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

NCT07611188 | Not Yet Recruiting DMC

• 2 other identifiers: PI 143/25PI25/00394
• Study Type: interventional
• Target: 78
• Locations: 1 country
• Sites: 10

Brief 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.

Conditions

Heart Failure; Advanced Heart Failure; Left Ventricular Assist Device; LVAD; Cardiac Rehabilitation; Telemedicine; Remote Exercise; Ventricular Assist Device; Exercise Training; Conditioning Therapy; Cardiopulmonary Exercise Test; Six Minute Walk Test; Quality of Life; Telerehabilitation

Keywords

Left Ventricular Assist Device; Advanced Heart Failure; Heart Failure; Cardiac Rehabilitation; Remote rehabilitation; Telemedicine; 6 minute walking test; Quality of Life; Cardiopulmonary Exercise Test; Telerehabilitation

Outcome Measures

Primary Outcomes (1)

• Six-Minute Walk Test (6MWT)

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

  3 months

Secondary Outcomes (17)

• Program Safety

  6 months

• Cardiopulmonary Exercise Test (CPET): peak oxygen consumption (VO₂peak)

  3 months

• Cardiopulmonary Exercise Test (CPET): VE/VO₂ slope

  3 months

• Cardiopulmonary Exercise Test (CPET): oxygen consumption at the first and second ventilatory thresholds

  3 months

• Cardiopulmonary Exercise Test (CPET): ventilatory equivalents

  3 months

Other Outcomes (3)

• Program Satisfaction and Adherence

  6 months

• Comparison of Outcomes Between Remote conditioning and Supervised Rehabilitation

  6 months

• Evaluation of Outcomes by Sex and by the aim of LVAD

  6 months

Study Arms (2)

Remote Exercise Training Via Telemedicine

EXPERIMENTAL

Warm-up, Respiratory Training, Continuous Aerobic Exercise, and Strength Training. Remote Monitoring via Telemedicine.

Other: Remote Physical Conditioning Program (Telerehabilitation)

Control Group

OTHER

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

Other: Usual care. No Remote Monitoring.

Interventions

Remote Physical Conditioning Program (Telerehabilitation) OTHER

The program includes structured warm-up routines, respiratory training, continuous aerobic exercise, and strength training, with remote follow-up conducted via telemedicine.

Remote Exercise Training Via Telemedicine

Usual care. No Remote Monitoring. OTHER

General Exercise Recommendations (Written Instructions). No Remote Monitoring.

Control Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

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

Sponsors & Collaborators

• Puerta de Hierro University Hospital: lead
• Carlos III Health Institute: collaborator

Study Sites (10)

Hospital Virgen del Rocío

Seville, Andalusia, 41013, Spain

Location

Hospital Universitario de Salamanca

Salamanca, Castille and León, 37007, Spain

Location

Hospital Clinic de Barcelona

Barcelona, Catalonia, 03036, Spain

Location

Hospital Universitari de Bellvitge

Barcelona, Catalonia, Spain

Location

Complejo Hospitalario Universitario de A Coruña

A Coruña, Galicia, 15006, Spain

Location

Complejo Hospitalario Universitario Santiago de Compostela

Santiago de Compostela, Galicia, 15706, Spain

Location

Hospital Ramon y Cajal

Madrid, Madrid, 28034, Spain

Location

Hospital Clinico San Carlos

Madrid, Madrid, 28040, Spain

Location

Hospital 12 de Octubre

Madrid, Madrid, 28041, Spain

Location

Hospital Puerta de Hierro

Majadahonda, Madrid, 28028, Spain

Location

MeSH Terms

Conditions

Heart Failure

Interventions

Telerehabilitation

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Health Services; Health Care Facilities Workforce and Services; Telemedicine; Delivery of Health Care; Patient Care Management; Health Services Administration

Study Officials

• Mercedes Rivas-Lasarte, MD, PhD

  Hospital Puerta de Hierro, Madrid (Spain)

  PRINCIPAL INVESTIGATOR

• Ramon Garrido Gonzalez, MD

  Hospital Puerta de Hierro, Madrid (Spain)

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Mercedes Rivas-Lasarte, MD, PhD, Cardiologist

CONTACT

+34911917843; rivaslasarte@gmail.com

Ramon Garrido Gonzalez, MD, Cardiologist

CONTACT

+34911917843; ramongarrido15@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Cardiologist, MD, PhD

Model Details: Multicenter, randomized, and controlled clinical trial

Study Record Dates

• First Submitted: March 6, 2026
• First Posted: May 28, 2026
• Study Start: May 1, 2026
• Primary Completion (Estimated): December 1, 2029
• Study Completion (Estimated): December 1, 2030
• Last Updated: May 28, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: Data are expected to be available beginning in January 2031, following completion of the study and publication of the primary analysis.
• Access Criteria: Data will be shared with investigators who provide a methodologically sound research proposal and demonstrate legitimate scientific interest.

Locations

ES (10)