Recruiting

Physical Activity

Sponsor:

University of North Carolina, Chapel Hill

Code:

NCT06740162

Conditions

Intellectual Disability

Neurodevelopmental Disorders

Autism Spectrum Disorder

Down Syndrome

Fragile X Syndrome

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Interventions

PACE Program

Study Details

Brief 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

Study ID

NCT06740162

Start date

Jan 10, 2025

Status verified date

Feb, 2026

Completion date

Jun, 2028

Anticipated

Primary completion date

Dec, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Inclusion criteria for adults with ID will include:

  • ages 18 and older with a prior clinical diagnosis of ID, confirmed by scores < 70 and + 90% on the Leiter-3 International Performance Scales and/or an adaptive behavior measure using the Vineland Adaptive Behavior Scales,
  • Medical clearance to participate in moderate-to-vigorous physical activity as determined by the American College of Sports Medicine (ACSM) preparticipation algorithm,
  • Adult does not show clinically elevated symptoms of Alzheimer's Disease (AD)/ Alzheimer's Disease and Related Dementias (ADRD) as indicated by a score of < 20 on the Dementia Screening Questionnaire for Individuals with Intellectual Disabilities.
  • One caregiver/guardian is able and willing to participate.
  • must tolerate at least 8 hours of daily wear-time of Actigraph device during initial assessment period (4 of 7 days),
  • must average 20 minutes or less of moderate to vigorous physical activity (MVPA) minutes per day (140 MVPA minutes or less across 7-day period measured during the initial assessment period, and
  • must reside in North Carolina or Arkansas.

Exclusion Criteria for adults with ID:

• Diagnosis of AD, dementia, or related disorders. Participants will not be excluded based on gender, race, or ethnicity. There will be no upper age limit due to the heterogeneity of onset of AD/ADRD in individuals with ID.

Inclusion criteria for coach will include:

  • access to the internet and a mobile device,
  • has weekly contact with the adult participant with ID,
  • can converse and read in English to comprehend intervention materials and website content, and
  • must reside in North Carolina or Arkansas

Inclusion criteria for caregiver will include:

  • ability to converse and read in English to comprehend and answer interview questions, (2) must care for an adult with ID who is willing to participate in the study,
  • must reside in North Carolina or Arkansas, and
  • must attend all study visits with adult with ID.

Study Design

Enrollment

376 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

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.

Interventions

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.

Primary outcome measure

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

Central Contacts and Locations

Central contacts

Brianne R Tomaszewski, PhD, MPH

919-962-8563Brianne_Tomaszewski@med.unc.edu

Kara Hume, PhD

919-843-2291kara.hume@unc.edu

Locations

University of North Carolina

Recruiting

Chapel Hill, North Carolina, United States, 27517

Contacts

Brianne R Tomaszewski, Ph.D., MPH

919-962-8563Brianne_Tomaszewski@med.unc.edu

Kara Hume, Ph.D.

919-843-2291kara.hume@unc.edu

Principal Investigator:

Brianne R Tomaszewski, Ph.D., MPH

More Information

Sponsor

University of North Carolina, Chapel Hill

Last update posted

Feb 23, 2026

Last verified

Feb, 2026

Keywords

  • physical activity
  • intellectual disability
  • age-associated memory impairment
  • aging
  • Alzheimer Disease prevention

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by University of North Carolina, Chapel Hill on 2026-02-23.