Adapting RDAD for DS (CareFit DS/AD)

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.

Study Overview

• Status: Recruiting
• Conditions: Alzheimer's Disease (AD); Down Syndrome (DS)
• Intervention / Treatment: Behavioral: Remote Exercise Sessions; Behavioral: Caregiver Education Sessions

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.

• Study Type: Interventional
• Enrollment (Estimated): 40
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Amy Bodde, PhD; Phone Number: 913-574-2447; Email: abodde@kumc.edu
• Study Contact Backup: Name: Joseph Sherman, MS; Email: jsherman7@kumc.edu

Study Locations

• United States
  • Kansas
    • Kansas City, Kansas, United States, 66160
      • Recruiting
      • University of Kansas Medical Center
      • Contact: Amy Bodde, PhD; Phone Number: 913-574-2447; Email: abodde@kumc.edu
      • Contact: Joseph Sherman; Email: jsherman7@kumc.edu
      • Principal Investigator: Amy Bodde, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Remote Exercise and Caregiver Education; Single Arm with active intervention for remote exercise and caregiver education sessions

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Feasibility: Participant Recruitment	Number of participants enrolled divided by number eligible on questionnaire	Baseline
Feasibility: Recruitment Rate	Number of participants enrolled per month of active recruitment	Baseline
Feasibility: Participant retention	Calculated as number of participants completing the intervention divided by the number who initiate the intervention multiplied by 100	Baseline to Week 12
Feasibility: Session Attendance	Calculated as the percentage of sessions attended across 12 weeks.	Across 12 week intervention
Feasibility: Participant Safety	Will be expressed as the total number of self-reported adverse events.	Across 12 week intervention

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Participant Sedentary Time	Assessed using an ActiGraph wGT3x-BT accelerometer (ActiGraph LLC, Pensacola, FL) worn on the non-dominant wrist over 7 consecutive days.	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.	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.	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.	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.	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.	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.	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.	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.	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.	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.	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.	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.	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.	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.	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.	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.	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.	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.	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.	Baseline and Week 12
Caregiver Depression	Will be measured with the Center for Epidemiologic Studies Depression Scale. Higher scores indicate increased caregiver depression risk.	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.	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.	Baseline and Week 12

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Physiological Stress	Will be measured by collection and analysis of salivary cortisol. Higher levels of salivary cortisol are correlated with increased stress.	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	Week 12

Collaborators and Investigators

• Sponsor: University of Kansas Medical Center
• Collaborators: National Center for Advancing Translational Sciences (NCATS)

Study record dates

Study Major Dates

• Study Start (Actual): March 31, 2026
• Primary Completion (Estimated): July 31, 2026
• Study Completion (Estimated): July 31, 2026

Study Registration Dates

• First Submitted: February 11, 2026
• First Submitted That Met QC Criteria: February 19, 2026
• First Posted (Actual): February 23, 2026

Study Record Updates

• Last Update Posted (Actual): May 6, 2026
• Last Update Submitted That Met QC Criteria: May 5, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neurologic Manifestations; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Mental Disorders; Genetic Diseases, Inborn; Neurobehavioral Manifestations; Neurocognitive Disorders; Dementia; Tauopathies; Neurodegenerative Diseases; Congenital Abnormalities; Abnormalities, Multiple; Intellectual Disability; Chromosome Disorders; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Alzheimer Disease; Down Syndrome
• Other Study ID Numbers: STUDY00162196; KL2TR002367 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No