Physical Activity and Community EmPOWERment Project
Launched by UNIVERSITY OF NORTH CAROLINA, CHAPEL HILL · Dec 13, 2024
Trial Information
Current as of July 21, 2025
Recruiting
Keywords
ClinConnect Summary
The Physical Activity and Community EmPOWERment Project (PACE) is a study designed to see how an inclusive exercise program can benefit adults with intellectual disabilities who are not showing signs of Alzheimer's disease or related conditions. The trial will involve 120 adults, along with their caregivers and coaches, who will be grouped into teams of three. Participants will be randomly assigned to either take part in the PACE program or wait for the program to begin later.
To be eligible for this study, adults must be at least 18 years old, have a clinical diagnosis of intellectual disability, and not show signs of Alzheimer's or other forms of dementia. They also need to have a caregiver who is willing to participate and live in North Carolina or Arkansas. Participants can expect to engage in physical activities while being supported by coaches and caregivers throughout the study. This trial aims to explore the positive effects of physical activity on the well-being of adults with intellectual disabilities, and it welcomes individuals of all genders and backgrounds.
Gender
ALL
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.
About University Of North Carolina, Chapel Hill
The University of North Carolina at Chapel Hill (UNC) is a leading research institution renowned for its commitment to advancing health and science through innovative clinical trials. With a robust infrastructure that supports multidisciplinary collaboration, UNC conducts cutting-edge research across various fields, including medicine, public health, and biomedical sciences. The university is dedicated to improving patient care and health outcomes by translating its research findings into practical applications. UNC’s clinical trials are designed to evaluate new therapies, interventions, and technologies, ensuring that they meet the highest ethical and scientific standards while fostering a culture of inclusivity and community engagement.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Fayetteville, Arkansas, United States
Chapel Hill, North Carolina, United States
Patients applied
Trial Officials
Brianne R Tomaszewski, PhD., MPH
Principal Investigator
University of North Carolina, Chapel Hill
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported