Remote exercise and caregiver dementia education program for adults with Down syndrome
Adapting the RDAD Intervention for Individuals With Down Syndrome Phase 3- Pilot Test
NA · University of Kansas Medical Center · NCT07425769
This 12-week program will test whether remote group exercise for adults with Down syndrome plus weekly caregiver dementia training can be delivered and help improve physical function and caregiver support.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 40 (estimated) |
| Sex | All |
| Sponsor | University of Kansas Medical Center (other) |
| Locations | 1 site (Kansas City, Kansas) |
| Trial ID | NCT07425769 on ClinicalTrials.gov |
What this trial studies
This is a single-arm, 12-week pilot enrolling 20 adult-with-DS/caregiver dyads to test feasibility and initial signals of benefit. Adults with Down syndrome will join three ~30-minute group exercise video sessions per week using pre-recorded classes covering endurance, strength, balance, and flexibility, while caregivers attend a weekly ~40-minute group dementia-training/support video call. Study staff will visit homes at baseline and after 12 weeks to set up Actigraph accelerometers, collect saliva kits, deliver equipment, and perform physical function assessments. The intervention is remote-delivered with live group video calls supplemented by staff home visits for measurements and equipment setup.
Who should consider this trial
Good fit: Adults with Down syndrome aged over 35 who can follow directions, communicate basic needs, are able to participate in moderate physical activity, and who live with or have a caregiver willing to take part (caregiver ≥18 years and English-speaking) are ideal candidates.
Not a fit: People who cannot safely do moderate physical activity, have active cardiovascular/metabolic/renal disease or severe communication limitations, lack a willing caregiver, or do not have video/internet access are unlikely to benefit from this program.
Why it matters
Potential benefit: If successful, the program could improve everyday physical function for adults with Down syndrome and give caregivers practical dementia-care skills and support.
How similar studies have performed: RDAD-style combined exercise and caregiver-training programs have demonstrated benefits in dementia populations, but adapting this approach specifically for older adults with Down syndrome is novel and currently being piloted.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria - Adults with Down syndrome: * Age \>35 yrs. with a diagnosis of DS as self-reported or reported by caregiver. This age range was selected as cognitive decline related to AD is observed at age \~31 in adults with DS. * Sufficient functional ability to understand directions, communicate preferences, wants, and needs through spoken language. * Living at home or in a supported living environment with a parent/caregiver who agrees to serve as a study partner. * Self-reported ability to participate in physical activity. Exclusion Criteria - Adults with Down syndrome: * Unable to participate in moderate-to-vigorous physical activity. * Self-reported, cardiovascular, metabolic or renal disease and/or signs or symptoms. Inclusion Criteria - Caregivers * Age ≥18 yrs. * Reports being a primary caregiver of an adult with DS. * English speaking. * Self-reported ability to participate in physical activity. Exclusion Criteria - Caregivers * Unable to participate in moderate PA, i.e., brisk walking. * Self-reported, cardiovascular, metabolic or renal disease and/or signs or symptoms.
Where this trial is running
Kansas City, Kansas
- University of Kansas Medical Center — Kansas City, Kansas, United States (RECRUITING)
Study contacts
- Study coordinator: Amy Bodde, PhD
- Email: abodde@kumc.edu
- Phone: 913-574-2447
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Down Syndrome, Alzheimer's Disease