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Rhythm Experience and Africana Culture Trial

Rhythm Experience and Africana Culture Trial II

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03771716
Acronym
REACT
Enrollment
151
Registered
2018-12-11
Start date
2019-05-21
Completion date
2024-08-16
Last updated
2025-08-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Brain Structure, Cognitive Performance

Brief summary

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.

Detailed description

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.

Interventions

BEHAVIORALAfrican 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.

BEHAVIORALAfrican 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.

Sponsors

National Institute on Aging (NIA)
CollaboratorNIH
University of Pittsburgh
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
DOUBLE (Investigator, Outcomes Assessor)

Masking description

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.

Intervention model description

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.

Eligibility

Sex/Gender
ALL
Age
60 Years to 80 Years
Healthy volunteers
Yes

Inclusion criteria

* self identifies race as African American * between 60 and 80 years of age * ambulatory without pain or the assistance of walking devices * no history of falls or balance problems * able to speak and read English * available during the times classes are offered and able to make at least 80% of classes (e.g., no long-term travel plans) * reliable means of transportation * scores above the range on the Brief Telephone Interview for Cognitive Status (TICS) indicative of moderate to severe cognitive impairment (scores 21 or above) * no diagnosis of a neurological disease or psychiatric conditions * eligible to undergo MRI (not claustrophobic and no metal or history of injury involving metal). * Fully vaccinated for coronavirus disease (COVID-19).

Exclusion criteria

* self identifies race as other than African American * not between 60 and 80 years of age * not ambulatory without pain or the assistance of walking devices * history of falls or balance problems * unable to speak and read English * unavailable during the times classes are offered or unable to make at least 80% of classes (e.g., indicates long-term travel plans during intervention period) * no reliable means of transportation * scores in range on the TICS indicative of moderate to severe cognitive impairment (scores 21 or below) * has a diagnosis of a neurological disease or psychiatric condition * ineligible to undergo MRI (claustrophobic and/or metal in body or history of injury involving metal).

Design outcomes

Primary

MeasureTime frameDescription
Flanker PerformanceChanges from baseline to 6-monthsA 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.

Secondary

MeasureTime frameDescription
Hippocampal Volume (mm3)Changes from baseline to 6-monthsStructural 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.

Other

MeasureTime frameDescription
Cardiorespiratory FitnessChanges from baseline to 6-monthsThe 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.
Functional FitnessChanges from baseline to 6-monthsSenior 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.
Actigraphy Steps Per DayChanges from baseline to 6-monthsThe 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.
Change in Exercise FrequencyChanges from baseline to 6-monthsExercise 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.
Change in Exercise IntensityChanges from baseline to 6-monthsExercise 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.
Change in Exercise DurationChanges from baseline to 6-monthsExercise 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.
WeightChanges from baseline to 6-monthsParticipants 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.
Change in Hippocampal Subfield VolumesChanges from baseline to 6-monthsMRI will be used to measure volumetric changes in hippocampal subfields.
Change in White Matter LesionsChanges from baseline to 6-monthsMRI will be used to measure changes in white matter microstructure in relation to the intervention.
Change in White Matter Diffusion PropertiesChanges from baseline to 6-monthsMRI will be used to measure changes in white matter microstructure in relation to the intervention.
Change in Cerebral Blood FlowChanges from baseline to 6-monthsMRI will be used to measure changes in cerebral blood flow. Total cerebral blood flow changes over the course of the intervention will be evaluated.
Change in Resting State Brain ActivityChanges from baseline to 6-monthsMRI will be used to measure changes in resting state brain function. We will examine whether the intervention alters resting state connectivity metrics.
Change in Task-evoked Relational Memory Brain ActivityChanges from baseline to 6-monthsMRI will be used to measure changes in encoding and retrieval during a relational memory task.
Change in Task-evoked Working Memory Brain ActivityChanges from baseline to 6-monthsMRI will be used to measure changes in brain activity task-evoked patterns using an N-back working memory task.
Change in Cortical ThicknessChanges from baseline to 6-monthsMRI will be used to measure average cortical thickness over the course of the intervention.
Changes in Blood Levels of CholesterolChanges from baseline to 6-monthsThe 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.
Change in Blood Levels of GlucoseChanges from baseline to 6-monthsThe investigators will examine whether changes in markers of insulin resistance change over the course of the intervention and whether these changes mediate neurocognitive outcomes.
Change in Blood Levels of HemoglobinChanges from baseline to 6-monthsThe investigators are collecting data on changes in average blood sugar levels (HbA1C)
Socioeconomic Status (SES) CompositeBaselineCombining 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.
Health History & Lifestyle HabitsChanges from baseline to 6-monthsHealth 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.
DepressionChanges from baseline to 6-monthsThe 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.
LonelinessChanges from baseline to 6-monthsThe 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.
MindfulnessChanges from baseline to 6-monthsThe 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.
Positive and Negative AffectChanges from baseline to 6-monthsThe 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.
State Trait Anxiety Inventory (STAI)Changes from baseline to 6-monthsThe 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.
Perceived PainChanges from baseline to 6-monthsThe 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.
Perceived FatigabilityChanges from baseline to 6-monthsThe 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.
Levels of InactivityChanges from baseline to 6-monthsSitting 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)
Lifestyle Physical ActivitiesChanges from baseline to 6-monthsThe 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.
Perceived Sleep QualityChanges from baseline to 6-monthsPittsburgh 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.
Exercise Self-EfficacyChanges from baseline to 6-monthsThe 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
Barriers to Exercise (BARSE)Changes from baseline to 6-monthsBARSE 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
Social ProvisionsChanges from baseline to 6-monthsSocial 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)
Physical Activity Self-RegulationChanges from baseline to 6-monthsPhysical 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
Perceived Weight DiscriminationChanges from baseline to 6-monthsHunger 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.
Perceived Health & Quality of LifeChanges from baseline to 6-monthsThe 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.
Life SatisfactionChanges from baseline to 6-monthsWe 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.
Subjective Cognitive PerformanceChanges from baseline to 6-monthsEveryday 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.
Change in Cognitive FunctionChanges from baseline to 6-monthsInvestigators 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.
Perceived Cognition for Daily LifeChanges from baseline to 6-monthsPROMIS 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
Black Identity6-month postThe 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.
Race-Related Stress6-month postThe 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.
Perceived Cognitive AbilitiesChanges from baseline to 6-monthsPatient 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.
Medication UseChanges from baseline to 6-monthsWe 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.

Countries

United States

Participant flow

Participants by arm

ArmCount
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.
75
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.
76
Total151

Baseline characteristics

CharacteristicAfrican DanceAfrican Cultural ImmersionTotal
Age, Continuous67.23 years
STANDARD_DEVIATION 4.94
67.11 years
STANDARD_DEVIATION 4.58
67.17 years
STANDARD_DEVIATION 4.75
Cardiorespiratory fitness (VO2peak)16.45 mL/kg/min
STANDARD_DEVIATION 4.12
15.89 mL/kg/min
STANDARD_DEVIATION 3.83
16.17 mL/kg/min
STANDARD_DEVIATION 3.98
Ethnicity (NIH/OMB)
Hispanic or Latino
4 Participants2 Participants6 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
71 Participants74 Participants145 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
0 Participants0 Participants0 Participants
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Asian
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Black or African American
74 Participants71 Participants145 Participants
Race (NIH/OMB)
More than one race
1 Participants5 Participants6 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Unknown or Not Reported
0 Participants0 Participants0 Participants
Race (NIH/OMB)
White
0 Participants0 Participants0 Participants
Sex: Female, Male
Female
64 Participants63 Participants127 Participants
Sex: Female, Male
Male
11 Participants13 Participants24 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
0 / 750 / 76
other
Total, other adverse events
12 / 7510 / 76
serious
Total, serious adverse events
4 / 755 / 76

Outcome results

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.

Time frame: Changes from baseline to 6-months

Population: All participants data were included, as we conducted intention-to-treat (ITT) analysis.

ArmMeasureValue (LEAST_SQUARES_MEAN)
African DanceFlanker Performance-0.1055 score on a scale
African Cultural ImmersionFlanker Performance-0.0586 score on a scale
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.

Time frame: Changes from baseline to 6-months

Population: All participants data were included, as we conducted intention-to-treat (ITT) analysis.

ArmMeasureValue (LEAST_SQUARES_MEAN)
African DanceHippocampal Volume (mm3)-7.57 cubic millimeters (mm³)
African Cultural ImmersionHippocampal Volume (mm3)-59.71 cubic millimeters (mm³)
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.

Time frame: Changes from baseline to 6-months

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

Time frame: Changes from baseline to 6-months

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.

Time frame: 6-month post

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.

Time frame: Changes from baseline to 6-months

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.

Time frame: Changes from baseline to 6-months

Other Pre-specified

Change in Blood Levels of Hemoglobin

The investigators are collecting data on changes in average blood sugar levels (HbA1C)

Time frame: Changes from baseline to 6-months

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.

Time frame: Changes from baseline to 6-months

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.

Time frame: Changes from baseline to 6-months

Other Pre-specified

Change in Cortical Thickness

MRI will be used to measure average cortical thickness over the course of the intervention.

Time frame: Changes from baseline to 6-months

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.

Time frame: Changes from baseline to 6-months

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.

Time frame: Changes from baseline to 6-months

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.

Time frame: Changes from baseline to 6-months

Other Pre-specified

Change in Hippocampal Subfield Volumes

MRI will be used to measure volumetric changes in hippocampal subfields.

Time frame: Changes from baseline to 6-months

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.

Time frame: Changes from baseline to 6-months

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.

Time frame: Changes from baseline to 6-months

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.

Time frame: Changes from baseline to 6-months

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.

Time frame: Changes from baseline to 6-months

Other Pre-specified

Change in White Matter Lesions

MRI will be used to measure changes in white matter microstructure in relation to the intervention.

Time frame: Changes from baseline to 6-months

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.

Time frame: Changes from baseline to 6-months

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.

Time frame: Changes from baseline to 6-months

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

Time frame: Changes from baseline to 6-months

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.

Time frame: Changes from baseline to 6-months

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.

Time frame: Changes from baseline to 6-months

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)

Time frame: Changes from baseline to 6-months

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.

Time frame: Changes from baseline to 6-months

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.

Time frame: Changes from baseline to 6-months

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.

Time frame: Changes from baseline to 6-months

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.

Time frame: Changes from baseline to 6-months

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.

Time frame: Changes from baseline to 6-months

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

Time frame: Changes from baseline to 6-months

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.

Time frame: Changes from baseline to 6-months

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.

Time frame: Changes from baseline to 6-months

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.

Time frame: Changes from baseline to 6-months

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.

Time frame: Changes from baseline to 6-months

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.

Time frame: Changes from baseline to 6-months

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.

Time frame: Changes from baseline to 6-months

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

Time frame: Changes from baseline to 6-months

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.

Time frame: Changes from baseline to 6-months

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.

Time frame: 6-month post

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)

Time frame: Changes from baseline to 6-months

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.

Time frame: Baseline

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.

Time frame: Changes from baseline to 6-months

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.

Time frame: Changes from baseline to 6-months

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.

Time frame: Changes from baseline to 6-months

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026