Physical Exercise for Augmenting Cognitive Health (PEACH)

University of Pittsburgh

Status and phase: Terminated; Early Phase 1

Conditions: Cognitive Aging; Adverse Childhood Experiences

Treatments: Behavioral: Home-based aerobic exercise

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT04922710

R24AG065174-01 (U.S. NIH Grant/Contract)

STUDY20120192

Details and patient eligibility

About

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.

Full 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.

Enrollment: 8 patients

Sex: All

Ages: 30 to 55 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

8 participants in 1 patient group

Home-based aerobic exercise

Experimental group

Description:

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.

Treatment:

Behavioral: Home-based aerobic exercise