Efficacy of Early Inspiratory Muscle Training in Lung Transplanted Patients
NCT ID: NCT05271019
Last Updated: 2024-04-02
Study Results
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Basic Information
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RECRUITING
NA
54 participants
INTERVENTIONAL
2022-02-04
2025-04-30
Brief Summary
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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.
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Control group: Conventional Rehabilitation Program
Standard rehabilitation program for 3 months, starting in the early phase in the ICU. A daily session from monday to friday. It includes breathing and secretions management exercises, building upper and lower extremity range of motion. Exercise progression should gradually incorporate aerobic exercises (treadmill, cycloergometer and upper and lower limb strength exercises) and limb strength training.
Aerobic exercise at moderate intensity (no more than 3-4/10 on the modified Borg scale). Aerobic exercise starting with 20 minutes and gradually increasing up to 30 minutes.
Limb strength training from 1 to 3 sets of 8-10 repetitions at moderate intensity.
No interventions assigned to this group
Experimental group: Conventional Rehabilitation Program + Inspiratory Muscle Training (IMT)
Standard rehabilitation program for 3 months, starting in the early phase in the ICU. A daily session from monday to friday. It includes breathing and secretions management exercises, building upper and lower extremity range of motion. Exercise progression should gradually incorporate aerobic exercises (treadmill, cycloergometer and upper and lower limb strength exercises) and limb strength training.
Aerobic exercise at moderate intensity (no more than 3-4/10 on the modified Borg scale). Aerobic exercise starting with 20 minutes and gradually increasing up to 30 minutes.
Limb strength training from 1 to 3 sets of 8-10 repetitions at moderate intensity.
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.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
* Able to give Informed Consent and sign it.
* Haemodynamically stable clinical situation or requiring minimal ventilatory support.
Exclusion Criteria
* 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
18 Years
80 Years
ALL
No
Sponsors
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Universidad Complutense de Madrid
OTHER
Puerta de Hierro University Hospital
OTHER
Responsible Party
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Laura Muelas Gomez
Clinical physiotherapist
Principal Investigators
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Laura Muelas Gómez, PT, MSc
Role: PRINCIPAL_INVESTIGATOR
Hospital Universitario Puerta de Hierro Majadahonda
Maria de los Angeles Atín Arratibel, MD, PhD
Role: STUDY_DIRECTOR
Universidad Complutense de Madrid
Maria A Cebria i Iranzo, PT, PhD
Role: STUDY_DIRECTOR
Hospital Universitario y Politécnico La Fe,Valencia
Ignacio Latorre-Marco, DUE
Role: STUDY_CHAIR
Hospital Universitario Puerta de Hierro Majadahonda
Montserrat Solis Muñoz, DUE, PhD
Role: STUDY_CHAIR
Hospital Universitario Puerta de Hierro Majadahonda
Ana Royuela Vicente, Phd
Role: STUDY_CHAIR
Hospital Universitario Puerta de Hierro Majadahonda
Cristina Ruiz González, PT
Role: STUDY_CHAIR
Hospital Universitario Puerta de Hierro Majadahonda
Silvia Herguedas Cristobal, PT
Role: STUDY_CHAIR
Hospital Universitario Puerta de Hierro Majadahonda
Sofia González López, MD
Role: STUDY_CHAIR
Hospital Universitario Puerta de Hierro Majadahonda
Locations
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Laura Muelas Gómez
Majadahonda, Madrid, Spain
Countries
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Central Contacts
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Facility Contacts
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References
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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.
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.
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.
Pehlivan E, Mutluay F, Balci A, Kilic L. The effects of inspiratory muscle training on exercise capacity, dyspnea and respiratory functions in lung transplantation candidates: a randomized controlled trial. Clin Rehabil. 2018 Oct;32(10):1328-1339. doi: 10.1177/0269215518777560. Epub 2018 May 30.
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.
Neumannova K, Kuzilkova V, Zurková M, Hubackova L, Michalcikova T, Jakubec P, et al. Respiratory muscle training improves the work of breathing and decreases inspiratory muscle fatigue in patients after lung transplantation. Eur Respir J. 2019 Sep 28;54(suppl 63)
Gosselink R, De Vos J, van den Heuvel SP, Segers J, Decramer M, Kwakkel G. Impact of inspiratory muscle training in patients with COPD: what is the evidence? Eur Respir J. 2011 Feb;37(2):416-25. doi: 10.1183/09031936.00031810.
Hoffman M, Augusto VM, Eduardo DS, Silveira BMF, Lemos MD, Parreira VF. Inspiratory muscle training reduces dyspnea during activities of daily living and improves inspiratory muscle function and quality of life in patients with advanced lung disease. Physiother Theory Pract. 2021 Aug;37(8):895-905. doi: 10.1080/09593985.2019.1656314. Epub 2019 Aug 20.
Kendall F, Oliveira J, Peleteiro B, Pinho P, Bastos PT. Inspiratory muscle training is effective to reduce postoperative pulmonary complications and length of hospital stay: a systematic review and meta-analysis. Disabil Rehabil. 2018 Apr;40(8):864-882. doi: 10.1080/09638288.2016.1277396. Epub 2017 Jan 17.
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.
Other Identifiers
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PI 195/21
Identifier Type: -
Identifier Source: org_study_id
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