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Home-Based Exercise Program Using Mobile Technology After Left Ventricular Assist Device Implantation

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years and older
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Mentioned in the study description

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Procedures mentioned: Questionnaires, CT scans, Phone or video check-ins

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "As part of the baseline assessment, all subjects will measure their average daily steps during week 1 using a Garmin activity tracking watch, complete a six-minute walk test, complete frailty testing (including measurements of handgrip strength and gait speed), and complete surveys."
  • "Subjects will also complete a CT scan to evaluate muscle mass."
  • "In addition to standard of care clinic visits, they will receive phone calls from the study research coordinator reminding them to wear the watch and to walk."
  • "Subjects' progress in the exercise program will be remotely monitored using the activity tracking watch and the smartphone app, and subjects will complete questionnaires through the app."
  • "Subjects will complete video calls with the interventionist throughout the duration of the study and will receive updated personalized exercise prescriptions based on their progress."
Compensation
Mentioned in the study description
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests a home exercise program using mobile technology for adults who recently got their first HeartMate 3 LVAD, a pump that helps the heart move blood. It compares the program with usual care to see how it affects activity, ability to exercise, weakness, muscle size, and quality of life.

The goal of this clinical trial is to evaluate the effects of a home-based exercise program using mobile technology on physical activity and capacity, frailty and muscle mass, and quality of life in patients with a newly implanted HeartMate 3 left ventricular assist device (HM3 LVAD). Researchers will compare the effects of an exercise intervention vs. usual care on physical activity and capacity, frailty and muscle mass, and quality of life.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • You are 18 or older.
  • You recently got a HeartMate 3 LVAD for the first time.
  • You can walk on your own, with or without a walking aid.
  • You own a smartphone with internet access.
  • You will go home with your LVAD after leaving the hospital, or live at home within 45 days after leaving.

Who can't join

  • You have a major health problem or limitation that could make exercise training difficult or unsafe. Examples include serious bone, joint, muscle, or nerve problems; worsening heart failure; an uncontrolled uneven heartbeat; or chest pain that is new, worsening, or happens at rest.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

Inclusion Criteria: 1. ≥ 18 years of age 2. Newly implanted with a HeartMate 3™ LVAD for the first time 3. Able to ambulate independently (with or without the use of an assistive device) 4. Owns a smartphone with Internet connection 5. Patient will be discharged home with LVAD or patient will be living at home with LVAD within 45 days of index discharge Exclusion Criteria: 1\. Major comorbidities or limitations that may interfere with exercise training (including significant orthopedic/neurologic limitations, decompensated heart failure, uncontrolled arrhythmias, unstable angina)

Study sites (4)

MI

OH

  • Cleveland Clinic Foundation · Cleveland, OH 44195Clinical Research Coordinator · Study contactMore trials in Cleveland

PA

UT