- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03771716
Rhythm Experience and Africana Culture Trial (REACT)
August 11, 2025 updated by: Kirk Erickson, PhD, University of Pittsburgh
Rhythm Experience and Africana Culture Trial II
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Actual)
151
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Pennsylvania
-
Pittsburgh, Pennsylvania, United States, 15260
- University of Pittsburgh
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
56 years to 76 years (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Description
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).
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: 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.
|
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.
Other Names:
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Active Comparator: 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.
|
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.
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Flanker Performance
Time Frame: Changes from baseline to 6-months
|
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.
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Changes from baseline to 6-months
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Hippocampal Volume (mm3)
Time Frame: Changes from baseline to 6-months
|
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.
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Changes from baseline to 6-months
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Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Weight
Time Frame: Changes from baseline to 6-months
|
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.
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Changes from baseline to 6-months
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Loneliness
Time Frame: Changes from baseline to 6-months
|
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.
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Changes from baseline to 6-months
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Depression
Time Frame: Changes from baseline to 6-months
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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.
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Changes from baseline to 6-months
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Change in Cognitive Function
Time Frame: Changes from baseline to 6-months
|
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.
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Changes from baseline to 6-months
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Health History & Lifestyle Habits
Time Frame: Changes from baseline to 6-months
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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.
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Changes from baseline to 6-months
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Positive and Negative Affect
Time Frame: Changes from baseline to 6-months
|
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.
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Changes from baseline to 6-months
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Perceived Pain
Time Frame: Changes from baseline to 6-months
|
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.
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Changes from baseline to 6-months
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Perceived Fatigability
Time Frame: Changes from baseline to 6-months
|
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.
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Changes from baseline to 6-months
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Levels of Inactivity
Time Frame: Changes from baseline to 6-months
|
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)
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Changes from baseline to 6-months
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Lifestyle Physical Activities
Time Frame: Changes from baseline to 6-months
|
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.
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Changes from baseline to 6-months
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Perceived Sleep Quality
Time Frame: Changes from baseline to 6-months
|
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.
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Changes from baseline to 6-months
|
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Exercise Self-Efficacy
Time Frame: Changes from baseline to 6-months
|
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
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Social Provisions
Time Frame: Changes from baseline to 6-months
|
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)
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Changes from baseline to 6-months
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Physical Activity Self-Regulation
Time Frame: Changes from baseline to 6-months
|
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
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Changes from baseline to 6-months
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Perceived Weight Discrimination
Time Frame: Changes from baseline to 6-months
|
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.
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Changes from baseline to 6-months
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Life Satisfaction
Time Frame: Changes from baseline to 6-months
|
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.
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Changes from baseline to 6-months
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Subjective Cognitive Performance
Time Frame: Changes from baseline to 6-months
|
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.
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Changes from baseline to 6-months
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Perceived Cognition for Daily Life
Time Frame: Changes from baseline to 6-months
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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
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Changes from baseline to 6-months
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Black Identity
Time Frame: 6-month post
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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.
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6-month post
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Race-Related Stress
Time Frame: 6-month post
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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.
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6-month post
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Medication Use
Time Frame: Changes from baseline to 6-months
|
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
|
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Cardiorespiratory Fitness
Time Frame: Changes from baseline to 6-months
|
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
|
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Functional Fitness
Time Frame: Changes from baseline to 6-months
|
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
|
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Actigraphy Steps Per Day
Time Frame: Changes from baseline to 6-months
|
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
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Change in Exercise Frequency
Time Frame: Changes from baseline to 6-months
|
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
|
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Change in Exercise Intensity
Time Frame: Changes from baseline to 6-months
|
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
|
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Change in Exercise Duration
Time Frame: Changes from baseline to 6-months
|
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
|
|
Change in Hippocampal Subfield Volumes
Time Frame: Changes from baseline to 6-months
|
MRI will be used to measure volumetric changes in hippocampal subfields.
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Changes from baseline to 6-months
|
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Change in White Matter Lesions
Time Frame: Changes from baseline to 6-months
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MRI will be used to measure changes in white matter microstructure in relation to the intervention.
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Changes from baseline to 6-months
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Change in White Matter Diffusion Properties
Time Frame: Changes from baseline to 6-months
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MRI will be used to measure changes in white matter microstructure in relation to the intervention.
|
Changes from baseline to 6-months
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Change in Cerebral Blood Flow
Time Frame: Changes from baseline to 6-months
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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.
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Changes from baseline to 6-months
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Change in Resting State Brain Activity
Time Frame: Changes from baseline to 6-months
|
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
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Change in Task-evoked Relational Memory Brain Activity
Time Frame: Changes from baseline to 6-months
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MRI will be used to measure changes in encoding and retrieval during a relational memory task.
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Changes from baseline to 6-months
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Change in Task-evoked Working Memory Brain Activity
Time Frame: Changes from baseline to 6-months
|
MRI will be used to measure changes in brain activity task-evoked patterns using an N-back working memory task.
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Changes from baseline to 6-months
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Change in Cortical Thickness
Time Frame: Changes from baseline to 6-months
|
MRI will be used to measure average cortical thickness over the course of the intervention.
|
Changes from baseline to 6-months
|
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Changes in Blood Levels of Cholesterol
Time Frame: Changes from baseline to 6-months
|
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.
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Changes from baseline to 6-months
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Change in Blood Levels of Glucose
Time Frame: Changes from baseline to 6-months
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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.
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Changes from baseline to 6-months
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Change in Blood Levels of Hemoglobin
Time Frame: Changes from baseline to 6-months
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The investigators are collecting data on changes in average blood sugar levels (HbA1C)
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Changes from baseline to 6-months
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Socioeconomic Status (SES) Composite
Time Frame: Baseline
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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.
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Baseline
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Mindfulness
Time Frame: Changes from baseline to 6-months
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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.
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Changes from baseline to 6-months
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State Trait Anxiety Inventory (STAI)
Time Frame: Changes from baseline to 6-months
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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.
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Changes from baseline to 6-months
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Barriers to Exercise (BARSE)
Time Frame: Changes from baseline to 6-months
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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
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Changes from baseline to 6-months
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Perceived Health & Quality of Life
Time Frame: Changes from baseline to 6-months
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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.
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Changes from baseline to 6-months
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Perceived Cognitive Abilities
Time Frame: Changes from baseline to 6-months
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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.
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Changes from baseline to 6-months
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Kirk I Erickson, PhD, University of Pittsburgh
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
May 21, 2019
Primary Completion (Actual)
July 25, 2024
Study Completion (Actual)
August 16, 2024
Study Registration Dates
First Submitted
November 30, 2018
First Submitted That Met QC Criteria
December 8, 2018
First Posted (Actual)
December 11, 2018
Study Record Updates
Last Update Posted (Actual)
August 13, 2025
Last Update Submitted That Met QC Criteria
August 11, 2025
Last Verified
August 1, 2025
More Information
Terms related to this study
Other Study ID Numbers
- STUDY19020263
- 1R01AG060741-01 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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