MedTrace Logo

Physical Activity and Community EmPOWERment Project

NCT06740162 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 376

Last updated 2026-02-23

No results posted yet for this study

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.

Conditions

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

Interventions

BEHAVIORAL

PACE 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.

Sponsors & Collaborators

  • National Institute on Aging (NIA)

    collaborator NIH

  • University of North Carolina, Chapel Hill

    lead OTHER

Principal Investigators

  • Brianne R Tomaszewski, PhD., MPH · University of North Carolina, Chapel Hill

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2025-01-10
Primary Completion
2027-12-31
Completion
2028-06-30

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06740162 on ClinicalTrials.gov