An Early Phase 1 interventional study of Home-based aerobic exercise in Cognitive Aging and Adverse Childhood Experiences, sponsored by University of Pittsburgh. Terminated at 2 sites in 2 countries. Open to participants aged 30 Years to 55 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-06-06.
Sponsored by University of Pittsburgh · Early Phase 1, Interventional, and Treatment
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.
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.
9,798 studies on the registry are indexed under Motor Activity; 1,910 are open to participants now.
This study's enrollment of 8 is below the median of 60 across 8,388 interventional studies indexed under Motor Activity.
Browse Motor Activity studies →University of Pittsburgh is the lead sponsor of 1,419 studies on the registry; 168 are open to participants now.
Of its 9 completed or terminated interventional studies of FDA-regulated products, 4 (44%) have results posted.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Un-supervised exercise will be held 3 times a week for 60 minutes in the participant's home. Those who are unable to do a 60-minute session would instead complete it in two 30-minute sessions to reach the goal of exercising 150 minutes per week.
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.
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.
Time frame: baseline to 12 weeks
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.
Time frame: baseline to 12 weeks
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.
Time frame: baseline to 12 weeks
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.
Time frame: baseline to 12 weeks
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.
Time frame: baseline to 12 weeks
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.
Time frame: baseline to 12 weeks
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.
Time frame: 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.
Time frame: 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).
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: baseline to 12 weeks
| Milestone | Home-based Aerobic Exercise |
|---|---|
| Started | 5 |
| Completed | 4 |
| Not completed | 1 |
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.
| Minutes | Home-based Aerobic Exercise |
|---|---|
| Adherence to Exercise Intervention Program: Average Minutes Spent in Moderate to Vigorous Exercise | 1578.5 ± 721.73 |
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.
| Number of sessions | Home-based Aerobic Exercise |
|---|---|
| Adherence to Exercise Intervention Program: Number of Sessions Completed | 51.25 ± 13.15 |
Systolic blood pressure (SBP) will be measured at baseline and 12-weeks to determine whether there is a change in SBP.
Results for this outcome have not been posted.
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.
Results for this outcome have not been posted.
Heart rate will be measured throughout the intervention and changes in heart rate from baseline to the end of the intervention will be calculated.
Results for this outcome have not been posted.
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.
Results for this outcome have not been posted.
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.
Results for this outcome have not been posted.
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.
Results for this outcome have not been posted.
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).
Results for this outcome have not been posted.
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.
Results for this outcome have not been posted.
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.
Results for this outcome have not been posted.
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.
Results for this outcome have not been posted.
Data regarding the average duration of sessions will be collected to operationalize adherence. Adherence will be used as a metric of feasibility and acceptability.
Results for this outcome have not been posted.
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.
Results for this outcome have not been posted.
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.
Results for this outcome have not been posted.
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.
Results for this outcome have not been posted.
Collected over 6 months. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Home-based Aerobic Exercise | 0/5 (0%) | 0/5 (0%) | 0/5 (0%) |
| Age, Continuous(years) | Home-based Aerobic Exercise |
|---|---|
| Mean | 40.40 ± 9.94 |
| Sex: Female, Male(Participants) | Home-based Aerobic Exercise |
|---|---|
| Female | 4 |
| Male | 1 |
| Ethnicity (NIH/OMB)(Participants) | Home-based Aerobic Exercise |
|---|---|
| Hispanic or Latino | 0 |
| Not Hispanic or Latino | 5 |
| Unknown or Not Reported | 0 |
| Race (NIH/OMB)(Participants) | Home-based Aerobic Exercise |
|---|---|
| American Indian or Alaska Native | 0 |
| Asian | 0 |
| Native Hawaiian or Other Pacific Islander | 0 |
| Black or African American | 5 |
| White | 0 |
| More than one race | 0 |
| Unknown or Not Reported | 0 |
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: Yes — The data from this study will be made available to outside investigators under a data-sharing agreement. The data will be available to outside investigators after publication of the primary aims and at completion of quality control assessments and data organization. The investigators expect that the data from this study will result in interest from internal and external investigators for secondary analysis and ancillary projects.
Supporting information: Study protocol, Clinical study report, Analytic code
Time frame: Will be made available after study investigators have published summary data and primary aims results. Will be available for unlimited amount of time.
Access criteria: Data requests will be approved by the PI and Co-PIs.
This study is terminated, as verified in May 2024. You cannot join it, but the record below documents what was studied.
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