RecruitingNot ApplicableNCT06740162

Physical Activity and Community EmPOWERment Project

A Stage 1 Pilot Test for Feasibility and Efficacy of a Multi-Level Intervention to Increase Physical Activity in Adults With Intellectual Disability: Physical Activity and Community EmPOWERment (PACE)

Sponsor

University of North Carolina, Chapel Hill

Enrollment

376 participants

Start Date

Jan 10, 2025

Study Type

INTERVENTIONAL

Conditions

Williams Syndrome WAGR Syndrome Prader-Willi Syndrome Fragile X Syndrome Autism Spectrum Disorder Neurodevelopmental Disorders Down Syndrome Intellectual Disability Cri-du-Chat Syndrome De Lange Syndrome Mental Retardation, X-Linked Rubinstein-Taybi Syndrome Trisomy 13 Syndrome

Summary

Purpose: Conduct a wait-list randomized controlled trial (RCT) of an inclusive physical activity program called PACE for adults with intellectual disability (ID) who are not yet showing signs of Alzheimer's Disease (AD)/age-related dementias (ARD). Participants: Participants include 120 adults with ID, their caregivers, and their coaches (up to 360 individual participants, grouped as triads), recruited through the University of North Carolina at Chapel Hill and the University of Arkansas. Participants also include 16 exercise professionals. Procedures (methods): Each cohort will include 20 triads who are randomly assigned to the PACE program or the waitlist control group.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study tests a community-based physical activity program designed specifically for adults with intellectual disabilities (ID). It aims to increase participation in moderate-to-vigorous physical activity and improve overall health and community involvement among this underserved population. **You may be eligible if...** - You are 18 or older and have a prior clinical diagnosis of intellectual disability - You have medical clearance to participate in moderate-to-vigorous physical activity - You do not show signs of Alzheimer's disease or significant cognitive decline - A caregiver or support person is available to assist with participation if needed **You may NOT be eligible if...** - You have clinically significant symptoms of Alzheimer's disease or related dementia - You are not medically cleared for physical activity - You do not have the required level of intellectual disability based on assessment scores Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

BEHAVIORALPACE Program

The PACE program is a 16-week inclusive exercise program taught and adapted by certified Inclusive Fitness Specialists. Study participants, called athletes, will engage in the fitness class with non-study participants with and without disabilities. Athlete participants will also meet weekly with their coaches (also study participants) to discuss goal setting and interact with the web-based dashboard.

Locations(2)

University of Arkansas

Fayetteville, Arkansas, United States

University of North Carolina

Chapel Hill, North Carolina, United States

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NCT06740162

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