Recruiting

Home-Based Cardiac Rehabilitation

Sponsor:

Vanderbilt University Medical Center

Code:

NCT06479876

Conditions

Heart Failure With Preserved Ejection Fraction

Heart Failure With Reduced Ejection Fraction

Cardiovascular Diseases

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

HBCR

Study Details

Brief summary:

The vast majority of individuals with heart failure do not participate in center based cardiac rehabilitation (CBCR). While steps to increase utilization of CBCR are important, many individuals will still not participate for a variety of reasons. This pilot randomized controlled trial is evaluating a home-based cardiac rehabilitation (HBCR) intervention delivered using a custom app and digital tools in patients with heart failure. After a brief roll-in period, participants are randomized to one of two groups: (1) control or (2) HBCR mobile health intervention. The intervention targets key health behaviors and includes traditional cardiac rehabilitation components. The study will assess the effect of the intervention on physical activity, quality of life, clinical events, and other outcomes.

Conditions

Heart Failure With Preserved Ejection Fraction

Heart Failure With Reduced Ejection Fraction

Cardiovascular Diseases

Study ID

NCT06479876

Start date

Aug 5, 2024

Status verified date

Sep, 2025

Completion date

Aug, 2026

Anticipated

Primary completion date

Aug, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria Roll-in Phase

1. Stage C HF (NYHA Class I-III) AND

1. Discharged from a HF hospitalization OR
2. Scheduled for appointment in a cardiology clinic with a prior HF hospitalization within the past 12 months OR
3. Scheduled for appointment in a cardiology clinic with a KCCQ-SS <75
2. Receives longitudinal HF care at VUMC, including at least one visit prior to the roll-in phase

Randomized Controlled Trial (beyond roll-in phase)

1\. Willingness to continue and participate in the study visits and other study activities required for the RCT

Exclusion Criteria Roll-in Phase

1. Unwilling or unable to provide informed consent for participation in the RCT
2. Requires a wheelchair all (or most) of the time inside and outside the house; it is acceptable if a wheelchair is needed, for example, for parking lot transfer for a clinic visit and navigating around the hospital without it being needed in the home
3. If an individual uses a walker or cane all (or most) of the time, then he/she will be excluded if he/she scores 2 or lower on the Mini-Cog or the patient is unable to perform 2 chair sit-to-stands independently or is deemed to be at high fall risk during baseline visit assessment.
4. History of falls over the last 6 months; an isolated explainable fall with no injury would not exclude the patient, but a tendency to falls indicative of balance/stability issues would exclude the patient.
5. Age < 18 years
6. Stage D HF (advanced HF under evaluation for LVAD or transplant)
7. NYHA class IV symptoms
8. Congenital heart disease
9. Pregnant
10. Group 1 pulmonary hypertension
11. Moderate-severe or severe (> 3+) mitral or aortic valvular disease
12. Physical or neuropsychiatric limitations that would prevent proficient use of the study tools and successful completion of the physical and quality of life assessments (e.g. blindness, dementia)
13. Planned surgery within 3 months
14. Planned discharge from hospital to hospice, assisted living, or inpatient rehabilitation facility (discharge to a senior facility permitted as long as they are considered Independent Living)
15. Treating provider or study team physician indicates that participation in the RCT would be unsafe
16. Participation in any ongoing randomized trial that has not completed follow-up

Randomized Controlled Trial (beyond roll-in phase)

1. Not adherent to wearing the Actigraph activity tracker during the roll-in phase for a minimum of 4 (out of 10) compliant days (worn ³10 hours/day). Allowance will be made to include participants who wear the ActiGraph device ³10 hours/day for 3 days and also wear the ActiGraph device >9 hours/day for at least 1 day.
2. Unable to complete the baseline study visit within 4 weeks of the completion of the roll-in actigraphy assessment.

Study Design

Enrollment

100 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Home-based cardiac rehabilitation mobile health intervention

Home-based cardiac rehabilitation with mobile application and periodic video calls with exercise physiologist + AHA Life's Essential 8 sheets.

no intervention: Control

Standard of care course for an individual not participating in center based cardiac rehabilitation. AHA Life's Essential 8 Fact Sheets are provided to promote healthy living.

Interventions

HBCR

Home-based cardiac rehabilitation intervention facilitated by a custom app to deliver education, counseling on healthy living and modification of risk factors, mindfulness, and physical activity guidance. Additionally, there are periodic video calls with an exercise physiologist.

Primary outcome measure

  • Average daily total activity counts [ Time Frame: The actigraphy device will be worn for approximately one week and, using data from days when the device was worn >10 hours, the average daily total activity counts determined. The primary comparison will be at 12 weeks after randomization. ]

Central Contacts and Locations

Central contacts

Locations

Vanderbilt University Medical Center

Recruiting

Nashville, Tennessee, United States, 37232

More Information

Sponsor

Vanderbilt University Medical Center

Last update posted

Sep 24, 2025

Last verified

Sep, 2025

Keywords

  • cardiac rehabilitation, physical activity, functional capacity, quality of life, outcomes

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Vanderbilt University Medical Center on 2025-09-24.