Training to strengthen breathing muscles in lung transplant patients
Efficacy of Early Inspiratory Muscle Training Combined With the Conventional Rehabilitation Programme in Lung Transplanted Patients
NA · Puerta de Hierro University Hospital · NCT05271019
This study is testing if a special breathing exercise program can help lung transplant patients get stronger and feel better after their surgery.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 54 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Sponsor | Puerta de Hierro University Hospital (other) |
| Locations | 1 site (Majadahonda, Madrid) |
| Trial ID | NCT05271019 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the effects of early inspiratory muscle training (IMT) on lung transplant recipients who often experience muscle weakness and exercise intolerance post-surgery. Participants will be randomly assigned to either a control group receiving standard rehabilitation or an experimental group undergoing IMT using a threshold load device. The study aims to assess improvements in respiratory muscle strength, exercise tolerance, and overall quality of life. By focusing on this specific population, the trial seeks to provide evidence for incorporating IMT into standard pulmonary rehabilitation protocols.
Who should consider this trial
Good fit: Ideal candidates for this study are adult lung transplant recipients who are alert and able to cooperate with treatment.
Not a fit: Patients with severe respiratory complications or those requiring high levels of ventilatory support may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly enhance recovery and quality of life for lung transplant patients by improving their respiratory muscle strength and exercise capacity.
How similar studies have performed: Previous studies have shown favorable effects of inspiratory muscle training in similar patient populations, suggesting potential for success in this trial.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Majadahonda, Madrid
- Laura Muelas Gómez — Majadahonda, Madrid, Spain (RECRUITING)
Study contacts
- Principal investigator: Laura Muelas Gómez, PT, MSc — Hospital Universitario Puerta de Hierro Majadahonda
- Study coordinator: Laura Muelas Gómez, PT, MSc
- Email: laura.muelas@salud.madrid.org
- Phone: +0034 656605303
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Lung Transplant Recipients, Muscle Weakness, Respiratory Insufficiency, Pulmonary Rehabilitation, Chronic Lung Disease, respiratory muscle training, post lung transplant, breathing exercises