Effects of Home-based Exercise Rehabilitation on Healthcare Utilization in HeartMate 3 Patients

Not Applicable

Completed

• Conditions: Heart Failure; Left Ventricular Dysfunction
• Interventions: Behavioral: Usual Care; Behavioral: Home-based Exercise Rehabilitation.

• Registration Number: NCT04942353
• Lead Sponsor: University of Rochester

Brief Summary

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).

Detailed Description

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

Study Timeline

• Study Start: 2020-10-19
• Study First Submitted: 2021-06-17
• Study First Submitted QC: 2021-06-25
• Study First Posted: 2021-06-28
• Primary Completion: 2023-04-17
• Study Completion: 2023-04-17
• Status Verified: 2023-11
• Last Update Submitted: 2023-11-06
• Last Update Posted: 2023-11-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

• ≥ 18 years of age on the date of randomization
• Patient implanted with a new HeartMate 3 LVAD at URMC
• Patients enrolling in the study at the time of index discharge home following new HM3 LVAD implantation will be evaluated by a HF cardiologist and physical therapist and will need to demonstrate ability to ambulate independently. Patients enrolling in the study after their index discharge home following HM3 LVAD implantation will be evaluated by a HF cardiologist or VAD Coordinator and will need to demonstrate ability to ambulate independently.
• Patient willing to participate in HER.
• Patient owns a smartphone with Internet connection.

Exclusion Criteria

• Major comorbidities or limitations that may interfere with exercise training (including significant orthopedic/neurologic limitations, decompensated HF, uncontrolled arrhythmias, unstable angina).
• Patient with a life expectancy <12 months.
• Patient unwilling to sign the consent for participation.
• Patient unwilling or unable to cooperate with the study protocol
• Patient who does not anticipate being a resident of the area for the scheduled duration of the research study
• Pregnancy

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Usual Care	Usual Care	-
Home-based Exercise Rehabilitation	Home-based Exercise Rehabilitation.	-

Primary Outcome Measures

Name	Time	Method
Mean number of clinic visits	1 year	Healthcare utilization will be measured as the sum of all-cause rehospitalizations, outpatient VAD Clinic visits and emergency room visits room visits

Secondary Outcome Measures

Name	Time	Method
Mean change 6-minute walk distance	baseline to 1 year
Mean change in number of participants with improved quality of life	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.
Mean number of days out of the hospital	1 year
Mean change in the number of daily steps taken	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.

Trial Locations

Locations (1)

University of Rochester Medical Center; 🇺🇸 Rochester, New York, United States