Clinical trial NCT04942353: Effects of Home-based Exercise Rehabilitation on Healthcare Utilization in HeartMate 3 Patients
Official title: Effects of Home-based Exercise Rehabilitation on Healthcare Utilization in HeartMate 3TM Patients: A Randomized Controlled Pilot Study (MOVE-LVAD)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Heart Failure
Left Ventricular Dysfunction
Lead sponsor: University of Rochester
Sponsor class: OTHER
Collaborators: name: Abbott
First posted: 2021-06-28
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

Eligibility criteria: 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

Primary outcomes:
measure: Mean number of clinic visits
timeFrame: 1 year
Secondary outcomes:
measure: Mean number of days out of the hospital
timeFrame: 1 year
measure: Mean change in the number of daily steps taken
timeFrame: 1 year
measure: Mean change 6-minute walk distance
timeFrame: baseline to 1 year
measure: Mean change in number of participants with improved quality of life
timeFrame: baseline to 1 year
Other outcomes:
Locations:
city: Rochester
country: United States
facility: University of Rochester Medical Center
state: New York
Study officials:
References: