Ignite Creation Date:
2026-03-26 @ 3:17 PM
Ignite Modification Date:
2026-03-29 @ 11:26 PM
Study NCT ID:
NCT07425769
Status:
NOT_YET_RECRUITING
Last Update Posted:
2026-02-23
First Post:
2026-02-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Adapting RDAD for DS
Sponsor:
University of Kansas Medical Center
Organization:
Study Overview
Official Title:
Adapting the RDAD Intervention for Individuals With Down Syndrome Phase 3- Pilot Test
Status:
NOT_YET_RECRUITING
Status Verified Date:
2026-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
CareFit DS/AD
Brief 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.
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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| KL2TR002367 | NIH | None | https://reporter.nih.gov/quic… | View |