RecruitingNot ApplicableNCT05271019

Efficacy of Early Inspiratory Muscle Training in Lung Transplanted Patients

Efficacy of Early Inspiratory Muscle Training Combined With the Conventional Rehabilitation Programme in Lung Transplanted Patients

Sponsor

Puerta de Hierro University Hospital

Enrollment

54 participants

Start Date

Feb 4, 2022

Study Type

INTERVENTIONAL

Conditions

Muscle Weakness Chronic Lung Disease Pulmonary Rehabilitation Respiratory Insufficiency Lung Transplant Recipients

Summary

Lung transplantation is an effective therapeutic option in the end-stage of chronic respiratory diseases. Lung transplantation improves lung function in terms of capacity and volume. However, the transplanted patient still suffers from muscle weakness and exercise intolerance. In recent years, respiratory physiotherapy work has intensified in critically ill patients with respiratory muscle weakness and the application of inspiratory muscle training (IMT), which has been shown in several studies to increase inspiratory muscle strength (IMT), improve ventilation and reduce the sensation of shortness of breath. Despite this emerging evidence, inspiratory muscle training (IMT) is not standard practice in most ICUs around the world, nor is it included in a protocolised manner among the components of a pulmonary rehabilitation programme. Given the limited evidence, the investigators propose to conduct this randomised controlled clinical trial in lung transplant recipients. The study will compare two groups of transplanted patients, a control group that will follow the rehabilitation programme and standard medical care and another experimental group that will also perform inspiratory muscle training. This study aims to analyse the effect of IMT on inspiratory muscle strength, exercise capacity and quality of life in lung transplant patients.

Eligibility

Min Age: 18 YearsMax Age: 80 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying whether early inspiratory muscle training — exercises to strengthen the breathing muscles — can help lung transplant patients recover faster and breathe better after surgery. Lung transplant patients often experience significant muscle weakness and reduced exercise tolerance even after the transplant improves their lung function, and this study tests whether adding targeted breathing exercises to the standard rehabilitation program makes a measurable difference. Adults aged 18 and over who receive a single or double lung transplant and are medically stable may be eligible, unless they have diaphragm paralysis, severe pain, or an unstable clinical condition. Participation involves performing daily breathing exercises supervised by a physiotherapist in hospital, starting in the ICU, for up to 3 months post-transplant. This summary was prepared to help patients understand the study in plain language.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICEThreshold load device

Inspiratory Muscle Training (IMT) for 3 months: Though a threshold loading device (5 sets of 6 repetitions, 1session/day, 5 days/week). the inspiratory load will start at 30% of MIP, or up to the maximum patient-tolerable load (max 60% of MIP), no more than 3-5/10 on the modified Borg scale.