Inclusive physical activity program for adults with intellectual disabilities

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This project conducts a wait-list randomized controlled trial of the PACE program, an inclusive physical activity initiative aimed at adults with intellectual disabilities who are not exhibiting signs of Alzheimer's Disease or age-related dementias. The study will involve 120 adults with intellectual disabilities, their caregivers, and exercise professionals, who will be grouped into triads and randomly assigned to either the PACE program or a waitlist control group. Participants will undergo screening for eligibility, including cognitive testing and physical activity baseline measures, before being assigned to their respective groups for a 16-week intervention. The program includes weekly group fitness classes designed to enhance physical activity levels and overall well-being.

Why it matters

Who can join: the full rules

Inclusion criteria for adults with ID will include:

* 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.

Exclusion Criteria for adults with ID:

• Diagnosis of AD, dementia, or related disorders. Participants will not be excluded based on gender, race, or ethnicity. There will be no upper age limit due to the heterogeneity of onset of AD/ADRD in individuals with ID.

Inclusion criteria for coach will include:

* 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

Inclusion criteria for caregiver will include:

* 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.

Where it's running

• University of North Carolina
  Chapel Hill, North Carolina, United States Recruiting
• University of Arkansas
  Fayetteville, Arkansas, United States Not yet recruiting

Study contacts

• Principal investigator: Brianne R Tomaszewski, PhD., MPH — University of North Carolina, Chapel Hill
• Study coordinator: Brianne R Tomaszewski, PhD, MPH
• Email: Brianne_Tomaszewski@med.unc.edu
• Phone: 919-962-8563

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.