About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
≥ 18 years of age
Newly implanted with a HeartMate 3™ LVAD for the first time
Able to ambulate independently (with or without the use of an assistive device)
Owns a smartphone with Internet connection
Disqualifiers
None
Trial design
Parallel
Treatments tested in this trial
Exercise Intervention
BehavioralSee arm description.
Usual Care
BehavioralSee arm description.
Treatment groups
Trial outcomes
Primary outcomes
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.
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.
Secondary outcomes
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).
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).
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.
Cost-effectiveness of the exercise intervention vs. usual care
The investigators will determine the cost-effectiveness of the exercise intervention vs. usual care
Sponsors and contacts
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University of Pennsylvania
Lead sponsor
National Heart, Lung, and Blood Institute (NHLBI)
Collaborator