NCT07425769 · University of Kansas Medical Center
Adapting RDAD for DS
(CareFit DS/AD)
What this study is about
The goal of this clinical trial is to observe feasibility and initial effectiveness of a remotely delivered exercise and dementia caregiving intervention in older adults with Down syndrome and their caregivers.
View original scientific description
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.
Interventions
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.
Primary outcome measures
Feasibility: Participant Recruitment
Time frame: Baseline
Number of participants enrolled divided by number eligible on questionnaire
Feasibility: Recruitment Rate
Time frame: Baseline
Number of participants enrolled per month of active recruitment
Feasibility: Participant retention
Time frame: Baseline to Week 12
Calculated as number of participants completing the intervention divided by the number who initiate the intervention multiplied by 100
Feasibility: Session Attendance
Time frame: Across 12 week intervention
Calculated as the percentage of sessions attended across 12 weeks.
Feasibility: Participant Safety
Time frame: Across 12 week intervention
Will be expressed as the total number of self-reported adverse events.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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
- Kansas City, Kansas
Collaborators
National Center for Advancing Translational Sciences (NCATS)
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Aug 3, 2026 · Source of record for eligibility and locations