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Search / Trial NCT05271019

Efficacy of Early Inspiratory Muscle Training in Lung Transplanted Patients

Launched by PUERTA DE HIERRO UNIVERSITY HOSPITAL · Feb 26, 2022

Trial Information

Current as of June 27, 2025

Recruiting

Keywords

Respiratory Muscle Training Post Lung Transplant Breathing Exercises Respiratory Exercises Pulmonary Rehabilitation Exercise Capacity

ClinConnect Summary

This clinical trial is studying the effects of a type of exercise called Inspiratory Muscle Training (IMT) on lung transplant patients. After receiving a lung transplant, many patients experience muscle weakness and have difficulty exercising. The researchers want to find out if adding IMT to the usual rehabilitation program can help improve muscle strength, increase exercise ability, and enhance the overall quality of life for these patients.

To participate in the study, patients need to be alert and able to cooperate with the treatment, and their health must be stable. They should also be able to give their consent to join the trial. Participants will be divided into two groups: one will follow the standard rehabilitation program, while the other will also include IMT exercises. Throughout the study, participants can expect support and guidance as they work on improving their breathing and physical abilities. This trial is important because it could help shape better rehabilitation practices for lung transplant recipients in the future.

Gender

ALL

Eligibility criteria

  • Inclusion Criteria:
  • Alert or able to cooperate with treatment.
  • Able to give Informed Consent and sign it.
  • Haemodynamically stable clinical situation or requiring minimal ventilatory support.
  • Exclusion Criteria:
  • Detection of complete paralysis of the diaphragm.
  • Progressive neuromuscular diseases or with spinal cord injury.
  • Lack of collaboration or cooperation, or non-alertness (Glasgow ≤8).
  • Unstable clinical situation (patients requiring high levels of ventilatory support (e.g., Positive End Expiratory Pressure (PEEP)\> 10 cmH2O, Fraction Pressure of Inspired Oxygen (FiO2)\> 0.60, nitric oxide, nebulised prostacyclin, high frequency oscillation).
  • Clinical situation compromising the patient's recovery (cardiac arrhythmias, acute sepsis).
  • When the medical treatment team and/or physiotherapy consider that there may be risks.
  • Severe pain or dyspnoea that interferes with or impedes the ability to breathe (e.g. rib fracture).
  • Patients with lung retransplantation.
  • Heart and lung transplant patients.
  • When the patient is on palliative treatment

About Puerta De Hierro University Hospital

Puerta de Hierro University Hospital is a leading medical institution dedicated to advancing healthcare through innovative research and clinical trials. As a prominent sponsor of clinical studies, the hospital integrates cutting-edge medical practices with a commitment to patient safety and ethical standards. With a multidisciplinary team of experienced researchers and clinicians, Puerta de Hierro University Hospital fosters an environment conducive to scientific inquiry, aiming to enhance treatment options and improve patient outcomes across a range of medical disciplines. Their robust infrastructure and collaborative approach with academic and industry partners underscore their role as a key player in the global clinical research landscape.

Locations

Majadahonda, Madrid, Spain

Patients applied

0 patients applied

Trial Officials

Laura Muelas Gómez, PT, MSc

Principal Investigator

Hospital Universitario Puerta de Hierro Majadahonda

Maria de los Angeles Atín Arratibel, MD, PhD

Study Director

Universidad Complutense de Madrid

Maria A Cebria i Iranzo, PT, PhD

Study Director

Hospital Universitario y Politécnico La Fe,Valencia

Ignacio Latorre-Marco, DUE

Study Chair

Hospital Universitario Puerta de Hierro Majadahonda

Montserrat Solis Muñoz, DUE, PhD

Study Chair

Hospital Universitario Puerta de Hierro Majadahonda

Ana Royuela Vicente, Phd

Study Chair

Hospital Universitario Puerta de Hierro Majadahonda

Cristina Ruiz González, PT

Study Chair

Hospital Universitario Puerta de Hierro Majadahonda

Silvia Herguedas Cristobal, PT

Study Chair

Hospital Universitario Puerta de Hierro Majadahonda

Sofia González López, MD

Study Chair

Hospital Universitario Puerta de Hierro Majadahonda

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

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