An interventional study of Remote Exercise Sessions and Caregiver Education Sessions in Down Syndrome (DS) and Alzheimer's Disease (AD), sponsored by University of Kansas Medical Center. Active, not recruiting at 1 site in United States. Per ClinicalTrials.gov, last updated 2026-11-10.
Sponsored by University of Kansas Medical Center · Not applicable, Interventional, and Supportive care
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.
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.
For participants within 50 miles of the study site, 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
For participants greater than 50 miles of the study site, staff will mail study equipment, including the Actigraph accelerometer, and schedule a video orientation meeting to assist with equipment setup. Physical function and caregiver saliva collection will not be collected for these participants.
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.
438 studies on the registry are indexed under Down Syndrome; 99 are open to participants now.
This study's planned enrollment of 40 is close to the median of 37 across 286 interventional studies indexed under Down Syndrome.
Browse Down Syndrome studies →University of Kansas Medical Center is the lead sponsor of 492 studies on the registry; 110 are open to participants now.
Of its 38 completed or terminated interventional studies of FDA-regulated products, 24 (63%) have results posted.
Counted across the registry records on this site, refreshed daily.
Inclusion Criteria - Adults with Down syndrome:
Exclusion Criteria - Adults with Down syndrome:
Inclusion Criteria - Caregivers
Exclusion Criteria - Caregivers
Single Arm with active intervention for remote exercise and caregiver education sessions
Behavioral: Remote Exercise Sessions · Behavioral: Caregiver Education 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.
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.
Feasibility: Participant Recruitment
Number of participants enrolled divided by number eligible on questionnaire
Time frame: Baseline
Feasibility: Recruitment Rate
Number of participants enrolled per month of active recruitment
Time frame: Baseline
Feasibility: Participant retention
Calculated as number of participants completing the intervention divided by the number who initiate the intervention multiplied by 100
Time frame: Baseline to Week 12
Feasibility: Session Attendance
Calculated as the percentage of sessions attended across 12 weeks.
Time frame: Across 12 week intervention
Feasibility: Participant Safety
Will be expressed as the total number of self-reported adverse events.
Time frame: Across 12 week intervention
Participant Sedentary Time
Assessed using an ActiGraph wGT3x-BT accelerometer (ActiGraph LLC, Pensacola, FL) worn on the non-dominant wrist over 7 consecutive days.
Time frame: Baseline and Week 12
Participant Physical Activity
Light, moderate and vigorous physical activity will be assessed using an ActiGraph wGT3x-BT accelerometer (ActiGraph LLC, Pensacola, FL) worn on the non-dominant wrist over 7 consecutive days.
Time frame: Baseline and Week 12
Participant Five Times Sit to Stand
Time required to stand up and return to seated position 5 times. Lower time indicates increased physical function. This will be collected from participants living within 50 miles of the study site during a home visit.
Time frame: Baseline and Week 12
Participant Timed Up and Go
Time required to stand from a chair, walk 3 meters, pivot around a cone and return to a seated position. Lower times indicate increased physical function. This will be collected from participants living within 50 miles of the study site during a home visit.
Time frame: Baseline and Week 12
Participant 2 Minute Step Test
Number of steps with knees reaching a height of the midpoint of the femur participants are able to complete in 2 minutes. Higher scores indicate increased physical function. This will be collected from participants living within 50 miles of the study site during a home visit.
Time frame: Baseline and Week 12
Participant Frailty and Injuries: Cooperative Studies of Intervention Techniques (FICSIT-4)
The FICSIT-4 assesses static balance by positioning participants in 4 different stances: feet side-by-side; feet semi-tandem; feet tandem; and one foot. Each stance is attempted to be held for 10 seconds. Higher scores indicate improved physical function. This will be collected from participants living within 50 miles of the study site during a home visit.
Time frame: Baseline and Week 12
Participant Hand Grip Strength
Grip strength for both the dominant and non-dominant hands will be assessed in triplicate and then scores averaged. Higher number indicate increased physical function. This will be collected from participants living within 50 miles of the study site during a home visit.
Time frame: Baseline and Week 12
Participant Basic and Instrumental Activities of Daily Living
Will be assessed by proxy (caregiver report) using the 17-item Waisman Activities of Daily Living survey. Higher scores indicate increased independence with ADLs.
Time frame: Baseline and Week 12
Participant Behavioral Symptom-Related Severity
Will be assessed by proxy report with the Neuropsychiatric Inventory Questionnaire (NPI-Q). Higher scores indicate increased frequency and severity of behavioral symptoms.
Time frame: Baseline and Week 12
Participant Physical Function: PROMIS Short Form V2.0 Physical Function Surveys 8b and 8c
Participant physical function will be assessed by self-report using PROMIS Short Form Surveys 8b and 8c. These surveys consist of questions pertaining to ability to perform activities of daily living. Responses are on a 5 point scale ranging from 'Without any difficulty' scoring 5, to 'Unable to do' scoring 1. Higher scores indicate improved physical function.
Time frame: Baseline and week 12
Caregiver Sedentary Time
Assessed using an ActiGraph wGT3x-BT accelerometer (ActiGraph LLC, Pensacola, FL) worn on the non-dominant wrist over 7 consecutive days.
Time frame: Baseline and Week 12
Caregiver Physical Activity
Light, moderate and vigorous physical activity will be assessed using an ActiGraph wGT3x-BT accelerometer (ActiGraph LLC, Pensacola, FL) worn on the non-dominant wrist over 7 consecutive days.
Time frame: Baseline and Week 12
Caregiver Five Times Sit to Stand
Time required to stand up and return to seated position 5 times. Lower time indicates increased physical function. This will be collected from participants living within 50 miles of the study site during a home visit.
Time frame: Baseline and Week 12
Caregiver Timed Up and Go
Time required to stand from a chair, walk 3 meters, pivot around a cone and return to a seated position. Lower times indicate increased physical function. This will be collected from participants living within 50 miles of the study site during a home visit.
Time frame: Baseline and Week 12
Caregiver 2 Minute Step Test
Number of steps with knees reaching a height of the midpoint of the femur participants are able to complete in 2 minutes. Higher scores indicate increased physical function. This will be collected from participants living within 50 miles of the study site during a home visit.
Time frame: Baseline and Week 12
Caregiver Frailty and Injuries: Cooperative Studies of Intervention Techniques (FICSIT-4)
The FICSIT-4 assesses static balance by positioning participants in 4 different stances: feet side-by-side; feet semi-tandem; feet tandem; and one foot. Each stance is attempted to be held for 10 seconds. Higher scores indicate improved physical function. This will be collected from participants living within 50 miles of the study site during a home visit.
Time frame: Baseline and Week 12
Caregiver Hand Grip Strength
Grip strength for both the dominant and non-dominant hands will be assessed in triplicate and then scores averaged. Higher number indicate increased physical function. This will be collected from participants living within 50 miles of the study site during a home visit.
Time frame: Baseline and Week 12
Caregiver Strain
Will be assessed using the Modified Caregiver Strain Index which captures multiple domains of caregiver strain (physical, emotional, financial). Higher scores indicate greater burden and need for support or intervention.
Time frame: Baseline and Week 12
Caregiver Unmet Needs
Will be assessed by the Measure of Unmet Needs survey. Higher scores indicate larger amounts of unmet caregiver needs.
Time frame: Baseline and Week 12
Caregiver Self Efficacy
Will be measured using a 9-item dementia caregiver self-efficacy measure. Caregivers will rate their certainty of handling challenging behaviors and access to community services. Higher scores indicate higher self-efficacy.
Time frame: Baseline and Week 12
Caregiver Social Support
Will be assessed with the Multidimensional Scale of Perceived Social Support (MSPSS). The MSPSS is a 12-item measure of perceived social support measured on a total sum scale and on 3 domains: family, friends, and significant others. Higher scores indicate increased perception of social support.
Time frame: Baseline and Week 12
Caregiver Depression
Will be measured with the Center for Epidemiologic Studies Depression Scale. Higher scores indicate increased caregiver depression risk.
Time frame: Baseline and Week 12
Caregiver Anxiety
Will be measured with the Generalized Anxiety Disorder 7-item scale (GAD-7). Higher scores indicate increased anxiety symptoms.
Time frame: Baseline and Week 12
Caregiver Behavioral symptom-related distress
Will be assessed by a subscale of NPI-Q. higher scores indicate increase symptom-related caregiver distress.
Time frame: Baseline and Week 12
Caregiver Physical Function: PROMIS Short Form V2.0 Physical Function Surveys 8b and 8c
Caregiver physical function will be assessed by self-report using PROMIS Short Form Surveys 8b and 8c. These surveys consist of questions pertaining to ability to perform activities of daily living. Responses are on a 5 point scale ranging from 'Without any difficulty' scoring 5, to 'Unable to do' scoring 1. Higher scores indicate improved physical function.
Time frame: Baseline and week 12
Physiological Stress
Will be measured by collection and analysis of salivary cortisol. Higher levels of salivary cortisol are correlated with increased stress. This will be collected from participants living within 50 miles of the study site during a home visit.
Time frame: Baseline and Week 12
Intervention Acceptability
Will be assessed from audio recorded semi-structured interviews conducted with adult with DS/caregiver dyads within 2 weeks following completion of the 12 week intervention
Time frame: Week 12
Plan to share: No
No publications or documents are linked to this record.
Started Mar 2026 (actual). Primary completion is estimated for Jan 2027, 9 months after the start.
Of 163 non-industry interventional studies with no phase under Down Syndrome, half reached primary completion within 11 months of starting (the median), counting those still running; a quarter within 3 and three quarters within 35. This study's planned 9 months is below that.
Counting every sponsor, half of 165 studies reached it within 11 months; a quarter within 3 and three quarters within 35.
Since we started tracking on Sep 25, 2026, the dates moved once, on Nov 10, 2026: primary completion Dec 2026 → Jan 2027 and completion Dec 2026 → Feb 2027.
Earlier changes are on the record history on ClinicalTrials.gov ↗
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is active, not recruiting, as verified in Nov 2026. You cannot join it, but the record below documents what was studied.
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