Physical Exercise for Augmenting Cognitive Health (PEACH)

Early Phase 1TerminatedNCT04922710

University of Pittsburgh8 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Cognitive Aging Adverse Childhood Experiences

Interventions

Home-based aerobic exerciseBEHAVIORAL

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.

Eligibility

Sex: ALLMin age: 30 YearsMax age: 55 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (2)

Sennott Square

Pittsburgh, Pennsylvania, United States

University of the West Indies

Kingston, Jamaica

Outcomes

Primary Outcomes

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

Secondary Outcomes

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

Data from ClinicalTrials.gov

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