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

20 maggio 2026 aggiornato da: Mercedes Rivas-Lasarte, Puerta de Hierro University Hospital

Efficacy and Safety of a Remote Conditioning Program in Patients Supported With a Ventricular Assist Device: THE RE-ACTION-VAD 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.

Panoramica dello studio

Stato

Non ancora reclutamento

Condizioni

Intervento / Trattamento

Descrizione dettagliata

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:

  1. Remote conditioning group: patients will undergo a three-month home-based program including aerobic, resistance, and respiratory training. Follow-up will be conducted through Telemedicine (mobile application and a smart watch); or
  2. Usual care group: patients will receive written general exercise recommendations.

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:

  1. Educational Phase (Week 1): Three in-person sessions to train patients on exercise execution, load management, and the use of respiratory devices.
  2. Remote Phase (Weeks 2-12): Individualized home routines including aerobic training, strength training, and respiratory.

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:

  • Site Monitoring: The study has contracted a Contract Research Organization (CRO), to perform clinical trial monitoring and auditing over a three-year period.
  • Standardization of Procedures: Researchers from all centers are required to complete a rotation at the Hospital Ramón y Cajal Rehabilitation Unit to unify exercise protocols. Monthly supervision meetings are held to evaluate compliance and resolve clinical doubts.

Safety monitoring board: independent adverse event assessment blinded to the intervention group.

• Technical Validation: The mobile platform utilized for monitoring holds the requisite certifications, ensuring technical reliability and data security.

Data Management and Registry Procedures

  • Data Entry and Validation: Data is captured using an electronic data capture system. The system includes predefined rules for data ranges and consistency to minimize entry errors.
  • Source Data Verification (SDV): Investigators may cross-reference data from the electronic data capture system with hospital medical records to ensure accuracy, completeness, and representativeness.
  • Data Dictionary: A comprehensive data dictionary is maintained within the study's electronic data management system, encompassing variables such as anthropometric measures, cardiopulmonary exercise test (CPET) parameters (VO₂ peak, VE/VCO₂, RER), 6-minute walk test (6MWT) distance, biomarkers (NT-proBNP, CA125), and validated quality-of-life scales (KCCQ, MLHFQ).
  • Audit Trails: the electronic data capture system provides automated audit logs to track all data manipulations and user activity, ensuring full traceability.

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.

  • Continuous Variables: Will be compared using the Student's T-test for independent samples or the Mann-Whitney U-test for non-parametric data.
  • Categorical Variables: Will be analyzed using Chi-square or Fisher's Exact test.
  • Missing Data Plan: While the ITT principle handles participants as randomized, the study also includes monthly supervision to incentivize compliance and minimize missing data.
  • Significance: A p-value < 0.05 will be considered statistically significant.

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.

Tipo di studio

Interventistico

Iscrizione (Stimato)

78

Fase

  • Non applicabile

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Contatto studio

  • Nome: Mercedes Rivas-Lasarte, MD, PhD, Cardiologist
  • Numero di telefono: +34911917843
  • Email: rivaslasarte@gmail.com

Backup dei contatti dello studio

Luoghi di studio

  • Spagna
    • Andalusia
      • Seville, Andalusia, Spagna, 41013
        • Hospital Virgen del Rocío
        • Contatto:
          • Carlos Palacios Castelló, MD
          • Numero di telefono: +34955012000
    • Castille and León
      • Salamanca, Castille and León, Spagna, 37007
        • Hospital Universitario de Salamanca
    • Catalonia
      • Barcelona, Catalonia, Spagna, 03036
        • Hospital Clínic de Barcelona
        • Contatto:
          • María Sanz de la Garza, MD, PhD
          • Numero di telefono: +34932275400
          • Email: sanz1@clinic.cat
      • Barcelona, Catalonia, Spagna
        • Hospital Universitari de Bellvitge
        • Contatto:
    • Galicia
      • A Coruña, Galicia, Spagna, 15006
        • Complejo Hospitalario Universitario de a Coruna
        • Contatto:
      • Santiago de Compostela, Galicia, Spagna, 15706
        • Complejo Hospitalario Universitario Santiago de Compostela
        • Contatto:
    • Madrid
      • Madrid, Madrid, Spagna, 28040
        • Hospital Clinico San Carlos
        • Contatto:
      • Madrid, Madrid, Spagna, 28034
        • Hospital Ramón Y Cajal
        • Contatto:
      • Madrid, Madrid, Spagna, 28041
        • Hospital 12 de Octubre
        • Contatto:
      • Majadahonda, Madrid, Spagna, 28028
        • Hospital Puerta de Hierro
        • Contatto:
        • Contatto:
          • Ramon Garrido Gonzalez, MD

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

  • Adulto
  • Adulto più anziano

Accetta volontari sani

No

Descrizione

Inclusion Criteria (must meet all):

  • 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).

Exclusion Criteria (any):

  • Functional Inability to Perform Cardiopulmonary Exercise Testing
  • Prior Participation in a Supervised Rehabilitation Program (after the LVAD implantation)

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Trattamento
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Separare

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Sperimentale: Remote Exercise Training Via Telemedicine
Warm-up, Respiratory Training, Continuous Aerobic Exercise, and Strength Training. Remote Monitoring via Telemedicine.
Altro: 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.
Altro: Control Group
Usual care. General Exercise Recommendations (Written Instructions). No Remote Monitoring.
Altro: Usual care. No Remote Monitoring.
General Exercise Recommendations (Written Instructions). No Remote Monitoring.

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Six-Minute Walk Test (6MWT)
Lasso di tempo: 3 months
Difference in walking distance (meters) in the Six-Minute Walk Test (6MWT).
3 months

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Program Safety
Lasso di tempo: 6 months
Evaluate program safety: composite of device alarms, driveline infections, device-related thromboembolic or hemorrhagic complications, cardiovascular events, ventricular arrhythmias, and heart failure decompensations.
6 months
Cardiopulmonary Exercise Test (CPET): peak oxygen consumption (VO₂peak)
Lasso di tempo: 3 months
Changes in peak oxygen consumption (VO₂peak measured in ml/kg/m2)
3 months
Cardiopulmonary Exercise Test (CPET): VE/VO₂ slope
Lasso di tempo: 3 months
Changes in submaximal parameters: VE/VO₂ slope (dimensionless ratio)
3 months
Cardiopulmonary Exercise Test (CPET): oxygen consumption at the first and second ventilatory thresholds
Lasso di tempo: 3 months
Changes in submaximal parameters: oxygen consumption at the first and second ventilatory thresholds (measured in ml/kg/min)
3 months
Cardiopulmonary Exercise Test (CPET): ventilatory equivalents
Lasso di tempo: 3 months
Changes in submaximal parameters: ventilatory equivalents (measured in L/min)
3 months
Cardiopulmonary Exercise Test (CPET): Oxygen Uptake Efficiency Score (OUES)
Lasso di tempo: 3 months
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).
3 months
Cardiopulmonary Exercise Test (CPET): Respiratory Exchange Ratio
Lasso di tempo: 3 months
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.
3 months
Cardiopulmonary Exercise Test (CPET): oscillatory patterns
Lasso di tempo: 3 months
Changes in submaximal parameters: oscillatory patterns (Yes/No)
3 months
Quality of life (QoL): Kansas City Cardiomyopathy Questionnaire (KCCQ).
Lasso di tempo: 3 months
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.
3 months
Quality of life (QoL): Minnesota Living with Heart Failure Questionnaire (MLHFQ).
Lasso di tempo: 3 months
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.
3 months
Frailty screening (FRAIL scale)
Lasso di tempo: 3 months
Frailty screening using the FRAIL scale. FRAIL is scored 0 to 5, with higher scores indicating greater frailty.
3 months
Fried physical frailty phenotype
Lasso di tempo: 3 months
Frailty measured using the Fried Physical Frailty Phenotype. Fried is a score ranging from 0 to 5, with higher scores indicate greater frailty.
3 months
Psychological changes: depression (Beck Depression Inventory-II).
Lasso di tempo: 3 months
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.
3 months
Psychological changes: anxiety (HADS)
Lasso di tempo: 3 months
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.
3 months
Psychological changes: caregiver burden (Zarit)
Lasso di tempo: 3 months
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.
3 months
Respiratory muscle strength
Lasso di tempo: 3 months
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.
3 months
Prior outcomes in a 6-mont follow-up
Lasso di tempo: 6 months
All previously described outcomes will be compared at 6 months after study initiation.
6 months

Altre misure di risultato

Misura del risultato
Misura Descrizione
Lasso di tempo
Program Satisfaction and Adherence
Lasso di tempo: 6 months
Satisfaction with the program was measured via telemedicine app (daily questionnaires and adherence data).
6 months
Comparison of Outcomes Between Remote conditioning and Supervised Rehabilitation
Lasso di tempo: 6 months
All previously described outcomes will be compared with those of our previous supervised rehabilitation pilot study (REHAB-ASSIST pilot study).
6 months
Evaluation of Outcomes by Sex and by the aim of LVAD
Lasso di tempo: 6 months
All previously described outcomes will be analyzed by subgroups according to sex and the aim of the LVAD
6 months

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

Puerta de Hierro University Hospital

Collaboratori

Carlos III Health Institute

Investigatori

  • Investigatore principale: Mercedes Rivas-Lasarte, MD, PhD, Hospital Puerta de Hierro, Madrid (Spain)
  • Investigatore principale: Ramon Garrido Gonzalez, MD, Hospital Puerta de Hierro, Madrid (Spain)

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Stimato)

1 maggio 2026

Completamento primario (Stimato)

1 dicembre 2029

Completamento dello studio (Stimato)

1 dicembre 2030

Date di iscrizione allo studio

Primo inviato

6 marzo 2026

Primo inviato che soddisfa i criteri di controllo qualità

20 maggio 2026

Primo Inserito (Effettivo)

28 maggio 2026

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

28 maggio 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

20 maggio 2026

Ultimo verificato

1 maggio 2026

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • PI 143/25
  • PI25/00394 (Altro numero di sovvenzione/finanziamento: Instituto de Salud Carlos III (ISCIII). Fondo de Investigaciones Sanitarias (FIS).)

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

SÌ

Descrizione del piano IPD

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.

Periodo di condivisione IPD

Data are expected to be available beginning in January 2031, following completion of the study and publication of the primary analysis.

Criteri di accesso alla condivisione IPD

Data will be shared with investigators who provide a methodologically sound research proposal and demonstrate legitimate scientific interest.

Tipo di informazioni di supporto alla condivisione IPD

  • STUDIO_PROTOCOLLO
  • LINFA
  • ICF
  • CODICE_ANALITICO
  • RSI

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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