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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)

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years and older
Sex
All sexes
Healthy volunteers
Accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Visits mentioned: 2 visits
  • Procedures mentioned: Interviews, Questionnaires, X-rays

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "Participants will complete demographic measures, primary and secondary outcome measures, and feasibility and acceptability measures across the first two study visits."
  • "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."
  • "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."
  • "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)."
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests PACE, a physical activity program for adults with intellectual disability, which affects learning and daily life skills. It is for adults who are not showing signs of Alzheimer’s disease or related dementia, which affect memory and thinking. Adults join with a caregiver and coach and are assigned by chance to start PACE or join a waiting list.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Adults: Be age 18 or older with a past diagnosis of intellectual disability, confirmed by study tests.
  • Adults: Have medical approval to do exercise that takes moderate to hard effort.
  • Adults: Have no raised signs of dementia, with a score below 20 on the study’s dementia screening form.
  • Adults: Have a caregiver or guardian who can and wants to take part, and live in North Carolina or Arkansas.
  • Adults: Be able to wear an Actigraph activity tracker for at least 8 hours a day on 4 of 7 days during the first assessment.
  • Adults: Average no more than 20 minutes of moderate to hard exercise daily, or 140 minutes over 7 days, during the first assessment.
  • Coaches: Have internet and a mobile device, have weekly contact with the adult, speak and read English, and live in North Carolina or Arkansas.
  • Caregivers: Speak and read English, care for an adult with intellectual disability who wants to join, live in North Carolina or Arkansas, and attend all study visits with the adult.

Who can't join

  • Adults: Have a diagnosis of Alzheimer’s disease, dementia, or a related disorder.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

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 sites (2)

AR

NC