+1 877 705 191424 / 7
HIPAA Compliant
ISO 27001 Certified

Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
Healthy Volunteers
ID06740162

Testing the PACE Program A 16-Week Physical Activity Intervention to Increase Exercise in Adults with Intellectual Disability Without Signs of Alzheimers Disease

Led by University of North Carolina, Chapel Hill · Updated on 2026-02-23

376

Participants Needed

2

Research Sites

26 weeks

Total Duration

On this page

Sponsors

U

University of North Carolina, Chapel Hill

Lead Sponsor

N

National Institute on Aging (NIA)

Collaborating Sponsor

AI-Summary

What this Trial Is About

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

Brief Title

Physical Activity and Community EmPOWERment Project

Who Can Participate

Age: 18Years +
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Adults aged 18 and older with a prior clinical diagnosis of intellectual disability confirmed by cognitive and adaptive behavior assessments
  • Medical clearance to participate in moderate-to-vigorous physical activity according to ACSM guidelines
  • No clinically elevated symptoms of Alzheimer's Disease or related dementias based on dementia screening
  • One caregiver or guardian able and willing to participate
  • Able to tolerate at least 8 hours daily wear of the Actigraph device during assessment (4 out of 7 days)
  • Average 20 minutes or less of moderate to vigorous physical activity per day during initial assessment
  • Reside in North Carolina or Arkansas
  • Coaches must have internet and mobile device access, weekly contact with adult participant, English comprehension, and reside in NC or AR
  • Caregivers must be able to read and converse in English, care for an adult with ID participant, reside in NC or AR, and attend study visits with participant
Not Eligible

You will not qualify if you...

  • Diagnosis of Alzheimer's Disease, dementia, or related disorders
  • No exclusion based on gender, race, or ethnicity
  • No upper age limit due to variability in onset of Alzheimer's in adults with intellectual disability
  • Pregnant participants or those who might be pregnant will not receive DXA scans as part of assessments

Research Team

B

Brianne R Tomaszewski, PhD, MPH

K

Kara Hume, PhD

Not the Right Trial for You?

Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.

Already have an account? Log in here