REACTION-VAD Trial: Remote Exercise Training Via Telemedicine in Patients With Long-Term Ventricular Assist Devices

Condition(s) studied

Investigational drug(s) / intervention(s)

Remote Physical Conditioning Program (Telerehabilitation): The program includes structured warm-up routines, respiratory training, continuous aerobic exercise, and strength training, with remote follow-up conducted via telemedicine.

Usual care. No Remote Monitoring.: General Exercise Recommendations (Written Instructions). No Remote Monitoring.

Study summary

Current international guidelines recommend that patients with a heart pump (left ventricular assist device, LVAD) participate in supervised exercise cardiac rehabilitation programs. However, not all patients with a heart pump are able to attend to a supervised program on a daily basis.

The goal of this clinical trial is to determine whether a home-based exercise program helps patients with a heart pump improve their exercise capacity and quality of life, guided by telemedicine tools including a mobile app, smartwatch, and remote medical checkups. The study will also provide information about the safety of this program by monitoring for any issues or symptoms during home activity.

The trial aims to answer the following questions:

* Does a 12-week remote exercise program improve patients' exercise capacity? This will be measured using the 6-minute walk test and a cardiopulmonary exercise test.
* Is it safe for patients to follow this exercise plan at home while being monitored through a mobile app and smartwatch?
* Does the program improve quality of life and reduce feelings of anxiety or depression? This will be assessed using widely validated questionnaires, such as the Kansas City Cardiomyopathy Questionnaire.

Researchers will compare the remote exercise program to standard care, which usually does not include exercise for patients who are unable to attend the hospital daily.

Participants will:

* Join the study voluntarily after signing a consent form.
* Be randomly assigned, with a 50% chance of being in either the exercise group (following a structured plan with a mobile app) or the usual care group (receiving general written advice), to see which approach works best for recovery.
* Follow a 12-week home-based routine if in the exercise group, including warm-up routine, walking or cycling, respiratory exercises, and light strength training, all supported by the mobile app, smartwatch, and professional monitoring.
* Visit the hospital three times over six months for medical checkups, including walking and exercise tests, blood analyses, and questionnaires about physical and emotional health.

Eligibility

Primary outcome measure(s)

• Six-Minute Walk Test (6MWT) — 3 months
  Difference in walking distance (meters) in the Six-Minute Walk Test (6MWT).

Trial sites (10)

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