Recruiting

Exercise & Caregiving

Sponsor:

University of Kansas Medical Center

Code:

NCT07425769

Conditions

Down Syndrome (DS)

Alzheimer's Disease (AD)

Eligibility Criteria

Sex: All

Age: 0+

Healthy Volunteers: Not accepted

Interventions

Remote Exercise Sessions

Caregiver Education Sessions

Study Details

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)

Study ID

NCT07425769

Start date

Mar 31, 2026

Status verified date

May, 2026

Completion date

Dec 31, 2026

Anticipated

Primary completion date

Dec 31, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 0+

Healthy Volunteers: Not accepted

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 Design

Enrollment

40 participants

Anticipated

Intervention Model

Single group

Primary purpose

Supportive Care

Interventions and Outcome Measures

Arms

experimental: Remote Exercise and Caregiver Education

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

Interventions

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.

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 measure

  • Feasibility: Participant Recruitment [ Time Frame: Baseline ]
  • Feasibility: Recruitment Rate [ Time Frame: Baseline ]
  • Feasibility: Participant retention [ Time Frame: Baseline to Week 12 ]
  • Feasibility: Session Attendance [ Time Frame: Across 12 week intervention ]
  • Feasibility: Participant Safety [ Time Frame: Across 12 week intervention ]

Central Contacts and Locations

Central contacts

Amy Bodde, PhD

913-574-2447abodde@kumc.edu

Joseph Sherman, MS

jsherman7@kumc.edu

Locations

University of Kansas Medical Center

Recruiting

Kansas City, Kansas, United States, 66160

Contacts

Amy Bodde, PhD

913-574-2447abodde@kumc.edu

Joseph Sherman

jsherman7@kumc.edu

Principal Investigator:

Amy Bodde, PhD

More Information

Sponsor

University of Kansas Medical Center

Last update posted

Aug 3, 2026

Last verified

May, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Kansas Medical Center on 2026-08-03.