Home-based Cardiac Rehabilitation in Heart Failure

NCT06349941 | Recruiting Phase 3

• 1 other identifier: STU-2023-0745
• Study Type: interventional
• Target: 332
• Locations: 1 country
• Sites: 2

Brief Summary

This study evaluates a mobile health (mHealth) home-based cardiac rehabilitation program for patients with heart failure. We will stratify randomization between rural and urban populations, with the goal to assess implementation of cardiac rehabilitation across these two geographic areas. . The study will randomize 332 patients with heart failure (ejection fraction ≥35%) who are not eligible for center-based rehabilitation to either a 12-week mHealth cardiac rehabilitation program or an attention control group, with outcomes measured over 6 months using a composite endpoint of mortality, hospitalizations, and quality of life. We will then assess the implementation of the intervention.

Conditions

Heart Failure

Keywords

telehealth; heart failure; rural; cardiac rehabilitaion

Outcome Measures

Primary Outcomes (1)

• Composite Hierarchical Endpoint

  A composite outcome incorporating all-cause mortality, time to first heart failure hospitalization, total heart failure hospitalizations, and a 5-point difference in disease-specific quality of life score as assessed by the Kansas City Cardiomyopathy Questionnaire (KCCQ). The KCCQ ranges from 0-100, where 0 indicates worst quality of life and 100 indicates best quality of life.

  6 months.

Secondary Outcomes (5)

• Physical Activity Level

  Continuously measured over 6 months.

• General Health-Related Quality of Life

  Baseline, 3 months, and 6 months

• Implementation Outcomes

  Assessed at 3 and 6 months.

• Depressive Symptoms

  Baseline, 3 months, and 6 months

• Anxiety Symptoms

  Baseline, 3 months, and 6 months

Study Arms (2)

Movn cardiac rehabilitation

EXPERIMENTAL

Cardiac rehabilitation delivered through Movn app through the use of mHealth.

Device: Movn app

Attention Control

ACTIVE COMPARATOR

This group will receive a wearable device for step count tracking and will get periodic check ins to minimize differential attention between groups. They will not receive an exercise plan.

Device: Accelerometer

Interventions

Movn app DEVICE

Participants will have 12-week home-based exercise program delivered via a commercially available home-based cardiac rehabilitation platform called Movn. The plan includes an accelerometer, blood pressure scale, and mobile application.

Also known as: Cardiac Rehabilitation

Movn cardiac rehabilitation

Accelerometer DEVICE

Participants will receive a FitBit for monitoring of physical function.

Also known as: FitBit

Attention Control

Eligibility Criteria

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

You may qualify if:

• Adults aged 18 years or older
• History of hospitalization for acute heart failure with ejection fraction ≥ 35%
• Ability to participate in telemedicine visits
• Access to smartphone or device capable of running the mHealth application
• Willingness to participate in home-based cardiac rehabilitation program

You may not qualify if:

• Heart failure with reduced ejection fraction (ejection fraction \< 35%)
• Inability to participate in physical exercise or cardiac rehabilitation due to medical contraindications
• Inability to provide informed consent
• Lack of access to required technology (smartphone, internet connectivity)
• Life expectancy less than 6 months
• Inability to participate in telemedicine visits or remote monitoring
• Current participation in another cardiac rehabilitation program

Sponsors & Collaborators

• University of Texas Southwestern Medical Center: lead

Study Sites (2)

University of Texas Southwestern Medical Center

Dallas, Texas, 75209, United States

RECRUITING

Baylor Scott and White Health System

Dallas, Texas, 75246, United States

NOT YET RECRUITING

MeSH Terms

Conditions

Heart Failure

Interventions

Cardiac Rehabilitation

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Health Services; Health Care Facilities Workforce and Services

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: March 31, 2024
• First Posted: April 5, 2024
• Study Start: August 15, 2025
• Primary Completion (Estimated): December 1, 2028
• Study Completion (Estimated): December 1, 2028
• Last Updated: August 21, 2025

Record last verified: 2025-08

Locations

US (2)