Inclusive physical activity program for adults with intellectual disabilities
A Stage 1 Pilot Test for Feasibility and Efficacy of a Multi-Level Intervention to Increase Physical Activity in Adults With Intellectual Disability: Physical Activity and Community EmPOWERment (PACE)
This study is testing a new fitness program for adults with intellectual disabilities to see if it helps them be more active and feel better over 16 weeks.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 376 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of North Carolina, Chapel Hill Academic / other |
| Locations | 2 sites (Fayetteville, Arkansas and 1 other locations) |
| Trial ID | NCT06740162 on ClinicalTrials.gov |
What this trial studies
This project conducts a wait-list randomized controlled trial of the PACE program, an inclusive physical activity initiative aimed at adults with intellectual disabilities who are not exhibiting signs of Alzheimer's Disease or age-related dementias. The study will involve 120 adults with intellectual disabilities, their caregivers, and exercise professionals, who will be grouped into triads and randomly assigned to either the PACE program or a waitlist control group. Participants will undergo screening for eligibility, including cognitive testing and physical activity baseline measures, before being assigned to their respective groups for a 16-week intervention. The program includes weekly group fitness classes designed to enhance physical activity levels and overall well-being.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with a clinical diagnosis of intellectual disability who do not show signs of Alzheimer's Disease.
Not a fit: Patients who are already exhibiting clinically elevated symptoms of Alzheimer's Disease or related dementias may not benefit from this program.
Why it matters
Potential benefit: If successful, this program could improve physical health and cognitive function in adults with intellectual disabilities, potentially delaying the onset of Alzheimer's Disease.
How similar studies have performed: Other studies have shown success with physical activity interventions for similar populations, suggesting potential for positive outcomes in this approach.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Fayetteville, Arkansas and 1 other locations
- University of Arkansas — Fayetteville, Arkansas, United States (Not_yet_recruiting)
- University of North Carolina — Chapel Hill, North Carolina, United States (Recruiting)
Study contacts
- Principal investigator: Brianne R Tomaszewski, PhD., MPH — University of North Carolina, Chapel Hill
- Study coordinator: Brianne R Tomaszewski, PhD, MPH
- Email: Brianne_Tomaszewski@med.unc.edu
- Phone: 919-962-8563
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.