Clinical trial · Interventional
Physical Activity and Community EmPOWERment Project
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)
NCT06740162CI-TRIAL-00103849PACErecruitingN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (13)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Autism Spectrum Disorder | — | UNRESOLVED | — |
| Cri-du-Chat Syndrome | — | UNRESOLVED | — |
| De Lange Syndrome | — | UNRESOLVED | — |
| Down Syndrome | — | UNRESOLVED | — |
| Fragile X Syndrome | — | UNRESOLVED | — |
| Intellectual Disability | — | UNRESOLVED | — |
| Mental Retardation, X-Linked | — | UNRESOLVED | — |
| Neurodevelopmental Disorders | — | UNRESOLVED | — |
| Prader-Willi Syndrome | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| PACE Program | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- PACE Program
- description
- 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.
- interventionNames
- Behavioral: PACE Program
- type
- NO_INTERVENTION
- label
- Waitlist Control
- description
- 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.
Primary outcomes (2)
- measure
- Number of Steps Per Day as Measured by the ActiGraph GT9X Link
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (6)
- BACKGROUNDSavage 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 31788881
- BACKGROUNDDe 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 32780691
- BACKGROUNDSinai 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 22744404
- BACKGROUNDShooshtari 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 22295184
- BACKGROUNDMcCallion 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