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New treatment option for Intellectual Disability
Official title Physical Activity and Community EmPOWERment Project
ClinicalTrials.gov ID: NCT06740162
What this study is testing
- What it's testing
- 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.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older. Healthy volunteers may be eligible.
You may be able to join if
- 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...
- Medical clearance to participate in moderate-to-vigorous physical activity as determined by the American College of Sports Medicine (ACSM)...
- Adult does not show clinically elevated symptoms of Alzheimer's Disease (AD)/ Alzheimer's Disease and Related Dementias (ADRD) as indicated by a...
- One caregiver/guardian is able and willing to participate.
You likely can't join if
- 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...
- 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:
See the full eligibility 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...
- 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...
- 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.
- 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...
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Fayetteville, Arkansas, United States
- Chapel Hill, North Carolina, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Fayetteville, Arkansas, United States; Chapel Hill, North Carolina, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.