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| Funder | NATIONAL HEART, LUNG, AND BLOOD INSTITUTE |
|---|---|
| Recipient Organization | University of Pennsylvania |
| Country | United States |
| Start Date | Sep 11, 2023 |
| End Date | Jun 30, 2028 |
| Duration | 1,754 days |
| Number of Grantees | 1 |
| Roles | Principal Investigator |
| Data Source | NIH (US) |
| Grant ID | 10563304 |
A growing number of patients with advanced heart failure are undergoing HeartMate 3 (HM3; Abbott, Abbott Park, IL) left ventricular assist device (LVAD) implantation around the world. Despite contemporary durable mechanical support of the heart, LVAD recipients continue to demonstrate low levels of physical activity and
functional capacity, characterized by daily steps and six-minute walk test (6MWT) distance, even 1-year after surgery. In addition, LVAD recipients frequently meet criteria for prefrailty/frailty and associated sarcopenia, including low muscle strength and muscle quantity. These deficits may contribute to increased healthcare
utilization in this high-risk population. Walking and strengthening exercises can help to improve muscle strength and quantity as well as physical activity and capacity, but exercise interventions in LVAD recipients are not well established. A large proportion of LVAD recipients do not participate in center-based, supervised cardiac rehabilitation (CR), and
patients participating in CR initiate therapy a mean of 3 months after hospital discharge. A home-based exercise program using mobile technology may allow patients to begin exercise rehabilitation at an earlier time after LVAD implantation. We are conducting a randomized, controlled pilot study of a home-based exercise program
including walking and strengthening exercises with a standardized protocol to guide exercise prescription and exercise progression based on data obtained from an activity tracking watch and smartphone app. Our pilot data suggest that our innovative home-based exercise program is feasible, safe, and may be associated with a greater
increase in daily physical activity in patients newly implanted with a HM3 LVAD. The effects of a home-based exercise program using mobile technology on daily physical activity and capacity, frailty and sarcopenia, and quality of life in LVAD recipients have not been previously studied in a multicenter study. We propose a randomized study of 80 newly implanted HM3 LVAD patients at 4 LVAD centers.
Following index hospital discharge after LVAD implantation, patients will be enrolled and randomized to a 6- month novel exercise program using mobile technology or usual care (UC). We will evaluate the following specific aims: Specific Aim #1 is to compare the effects of the exercise intervention vs. UC on physical activity and
capacity measured by a) daily steps (captured by the activity monitor) and b) 6MWT distance. Specific Aim #2 is to compare the effects of the exercise intervention vs. UC on frailty and sarcopenia, by evaluating a) frailty status and b) muscle quantity. Specific Aim #3 is to compare the effects of the exercise intervention vs. UC on
quality of life (measured by the Kansas City Cardiomyopathy Questionnaire-12). Specific Aim #4 is to evaluate the cost-benefit of the exercise intervention vs. UC. Findings from this study have the potential to improve low physical activity and capacity, frailty and sarcopenia, quality of life, and increased rates of healthcare utilization
in the growing population of LVAD recipients.
University of Pennsylvania
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