Clinical trial NCT05271019: Efficacy of Early Inspiratory Muscle Training in Lung Transplanted Patients
Official title: Efficacy of Early Inspiratory Muscle Training Combined With the Conventional Rehabilitation Programme in Lung Transplanted Patients
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Lung Transplant Recipients
Muscle Weakness
Respiratory Insufficiency
Pulmonary Rehabilitation
Chronic Lung Disease
Keywords: respiratory muscle training
post lung transplant
breathing exercises
respiratory exercises
pulmonary rehabilitation
exercise capacity
Lead sponsor: Puerta de Hierro University Hospital
Sponsor class: OTHER
Collaborators: name: Universidad Complutense de Madrid
First posted: 2022-03-08
Enrollment: 54
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Parallel assignment
Primary purpose: TREATMENT

Brief 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.

Detailed description: 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

Primary outcomes:
measure: Change in respiratory strength: maximal inspiratory pressure (MIP) and maximal expiratory pressure (MEP) measured in water centimeters (cmH2O).
timeFrame: The groups will be assessed at six times:Pre -Lung transplantation (Pre-LT), at baseline, every 15 days and 3 months after LT
measure: Change in functional capacity: 6 minutes walk test (6MWT) measured in meters
timeFrame: The groups will be assessed Pre-LT and 3 months after LT
measure: Change in Quality of life related with Health(SF-36) measured with a score from 0 to100
timeFrame: The groups will be assessed Pre-LT and 3 months after LT
measure: Change in Respiratory mechanics parameters: respiratory work measured in Joules (J)
timeFrame: The groups will be assessed at baseline, every 15 days and 3 months after LT
measure: Change in Inspiratory muscle endurance (Tlim) measure in seconds (s)
timeFrame: The groups will be assessed at baseline, every 15 days and 3 months after LT
Secondary outcomes:
measure: Changes in dyspnea measured with the modified borg scale 0-10
timeFrame: The groups will be assessed at baseline, every 15 days and 3 months after LT
measure: Incidence of atelectasis measured with a score from 0 to 4
timeFrame: The patients will be assessed through study completion, an average of 3 months
measure: Change in Pulmonary Function measured with Spirometry Test. FEV1/FVC measured in %
timeFrame: The groups will be assessed Pre-LT, at baseline and 3 months after LT
Other outcomes:
Locations:
city: Majadahonda
country: Spain
facility: Laura Muelas Gómez
state: Madrid
Study officials:
affiliation: Hospital Universitario Puerta de Hierro Majadahonda
name: Laura Muelas Gómez, PT, MSc
role: PRINCIPAL_INVESTIGATOR
affiliation: Universidad Complutense de Madrid
name: Maria de los Angeles Atín Arratibel, MD, PhD
role: STUDY_DIRECTOR
affiliation: Hospital Universitario y Politécnico La Fe,Valencia
name: Maria A Cebria i Iranzo, PT, PhD
role: STUDY_DIRECTOR
affiliation: Hospital Universitario Puerta de Hierro Majadahonda
name: Ignacio Latorre-Marco, DUE
role: STUDY_CHAIR
affiliation: Hospital Universitario Puerta de Hierro Majadahonda
name: Montserrat Solis Muñoz, DUE, PhD
role: STUDY_CHAIR
affiliation: Hospital Universitario Puerta de Hierro Majadahonda
name: Ana Royuela Vicente, Phd
role: STUDY_CHAIR
affiliation: Hospital Universitario Puerta de Hierro Majadahonda
name: Cristina Ruiz González, PT
role: STUDY_CHAIR
affiliation: Hospital Universitario Puerta de Hierro Majadahonda
name: Silvia Herguedas Cristobal, PT
role: STUDY_CHAIR
affiliation: Hospital Universitario Puerta de Hierro Majadahonda
name: Sofia González López, MD
role: STUDY_CHAIR
References:
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citation: Nissan Graur PW and MRK. Annals of Physiotherapy Clinics Effects of Inspiratory Muscle Training on Respiratory Muscle Strength , Functional Capacity and Health Related Quality of Life of Patients Following Lung Transplantation. Ann Physiother Clin. 2020;2(1):10-2.
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citation: Langer D, Burtin C, Schepers L, Ivanova A, Verleden G, Decramer M, Troosters T, Gosselink R. Exercise training after lung transplantation improves participation in daily activity: a randomized controlled trial. Am J Transplant. 2012 Jun;12(6):1584-92. doi: 10.1111/j.1600-6143.2012.04000.x. Epub 2012 Mar 5.
citation: Candemir I, Ergun P, Kaymaz D, Demir N, Tasdemir F, Sengul F, Egesel N, Yekeler E. The Efficacy of Outpatient Pulmonary Rehabilitation After Bilateral Lung Transplantation. J Cardiopulm Rehabil Prev. 2019 Jul;39(4):E7-E12. doi: 10.1097/HCR.0000000000000391.
citation: Yamaga T, Yamamoto S, Sakai Y, Ichiyama T. Effects of inspiratory muscle training after lung transplantation in children. BMJ Case Rep. 2021 Jul 21;14(7):e241114. doi: 10.1136/bcr-2020-241114.
citation: Langer D, Gosselink R, Pitta F, Burtin C, Verleden G, Dupont L, Decramer M, Troosters T. Physical activity in daily life 1 year after lung transplantation. J Heart Lung Transplant. 2009 Jun;28(6):572-8. doi: 10.1016/j.healun.2009.03.007. Epub 2009 May 5.