University of Rochester Medical Center
Rochester, New York, 14642, United States
NCT Number: NCT04942353
To demonstrate that home-based exercise rehabilitation (HER) compared to usual care (UC) results in a significant reduction in healthcare utilization in HeartMate 3 (HM3) left ventricular assist device (LVAD) patients.(defined as rehospitalization, VAD Clinic visits, and ER visits during the 1st year after index discharge following LVAD implantation).
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Notify Me18 year and older
All sexes
Interventional
Not applicable
Rochester, New York, 14642, United States
HER Subjects:
Get Garmin activity watch (has its own smartphone app to be activated)*, Datos app Get resistance bands and light weights Exercise prescription: Initially by physical therapist prior to discharge home & updated every month.
UC Subjects:
Get Garmin activity watch (has its own smartphone app to be activated), Datos app Exercise prescription: Try to get to 30 min of exercise 5 days a week
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Based on physical therapist or exercise physiologist assessment, subjects will receive an individualized exercise prescription for frequency, duration, and intensity of walking and strength training (including exercises using light-weight hand-weights and upper and lower body exercises using resistance bands). Research team will provide updated exercise prescription based on Garmin watch/Datos app activity data and Datos app data (including Borg scale).
Patients receive a standardized recommendation to increase their walking activity to 30 minutes 5 days/week.
Time frame: 1 year
Healthcare utilization will be measured as the sum of all-cause rehospitalizations, outpatient VAD Clinic visits and emergency room visits room visits
Time frame: 1 year
Time frame: 1 year
Steps will be tracked using the Garmin watch. The Garmin watch uses Global Positioning System (GPS) tracking and an accelerometer to continuously monitor activity and provides data on average number of steps per day.
Time frame: baseline to 1 year
Time frame: baseline to 1 year
Quality of life will be measured using the Kansas City Cardiomyopathy Questionnaire-12 (KCCQ-12). The scale ranges from 12-70 with higher scores indicating better quality of life.
University of Rochester
Other
Effects of Home-based Exercise Rehabilitation on Healthcare Utilization in HeartMate 3TM Patients: A Randomized Controlled Pilot Study (MOVE-LVAD)
Acronym: MOVE-LVAD
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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