About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
Recent LVAD Implantation (<6 months)
Clinical stability (defined as meeting all of the following criteria): discharge from the LVAD implantation hospitalization, absence of inotropic medication, hemoglobin >9 g/dL, and no active infection.
Inability to participate in a supervised rehabilitation program (due to lack of availability, or inability because geographical reasons).
Disqualifiers
Functional Inability to Perform Cardiopulmonary Exercise Testing
Prior Participation in a Supervised Rehabilitation Program (after the LVAD implantation)
Trial design
Parallel
Treatments tested in this trial
Remote Physical Conditioning Program (Telerehabilitation)
Other interventionThe 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.
Other interventionGeneral Exercise Recommendations (Written Instructions). No Remote Monitoring.
Treatment groups
Trial outcomes
Primary outcomes
Six-Minute Walk Test (6MWT)
Difference in walking distance (meters) in the Six-Minute Walk Test (6MWT).
Secondary outcomes
Program Safety
Evaluate program safety: composite of device alarms, driveline infections, device-related thromboembolic or hemorrhagic complications, cardiovascular events, ventricular arrhythmias, and heart failure decompensations.
Cardiopulmonary Exercise Test (CPET): peak oxygen consumption (VO₂peak)
Changes in peak oxygen consumption (VO₂peak measured in ml/kg/m2)
Cardiopulmonary Exercise Test (CPET): VE/VO₂ slope
Changes in submaximal parameters: VE/VO₂ slope (dimensionless ratio)
Cardiopulmonary Exercise Test (CPET): oxygen consumption at the first and second ventilatory thresholds
Changes in submaximal parameters: oxygen consumption at the first and second ventilatory thresholds (measured in ml/kg/min)
Other outcomes
Program Satisfaction and Adherence
Satisfaction with the program was measured via telemedicine app (daily questionnaires and adherence data).
Comparison of Outcomes Between Remote conditioning and Supervised Rehabilitation
All previously described outcomes will be compared with those of our previous supervised rehabilitation pilot study (REHAB-ASSIST pilot study).
Evaluation of Outcomes by Sex and by the aim of LVAD
All previously described outcomes will be analyzed by subgroups according to sex and the aim of the LVAD
Sponsors and contacts
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Puerta de Hierro University Hospital
Lead sponsor
Carlos III Health Institute
Collaborator
This trial is not recruiting at the moment. You can still explore other options: