Study Summary
This trial found that home-based exercise rehabilitation compared to usual care resulted in a significant reduction in healthcare utilization in HeartMate 3 left ventricular assist device patients.
Eligible Conditions
- Left Ventricular Dysfunction
- Heart Failure
Treatment Effectiveness
Effectiveness Progress
Study Objectives
1 Primary · 4 Secondary · Reporting Duration: 1 year
1 year
Mean change in the number of daily steps taken
Mean number of clinic visits
Mean number of days out of the hospital
baseline to 1 year
Mean change 6-minute walk distance
Mean change in number of participants with improved quality of life
Trial Safety
Safety Progress
Trial Design
2 Treatment Groups
Usual Care
1 of 2
Home-based Exercise Rehabilitation
1 of 2
Active Control
Experimental Treatment
30 Total Participants · 2 Treatment Groups
Primary Treatment: Home-based Exercise Rehabilitation. · No Placebo Group · N/A
Home-based Exercise Rehabilitation
Behavioral
Experimental Group · 1 Intervention: Home-based Exercise Rehabilitation. · Intervention Types: BehavioralUsual Care
Behavioral
ActiveComparator Group · 1 Intervention: Usual Care · Intervention Types: BehavioralTrial Logistics
Trial Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 1 year
Who is running the clinical trial?
University of RochesterLead Sponsor
792 Previous Clinical Trials
501,854 Total Patients Enrolled
AbbottIndustry Sponsor
731 Previous Clinical Trials
477,307 Total Patients Enrolled
Eligibility Criteria
Age 18+ · All Participants · 5 Total Inclusion Criteria
Mark “Yes” if the following statements are true for you:You are at least 18 years of age.
You have a new HeartMate 3 LVAD implanted at URMC.
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Conditions
Cancer Related
Treatments