Physical Exercise for Augmenting Cognitive Health (PEACH)

NCT04922710 | Terminated Early Phase 1 Results

• 2 other identifiers: STUDY20120192R24AG065174-01
• Study Type: interventional
• Target: 8
• Locations: 2 countries
• Sites: 2

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.

Conditions

Cognitive Aging; Adverse Childhood Experiences

Keywords

Adverse Childhood Experiences; Brain Health; Cognitive Aging; Exercise; Reversibility Network

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Adherence to Exercise Intervention Program: Number of Sessions Completed

  baseline to 12 weeks

Other Outcomes (14)

• Mean Change in Systolic Blood Pressure

  baseline to 12 weeks

• Mean Change in Physical Activity

  baseline to 12 weeks

• Mean Change in Heart Rate

  baseline to 12 weeks

Study Arms (1)

Home-based aerobic exercise

EXPERIMENTAL

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

Interventions

Home-based aerobic exercise BEHAVIORAL

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.

Home-based aerobic exercise

Eligibility Criteria

• Age: 30 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Pittsburgh: lead
• National Institutes of Health (NIH): collaborator
• National Institute on Aging (NIA): collaborator

Study Sites (2)

Sennott Square

Pittsburgh, Pennsylvania, 15220-2505, United States

Location

University of the West Indies

Kingston, Jamaica

Location

MeSH Terms

Conditions

Motor Activity

Condition Hierarchy (Ancestors)

Behavior

Results Point of Contact

• Title: Kirk Erickson, Director of Translational Neuroscience
• Organization: AdventHealth Research Institute

kirk.erickson@adventhealth.com

412-576-3724

Study Officials

• Kirk I Erickson, PhD

  University of Pittsburgh

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: A single group assigned a remote exercise intervention

Study Record Dates

• First Submitted: June 8, 2021
• First Posted: June 11, 2021
• Study Start: January 4, 2022
• Primary Completion: May 3, 2023
• Study Completion: May 30, 2023
• Last Updated: June 6, 2024
• Results First Posted: June 6, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, CSR, 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.

Locations

JA (1); US (1)