Physical Exercise for Augmenting Cognitive Health (PEACH)

Early Phase 1

Terminated

Conditions: Adverse Childhood Experiences
Cognitive Aging

Interventions: Behavioral: Home-based aerobic exercise

Registration Number: NCT04922710

Lead Sponsor: University of Pittsburgh

Brief 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.

Detailed 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 & Eligibility

Status: TERMINATED

Sex: All

Target Recruitment: 8

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Home-based aerobic exercise	Home-based aerobic exercise	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.

Primary Outcome Measures

Name	Time	Method
Adherence to Exercise Intervention Program: Average Minutes Spent in Moderate to Vigorous Exercise	baseline to 12 weeks	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.

Secondary Outcome Measures

Name	Time	Method
Adherence to Exercise Intervention Program: Number of Sessions Completed	baseline to 12 weeks	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.