Adapting RDAD for DS
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Remote Exercise Sessions, Caregiver Education Sessions.
- Who it may be relevant to
- Registry conditions: Down Syndrome (DS), Alzheimer's Disease (AD). Basic parameters: No limits · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Adapting the RDAD Intervention for Individuals With Down Syndrome Phase 3- Pilot Test
Overview
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.
Interventions
- 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.
Primary outcome measures
- 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]
Secondary outcome measures (12)
- 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]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Supportive care
Study locations
United States · 1 center
- University of Kansas Medical Center — Kansas City
Identifiers
NCT: NCT07425769 · STUDY00162196 · KL2TR002367