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

NCT ID: NCT04942353

Last Updated: 2023-11-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-10-19

Study Completion Date

2023-04-17

Brief Summary

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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

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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

Conditions

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Heart Failure Left Ventricular Dysfunction

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Home-based Exercise Rehabilitation

Group Type EXPERIMENTAL

Home-based Exercise Rehabilitation.

Intervention Type 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

Group Type ACTIVE_COMPARATOR

Usual Care

Intervention Type BEHAVIORAL

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

Interventions

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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).

Intervention Type BEHAVIORAL

Usual Care

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

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Abbott

INDUSTRY

Sponsor Role collaborator

University of Rochester

OTHER

Sponsor Role lead

Responsible Party

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Himabindu Vidula

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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University of Rochester Medical Center

Rochester, New York, United States

Site Status

Countries

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United States

Other Identifiers

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STUDY00004656

Identifier Type: -

Identifier Source: org_study_id

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