Actively Recruiting
Adapting the RDAD Intervention for Individuals With Down Syndrome Phase 3 Pilot Test
Led by University of Kansas Medical Center · Updated on 2026-05-06
40
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
Sponsors
U
University of Kansas Medical Center
Lead Sponsor
N
National Center for Advancing Translational Sciences (NCATS)
Collaborating Sponsor
AI-Summary
What this Trial Is About
This research aims to assess the feasibility and initial effects of a remotely delivered exercise and dementia caregiving program for older adults with Down syndrome and their caregivers. The study focuses on adults with Down syndrome aged over 35 years, considering their increased risk for Alzheimer's disease-related cognitive decline. Caregivers participate to support the individuals with Down syndrome and receive training to manage dementia-related behaviors. Participants with Down syndrome will engage in 12 weeks of group exercise classes conducted via video calls, with sessions held three times a week, each lasting about 30 minutes. These sessions involve following pre-recorded exercise videos designed to improve endurance, strength, balance, and flexibility at light to moderate intensity. Caregivers may join the exercises optionally and will also attend weekly 40-minute group video sessions focused on dementia caregiving education and behavioral management strategies. Equipment and assessments are conducted at participants' homes at the start and after 12 weeks. Throughout the study, researchers will monitor participant recruitment, retention, session attendance, and safety. Physical function assessments, physical activity levels, and behavioral symptoms will be evaluated at baseline and after 12 weeks using various tests and questionnaires. Caregivers' strain, unmet needs, self-efficacy, social support, depression, and anxiety will also be assessed. The total participation includes baseline and follow-up home visits, remote exercise and education sessions, and saliva sample collection for caregivers.
CONDITIONS
Brief Title
Adapting RDAD for DS
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults with Down syndrome aged over 35 years with self-reported or caregiver-reported diagnosis
- Ability to understand directions and communicate preferences through spoken language
- Living at home or in a supported living environment with a parent or caregiver willing to participate
- Self-reported ability to participate in physical activity
- Caregivers aged 18 years or older
- Primary caregiver of an adult with Down syndrome
- English speaking
- Caregivers self-report ability to participate in physical activity
You will not qualify if you...
- Adults with Down syndrome unable to participate in moderate-to-vigorous physical activity
- Adults with Down syndrome with self-reported cardiovascular, metabolic, or renal disease or symptoms
- Caregivers unable to participate in moderate physical activity such as brisk walking
- Caregivers with self-reported cardiovascular, metabolic, or renal disease or symptoms
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 screening and enrollment visit at participant's home
Duration - 12 weeks
Participants with Down syndrome complete 12 weeks of remote-delivered group exercise sessions three times each week via video call, with a staff member providing encouragement and safety monitoring. Caregivers attend weekly group dementia caregiving training sessions via video call.
Three 30-minute exercise sessions per week and one weekly 40-minute caregiver education session via video call
Duration - At baseline and Week 12
Staff visit participant homes at baseline and after 12 weeks to perform physical function assessments and set up Actigraph accelerometers. Saliva kits for caregivers are mailed before visits.
2 in-person home visits for assessments and equipment setup
Trial Site Locations
Total: 1 location
1
University of Kansas Medical Center
Kansas City, Kansas, United States, 66160
Actively Recruiting
Research Team
A
Amy Bodde, PhD
J
Joseph Sherman, MS
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
SUPPORTIVE_CARE
Number of Arms
1
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