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Physical Activity and Community EmPOWERment (PACE) Project for Adults with Intellectual Disability

This study, called the PACE Project, is testing a 16-week inclusive exercise program for adults aged 18 and older who have an intellectual disability (ID), Neurodevelopmental Disorders, Autism Spectrum Disorder, Down Syndrome, or Fragile X Syndrome. The program, called PACE, involves fitness classes taught by certified specialists. Researchers want to see if participating in the PACE program increases the number of steps you take each day and the amount of moderate-to-vigorous physical activity you get. They will measure these at the beginning of the study and again after 16 weeks. The study aims to enroll 376 participants.

Study design
This is an interventional study with a planned enrollment of 376 participants. It is a wait-list randomized controlled trial, meaning participants will be randomly assigned to either the PACE program or a waiting list.
What's involved
You would undergo screening for eligibility, including cognitive testing and a dementia screener. You would also wear a device to measure physical activity for a week and complete assessments at two study visits, including body composition measurement.
Compensation
Not stated in the trial record.
Follow-up
Your physical activity levels will be measured at the beginning of the study and again after 16 weeks (post-intervention).

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06740162

Physical Activity and Community EmPOWERment Project

Recruiting
NAAges 18+InterventionalTreatment
University of North Carolina, Chapel Hill
~376 participants
Updated 2026-02-23 on ClinicalTrials.gov
What's tested:PACE Program

At a glance

Recruiting sites
1 of 2 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Number of Steps Per Day as Measured by the ActiGraph GT9X Link
Measured over Baseline, post-intervention (16 weeks)
+1 more outcome measured

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

Explore related trials

Alzheimer's DiseaseAutism Spectrum DisorderCornelia De Lange SyndromeCri du Chat SyndromeDown SyndromeFragile X SyndromeIntellectual DisabilityNeurodevelopmental DisorderPrader-Willi SyndromeRubinstein-Taybi SyndromeTrisomy 13 SyndromeWAGR SyndromeWilliams Syndrome

Where it's being run

2 sites across 2 states
Arkansas1
North Carolina1

Study leadership

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

Who to contact

Brianne R Tomaszewski, PhD, MPH
[email protected]
919-962-8563
Email the study team

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Eligibility criteria

Inclusion

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.
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
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.

What this trial measures

  • Number of Steps Per Day as Measured by the ActiGraph GT9X LinkBaseline, post-intervention (16 weeks)

    The Actigraph GT9X Links measures daily step counts. Step counts less than 2500 are classified as basal, step counts between 2500 to 4999 are classified as limited, step counts between 5000 to 7499 are classified as low, step counts between 7500-9999 are classified as somewhat active, step counts between 10000 to 12499 are classified as active, and step counts over 12500 are classified as very active.

  • Minutes of Moderate-to-Vigorous Activity Per Day as Measured by the ActiGraph GT9X LinkBaseline, post-intervention (16 weeks)

    The Actigraph GT9X Links measures activity counts each minute of wear time. Each activity count over 3,941 equals 1 minute of moderate-vigorous physical activity. A total of 150 or more weekly MVPA minutes meets Physical Activity guideline recommendations.