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临床试验/NCT07425769
NCT07425769招募中不适用

Adapting the RDAD Intervention for Individuals With Down Syndrome Phase 3- Pilot Test

University of Kansas Medical Center1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2026年3月31日最近更新:
干预措施

试验速览

阶段
不适用
状态
招募中
入组人数
40
试验地点
1
主要终点
Feasibility: Participant Recruitment

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Supportive Care
盲法
None

入排标准

性别
All
接受健康志愿者

入选标准

  • 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.

排除标准

  • 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.

研究组 & 干预措施

Remote Exercise and Caregiver Education

Experimental

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

干预措施: Remote Exercise Sessions (Behavioral)

Remote Exercise and Caregiver Education

Experimental

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

干预措施: Caregiver Education Sessions (Behavioral)

结局指标

主要结局

Feasibility: Participant Recruitment

时间窗: Baseline

Number of participants enrolled divided by number eligible on questionnaire

Feasibility: Recruitment Rate

时间窗: Baseline

Number of participants enrolled per month of active recruitment

Feasibility: Participant retention

时间窗: Baseline to Week 12

Calculated as number of participants completing the intervention divided by the number who initiate the intervention multiplied by 100

Feasibility: Session Attendance

时间窗: Across 12 week intervention

Calculated as the percentage of sessions attended across 12 weeks.

Feasibility: Participant Safety

时间窗: Across 12 week intervention

Will be expressed as the total number of self-reported adverse events.

次要结局

  • 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)
  • Participant Frailty and Injuries: Cooperative Studies of Intervention Techniques (FICSIT-4)(Baseline and Week 12)
  • Participant Hand Grip Strength(Baseline and Week 12)
  • Caregiver Five Times Sit to Stand(Baseline and Week 12)
  • Caregiver Timed Up and Go(Baseline and Week 12)
  • Caregiver 2 Minute Step Test(Baseline and Week 12)
  • Caregiver Frailty and Injuries: Cooperative Studies of Intervention Techniques (FICSIT-4)(Baseline and Week 12)
  • Caregiver Hand Grip Strength(Baseline and Week 12)
  • Participant Physical Function: PROMIS Short Form V2.0 Physical Function Surveys 8b and 8c(Baseline and week 12)
  • Caregiver Physical Function: PROMIS Short Form V2.0 Physical Function Surveys 8b and 8c(Baseline and week 12)
  • Participant Sedentary Time(Baseline and Week 12)
  • Participant Physical Activity(Baseline and Week 12)
  • Participant Basic and Instrumental Activities of Daily Living(Baseline and Week 12)
  • Participant Behavioral Symptom-Related Severity(Baseline and Week 12)
  • Caregiver Sedentary Time(Baseline and Week 12)
  • Caregiver Physical Activity(Baseline and Week 12)
  • Caregiver Strain(Baseline and Week 12)
  • Caregiver Unmet Needs(Baseline and Week 12)
  • Caregiver Self Efficacy(Baseline and Week 12)
  • Caregiver Social Support(Baseline and Week 12)
  • Caregiver Depression(Baseline and Week 12)
  • Caregiver Anxiety(Baseline and Week 12)
  • Caregiver Behavioral symptom-related distress(Baseline and Week 12)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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