RECRUITING

Physical Activity and Community EmPOWERment Project

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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)

Quick Facts

Study Start:2025-01-10
Study Completion:2028-06
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06740162

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:Yes
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. Age 18 years or older
  2. Willing and able to provide informed consent
  3. Able to understand and follow study procedures
  4. Stable medical condition
  1. Pregnancy or breastfeeding
  2. Severe psychiatric disorders
  3. Active substance abuse
  4. Unstable medical conditions
  5. Inability to comply with study requirements

Contacts and Locations

Study Contact

Brianne R Tomaszewski, PhD, MPH
CONTACT
919-962-8563
Brianne_Tomaszewski@med.unc.edu
Kara Hume, PhD
CONTACT
919-843-2291
kara.hume@unc.edu

Principal Investigator

Brianne R Tomaszewski, PhD., MPH
PRINCIPAL_INVESTIGATOR
University of North Carolina, Chapel Hill

Study Locations (Sites)

University of Arkansas
Fayetteville, Arkansas, 72701
United States
University of North Carolina
Chapel Hill, North Carolina, 27517
United States

Collaborators and Investigators

Sponsor: University of North Carolina, Chapel Hill

  • Brianne R Tomaszewski, PhD., MPH, PRINCIPAL_INVESTIGATOR, University of North Carolina, Chapel Hill

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-01-10
Study Completion Date2028-06

Study Record Updates

Study Start Date2025-01-10
Study Completion Date2028-06

Terms related to this study

Keywords Provided by Researchers

  • physical activity
  • intellectual disability
  • age-associated memory impairment
  • aging
  • Alzheimer Disease prevention

Additional Relevant MeSH Terms

  • Intellectual Disability
  • Neurodevelopmental Disorders
  • Autism Spectrum Disorder
  • Down Syndrome
  • Fragile X Syndrome
  • Cri-du-Chat Syndrome
  • De Lange Syndrome
  • Mental Retardation, X-Linked
  • Prader-Willi Syndrome
  • Rubinstein-Taybi Syndrome
  • Trisomy 13 Syndrome
  • WAGR Syndrome
  • Williams Syndrome