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)

Status: Recruiting
Location: See all (2) locations...
Intervention Type: Behavioral
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: t
View:

• 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.

• 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

• 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.

Locations
United States
Arkansas
University of Arkansas
NOT_YET_RECRUITING
Fayetteville
North Carolina
University of North Carolina
RECRUITING
Chapel Hill
Contact Information
Primary
Brianne R Tomaszewski, PhD, MPH
Brianne_Tomaszewski@med.unc.edu
919-962-8563
Backup
Kara Hume, PhD
kara.hume@unc.edu
919-843-2291
Time Frame
Start Date: 2025-01-10
Estimated Completion Date: 2028-06
Participants
Target number of participants: 376
Treatments
Experimental: PACE Program
The 16-week intervention includes: (1) a weekly group fitness class for adults with ID, (2) web-based training and resources for coaches and exercise professionals; (3) weekly coaching meetings for coaches and adults with ID, and (4) daily/weekly interactions with the PACE interactive web-based dashboard for adults with ID.
No_intervention: Waitlist Control
Participants assigned to the Waitlist Control Group will not receive any intervention during this interval. Participants will receive the PACE Program after the completion of the 16-weeks for the Intervention Group.
Sponsors
Collaborators: National Institute on Aging (NIA)
Leads: University of North Carolina, Chapel Hill

This content was sourced from clinicaltrials.gov