NCT04942353

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for not_applicable heart-failure

Timeline
Completed

Started Oct 2020

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 19, 2020

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

June 17, 2021

Completed
11 days until next milestone

First Posted

Study publicly available on registry

June 28, 2021

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 17, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 17, 2023

Completed
Last Updated

November 8, 2023

Status Verified

November 1, 2023

Enrollment Period

2.5 years

First QC Date

June 17, 2021

Last Update Submit

November 6, 2023

Conditions

Heart FailureLeft Ventricular Dysfunction

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (4)

  • Mean number of days out of the hospital

    1 year

  • Mean change in the number of daily steps taken

    1 year

  • Mean change 6-minute walk distance

    baseline to 1 year

  • Mean change in number of participants with improved quality of life

    baseline to 1 year

Study Arms (2)

Home-based Exercise Rehabilitation

EXPERIMENTAL
Behavioral: Home-based Exercise Rehabilitation.

Usual Care

ACTIVE COMPARATOR
Behavioral: Usual Care

Interventions

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).

Home-based Exercise Rehabilitation
Usual CareBEHAVIORAL

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

Usual Care

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • ≥ 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Rochester Medical Center

Rochester, New York, 14642, United States

Location

MeSH Terms

Conditions

Heart FailureVentricular Dysfunction, Left

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular DiseasesVentricular Dysfunction

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

June 17, 2021

First Posted

June 28, 2021

Study Start

October 19, 2020

Primary Completion

April 17, 2023

Study Completion

April 17, 2023

Last Updated

November 8, 2023

Record last verified: 2023-11

Data Sharing

IPD Sharing
Will not share

Locations

US(1)