NCT07425769

Adapting RDAD for DS

Adapting the RDAD Intervention for Individuals With Down Syndrome Phase 3- Pilot Test

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 40 (estimated)
• Sponsor: University of Kansas Medical Center · Academic / Other
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

Summary

The goal of this clinical trial is to observe feasibility and initial efficacy of a remotely delivered exercise and dementia caregiving intervention in older adults with Down syndrome and their caregivers.

Detailed description

In Adapting RDAD for DS Phase 3 (CareFit-DS/AD), we will conduct a 12-week, single arm pilot trial intervention in 20 adults with DS/caregiver dyads. This intervention includes remote-delivered functional exercise classes for adults with DS and their caregivers, and remote delivered dementia caregiving training sessions for the caregivers. Participants with DS will complete 12 weeks of group exercise sessions (three \~30-minute sessions per week, caregiver optional) over video call, and caregivers will also receive a weekly \~40-minute group video call session of a dementia caregiver training/support group. Staff will travel to participant homes at baseline and following 12 weeks to perform assessments of physical function and to set up the Actigraph accelerometers. Saliva collection kits for caregivers will be mailed ahead of time and picked up at the home visit. Additionally, at baseline staff will deliver equipment for intervention delivery Twelve unique pre-recorded exercise class sessions (endurance, strength, balance, and flexibility) will be performed 3 times each throughout the study (36 sessions total). The exercise session content and frequency are designed to improve functional fitness for daily activities and will challenge participants at a light and/or moderate intensity level. During the sessions, all participants will join a video call and follow along with a pre-recorded exercise video in a group format. A staff member trained in working with the population will be on the call to provide encouragement and feedback, while monitoring for participant safety. Caregivers may attend and participate in the exercise sessions, but will neither be encouraged or discouraged from doing so. Caregivers will be asked to attend weekly group behavioral management training sessions via video call immediately following one of the 3 exercise sessions. These meetings will consist of information and resources for caregiving for a person with DS who has been diagnosed with dementia. The group will be moderated by a staff member trained in working with the population and will include presented information as well as group discussion time. Topics include the Overview of Alzheimer's Disease in Down Syndrome; Behavior Management Strategies, Changing Expectations, etc.

Conditions

• Down Syndrome (DS)
• Alzheimer's Disease (AD)

Interventions

Type	Name	Description
BEHAVIORAL	Remote Exercise Sessions	Participants will take part in thrice weekly exercise sessions using pre-recorded videos designed for older adults with Down syndrome. Participants will join video call and follow along with the video. A staff member familiar with the population will be on the call to provide modifications, encouragement and ensure participant safety.
BEHAVIORAL	Caregiver Education Sessions	Caregivers will join a once-weekly education session held via video call and led by a trained staff member. Education content will include how to support and manage challenging behaviors of older adults with Down syndrome who may be experiencing Alzheimer's disease-related symptoms.

Timeline

• Start date: 2026-02-01
• Primary completion: 2026-07-31
• Completion: 2026-07-31
• First posted: 2026-02-23
• Last updated: 2026-02-23

Locations

1 site across 1 country: United States