3 times per week for the same duration as the Dance group. However, they will not participate in aerobic activity during the classes, and most activities will be conducted in a seated position. African Cultural Immersion: The Culture group will participate in activities, including cooking, art and games, music, traditional crafts, and lectures and discussions about other aspects of Africana culture and customs. Topics will vary from session to session to maintain interest and engagement. The sessions will be held in a small group format and will be lead my personnel with training in each topic. Participants will meet 1 hour per day, 3 times per week, for 6 months. | 0 | 76 | 5 | 76 | 10 | 76 |
| Hip replacement | Surgical and medical procedures | Non-systematic Assessment |
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| Fall; Multiple traumatic injuries | Injury, poisoning and procedural complications | Non-systematic Assessment |
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| Eye Surgery | Surgical and medical procedures | Non-systematic Assessment |
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| Ankle/Muscle injury | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
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| Gastro-Intestinal | Gastrointestinal disorders | Non-systematic Assessment |
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| Incidental finding | General disorders | Non-systematic Assessment |
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| Asthma | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
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| Allergy reaction | Immune system disorders | Non-systematic Assessment |
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| Skin disorder | Vascular disorders | Non-systematic Assessment |
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| COVID-19 | Infections and infestations | Non-systematic Assessment |
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Not provided
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