Efficacy of Early Inspiratory Muscle Training in Lung Transplanted Patients

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.

For many years, lung transplantation has become an effective therapeutic option for end-stage chronic lung diseases. With transplantation, an improvement in lung function is achieved, achieving volumes and capacities close to those predicted.

After transplantation, muscle deterioration and exercise intolerance are still present; and it will take, according to studies, between 6 months to 1 year to achieve recovery to near normal values. Even in some cases, such as patients with a longer stay in the critical care unit who present a greater deterioration, these values do not reach normal values. In lung transplant recipients, pulmonary rehabilitation including aerobic exercise, resistance exercise and respiratory physiotherapy is the most effective strategy to improve exercise capacity and muscle strength.

Some clinical trials on inspiratory muscle training have identified favourable effects on respiratory muscle fitness and strength.

The purpose of this study is to analyse the impact of early training in lung transplant patients on respiratory muscle strength, exercise tolerance and quality of life. To this end, a randomised controlled trial will be carried out including lung transplant patients (single or double lung adults over 18 years of age) admitted to the hospital where a control group will perform the standard rehabilitation programme: respiratory, aerobic and upper and lower limb strength exercises; while the experimental group will be given inspiratory muscle training with a load of at least 30% of the maximum inspiratory pressure (MIP) in an early manner. Both groups will start the treatment in the critical care unit under conditions of clinical stability (haemodynamic, respiratory and neurologic) and will continue it in hospitalisation. Treatment is performed once a day, 5 days a week from Monday to Friday supervised by a trained physiotherapist.

Every 15 days a data collection will be performed to monitor the follow-up and the data collection will end 3 months after the lung transplantation.

The data collected will be compared from the start of treatment (pre- and post-transplant measurements) and will be compared between the groups.

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