REACTION-VAD Trial: Remote Exercise Training Via Telemedicine in Patients With Long-Term Ventricular Assist Devices (REACTION-VAD)
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.
Studieoversigt
Status
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
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:
- 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
- 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:
- Educational Phase (Week 1): Three in-person sessions to train patients on exercise execution, load management, and the use of respiratory devices.
- 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.
Undersøgelsestype
Tilmelding (Anslået)
Fase
- Ikke anvendelig
Kontakter og lokationer
Studiekontakt
- Navn: Mercedes Rivas-Lasarte, MD, PhD, Cardiologist
- Telefonnummer: +34911917843
- E-mail: rivaslasarte@gmail.com
Undersøgelse Kontakt Backup
- Navn: Ramon Garrido Gonzalez, MD, Cardiologist
- Telefonnummer: +34911917843
- E-mail: ramongarrido15@gmail.com
Studiesteder
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Andalusia
-
Seville, Andalusia, Spanien, 41013
- Hospital Virgen Del Rocio
-
Kontakt:
- Carlos Palacios Castelló, MD
- Telefonnummer: +34955012000
-
-
Castille and León
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Salamanca, Castille and León, Spanien, 37007
- Hospital Universitario De Salamanca
-
-
Catalonia
-
Barcelona, Catalonia, Spanien, 03036
- Hospital Clinic de Barcelona
-
Kontakt:
- María Sanz de la Garza, MD, PhD
- Telefonnummer: +34932275400
- E-mail: sanz1@clinic.cat
-
Barcelona, Catalonia, Spanien
- Hospital Universitari de Bellvitge
-
Kontakt:
- Lorena Herrador Galindo, MD
- Telefonnummer: +34932607500
- E-mail: lherradorgalindo@gmail.com
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-
Galicia
-
A Coruña, Galicia, Spanien, 15006
- Complejo Hospitalario Universitario de A Coruña
-
Kontakt:
- Milena Antunez Ballesteros, MD
- Telefonnummer: +34981178000
- E-mail: antbalmil@gmail.com
-
Santiago de Compostela, Galicia, Spanien, 15706
- Complejo Hospitalario Universitario Santiago de Compostela
-
Kontakt:
- Maria Ines Gomez Otero, MD
- Telefonnummer: +34981950000
- E-mail: maria.ines.gomez.otero@sergas.es
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-
Madrid
-
Madrid, Madrid, Spanien, 28040
- Hospital Clinico San Carlos
-
Kontakt:
- Josebe Goirigolzarri Artaza, MD, PhD
- Telefonnummer: +34913303000
- E-mail: josebegoiri@gmail.com
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Madrid, Madrid, Spanien, 28034
- Hospital Ramon y Cajal
-
Kontakt:
- Carmen de Pablo Zarzosa, MD, PhD
- Telefonnummer: +34913368000
- E-mail: cpablozarzosa@gmail.com
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Madrid, Madrid, Spanien, 28041
- Hospital 12 de Octubre
-
Kontakt:
- Maria Paz Sanz Ayan, MD, PhD
- Telefonnummer: +34913908000
- E-mail: paz.sanz@salud.madrid.org
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Majadahonda, Madrid, Spanien, 28028
- Hospital Puerta de Hierro
-
Kontakt:
- Mercedes Rivas-Lasarte, MD, PhD
- Telefonnummer: +34911917843
- E-mail: rivaslasarte@gmail.com
-
Kontakt:
- Ramon Garrido Gonzalez, MD
-
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Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
- Voksen
- Ældre voksen
Tager imod sunde frivillige
Beskrivelse
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)
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Enkelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Eksperimentel: Remote Exercise Training Via Telemedicine
Warm-up, Respiratory Training, Continuous Aerobic Exercise, and Strength Training.
Remote Monitoring via Telemedicine.
|
The program includes structured warm-up routines, respiratory training, continuous aerobic exercise, and strength training, with remote follow-up conducted via telemedicine.
|
|
Andet: Control Group
Usual care.
General Exercise Recommendations (Written Instructions).
No Remote Monitoring.
|
General Exercise Recommendations (Written Instructions).
No Remote Monitoring.
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Six-Minute Walk Test (6MWT)
Tidsramme: 3 months
|
Difference in walking distance (meters) in the Six-Minute Walk Test (6MWT).
|
3 months
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Program Safety
Tidsramme: 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)
Tidsramme: 3 months
|
Changes in peak oxygen consumption (VO₂peak measured in ml/kg/m2)
|
3 months
|
|
Cardiopulmonary Exercise Test (CPET): VE/VO₂ slope
Tidsramme: 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
Tidsramme: 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
Tidsramme: 3 months
|
Changes in submaximal parameters: ventilatory equivalents (measured in L/min)
|
3 months
|
|
Cardiopulmonary Exercise Test (CPET): Oxygen Uptake Efficiency Score (OUES)
Tidsramme: 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
Tidsramme: 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
Tidsramme: 3 months
|
Changes in submaximal parameters: oscillatory patterns (Yes/No)
|
3 months
|
|
Quality of life (QoL): Kansas City Cardiomyopathy Questionnaire (KCCQ).
Tidsramme: 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).
Tidsramme: 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)
Tidsramme: 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
Tidsramme: 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).
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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
Tidsramme: 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
Tidsramme: 6 months
|
All previously described outcomes will be compared at 6 months after study initiation.
|
6 months
|
Andre resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Program Satisfaction and Adherence
Tidsramme: 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
Tidsramme: 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
Tidsramme: 6 months
|
All previously described outcomes will be analyzed by subgroups according to sex and the aim of the LVAD
|
6 months
|
Samarbejdspartnere og efterforskere
Samarbejdspartnere
Efterforskere
- Ledende efterforsker: Mercedes Rivas-Lasarte, MD, PhD, Hospital Puerta de Hierro, Madrid (Spain)
- Ledende efterforsker: Ramon Garrido Gonzalez, MD, Hospital Puerta de Hierro, Madrid (Spain)
Datoer for undersøgelser
Studer store datoer
Studiestart (Anslået)
Primær færdiggørelse (Anslået)
Studieafslutning (Anslået)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- PI 143/25
- PI25/00394 (Andet bevillings-/finansieringsnummer: Instituto de Salud Carlos III (ISCIII). Fondo de Investigaciones Sanitarias (FIS).)
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
IPD-planbeskrivelse
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.
IPD-delingstidsramme
IPD-delingsadgangskriterier
IPD-deling Understøttende informationstype
- STUDY_PROTOCOL
- SAP
- ICF
- ANALYTIC_CODE
- CSR
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