Efficacy of Early Inspiratory Muscle Training in Lung Transplanted Patients

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.

Conditions

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

Interventions

DEVICE

Threshold 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.

Sponsors & Collaborators

• Universidad Complutense de Madrid

  collaborator OTHER

• Puerta de Hierro University Hospital

  lead OTHER

Principal Investigators

• Laura Muelas Gómez, PT, MSc · Hospital Universitario Puerta de Hierro Majadahonda

• Maria de los Angeles Atín Arratibel, MD, PhD · Universidad Complutense de Madrid

• Maria A Cebria i Iranzo, PT, PhD · Hospital Universitario y Politécnico La Fe,Valencia

• Ignacio Latorre-Marco, DUE · Hospital Universitario Puerta de Hierro Majadahonda

• Montserrat Solis Muñoz, DUE, PhD · Hospital Universitario Puerta de Hierro Majadahonda

• Ana Royuela Vicente, Phd · Hospital Universitario Puerta de Hierro Majadahonda

• Cristina Ruiz González, PT · Hospital Universitario Puerta de Hierro Majadahonda

• Silvia Herguedas Cristobal, PT · Hospital Universitario Puerta de Hierro Majadahonda

• Sofia González López, MD · Hospital Universitario Puerta de Hierro Majadahonda

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

80 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2022-02-04

Primary Completion

2024-12-15

Completion

2025-04-30

Countries

• Spain

Study Locations