Description

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.

Theoretical Framework

The EMBRACE intervention is grounded in Self-Determination Theory (SDT), which holds that sustained behavior change requires support for three basic psychological needs: autonomy (choosing when and how to exercise), competence (developing skills and knowledge), and relatedness (social connection with peers). The intervention further incorporates self-regulation strategies (goal-setting and planning) and habit formation principles to promote long-term independent exercise beyond the structured program period.

Intervention Structure

The EMBRACE program is delivered over 6 months in two phases:

Months 1-3 (Structured Phase): 24 weekly virtual group exercise sessions (\~1 hour each), delivered in small groups of 6-7 participants across two daily time slots (morning and evening). Sessions follow a fixed structure: warm-up (5 min), cardiovascular exercise using a provided Cubii Total Body Elliptical (25 min), strength training (25 min), and cool-down (5 min). The first three sessions include theory-informed education modules on physical activity guidelines, habit formation, and exercise planning and goal-setting.

Months 4-6 (Independent Exercise Phase): Participants exercise independently, supported by weekly booster phone calls (5-10 min each) and weekly text message prompts functioning as behavioral habit cues.

Month 7: Exit focus groups are conducted to gather qualitative feedback on intervention facilitators and barriers.

All study equipment including a tablet, elliptical device, and accelerometer - is mailed to participants, enabling full remote participation.

Control Arm

Participants in the wait-list control arm complete all outcome measures at the same three time points as the intervention arm. The wait-list design is standard practice in behavioral trials involving caregivers and ensures participants eventually receive the program, which is ethically important given the established benefits of exercise for caregiver mental health.

Recruitment

Participants will be recruited through community-based advertising (churches, community centers) and patient referrals from the study's co-investigator geriatric psychiatrist. The study leverages an established community network developed through a related R24 project, including 12 local community leaders and over 300 newsletter recipients in Marion and Lake counties, Indiana.

Randomization and Blinding

Following baseline data collection, participants are randomized 1:1 to the EMBRACE or wait-list control arm. Data collectors administering outcome measures at all time points are blinded to group assignment.

Intervention Fidelity

Fidelity is maintained through standardized staff training, session recording with random fidelity checks using a structured quality assurance form, attendance tracking, and participant self-report exercise logs submitted via voice message.

Assistive Technology Component

To help caregivers carve out protected exercise time at home, the study incorporates multi-sensory assistive technologies designed to reduce disruptive or neuropsychiatric behaviors in individuals with dementia, thereby enabling caregivers to prioritize their own well-being during exercise sessions.

Future Directions

Findings from this Phase I trial will be used to refine the intervention and inform a Phase II efficacy trial. The investigators will also explore the feasibility of developing a concurrent caregiver-care recipient program.