Physical Activity and Community EmPOWERment Project

Part of paid clinical trials in Fayetteville, Arkansas.

Sponsor
University of North Carolina, Chapel Hill
Study ID
NCT06740162
Status
Recruiting
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Conditions

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

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Accepted

Interventions

  • PACE Program — BEHAVIORAL
    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.

Study Details

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.

Key Dates

Start date
Jan 10, 2025
Status verified
Feb 2026
Primary completion
Dec 31, 2027
Completion
Jun 30, 2028

Study Design

Enrollment
376 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: PACE Program
    The 16-week intervention includes: (1) a weekly group fitness class for adults with ID, (2) web-based training and resources for coaches and exercise professionals; (3) weekly coaching meetings for coaches and adults with ID, and (4) daily/weekly interactions with the PACE interactive web-based dashboard for adults with ID.
  • No Intervention: Waitlist Control
    Participants assigned to the Waitlist Control Group will not receive any intervention during this interval. Participants will receive the PACE Program after the completion of the 16-weeks for the Intervention Group.

Primary Outcome Measure

Number of Steps Per Day as Measured by the ActiGraph GT9X Link [ Time Frame: Baseline, post-intervention (16 weeks) ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
University of ArkansasFayettevilleArkansas72701
Melissa N Savage, PhD
[email protected]
479-575-4209
Kara Hume, PhD
[email protected]
919-843-2291
Melissa N Savage, PhD (SUB_INVESTIGATOR)
University of North CarolinaChapel HillNorth Carolina27517
Brianne R Tomaszewski, Ph.D., MPH
[email protected]
919-962-8563
Kara Hume, Ph.D.
[email protected]
919-843-2291
Brianne R Tomaszewski, Ph.D., MPH (PRINCIPAL_INVESTIGATOR)

Find similar trials in Fayetteville, AR

By condition
Autism spectrum disorder
By specialty
Pediatrics
By research site
University of Arkansas· Fayetteville, ARUniversity of North Carolina· Chapel Hill, NC

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