Older adults with intellectual disability.
Amanda Sinai, Ingrid Bohnen, Andre Strydom
https://pubmed.ncbi.nlm.nih.gov/22744404/Actively Recruiting
Led by University of North Carolina, Chapel Hill · Updated on 2026-02-23
376
Participants Needed
2
Research Sites
26 weeks
Total Duration
Researchers are evaluating an inclusive physical activity program called PACE for adults with intellectual disability ID who do not show signs of Alzheimers Disease or related dementias. This randomized controlled trial includes 120 adults with ID, their caregivers, and coaches, aiming to study the effects of physical activity on health and wellbeing in this population. The study is sponsored by the University of North Carolina, Chapel Hill. The study involves a 16-week intervention with weekly group fitness classes led by certified Inclusive Fitness Specialists. Participants in the intervention group will also use a web-based dashboard, attend weekly coaching meetings, and have access to web-based training for coaches and exercise professionals. Those in the waitlist control group will receive the PACE program after the initial 16-week period. The program is designed to encourage moderate-to-vigorous physical activity and community empowerment. Participants undergo screening and baseline assessments including cognitive testing, dementia screening, and physical activity monitoring with an Actigraph device worn for a week. Assessments include body composition scans, quality of life questionnaires, daily living skills, mental and cognitive functioning, emotional health, and physical fitness tests. Follow-up visits occur post-intervention and at 12 months to evaluate changes. The primary outcomes are steps per day and minutes of moderate-to-vigorous activity measured by the Actigraph at baseline and after 16 weeks.
CONDITIONS
Physical Activity and Community EmPOWERment Project
B
Brianne R Tomaszewski, PhD, MPH
K
Kara Hume, PhD
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University of North Carolina, Chapel Hill
Lead Sponsor
National Institute on Aging (NIA)
Collaborating Sponsor
This table compares participation in this trial with other options available for this condition. The information is drawn from published research and the trial’s study details and is provided for educational purposes only.
| Factors | PACE Inclusive Exercise Program | Waitlist Control (No Initial Program) |
|---|---|---|
| What it is | A 16-week, inclusive, supervised exercise and empowerment program for adults with intellectual disability, led by certified Inclusive Fitness Specialists and including goal-setting, coaching, and group classes with non-study community participants. | No exercise or empowerment program during the 16-week main study period; participants continue usual activities and are assessed at the same intervals. |
| Role in study | Investigational arm testing the effect of an adaptive group-based exercise and empowerment program. | Comparator group for measuring changes attributable to the intervention, receiving no structured program during the initial study period. |
| Primary use | Designed to increase physical activity, improve daily living skills, and enhance cognitive, emotional, and social wellbeing in adults with intellectual disability. | Serves as a comparison condition to evaluate lifestyle, activity, and wellbeing outcomes without the intervention. |
| How it is given or performed | Participants attend group-based exercise classes with their coaches weekly, participate in inclusive fitness sessions, set goals with their coaches, and interact with a web-based dashboard. The program lasts 16 weeks. | Participants do not receive any intervention or structured program during the 16-week main study period. They continue their usual daily routine. |
| Evidence status | The PACE program is under investigation in this randomized trial; no published results yet exist for this specific program. Broader studies show that increased physical activity is linked to better long-term health and decreased mortality in adults with intellectual disability. | No structured intervention is provided; this group reflects outcomes for those not participating in targeted exercise programs. |
| Important limitations | Effectiveness in increasing physical activity or improving wellbeing remains unproven until trial results are available. Program success may depend on coach engagement, participant motivation, and tolerance for group-based activities. Access is limited to those who can wear an activity tracker, tolerate group exercise, and have a caregiver or coach willing to participate. Results may not generalize to adults with intellectual disability living outside North Carolina or Arkansas. | No structured support or physical activity program may result in lower physical activity or fewer changes in wellbeing during the study. Outcomes in this group may be influenced by natural fluctuations or outside factors instead of intervention. |
Disclaimer: This comparison is created with the help of artificial intelligence(AI) and may contain errors or missing information. It is not medical advice and does not mean one option is better or safer than another. Clinical trials are still being studied, and joining a trial is your choice. Please consult your healthcare professional before making any decisions.
You may qualify if you...
You will not qualify if you...
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 screening visit (in-person)
Duration - Up to 1 week
Participants and caregivers complete baseline assessments including cognitive testing, dementia screening, physical activity measurement using an Actigraph device, demographic information, and body composition measurement.
1 pre-assessment visit (in-person) and 7 days wearing an Actigraph device at home
Duration - 16 weeks
Participants engage in a 16-week inclusive exercise program consisting of weekly group fitness classes, weekly coaching meetings, web-based training for coaches, and daily/weekly interactions with an interactive web-based dashboard.
Weekly fitness classes and coaching meetings; daily/weekly dashboard interactions
Duration - 1 to 2 weeks
Participants repeat baseline assessments to measure changes after the intervention, including physical activity, body composition, cognitive and emotional functioning, and quality of life. A subset also completes interviews about their program experience.
1 post-assessment visit (in-person)
Duration - 12 months after intervention
Participants have a 12-month follow-up visit to reassess body composition and other long-term outcomes.
1 follow-up visit (in-person)
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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Lead Sponsor
National Institute on Aging (NIA)
Collaborating Sponsor