An interventional study of Remote Physical Conditioning Program (Telerehabilitation) and Usual care. No Remote Monitoring. in Heart Failure, Advanced Heart Failure and Left Ventricular Assist Device, sponsored by Puerta de Hierro University Hospital. Not yet recruiting at 10 sites in Spain. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-05-28.
Sponsored by Puerta de Hierro University Hospital · Not applicable, Interventional, and Treatment
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:
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:
Introduction Although cardiac rehabilitation is recommended in patients with a durable Left Ventricular Assist Device (LVAD), approximately 50% of candidates cannot attend in-person programs due to geographical dificulties.
Study Rationale and Design The RE-ACTION-VAD Trial is the first multicenter randomized controlled trial designed to evaluate the efficacy and safety of a remote conditioning exercise program in patients with recent implantation of a durable Left Ventricular Assist Device (LVAD).
A total of 78 patients will be enrolled and randomized in a 1:1 ratio to:
The primary objective is to assess whether there is an improvement in the distance covered on the 6-minute walk test at 6-month follow-up. Secondary objectives include evaluation of safety, and improvements in cardiopulmonary exercise parameters, quality of life questionnaires, frailty scales, and psychological questionnaires.
Intervention Logistics
The 12-week program is divided into an initial educational phase and a remote phase:
Quality Assurance and Monitoring Plan
To ensure the integrity and standardization of the intervention across the 10 participating centers, the following quality measures are implemented:
Safety monitoring board: independent adverse event assessment blinded to the intervention group.
Data Management and Registry Procedures
Sample Size Assessment The study is powered to detect a clinically relevant difference of 35 meters in the 6MWT. Based on a standard deviation of 50 meters, an alpha of 0.05, and a power of 80%, 33 patients per group (66 total) are required. To account for an expected 15% dropout rate, the total sample size is set at 78 participants.
Statistical Analysis Plan (SAP) All analyses will follow the Intention-to-Treat (ITT) principle.
Ethics and Confidentiality The protocol was approved by the Hospital Universitario Puerta de Hierro Ethics Committee (PI 143/25). Data is codified, and the link between codes and patient identity is stored in a password-protected offline file. Upon completion, anonymized data will be deposited in the Zenodo repository.
Exclusion Criteria (any):
Warm-up, Respiratory Training, Continuous Aerobic Exercise, and Strength Training. Remote Monitoring via Telemedicine.
Other: Remote Physical Conditioning Program (Telerehabilitation)
Usual care. General Exercise Recommendations (Written Instructions). No Remote Monitoring.
Other: Usual care. No Remote Monitoring.
The program includes structured warm-up routines, respiratory training, continuous aerobic exercise, and strength training, with remote follow-up conducted via telemedicine.
General Exercise Recommendations (Written Instructions). No Remote Monitoring.
Six-Minute Walk Test (6MWT)
Difference in walking distance (meters) in the Six-Minute Walk Test (6MWT).
Time frame: 3 months
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.
Time frame: 6 months
Cardiopulmonary Exercise Test (CPET): peak oxygen consumption (VO₂peak)
Changes in peak oxygen consumption (VO₂peak measured in ml/kg/m2)
Time frame: 3 months
Cardiopulmonary Exercise Test (CPET): VE/VO₂ slope
Changes in submaximal parameters: VE/VO₂ slope (dimensionless ratio)
Time frame: 3 months
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)
Time frame: 3 months
Cardiopulmonary Exercise Test (CPET): ventilatory equivalents
Changes in submaximal parameters: ventilatory equivalents (measured in L/min)
Time frame: 3 months
Cardiopulmonary Exercise Test (CPET): Oxygen Uptake Efficiency Score (OUES)
Changes in submaximal parameters: The oxygen uptake efficiency slope (OUES) was calculated from the linear relationship between VO₂ and log₁₀VE and is expressed in mL·min-¹/log(L·min-¹).
Time frame: 3 months
Cardiopulmonary Exercise Test (CPET): Respiratory Exchange Ratio
Changes in submaximal parameters: Respiratory Exchange Ratio (RER). The respiratory exchange ratio (RER) was calculated as VCO₂/VO₂ and is reported as a unitless ratio.
Time frame: 3 months
Cardiopulmonary Exercise Test (CPET): oscillatory patterns
Changes in submaximal parameters: oscillatory patterns (Yes/No)
Time frame: 3 months
Quality of life (QoL): Kansas City Cardiomyopathy Questionnaire (KCCQ).
Changes in quality of life measured by the Kansas City Cardiomyopathy Questionnaire (KCCQ). KCCQ is scored from 0 to 100, with higher scores indicating better health status.
Time frame: 3 months
Quality of life (QoL): Minnesota Living with Heart Failure Questionnaire (MLHFQ).
Changes in quality of life measured by the Minnesota Living with Heart Failure Questionnaire (MLHFQ). MLHFQ is scored from 0 to 105, with lower scores indicating better quality of life.
Time frame: 3 months
Frailty screening (FRAIL scale)
Frailty screening using the FRAIL scale. FRAIL is scored 0 to 5, with higher scores indicating greater frailty.
Time frame: 3 months
Fried physical frailty phenotype
Frailty measured using the Fried Physical Frailty Phenotype. Fried is a score ranging from 0 to 5, with higher scores indicate greater frailty.
Time frame: 3 months
Psychological changes: depression (Beck Depression Inventory-II).
Depression symptoms were evaluated by the Beck Depression Inventory-II (BDI-II). BDI-II yields a total score ranging from 0 to 63, with higher scores reflecting greater severity of depressive symptoms.
Time frame: 3 months
Psychological changes: anxiety (HADS)
Anxiety symptoms were evaluated using the Hospital Anxiety and Depression Scale (HADS), specifically the anxiety subscale (HADS-A), which yields a score ranging from 0 to 21, with higher scores reflecting greater severity of anxiety.
Time frame: 3 months
Psychological changes: caregiver burden (Zarit)
Changes in caregiver burden were evaluated using the Zarit Burden Interview (ZBI), which yields a total score ranging from 0 to 88, with higher scores reflecting greater perceived caregiver burden.
Time frame: 3 months
Respiratory muscle strength
Respiratory muscle strength was assessed by measuring maximal inspiratory pressure (MIP) using a handheld device (RP Check, Sibelmed Diagnostics Ltd.). Maximal inspiratory pressure (MIP) is expressed in cmH₂O, with higher values indicating greater inspiratory muscle strength.
Time frame: 3 months
Prior outcomes in a 6-mont follow-up
All previously described outcomes will be compared at 6 months after study initiation.
Time frame: 6 months
Program Satisfaction and Adherence
Satisfaction with the program was measured via telemedicine app (daily questionnaires and adherence data).
Time frame: 6 months
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).
Time frame: 6 months
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
Time frame: 6 months
Documents are hosted by the registry — open the source record to download them.
Plan to share: Yes — Upon completion of the project and publication of the primary analysis, the data will be deposited in the Zenodo repository following appropriate anonymization procedures. The dataset will be accompanied by metadata in Zenodo including: (1) data provenance, (2) patient population characteristics, and (3) a detailed description of the study variables. Access to data stored in the internal repository for other investigators with legitimate scientific interest will be subject to approval by the Ethics Committee. This approach ensures compliance with open-access data requirements applicable to publicly funded research projects, while maintaining data within a controlled environment consistent with their nature as personal data.
Supporting information: Study protocol, Sap, Icf, Csr, Analytic code
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Puerta de Hierro University Hospital