Recruiting

EMBRACE Program

Sponsor:

Indiana University

Code:

NCT07486037

Conditions

Intervention Group

Treatment as Usual

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Accepted

Interventions

Exercise

Study Details

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

Study ID

NCT07486037

Start date

Mar 1, 2026

Status verified date

May, 2026

Completion date

Jun 1, 2028

Anticipated

Primary completion date

May 1, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Accepted

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Study Design

Enrollment

25 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

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.

Interventions

Exercise

Participants will engage in home-based exercise

Primary outcome measure

  • Physical Activity [ Time Frame: 6 months ]

Central Contacts and Locations

Central contacts

Navin Kaushal, PhD, FACM,FAHA

317 278-9598nkaushal@iu.edu

Locations

School of Health and Human Sciences

Recruiting

Indianapolis, Indiana, United States, 46240

Contacts

Navin Kaushal, PhD

3174505240nkaushal@iu.edu

More Information

Sponsor

Indiana University

Last update posted

May 11, 2026

Last verified

May, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Indiana University on 2026-05-11.