Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
Healthy Volunteers
NCT06740162

Physical Activity and Community EmPOWERment Project

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

376

Participants Needed

2

Research Sites

176 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

Purpose: Conduct a wait-list randomized controlled trial (RCT) of an inclusive physical activity program called PACE for adults with intellectual disability (ID) who are not yet showing signs of Alzheimer's Disease (AD)/age-related dementias (ARD). Participants: Participants include 120 adults with ID, their caregivers, and their coaches (up to 360 individual participants, grouped as triads), recruited through the University of North Carolina at Chapel Hill and the University of Arkansas. Participants also include 16 exercise professionals. Procedures (methods): Each cohort will include 20 triads who are randomly assigned to the PACE program or the waitlist control group.

CONDITIONS

Official 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 years and older with a prior clinical diagnosis of intellectual disability confirmed by cognitive and adaptive behavior assessments
  • Medical clearance to engage in moderate-to-vigorous physical activity as per ACSM guidelines
  • No clinically elevated symptoms of Alzheimer's Disease or related dementias based on dementia screening
  • One caregiver or guardian willing and able to participate
  • Ability to tolerate at least 8 hours of Actigraph device wear during initial assessment (4 of 7 days)
  • Average 20 minutes or less of moderate-to-vigorous physical activity per day measured during baseline week
  • Residence in North Carolina or Arkansas
  • Coaches must have internet access and a mobile device, weekly contact with the adult participant, English reading and speaking ability, and reside in North Carolina or Arkansas
  • Caregivers must be able to read and speak English, care for a participating adult with ID, reside in North Carolina or Arkansas, and attend all study visits with the adult
Not Eligible

You will not qualify if you...

  • Diagnosis of Alzheimer's Disease, dementia, or related disorders
  • Participants are not excluded based on gender, race, or ethnicity
  • No upper age limit due to variable onset of Alzheimer's in individuals with intellectual disability

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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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

CONTACT

K

Kara Hume, PhD

CONTACT

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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