Home-Based Exercise Program Using Mobile Technology After Left Ventricular Assist Device Implantation (MOVE-LVAD II)

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.

Study Overview

• Status: Recruiting
• Conditions: Heart Failure
• Intervention / Treatment: Behavioral: Exercise Intervention; Behavioral: Usual Care

Detailed Description

Eligible subjects who sign the consent form will be randomized to either the exercise intervention arm or the usual care arm. As part of the baseline assessment, all subjects will measure their average daily steps during week 1 using a Garmin activity tracking watch, complete a six-minute walk test, complete frailty testing (including measurements of handgrip strength and gait speed), and complete surveys. Subjects will also complete a CT scan to evaluate muscle mass. After completing baseline assessments, subjects will be randomized to one of the study arms.

Subjects in the usual care arm will receive a Garmin activity tracking watch to wear continuously. Subjects will receive reminders from a smartphone app (Datos) to wear the watch. Subjects will be encouraged to increase daily walking as tolerated. In addition to standard of care clinic visits, they will receive phone calls from the study research coordinator reminding them to wear the watch and to walk.

Subjects in the exercise intervention arm will first have an initial training session with an interventionist to review exercises and safe practices. Subjects will receive an individualized exercise prescription for frequency, duration, and intensity of walking and strengthening exercises (including use of resistance bands and light weights). Subjects' progress in the exercise program will be remotely monitored using the activity tracking watch and the smartphone app, and subjects will complete questionnaires through the app. Subjects will complete video calls with the interventionist throughout the duration of the study and will receive updated personalized exercise prescriptions based on their progress.

Subjects in both study arms will have regular follow up VAD Clinic appointments per standard of care practices. Subjects will complete questionnaires, complete six-minute walk testing, complete frailty testing (including measurements of handgrip strength and gait speed), and undergo a chest CT scan without contrast as part of follow up activities. Throughout the study, data will be collected from the medical record.

• Study Type: Interventional
• Enrollment (Estimated): 100
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Clinical Research Coordinator; Phone Number: 215-615-4480; Email: sadie.butcher@pennmedicine.upenn.edu

Study Locations

• United States
  • Michigan
    • Detroit, Michigan, United States, 48202
      • Recruiting
      • Henry Ford Health
      • Contact: Clinical Research Coordinator
  • Ohio
    • Cleveland, Ohio, United States, 44195
      • Recruiting
      • Cleveland Clinic Foundation
      • Contact: Clinical Research Coordinator
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19104
      • Recruiting
      • University of Pennsylvania
      • Contact: Clinical Research Coordinator
  • Utah
    • Salt Lake City, Utah, United States, 84112
      • Recruiting
      • University of Utah Health
      • Contact: Clinical Research Coordinator

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.	Behavioral: Exercise Intervention; See arm description.
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.	Behavioral: Usual Care; See arm description.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Effects of exercise intervention on physical activity and capacity (step count)	The investigators will compare the effects of the exercise intervention vs. usual care on physical activity and capacity measured by daily steps captured by an activity tracking watch.	6 months
Effects of exercise intervention on physical activity and capacity (distance)	The investigators will compare the effects of the exercise intervention vs. usual care on physical activity and capacity measured by six-minute walk test distance.	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Effects of exercise intervention on frailty and muscle mass (frailty status)	The investigators will compare the effects of the exercise intervention vs. usual care on frailty and muscle mass by evaluating frailty status (number of abnormal Fried frailty criteria, including handgrip strength).	6 months
Effects of exercise intervention on frailty and muscle mass (muscle quantity)	The investigators will compare the effects of the exercise intervention vs. usual care on frailty and muscle mass by evaluating muscle quantity (pectoralis muscle assessed by chest computed tomography scan).	6 months
Effects of exercise intervention on quality of life	The investigators will compare the effects of the exercise intervention vs. usual care on quality of life measured by the Kansas City Cardiomyopathy Questionnaire-12.	6 months
Cost-effectiveness of the exercise intervention vs. usual care	The investigators will determine the cost-effectiveness of the exercise intervention vs. usual care	6 months

Collaborators and Investigators

• Sponsor: University of Pennsylvania
• Collaborators: National Heart, Lung, and Blood Institute (NHLBI)
• Investigators: Principal Investigator: Himabindu Vidula, MD, University of Pennsylvania

Study record dates

Study Major Dates

• Study Start (Actual): August 14, 2024
• Primary Completion (Estimated): June 30, 2028
• Study Completion (Estimated): June 30, 2028

Study Registration Dates

• First Submitted: February 19, 2024
• First Submitted That Met QC Criteria: February 26, 2024
• First Posted (Actual): March 4, 2024

Study Record Updates

• Last Update Posted (Estimated): September 26, 2025
• Last Update Submitted That Met QC Criteria: September 22, 2025
• Last Verified: September 1, 2025

More Information

Terms related to this study

• Keywords: Exercise; Left ventricular assist device; Ventricular assist device; HeartMate 3 (HM3)
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Heart Diseases; Behavior; Heart Failure; Motor Activity
• Other Study ID Numbers: 853181; R01HL166621 (U.S. NIH Grant/Contract)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No