Physical Exercise for Augmenting Cognitive Health (PEACH)

Adverse Childhood Experiences Clinical Trial

— PEACH  

Official title:

Physical Exercise for Augmenting Cognitive Health

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04922710
• Other study ID #: STUDY20120192
• Secondary ID: R24AG065174-01
• Status: Terminated
• Phase: Early Phase 1
• Start date: January 4, 2022
• Est. completion date: May 30, 2023

Study information

• Verified date: May 2024
• Source: University of Pittsburgh
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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, contingent on the feasibility. We realized that placing the health-related outcomes as primary or secondary outcomes would only make sense if the approach was feasible. Therefore, we revised the primary and secondary outcome measures to reflect the feasibility of the home-based exercise intervention program in terms of adherence and attendance.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 8
• Est. completion date: May 30, 2023
• Est. primary completion date: May 3, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 30 Years to 55 Years

Eligibility

Inclusion Criteria:

1. adults aged 30-55 years

2. 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

3. Self-identified Black or African American Race

4. access to high-speed internet

5. sedentary lifestyle (<60 minutes of PA/week).

6. no difficulties with mobility

7. Does not currently require the use of an assisted walking device

8. Does not have a history of balance difficulties

9. Not currently pregnant or planning to become pregnant in the next 12 months

Exclusion Criteria:

1. Psychosis

2. Significant suicide risk (i.e., current, active suicidal ideation with a plan)

3. Engaging in moderate-intensity exercise >=20 min per day, >=3 times per week

4. Current treatment for cancer

5. Neurological condition (MS, Parkinson's, Dementia, MCI) or brain injury (Stroke)

6. Substance use disorder in the past 3-months

7. Current treatment for congestive heart failure, angina, uncontrolled arrhythmia, deep vein thrombosis (DVT) or other cardiovascular event

8. Myocardial infarction, coronary artery bypass grafting, angioplasty or other cardiac condition in the past year

9. Sensory Impairment that would preclude neuropsychological testing

10. Not fluent in English

11. Travelling consecutively for 2+ weeks during the study

12. uncontrolled hypertension

13. Insulin-Dependent Diabetes Mellitus

14. Self-identified race anything other than Black or African American

15. Currently pregnant or planning to become pregnant in the next 12 months

Related Conditions & MeSH terms

• Adverse Childhood Experiences
• Cognitive Aging

Intervention

Behavioral:
• Home-based aerobic exercise
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. Participants who are unable to do a 60-minute session would instead complete it in two 30-minute sessions. 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.

Locations

Country	Name	City	State
Jamaica	University of the West Indies	Kingston
United States	Sennott Square	Pittsburgh	Pennsylvania

Sponsors (3)

Lead Sponsor	Collaborator
University of Pittsburgh	National Institute on Aging (NIA), National Institutes of Health (NIH)

Countries where clinical trial is conducted

United States,  Jamaica, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Mean Change in Systolic Blood Pressure	Systolic blood pressure (SBP) will be measured at baseline and 12-weeks to determine whether there is a change in SBP.	baseline to 12 weeks
Other	Mean Change in Physical Activity	Participants will complete one week of actigraphy at baseline and again at follow-up to determine whether physical activity levels change. This will be operationalized as change in average number of steps per day.	baseline to 12 weeks
Other	Mean Change in Heart Rate	Heart rate will be measured throughout the intervention and changes in heart rate from baseline to the end of the intervention will be calculated.	baseline to 12 weeks
Other	Percent Change in Total Body Weight	Participants will be weighed on a calibrated stadiometer both before and after the intervention. The investigators will examine percent changes in body weight before and after the intervention.	baseline to 12 weeks
Other	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
Other	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
Other	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
Other	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
Other	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
Other	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
Other	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
Other	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
Other	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
Other	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
Primary	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	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