Home-Based Cardiac Rehabilitation for Patients With Heart Failure

NCT06479876 | Recruiting DMC

• 1 other identifier: 240749
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Average daily total activity counts

  Daily total activity counts are determined by a triaxial actigraphy device.

  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.

Secondary Outcomes (26)

• Average daily active minutes

  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 activity minutes determined. The comparison will be at 12 weeks after randomization.

• Average daily steps

  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 steps determined. The comparison will be at 12 weeks after randomization.

• Average daily energy expenditure

  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 energy expenditure determined. The comparison will be at 12-weeks after randomization.

• Average daily moderate to vigorous active minutes

  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 moderate to vigorous active mins determined. The comparison will be at 12-weeks after randomization.

• Sustained physical activity bursts of 10 minutes or greater per day

  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 steps determined. The comparison will be at 12 weeks after randomization.

Study Arms (2)

Home-based cardiac rehabilitation mobile health intervention

EXPERIMENTAL

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

Other: HBCR

Control

NO INTERVENTION

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 OTHER

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.

Home-based cardiac rehabilitation mobile health intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Stage C HF (NYHA Class I-III) AND
• Discharged from a HF hospitalization OR
• Scheduled for appointment in a cardiology clinic with a prior HF hospitalization within the past 12 months OR
• Scheduled for appointment in a cardiology clinic with a KCCQ-SS \<75
• Receives longitudinal HF care at VUMC, including at least one visit prior to the roll-in phase
• Randomized Controlled Trial (beyond roll-in phase)
• \. Willingness to continue and participate in the study visits and other study activities required for the RCT

You may not qualify if:

• Unwilling or unable to provide informed consent for participation in the RCT
• 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
• 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.
• 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.
• Age \< 18 years
• Stage D HF (advanced HF under evaluation for LVAD or transplant)
• NYHA class IV symptoms
• Congenital heart disease
• Pregnant
• Group 1 pulmonary hypertension
• Moderate-severe or severe (\> 3+) mitral or aortic valvular disease
• 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)
• Planned surgery within 3 months
• 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)
• Treating provider or study team physician indicates that participation in the RCT would be unsafe

Sponsors & Collaborators

• Vanderbilt University Medical Center: lead

Study Sites (1)

Vanderbilt University Medical Center

Nashville, Tennessee, 37232, United States

RECRUITING

MeSH Terms

Conditions

Cardiovascular Diseases; Motor Activity

Condition Hierarchy (Ancestors)

Behavior

Study Officials

• Brian R Lindman, MD, MSCI

  Vanderbilt University Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Bassim El-Sabawi, MD

CONTACT

615-589-6076; bassim.el-sabawi@vumc.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Assessments performed at baseline visit and final (12-week visit) will be performed by a study team member unaware of randomization group. Clinical outcomes upon completion study will be assessed by an adjudicator who is blinded to randomization group.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: Participants randomized 1:1 to 2 groups.

Study Record Dates

• First Submitted: June 24, 2024
• First Posted: June 28, 2024
• Study Start: August 5, 2024
• Primary Completion (Estimated): August 1, 2026
• Study Completion (Estimated): August 1, 2026
• Last Updated: September 24, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)