Caring for Caregivers of Individuals With Alzheimer's Disease- Promoting Virtual Home-based Exercise for Caregiver Wellbeing
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 25
- 试验地点
- 1
- 主要终点
- Physical Activity
研究概览
简要总结
What is this study about? This study is called the EMBRACE Study - A Virtual Community Empowerment Approach Integrating Tradition and Technology for Family Caregivers of Individuals with Alzheimer's Disease. It tests whether a home-based virtual exercise program can reduce depression and anxiety in family caregivers of people living with Alzheimer's disease and related dementias (ADRD).
Why is this study needed? Caring for a loved one with ADRD is demanding and is strongly linked to depression and anxiety. Regular exercise is one of the most effective ways to reduce these symptoms - but caregivers often cannot leave home to exercise due to the needs of their loved one, transportation concerns, and safety issues.
What does participation involve? Participants will be randomly assigned (like a coin flip) to one of two groups:
- EMBRACE group: 24 weekly virtual group exercise sessions over 3 months (about 1 hour each), using an at-home elliptical device provided by the study. Months 4-6 include weekly check-in calls to support independent exercise. Educational sessions on habit-building and goal-setting are included.
- Wait-list control group: Completes the same surveys and measurements; receives the program after data collection ends.
Who can join? Adults (18+) who are the primary unpaid caregiver for someone with ADRD, can read and speak English, and are healthy enough to exercise. Participants do not need to leave home - everything is virtual.
What is being measured? Exercise time (using a wearable device), symptoms of depression and anxiety, and whether the program is feasible and acceptable to participants.
Where is the study based? Indiana University Indianapolis. The study is conducted entirely virtually and remotely.
详细描述
Background and Rationale
As the U.S. population ages, the number of individuals living with Alzheimer's disease and related dementias (ADRD) is growing substantially. Family caregivers of adults with ADRD perform complex daily tasks, including activities of daily living, financial management, and medication management, yet are frequently unprepared for the scope of the role. ADRD caregiving is associated with significantly elevated rates of anxiety and depression compared to non-caregivers. Depression is the leading cause of disability worldwide, making the mental health of caregivers a critical public health concern.
Regular physical exercise is one of the most evidence-based strategies for preventing and alleviating depression and anxiety. However, rates of physical activity remain low nationwide, and research has shown that caregivers struggle to maintain exercise routines outside of controlled settings. Caregivers face unique barriers including the inability to leave their care recipient unattended, transportation burden, and unpredictable schedules. Home-based and virtual exercise programs have been identified as viable alternatives that bypass these barriers.
Study Purpose
The purpose of this Phase I randomized controlled trial is to test the feasibility, acceptability, and preliminary efficacy of the EMBRACE intervention - a theory-informed, home-based, virtual group exercise program tailored for family caregivers of individuals with ADRD.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Triple (Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Self-identifies as African American
- •Age 18 years or older
- •Primary unpaid caregiver for an adult living with Alzheimer's disease or a related dementia (ADRD)
- •Able to read and speak English
- •Deemed sufficiently healthy to participate in exercise per the PAR-Q+ screening questionnaire
- •Has access to an email address
排除标准
- •Diagnosed psychiatric illness
- •Untreated severe major depression
- •Currently receiving advanced cancer treatment or hospice care
- •Currently receiving dialysis
- •Severe hearing loss without hearing aids
- •Severe vision impairment without corrective eyeglasses
- •No access to a phone or email
- •Unable to safely exercise based on PAR-Q+ screening
- •Already meeting the recommended physical activity guidelines at the time of enrollment
研究组 & 干预措施
Experimental: EMBRACE Virtual Home-Based Exercise
Participants in the EMBRACE arm will receive a 6-month home-based virtual exercise program consisting of 24 weekly group exercise sessions (months 1-3) followed by a supported independent exercise phase (months 4-6). All equipment, including a Cubii Total Body Elliptical and tablet, will be mailed to participants so the program can be completed entirely from home. Theory-informed educational content on habit formation, goal-setting, and self-regulation is embedded in the first three sessions to support long-term independent exercise adherence.
干预措施: Exercise (Behavioral)
No Intervention: Wait-List Control
Participants in the wait-list control arm will complete all study outcome measures at the same three time points as the experimental arm (baseline, month 3, and month 6) but will not receive the EMBRACE intervention during the data collection period. This treatment-as-usual approach is standard practice in behavioral trials involving caregivers and allows for a clean comparison of outcomes between groups. Upon completion of their data collection period, wait-list participants will be offered the full EMBRACE program as an ethical provision given the established benefits of exercise for caregiver mental health.
结局指标
主要结局
Physical Activity
时间窗: 6 months
Physical activity will be measured by using Actigraph GT3X acclerometers. Specfically the average weekly moderate-to-vigorus physical activity (MVPA) time over the span of two weeks will be the primary outcome and analyzed.
次要结局
未报告次要终点
研究者
Navin Kaushal
Associate Professor
Indiana University