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Adapting RDAD for DS

ConditionsDown Syndrome (DS)Alzheimer's Disease (AD)
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
AgeNot listed
SponsorUniversity of Kansas Medical Center

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial design

Design model

Single group

Treatments tested in this trial

  • 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.

  • 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.

Treatment groups

40 Participants
are divided into 1 treatment group
Group A: Remote Exercise and Caregiver EducationExperimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

Feasibility: Participant Recruitment

Number of participants enrolled divided by number eligible on questionnaire

Time frame
Baseline
2

Feasibility: Recruitment Rate

Number of participants enrolled per month of active recruitment

Time frame
Baseline
3

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
4

Feasibility: Session Attendance

Calculated as the percentage of sessions attended across 12 weeks.

Time frame
Across 12 week intervention

Secondary outcomes

1

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
2

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
3

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
4

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

Other outcomes

1

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
2

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

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Kansas Medical Center

Lead sponsor

National Center for Advancing Translational Sciences (NCATS)

Collaborator

Source ClinicalTrials.gov
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