Caring for Caregivers of Individuals With Alzheimer's Disease

NCT07486037 | Recruiting

• 1 other identifier: 29378
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Intervention Group; Treatment as Usual

Outcome Measures

Primary Outcomes (1)

• Physical Activity

  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.

  6 months

Study Arms (2)

Experimental: EMBRACE Virtual Home-Based Exercise

EXPERIMENTAL

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.

Behavioral: Exercise

No Intervention: Wait-List Control

NO INTERVENTION

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.

Interventions

Exercise BEHAVIORAL

Participants will engage in home-based exercise

Experimental: EMBRACE Virtual Home-Based Exercise

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Indiana University: lead

Study Sites (1)

School of Health and Human Sciences

Indianapolis, Indiana, 46240, United States

RECRUITING

MeSH Terms

Interventions

Exercise

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Central Study Contacts

Navin Kaushal, PhD, FACM,FAHA

CONTACT

317 278-9598; nkaushal@iu.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: Participants in the intervention arm will be prescribed with an exercise program

Study Record Dates

• First Submitted: March 14, 2026
• First Posted: March 20, 2026
• Study Start: March 1, 2026
• Primary Completion (Estimated): May 1, 2028
• Study Completion (Estimated): June 1, 2028
• Last Updated: May 11, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)