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

Heart Failure Clinical Trial

— MOVE-LVAD  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04942353
• Other study ID #: STUDY00004656
• Status: Completed
• Phase: N/A
• Start date: October 19, 2020
• Est. completion date: April 17, 2023

Study information

• Verified date: November 2023
• Source: University of Rochester
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: April 17, 2023
• Est. primary completion date: April 17, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Heart Failure
• Left Ventricular Dysfunction
• Ventricular Dysfunction
• Ventricular Dysfunction, Left

Intervention

Behavioral:
• Home-based Exercise Rehabilitation.
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
Patients receive a standardized recommendation to increase their walking activity to 30 minutes 5 days/week.

Locations

Country	Name	City	State
United States	University of Rochester Medical Center	Rochester	New York

Sponsors (2)

Lead Sponsor	Collaborator
University of Rochester	Abbott

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mean number of clinic visits	Healthcare utilization will be measured as the sum of all-cause rehospitalizations, outpatient VAD Clinic visits and emergency room visits room visits	1 year
Secondary	Mean number of days out of the hospital		1 year
Secondary	Mean change in the number of daily steps taken	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.	1 year
Secondary	Mean change 6-minute walk distance		baseline to 1 year
Secondary	Mean change in number of participants with improved quality of life	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.	baseline to 1 year