Adapting RDAD for DS

NCT07425769 | Recruiting

• 2 other identifiers: STUDY00162196KL2TR002367
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Down Syndrome (DS); Alzheimer's Disease (AD)

Outcome Measures

Primary Outcomes (5)

• 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 Outcomes (23)

• Participant Sedentary Time

  Baseline and Week 12

• Participant Physical Activity

  Baseline and Week 12

• Participant Five Times Sit to Stand

  Baseline and Week 12

• Participant Timed Up and Go

  Baseline and Week 12

• Participant 2 Minute Step Test

  Baseline and Week 12

Other Outcomes (2)

• Physiological Stress

  Baseline and Week 12

• Intervention Acceptability

  Week 12

Study Arms (1)

Remote Exercise and Caregiver Education

EXPERIMENTAL

Single Arm with active intervention for remote exercise and caregiver education sessions

Behavioral: Remote Exercise Sessions; Behavioral: Caregiver Education Sessions

Interventions

Remote Exercise Sessions BEHAVIORAL

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.

Remote Exercise and Caregiver Education

Caregiver Education Sessions BEHAVIORAL

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.

Remote Exercise and Caregiver Education

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Unable to participate in moderate-to-vigorous physical activity.
• Self-reported, cardiovascular, metabolic or renal disease and/or signs or symptoms.
• Age ≥18 yrs.
• Reports being a primary caregiver of an adult with DS.
• English speaking.
• Self-reported ability to participate in physical activity.
• Unable to participate in moderate PA, i.e., brisk walking.
• Self-reported, cardiovascular, metabolic or renal disease and/or signs or symptoms.

Sponsors & Collaborators

• University of Kansas Medical Center: lead
• National Center for Advancing Translational Sciences (NCATS): collaborator

Study Sites (1)

University of Kansas Medical Center

Kansas City, Kansas, 66160, United States

RECRUITING

MeSH Terms

Conditions

Down Syndrome; Alzheimer Disease

Condition Hierarchy (Ancestors)

Intellectual Disability; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Abnormalities, Multiple; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Chromosome Disorders; Genetic Diseases, Inborn; Dementia; Brain Diseases; Central Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders

Central Study Contacts

Amy Bodde, PhD

CONTACT

913-574-2447; abodde@kumc.edu

Joseph Sherman, MS

CONTACT

jsherman7@kumc.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 11, 2026
• First Posted: February 23, 2026
• Study Start: March 31, 2026
• Primary Completion (Estimated): July 31, 2026
• Study Completion (Estimated): July 31, 2026
• Last Updated: May 6, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)