Recruiting

Home-Based Exercise

Sponsor:

University of Pennsylvania

Code:

NCT06291922

Conditions

Heart Failure

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Exercise Intervention

Usual Care

Study Details

Brief summary:

The goal of this clinical trial is to evaluate the effects of a home-based exercise program using mobile technology on physical activity and capacity, frailty and muscle mass, and quality of life in patients with a newly implanted HeartMate 3 left ventricular assist device (HM3 LVAD). Researchers will compare the effects of an exercise intervention vs. usual care on physical activity and capacity, frailty and muscle mass, and quality of life.

Conditions

Heart Failure

Study ID

NCT06291922

Start date

Aug 14, 2024

Status verified date

Sep, 2025

Completion date

Jun 30, 2028

Anticipated

Primary completion date

Jun 30, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

1. ≥ 18 years of age
2. Newly implanted with a HeartMate 3™ LVAD for the first time
3. Able to ambulate independently (with or without the use of an assistive device)
4. Owns a smartphone with Internet connection
5. Patient will be discharged home with LVAD or patient will be living at home with LVAD within 45 days of index discharge

Exclusion Criteria:

1\. Major comorbidities or limitations that may interfere with exercise training (including significant orthopedic/neurologic limitations, decompensated heart failure, uncontrolled arrhythmias, unstable angina)

Study Design

Enrollment

100 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Exercise Intervention

The exercise intervention focuses on walking and strengthening exercises with a standardized protocol to guide exercise prescription and exercise progression based on data obtained from the activity tracking watch and smartphone app.

other: Usual Care

The usual care group will be encouraged to increase daily walking activity as they tolerate, while complying with any activity restrictions from their clinical team. The Physical Activity Guidelines for Americans recommend increasing daily walking activity as tolerated to an average of 30 minutes daily, 5 times a week.

Interventions

Exercise Intervention

See arm description.

Usual Care

See arm description.

Primary outcome measure

  • Effects of exercise intervention on physical activity and capacity (step count) [ Time Frame: 6 months ]
  • Effects of exercise intervention on physical activity and capacity (distance) [ Time Frame: 6 months ]

Central Contacts and Locations

Central contacts

Clinical Research Coordinator

215-615-4480sadie.butcher@pennmedicine.upenn.edu

Locations

Henry Ford Health

Recruiting

Detroit, Michigan, United States, 48202

Cleveland Clinic Foundation

Recruiting

Cleveland, Ohio, United States, 44195

University of Pennsylvania

Recruiting

Philadelphia, Pennsylvania, United States, 19104

University of Utah Health

Recruiting

Salt Lake City, Utah, United States, 84112

More Information

Sponsor

University of Pennsylvania

Last update posted

Sep 26, 2025

Last verified

Sep, 2025

Keywords

  • Left ventricular assist device
  • Exercise
  • Ventricular assist device
  • HeartMate 3 (HM3)

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by University of Pennsylvania on 2025-09-26.