Physical Activity and Community EmPOWERment Project (PACE Trial)

N/A

Waitlist Available

Led By Brianne R Tomaszewski, PhD., MPH

Research Sponsored by University of North Carolina, Chapel Hill

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

* 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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline, post-intervention (16 weeks), follow-up (74 weeks)

Awards & highlights

No Placebo-Only Group

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.

Who is the study for?

This trial is for adults with intellectual disabilities like Down Syndrome, Autism Spectrum Disorder, and several others. They should not show signs of Alzheimer's or age-related dementias. Participants will be grouped with their caregivers and coaches.

What is being tested?

The PACE Program, an inclusive physical activity program, is being tested through a wait-list randomized controlled trial to see if it benefits adults with intellectual disability who don't have dementia.

What are the potential side effects?

Since this trial involves a physical activity program rather than medication, side effects may include typical exercise-related issues such as muscle soreness or fatigue but are expected to be minimal.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline, post-intervention (16 weeks), follow-up (74 weeks)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline, post-intervention (16 weeks), follow-up (74 weeks)

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, post-intervention (16 weeks), follow-up (74 weeks) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Minutes of Moderate-to-Vigorous Activity Per Day as Measured by the ActiGraph GT9X Link

Number of Steps Per Day as Measured by the ActiGraph GT9X Link

Secondary study objectives

Ability to Maintain Balance from Baseline as Measured by the 4-Stage Balance Test

Body Composition from Baseline as Measured by percentage of total body mass

Daily Living Skills from Baseline as Measured by the Waisman Activities of Daily Living Scale

+8 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: PACE ProgramExperimental Treatment1 Intervention

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.

Group II: Waitlist ControlActive Control1 Intervention

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.

0 / 7Eligibility criteria met