Skip to main content
OpenTrials
Completed

NCT Number: NCT04942353

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

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).

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Rochester Medical Center

Rochester, New York, 14642, United States

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Home-based Exercise Rehabilitation.

Behavioral

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).

Usual Care

Behavioral

Patients receive a standardized recommendation to increase their walking activity to 30 minutes 5 days/week.

Primary outcomes

  1. Mean number of clinic visits

    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

Secondary outcomes

  1. Mean number of days out of the hospital

    Time frame: 1 year

  2. Mean change in the number of daily steps taken

    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.

  3. Mean change 6-minute walk distance

    Time frame: baseline to 1 year

  4. Mean change in number of participants with improved quality of life

    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.

Sponsors and collaborators

Lead sponsor

University of Rochester

Other

Collaborators

  • Abbott

Registry information

Official study title

Effects of Home-based Exercise Rehabilitation on Healthcare Utilization in HeartMate 3TM Patients: A Randomized Controlled Pilot Study (MOVE-LVAD)

Acronym: MOVE-LVAD

Important dates

Study start
2020
Primary completion
2023
Study completion
2023
First posted
Jun 28, 2021
Registry last updated
Nov 8, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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.

Published trials that share one or more normalized conditions with this study.