Down Syndrome (DS)CareFit DS/ADNCT07425769
Adapting RDAD for DS
A study testing Remote Exercise Sessions and Caregiver Education Sessions in people with Down Syndrome (DS) and Alzheimer's Disease (AD), run by University of Kansas Medical Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Down Syndrome (DS), Alzheimer's Disease (AD)
- What is being tested?
- Remote Exercise Sessions and Caregiver Education Sessions
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 31 Mar 2026to 31 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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.
- Age ≥18 yrs.
- Reports being a primary caregiver of an adult with DS.
- English speaking.
- Self-reported ability to participate in physical activity.
Who cannot join
- Unable to participate in moderate-to-vigorous physical activity.
- Self-reported, cardiovascular, metabolic or renal disease and/or signs or symptoms.
- Unable to participate in moderate PA, i.e., brisk walking.
- Self-reported, cardiovascular, metabolic or renal disease and/or signs or symptoms.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Joseph Sherman, MS contact
United States1 site, 1 recruiting
- Recruiting
University of Kansas Medical Center
Kansas City, Kansas, 66160
Amy Bodde, PhD, 913-574-2447, abodde@kumc.edu
Joseph Sherman, jsherman7@kumc.edu
About this study
Official title: Adapting the RDAD Intervention for Individuals With Down Syndrome Phase 3- Pilot Test
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.
Read the 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.
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.
- Conditions
- Down Syndrome (DS), Alzheimer's Disease (AD)
- Being tested
- Remote Exercise Sessions, Caregiver Education Sessions
- Medical subject headings
- Down Syndrome, Alzheimer Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Remote Exercise SessionsBehavioural
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.
Caregiver Education SessionsBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Remote Exercise and Caregiver Education | Experimental | Single Arm with active intervention for remote exercise and caregiver education sessions Receives: Behavioral: Remote Exercise Sessions; Behavioral: Caregiver Education Sessions |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility: Participant Recruitment
Number of participants enrolled divided by number eligible on questionnaire
Measured: Baseline
Feasibility: Recruitment Rate
Number of participants enrolled per month of active recruitment
Measured: Baseline
Feasibility: Participant retention
Calculated as number of participants completing the intervention divided by the number who initiate the intervention multiplied by 100
Measured: Baseline to Week 12
Feasibility: Session Attendance
Calculated as the percentage of sessions attended across 12 weeks.
Measured: Across 12 week intervention
Feasibility: Participant Safety
Will be expressed as the total number of self-reported adverse events.
Measured: Across 12 week intervention
Secondary outcomes (25)
Participant Sedentary Time
Assessed using an ActiGraph wGT3x-BT accelerometer (ActiGraph LLC, Pensacola, FL) worn on the non-dominant wrist over 7 consecutive days.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline and Week 12
Caregiver Depression
Will be measured with the Center for Epidemiologic Studies Depression Scale. Higher scores indicate increased caregiver depression risk.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline and week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2026
- Study start31 Mar 2026
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Down Syndrome (DS)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Kansas Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Center for Advancing Translational Sciences (NCATS)
- Responsible party
- Sponsor
- Investigators
- Amy Bodde, PhD, Principal investigator, University of Kansas Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07425769
- Sponsor's protocol ID
- STUDY00162196
- Other IDs
- KL2TR002367
- Acronym
- CareFit DS/AD
- Status last verified
- May 2026
- First submitted
- 11 Feb 2026
- Last updated
- 3 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Adapting the RDAD Intervention for Individuals With Down Syndrome Phase 3- Pilot Test
- ClinicalTrials.gov ID
- NCT07425769
- Acronym / sponsor ID
- CareFit DS/AD / STUDY00162196
- Conditions
- Down Syndrome (DS), Alzheimer's Disease (AD)
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- University of Kansas Medical CenterUniversity, hospital or other
- Collaborators
- National Center for Advancing Translational Sciences (NCATS)
- Study start
- 31 Mar 2026 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 23 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Remote Exercise and Caregiver Education | Experimental | Behavioral: Remote Exercise Sessions, Behavioral: Caregiver Education SessionsSingle Arm with active intervention for remote exercise and caregiver education sessions |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (8 listed)
- 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.
- Age ≥18 yrs.
Key exclusion criteria (4 listed)
- Unable to participate in moderate-to-vigorous physical activity.
- Self-reported, cardiovascular, metabolic or renal disease and/or signs or symptoms.
- Unable to participate in moderate PA, i.e., brisk walking.
- Self-reported, cardiovascular, metabolic or renal disease and/or signs or symptoms.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Remote Exercise SessionsParticipants 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. | Behavioural | Remote Exercise and Caregiver Education |
| Caregiver Education SessionsCaregivers 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. | Behavioural | Remote Exercise and Caregiver Education |
Primary outcome
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.
25 secondary outcomes
Participant Sedentary Time
Time frame: Baseline and Week 12
Participant Physical Activity
Time frame: Baseline and Week 12
Participant Five Times Sit to Stand
Time frame: Baseline and Week 12
Participant Timed Up and Go
Time frame: Baseline and Week 12
Participant 2 Minute Step Test
Time frame: Baseline and Week 12
Participant Frailty and Injuries: Cooperative Studies of Intervention Techniques (FICSIT-4)
Time frame: Baseline and Week 12
Participant Hand Grip Strength
Time frame: Baseline and Week 12
Participant Basic and Instrumental Activities of Daily Living
Time frame: Baseline and Week 12
Participant Behavioral Symptom-Related Severity
Time frame: Baseline and Week 12
Participant Physical Function: PROMIS Short Form V2.0 Physical Function Surveys 8b and 8c
Time frame: Baseline and week 12
Caregiver Sedentary Time
Time frame: Baseline and Week 12
Caregiver Physical Activity
Time frame: Baseline and Week 12
Caregiver Five Times Sit to Stand
Time frame: Baseline and Week 12
Caregiver Timed Up and Go
Time frame: Baseline and Week 12
Caregiver 2 Minute Step Test
Time frame: Baseline and Week 12
Caregiver Frailty and Injuries: Cooperative Studies of Intervention Techniques (FICSIT-4)
Time frame: Baseline and Week 12
Caregiver Hand Grip Strength
Time frame: Baseline and Week 12
Caregiver Strain
Time frame: Baseline and Week 12
Caregiver Unmet Needs
Time frame: Baseline and Week 12
Caregiver Self Efficacy
Time frame: Baseline and Week 12
Caregiver Social Support
Time frame: Baseline and Week 12
Caregiver Depression
Time frame: Baseline and Week 12
Caregiver Anxiety
Time frame: Baseline and Week 12
Caregiver Behavioral symptom-related distress
Time frame: Baseline and Week 12
Caregiver Physical Function: PROMIS Short Form V2.0 Physical Function Surveys 8b and 8c
Time frame: Baseline and week 12
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Aug 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Joseph Sherman, MS contact
Amy Bodde, PhD principal investigator
University of Kansas Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Remote Exercise Sessions and Caregiver Education Sessions in people with Down Syndrome (DS) and Alzheimer's Disease (AD), run by University of Kansas Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 3 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Amy Bodde, PhD (913-574-2447, abodde@kumc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility: Participant Recruitment (time frame: Baseline). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Aug 2026.