Physical Exercise for Augmenting Cognitive Health (PEACH)

Study Overview
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Brief Summary
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PEACH is a pilot project which is being conducted to determine the feasibility and acceptability of a 12-week home-based exercise intervention among Black and African American adults. A secondary aim of the project is to determine whether the exercise intervention improves cognitive and psychological functioning.

Detailed Description
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This pilot project aims to address the impact of early life adversity (ELA) on brain health in adulthood by conducting a pilot 12-week physical activity (PA) intervention delivered remotely using aerobic exercise bikes programmed to connect users with a trainer via an app. Investigators will recruit Black and African American individuals between the ages of 30-55 years (N = 40) who are currently sedentary and report experiencing at least one form of ELA prior to the age of 10. This study will be conducted at two sites: the University of Pittsburgh in Pittsburgh, PA, USA and the University of the West Indies in Kingston, Jamaica (site investigator: Terrence Forrester). At baseline and following the 12-week intervention, Investigators will collect a harmonized battery of cognitive, behavioral and psychosocial measures. The intervention itself will be home-based and will involve three 60-minute sessions of aerobic exercise per week using a Bluetooth-enable exercise bike. Participants' exercise programs will be supervised remotely by an exercise trainer and individualized depending on their age-adjusted heart rate reserve, with the goal being to have participants reach 50 minutes of moderate to vigorous intensity exercise per session by the end of the first 4 weeks of the intervention. The bikes will be outfitted with a tablet featuring an application called Neotiv. The Neotiv application will collect data from the bike regarding timing, duration, and intensity of exercise sessions, which will be securely shared with the exercise trainer to monitor attendance and adherence. The primary goals of this study are to determine whether the home-based exercise program (1) is feasible and acceptable (as measured by adherence and attendance), and (2) promotes improvements in cognitive and psychological functioning among adults who have been exposed to ELA.

Official Title
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Physical Exercise for Augmenting Cognitive Health

Conditions
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Cognitive Aging, Adverse Childhood Experiences

Intervention / Treatment
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* Behavioral: Home-based aerobic exercise


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: adults aged 30-55 years exposure to at least one form of threat-related adversity (e.g., exposure to violence; physical abuse) occurring prior to age 10 as documented by retrospective self-report Self-identified Black or African American Race access to high-speed internet sedentary lifestyle (<60 minutes of PA/week). no difficulties with mobility Does not currently require the use of an assisted walking device Does not have a history of balance difficulties Not currently pregnant or planning to become pregnant in the next 12 months Exclusion Criteria: Psychosis Significant suicide risk (i.e., current, active suicidal ideation with a plan) Engaging in moderate-intensity exercise >=20 min per day, >=3 times per week Current treatment for cancer Neurological condition (MS, Parkinson's, Dementia, MCI) or brain injury (Stroke) Substance use disorder in the past 3-months Current treatment for congestive heart failure, angina, uncontrolled arrhythmia, deep vein thrombosis (DVT) or other cardiovascular event Myocardial infarction, coronary artery bypass grafting, angioplasty or other cardiac condition in the past year Sensory Impairment that would preclude neuropsychological testing Not fluent in English Travelling consecutively for 2+ weeks during the study uncontrolled hypertension Insulin-Dependent Diabetes Mellitus Self-identified race anything other than Black or African American Currently pregnant or planning to become pregnant in the next 12 months

Ages Eligible for Study
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Minimum Age: 30 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Interventional Model Description: A single group assigned a remote exercise intervention
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Home-based aerobic exercise<br>Un-supervised exercise will be held 3 times a week for 60 minutes in the participant's home | Behavioral: Home-based aerobic exercise<br>* Guidelines for exercise programming (ACSM, 2018) will be followed including a warmup and cool down, progressive and gradual increments in duration, and instruction regarding avoidance of physical activity related injury. The exercise group will receive moderate to vigorous intensity aerobic exercise for 60 minutes per day, three times a week, for 12 weeks. The prescribed intensity will be based on estimated heart rate reserve, calculated using resting heart rate and age-adjusted heart rate maximum (220-age in years). Participants will maintain a minimum heart rate from their specific calculation that will be monitored by Polar Heart Rate straps.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adherence to exercise intervention program: Number of sessions completed | Data regarding the number of exercise sessions completed will be collected to operationalize adherence. Adherence will be used as a metric of feasibility and acceptability. | baseline to 12 weeks | 
| Adherence to exercise intervention program: Average duration of sessions | Data regarding the average duration of sessions will be collected to operationalize adherence. Adherence will be used as a metric of feasibility and acceptability. | baseline to 12 weeks | 
| Adherence to exercise intervention program: Average minutes spent in moderate to vigorous exercise | Data regarding the average number of minutes spent engaging in moderate to vigorous exercise (via heart rate monitoring and comparison of heart rate to calculations based on heart rate reserve) will be collected to operationalize adherence. Adherence will be used as a metric of feasibility and acceptability. | baseline to 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean change in negative and positive affect | This will be calculated via scores from the Positive and Negative Affect Scale. Scores can range from 1 to 100, with 1 meaning less positive affect and 100 meaning more positive affect. | baseline to 12 weeks | 
| Mean change in depressive symptoms | Participants will complete the Center for Epidemiological Studies-Depression Scale, a measure of the frequency of 20 common depressive symptoms rated along a 0 (rarely or none of the time) to 3 (most or all of the time) Likert scale. Responses are summed to yield a total symptom score (maximum possible score of 60) with higher scores reflecting more severe depressive symptoms. | baseline to 12 weeks | 
| Mean change in perceived stress | Participants will complete the Perceived Stress Scale (PSS) a measure of the frequency of 20 common depressive symptoms rated along a 0 (rarely or non, a 14-item measure that assesses experiences of daily life stress. The PSS is an instrument on which respondents use a 0 (never) to 4 (very often) Likert scale to rate the degree to which daily life events are perceived to be uncontrollable, unpredictable, or unmanageable. Responses are summed to form a total score (maximum possible score of 56). | baseline to 12 weeks | 
| Mean change in Flanker performance | A Flanker task will be administered at baseline, and then following the intervention (12-weeks). The main outcome from this task is an interference effect (in ms) which indicates how much longer it takes for a participant to make a directional response to a center arrow when the flanking arrows are arranged in congruent vs. incongruent direction from the center stimulus. A higher interference effect indicates worse executive functioning. | baseline to 12 weeks | 
| Mean change in Picture Sequence performance | A Picture Sequence task will be administered at baseline, and then following the intervention (12-weeks). The main outcome from this task is the cumulative number of adjacent pictures in which a participant correctly remembered the sequence. A lower number of correct items indicates worse episodic memory. | baseline to 12 weeks | 
| Mean change in Dimensional Card Sort performance | A Dimensional Card Sort task will be administered at baseline, and then following the intervention (12-weeks). The main outcome from this task is an interference effect (in ms) which indicates how much longer it takes for a participant to match a stimulus to other choice stimuli based on a feature (shape or color), with the feature participants must match on switching without warning during the task. A higher interference effect indicates worse executive functioning. | baseline to 12 weeks | 
| Mean change in List Sorting performance | A List Sorting task will be administered at baseline, and then following the intervention (12-weeks). Participants will be presented with a series of stimuli and then be asked to repeat the stimuli in order of size from smallest to largest. The main outcome from this task is total items answered correctly, with a lower scoring being indicative or worse working memory. | baseline to 12 weeks | 
| Mean change in Pattern Comparison performance | A Pattern Comparison task will be administered at baseline, and then following the intervention (12-weeks). Participants will be presented with visual patterns and asked to respond whether the patterns are the same or different. The main outcome from this task is total items answered correctly in the 90 seconds allotted for the task, with a lower number of items being indicative or worse processing speed. | baseline to 12 weeks | 
| Mean change in Picture Vocabulary performance | A Picture Vocabulary task will be administered at baseline, and then following the intervention (12-weeks). Participants will be presented with visual stimuli along with an auditory cue and will have to judge which of the visual stimuli match the auditory cue. The main outcome from this task is total items answered correctly, with a lower number of items being indicative or worse language ability. | baseline to 12 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Adverse Childhood Experiences, Brain Health, Cognitive Aging, Exercise, Reversibility Network