ClinicalTrials.gov record NCT06740162
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)
AI summaryWhat this study is about, in plain languageShow ▾Hide ▴
AI-written from the registry record, not the study's own wording. May contain errors or omissions. Check the registry text on this page and the original record ↗ before acting on it.
This randomized, wait-list trial tests a 16-week inclusive physical activity program called PACE for adults with intellectual disability who are not showing signs of dementia. Participants take part in weekly group fitness, coach training, coaching meetings, and use an interactive web dashboard; outcomes are measured before and after the 16-week period, with body composition rechecked at about 12 months. Triads of adults with ID, caregivers, and coaches are enrolled and assigned to immediate intervention or waitlist.
What it is studying. The study tests whether the multi-level PACE program changes physical activity (steps and minutes of moderate-to-vigorous activity) and measures related outcomes: body composition, quality of life, daily living skills, cognitive and emotional functioning, strength, balance, mobility, and endurance.
What the researchers hope to learn. Scientifically, the study aims to test feasibility and preliminary efficacy of an inclusive, multi-level exercise program for adults with intellectual disability and to gather data on physical activity, body composition, wellbeing, daily functioning, cognition, strength, balance, mobility, and endurance.
What this study is about
The study's own summary, as published on ClinicalTrials.gov. Underlined terms have a short explanation.
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.
Interventions being studied
Being studied in this trial does not mean the treatment or procedure is approved or available for this condition.
- Behavioral
- PACE Program
Eligibility
The criteria exactly as listed on ClinicalTrials.gov. Only the study team can say whether they apply to you.
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.
Study description and what participation involves
The study's detailed description, as published on ClinicalTrials.gov.
Show the detailed description from the registry
Each potential adult with ID or family who contacts the research team will be called and screened for eligibility in the study. To determine eligibility, screening questions will include asking if the adult participant has a formal diagnosis of ID; report of intellectual ability level will be confirmed with direct cognitive testing during the screening assessment visit using scales completed by the participant and caregiver. Also at the screening visit, caregivers will complete the dementia screener for the participants, and participants will be provided with an Actigraph GT9X Link device so they can complete a weeklong physical activity baseline measure. At the second study visit, participants and caregivers will complete the pre-assessments (described below and attached), and participants will have their body composition measured. Questions to all scorable assessments will be required to prevent missing data. Select demographic information will have an additional "prefer not to answer" choice. Participants will complete demographic measures, primary and secondary outcome measures, and feasibility and acceptability measures across the first two study visits. Those who qualify will be randomly assigned to one of two conditions: (1) initial intervention or (2) waitlist control. Individuals assigned to the waitlist control group will begin the intervention after the initial group completes post-assessments. 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. A post-assessment visit will be conducted to repeat the pre-assessment measures, and a subset of participants and coaches will also complete an interview to answer open-ended questions about their program experiences. A 12-month follow-up visit will also be scheduled to measure body composition again. Brief description of measures to be completed by Caregivers as follows: Vineland Adaptive Behavior Scales-3: (VABS) (Vineland-3) is a standardized assessment tool that utilizes semi-structured interview to measure adaptive behavior and support the diagnosis of intellectual and developmental disabilities, autism, and developmental delays. Interviews are expected to take 1-2 hours and will take place during the screening visit. National Task Group-Early Detection Screen for Dementia: (NTG-EDSD) This measure was adapted from the Dementia Screening Questionnaire for Individuals with Intellectual Disabilities (DSQIID) and can be used for the early detection screening of those adults with an intellectual disability who are suspected of or may be showing early signs of mild cognitive impairment or dementia. The NTG-EDSD is not an assessment or diagnostic instrument, but an administrative screen that can be used by staff and family caregivers to note functional decline and health problems and record information useful for further assessment. This assessment will take place during the screening visit. Add Health Wave 5 Questionnaire: Questions will be used from the Wave 5 Survey including questions on background (biological sex, gender, race/ethnicity), health and health care (co-occurring conditions and medical treatments, illness and physical limitations, and fitness tracking (experiences using fitness tracking devices, current exercise habits). This measure will take place during the pre and post study visits. Waisman Activities of Daily Living (W-ADL): The W-ADL is a caregiver-report that measures activities of daily living and assesses functioning. It has demonstrated high internal consistency (Cronbach alphas= .88-.94) and reliability over time (Kappas= .92-.93) in adults with ID. This measure will take place during the pre and post study visits. Brief description of adult with ID measures as follows: The Leiter-3: is a widely used nonverbal measure of intelligence and cognitive abilities that is suitable to use for individuals with cognitive delays, speech or hearing problems, Attention Deficit Hyperactivity Disorder (ADHD), or traumatic brain injury. The battery subtest scores are converted to a scaled score and the sum of the scaled scores yields a nonverbal intelligence quotient (IQ)/composite score. This assessment will take place during the screening visit. World Health Organization Quality of Life Brief Version Assessment (WHOQoL-BREF and WHO Disabilities Module): The WHOQoL-BREF and WHO Disabilities module is an abbreviated 39-item version of the original WHOQOL tool that has been used in adults with ID. The domain scores will be used to measure the general quality of life (Overall, Health, Physical, Psychological, Social, Environment, and Disabilities Module). This measure will take place during the pre and post study visits. NIH-Toolbox Cognitive Battery (NIHTB-CB): The NIHTB-CB will measure mental and cognitive functioning. It has been validated in individuals with ID and adults across the spectrum of Alzheimer's disease and age-related cognitive decline. It is an iPad-based assessment of memory, executive function, and crystallized intelligence. This measure will take place during the pre and post study visits. NIH-Toolbox Emotional Battery: The NIHTB-EB will measure emotional health across several domains: Psychological Well-Being, Social Relationships, Stress and Self-Efficacy, and Negative Affect. This is an iPad-based assessment that will take place during the pre and post study visits. Physical Activity Measures: These measures will take place during the pre and post study visits. Grip strength (NIH Toolbox): This test consists of squeezing the hand dynamometer for a 1-rep max strength assessment. The 4-Stage Balance Test: This test consists of four standing positions that are progressively harder to maintain. 30-Second Chair Stand: This test consists of participants getting up from a chair without using their arms. They get up and sit down repeatedly for 30 seconds. Their score is the number of times they can get up from the chair Timed Up \& Go (TUG): This test consists of participants getting up from a chair, walking 10 feet across the room around a cone, and sitting back down. 2-Minute Walk Endurance: This test consists of participants walking as fast as they can for two-minutes up and down the hallway of the assessment spaces. Bod Pod: This scan will measure body composition using Air Displacement Plethysmograph (ADP). Participants at the University of North Carolina site will be briefed on the Bod Pod and sit inside for up to 5 minutes. This measure will take place during the pre- and post-study visits, as well as the one-year follow-up visit. DXA Scan: This scan will measure body composition using dual energy X-ray absorptiometry. Participants at the University of Arkansas site will be briefed and lay on the DXA scan table for around 15 minutes. This measure will take place during the pre- and post-study visits, as well as the one-year follow-up visit. Participants who are pregnant, think they may be pregnant, or have had unprotected sex in the last 30 days will not receive a DXA scan.
AI summaryWhat participation may involve, in plain languageShow ▾Hide ▴
AI-written from the registry record, not the study's own wording. May contain errors or omissions. Check the registry text on this page and the original record ↗ before acting on it.
You and a caregiver begin with a screening visit that includes cognitive testing (Leiter-3), a caregiver interview about adaptive skills (Vineland-3), a dementia screen (NTG-EDSD), and wearing an ActiGraph activity tracker for about one week to measure baseline activity. If enrolled, you return for pre-assessments that include quality-of-life questionnaires, iPad-based cognitive and emotion tests (NIH Toolbox), physical tests (grip strength, 4-stage balance, 30-second chair stand, Timed Up & Go, 2-minute walk), and a body-composition measure (Bod Pod or DXA). Participants are randomly assigned to start the 16-week PACE program right away or to a waitlist; the PACE program includes a weekly group fitness class, weekly coaching meetings, web-based training for coaches, and daily/weekly use of an interactive online dashboard. After 16 weeks the pre-assessments are repeated, a subset of participants and coaches may be interviewed about their experience, and body composition is measured again at a 12-month follow-up; note that the Vineland interview can take 1–2 hours, the Bod Pod involves sitting inside an enclosed chamber, and DXA uses X‑ray (participants who are or may be pregnant will not receive a DXA scan).
How the study is structured. Participants are grouped in triads (adult with intellectual disability, a caregiver, and a coach) and cohorts are randomized to start the 16-week PACE program immediately or after a waitlist period. The PACE program includes a weekly group fitness class, web-based training and resources for coaches and exercise professionals, weekly coaching meetings, and use of a web dashboard. Study measures include a one-week baseline activity monitor, pre- and post-intervention assessments (physical tests, questionnaires, cognitive and emotional batteries, and body composition), and a follow-up body composition measure about 12 months later. A subset of participants and coaches will be interviewed about their experiences.
Questions you could ask
These questions are suggestions for a conversation with the study team or your own clinician, not advice.
- The listed sites are in United States. Is any of them reachable for me, and does the study help with travel?
- Which of the eligibility criteria would need to be checked with tests before I could join?
More on Prader-Willi syndrome
This trial is also listed on this site under fragile X syndrome.
Important dates
- Study start
- Jan 10, 2025
- Primary completion
- December 2027 (estimated)
- Study completion
- June 2028 (estimated)
- Target enrollment
- 376 participants (estimated)
- Last updated on registry
- Feb 23, 2026
- Data verified
- Oct 10, 2026
Sponsor and research team
The lead sponsor funds and oversees the trial. A pharmaceutical or biotech company sponsor typically means the study is testing that company's drug or device; a hospital, university, or government agency usually indicates investigator-initiated or publicly funded research.
- Lead sponsor
- University of North Carolina, Chapel Hill
- Collaborators
- National Institute on Aging (NIA)
Central study contact
If you're interested in participating, the central contact can answer general questions about the study — including eligibility requirements and how to find a recruiting site near you. Actual eligibility is determined by the site's medical team.
- Brianne R Tomaszewski, PhD, MPH 📞 919-962-8563 ✉ Brianne_Tomaszewski@med.unc.edu
- Kara Hume, PhD 📞 919-843-2291 ✉ kara.hume@unc.edu
Participating sites (2)
- University of ArkansasNot Yet Recruiting
Fayetteville, Arkansas, 72701 · United States
- Melissa N Savage, PhD · 479-575-4209 · mns029@uark.edu
- Kara Hume, PhD · 919-843-2291 · kara.hume@unc.edu
- Melissa N Savage, PhD
- University of North CarolinaRecruiting
Chapel Hill, North Carolina, 27517 · United States
- Brianne R Tomaszewski, Ph.D., MPH · 919-962-8563 · Brianne_Tomaszewski@med.unc.edu
- Kara Hume, Ph.D. · 919-843-2291 · kara.hume@unc.edu
- Brianne R Tomaszewski, Ph.D., MPH
Terms used on this page · explanations by MedicalUpdates.ai
- randomized
- Participants are assigned to the study groups by chance, like a coin toss, rather than chosen by the doctor or the participant. This is done so the groups are comparable.
- cohort
- A group of people who share a characteristic, such as a diagnosis, and are studied together. 'Prospective' means they are followed forward from enrolment; 'retrospective' means existing records are reviewed.
- control group
- The group the study treatment is compared with. It may receive a placebo, an existing treatment (active comparator), a sham procedure, or no intervention.
- Inclusion criteria
- The conditions a person must meet to be considered for the study, for example a confirmed diagnosis, an age range or a test result.
- Exclusion Criteria
- The conditions that rule a person out even if they meet the inclusion criteria, for example other illnesses, certain medicines or pregnancy.
- screening visit
- The checks done before enrolment to see whether a person qualifies, such as tests, scans or a review of medical history.
- baseline
- Measurements taken at the start of the study, before any study treatment, so that later results can be compared with them.
- secondary outcome
- An additional result the study measures alongside the primary outcome, for example quality of life or a laboratory value.
- follow-up
- The period after treatment or enrolment during which participants are observed or contacted, for example to record side effects or outcomes.
The study record on this page is reproduced from ClinicalTrials.gov, a database of the U.S. National Library of Medicine, where it was submitted by the study sponsor. MedicalUpdates.ai does not own this content, is not affiliated with or endorsed by ClinicalTrials.gov, NIH, or the U.S. Government, and does not verify the record. Plain-language notes, the glossary and the questions above are added by this site; text in the boxes marked "AI summary" was written by an AI model and may contain errors. Registry records change over time. Check the original record for the current version and discuss eligibility or participation with a qualified healthcare professional.
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