Physical Activity and Community EmPOWERment Project
PACE
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)
2 other identifiers
interventional
376
1 country
2
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jan 2025
Longer than P75 for not_applicable
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 13, 2024
CompletedFirst Posted
Study publicly available on registry
December 18, 2024
CompletedStudy Start
First participant enrolled
January 10, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
June 1, 2028
February 23, 2026
February 1, 2026
2.9 years
December 13, 2024
February 19, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Number of Steps Per Day as Measured by the ActiGraph GT9X Link
The Actigraph GT9X Links measures daily step counts. Step counts less than 2500 are classified as basal, step counts between 2500 to 4999 are classified as limited, step counts between 5000 to 7499 are classified as low, step counts between 7500-9999 are classified as somewhat active, step counts between 10000 to 12499 are classified as active, and step counts over 12500 are classified as very active.
Baseline, post-intervention (16 weeks)
Minutes of Moderate-to-Vigorous Activity Per Day as Measured by the ActiGraph GT9X Link
The Actigraph GT9X Links measures activity counts each minute of wear time. Each activity count over 3,941 equals 1 minute of moderate-vigorous physical activity. A total of 150 or more weekly MVPA minutes meets Physical Activity guideline recommendations.
Baseline, post-intervention (16 weeks)
Secondary Outcomes (11)
Body Composition from Baseline as Measured by percentage of total body mass
Baseline, post-intervention (16 weeks), Follow-up (74 weeks)
Wellbeing from Baseline as Measured by the World Health Organization Quality of Life Assessment and Disabilities Module
Baseline, post-intervention (16 weeks)
Daily Living Skills from Baseline as Measured by the Waisman Activities of Daily Living Scale
Baseline, post-intervention (16 weeks)
Mental and Cognitive Functioning from Baseline as Measured by the NIH-Toolbox Cognitive Battery
Baseline, post-intervention (16 weeks)
Psychological Well-Being, and Social Relationships from Baseline as Measured by the NIH Toolbox Emotion Battery
Baseline, post-intervention (16 weeks)
- +6 more secondary outcomes
Study Arms (2)
PACE Program
EXPERIMENTALThe 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.
Waitlist Control
NO INTERVENTIONParticipants 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.
Interventions
The PACE program is a 16-week inclusive exercise program taught and adapted by certified Inclusive Fitness Specialists. Study participants, called athletes, will engage in the fitness class with non-study participants with and without disabilities. Athlete participants will also meet weekly with their coaches (also study participants) to discuss goal setting and interact with the web-based dashboard.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
University of Arkansas
Fayetteville, Arkansas, 72701, United States
University of North Carolina
Chapel Hill, North Carolina, 27517, United States
Related Publications (6)
Savage MN, Tomaszewski BT, Hume KA. Step It Up: Increasing Physical Activity for Adults With Autism Spectrum Disorder and Intellectual Disability Using Supported Self-Management and Fitbit Technology. Focus Autism Other Dev Disabl. Published online January 25, 2022:108835762110737. doi:10.1177/10883576211073700
BACKGROUNDDiaz KM. Leisure-time physical activity and all-cause mortality among adults with intellectual disability: the National Health Interview Survey. J Intellect Disabil Res. 2020 Feb;64(2):180-184. doi: 10.1111/jir.12695. Epub 2019 Dec 2.
PMID: 31788881BACKGROUNDDe la Rosa A, Olaso-Gonzalez G, Arc-Chagnaud C, Millan F, Salvador-Pascual A, Garcia-Lucerga C, Blasco-Lafarga C, Garcia-Dominguez E, Carretero A, Correas AG, Vina J, Gomez-Cabrera MC. Physical exercise in the prevention and treatment of Alzheimer's disease. J Sport Health Sci. 2020 Sep;9(5):394-404. doi: 10.1016/j.jshs.2020.01.004. Epub 2020 Feb 4.
PMID: 32780691BACKGROUNDSinai A, Bohnen I, Strydom A. Older adults with intellectual disability. Curr Opin Psychiatry. 2012 Sep;25(5):359-64. doi: 10.1097/YCO.0b013e328355ab26.
PMID: 22744404BACKGROUNDShooshtari S, Martens PJ, Burchill CA, Dik N, Naghipur S. Prevalence of Depression and Dementia among Adults with Developmental Disabilities in Manitoba, Canada. Int J Family Med. 2011;2011:319574. doi: 10.1155/2011/319574. Epub 2011 Aug 8.
PMID: 22295184BACKGROUNDMcCallion P, McCarron M. Ageing and intellectual disabilities: a review of recent literature. Curr Opin Psychiatry. 2004;17(5):349-352. doi:10.1097/01.yco.0000139968.14695.95
BACKGROUND
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Brianne R Tomaszewski, PhD., MPH
University of North Carolina, Chapel Hill
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 13, 2024
First Posted
December 18, 2024
Study Start
January 10, 2025
Primary Completion (Estimated)
December 1, 2027
Study Completion (Estimated)
June 1, 2028
Last Updated
February 23, 2026
Record last verified: 2026-02
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ICF, ANALYTIC CODE
- Time Frame
- beginning 9 and continuing for 36 months following publication
- Access Criteria
- Investigator has approved IRB, IEC, or REB and an executed data use/sharing agreement with UNC.
Deidentified individual data that supports the results will be shared beginning 9 to 36 months following publication provided the investigator who proposes to use the data has approval from an Institutional Review Board (IRB), Independent Ethics Committee (IEC), or Research Ethics Board (REB), as applicable, and executes a data use/sharing agreement with UNC.