Actively Recruiting

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

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)

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 Alzheimer's 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

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 screening visit (in-person)

Pre-Assessment

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

Intervention

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

Post-Assessment

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)

Follow-up

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)

Trial Site Locations

Total: 2 locations

1

University of Arkansas

Fayetteville, Arkansas, United States, 72701

Not Yet Recruiting

2

University of North Carolina

Chapel Hill, North Carolina, United States, 27517

Actively Recruiting

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Research Team

B

Brianne R Tomaszewski, PhD, MPH

K

Kara Hume, PhD

How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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Published Research Related To This Trial

Prevalence of Depression and Dementia among Adults with Developmental Disabilities in Manitoba, Canada.

Shahin Shooshtari, Patricia Joan Martens, Charles A Burchill...

https://pubmed.ncbi.nlm.nih.gov/22295184