Dementia Clinical Trials

Find Dementia Clinical Trials Near You

Caring for Caregivers- Promoting Virtual Home-based Exercise for Caregiver Wellbeing

Status: Recruiting
Location: See location...
Intervention Type: Behavioral
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 99
Healthy Volunteers: t
View:

• 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

Locations
United States
Indiana
School of Health and Human Sciences
RECRUITING
Indianapolis
Contact Information
Primary
Navin Kaushal, PhD, FACM,FAHA
nkaushal@iu.edu
317 278-9598
Time Frame
Start Date: 2026-03-01
Estimated Completion Date: 2028-06-01
Participants
Target number of participants: 25
Treatments
Experimental: 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.
No_intervention: 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.
Related Therapeutic Areas
Sponsors
Leads: Indiana University

This content was sourced from clinicaltrials.gov