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

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

Inclusion Criteria3

  • 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 Criteria10

  • 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

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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.


Locations(1)

Laura Muelas Gómez

Majadahonda, Madrid, Spain

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NCT05271019


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