NCT06740162 Physical Activity and Community EmPOWERment Project
| NCT ID | NCT06740162 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of North Carolina, Chapel Hill |
| Condition | Intellectual Disability |
| Study Type | INTERVENTIONAL |
| Enrollment | 376 participants |
| Start Date | 2025-01-10 |
| Primary Completion | 2027-12 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 376 participants in total. It began in 2025-01-10 with a primary completion date of 2027-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
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.
Contact & Investigator
Brianne R Tomaszewski, PhD., MPH
PRINCIPAL INVESTIGATOR
University of North Carolina, Chapel Hill
Frequently Asked Questions
Who can join the NCT06740162 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Intellectual Disability. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06740162 currently recruiting?
Yes, NCT06740162 is actively recruiting participants. Contact the research team at Brianne_Tomaszewski@med.unc.edu for enrollment information.
Where is the NCT06740162 trial being conducted?
This trial is being conducted at Fayetteville, United States, Chapel Hill, United States.
Who is sponsoring the NCT06740162 clinical trial?
NCT06740162 is sponsored by University of North Carolina, Chapel Hill. The principal investigator is Brianne R Tomaszewski, PhD., MPH at University of North Carolina, Chapel Hill. The trial plans to enroll 376 participants.