Effects of Home-based Exercise Rehabilitation on Healthcare Utilization in HeartMate 3 Patients (MOVE-LVAD)
Primary Purpose
Heart Failure, Left Ventricular Dysfunction
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Home-based Exercise Rehabilitation.
Usual Care
Sponsored by
About this trial
This is an interventional treatment trial for Heart Failure
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
Sites / Locations
- University of Rochester Medical CenterRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Home-based Exercise Rehabilitation
Usual Care
Arm Description
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
Mean number of days out of the hospital
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.
Mean change 6-minute walk distance
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.
Full Information
NCT ID
NCT04942353
First Posted
June 17, 2021
Last Updated
August 24, 2022
Sponsor
University of Rochester
Collaborators
Abbott
1. Study Identification
Unique Protocol Identification Number
NCT04942353
Brief Title
Effects of Home-based Exercise Rehabilitation on Healthcare Utilization in HeartMate 3 Patients
Acronym
MOVE-LVAD
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
2. Study Status
Record Verification Date
August 2022
Overall Recruitment Status
Recruiting
Study Start Date
October 19, 2020 (Actual)
Primary Completion Date
June 1, 2023 (Anticipated)
Study Completion Date
June 1, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Rochester
Collaborators
Abbott
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heart Failure, Left Ventricular Dysfunction
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
30 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Home-based Exercise Rehabilitation
Arm Type
Experimental
Arm Title
Usual Care
Arm Type
Active Comparator
Intervention Type
Behavioral
Intervention Name(s)
Home-based Exercise Rehabilitation.
Intervention Description
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).
Intervention Type
Behavioral
Intervention Name(s)
Usual Care
Intervention Description
Patients receive a standardized recommendation to increase their walking activity to 30 minutes 5 days/week.
Primary Outcome Measure Information:
Title
Mean number of clinic visits
Description
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
Secondary Outcome Measure Information:
Title
Mean number of days out of the hospital
Time Frame
1 year
Title
Mean change in the number of daily steps taken
Description
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
1 year
Title
Mean change 6-minute walk distance
Time Frame
baseline to 1 year
Title
Mean change in number of participants with improved quality of life
Description
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.
Time Frame
baseline to 1 year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Lori Caufield
Phone
585 - 273 - 4956
Email
lori_caufield@urmc.rochester.edu
Facility Information:
Facility Name
University of Rochester Medical Center
City
Rochester
State/Province
New York
ZIP/Postal Code
14642
Country
United States
Individual Site Status
Recruiting
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Effects of Home-based Exercise Rehabilitation on Healthcare Utilization in HeartMate 3 Patients
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