Efficacy of Early Inspiratory Muscle Training in Lung Transplanted Patients

NCT05271019 | Recruiting

• 1 other identifier: PI 195/21
• Study Type: interventional
• Target: 54
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (5)

• Change in respiratory strength: maximal inspiratory pressure (MIP) and maximal expiratory pressure (MEP) measured in water centimeters (cmH2O).

  Maximum respiratory pressure will be measure using a Respiratory Pressure Meter (RPM) named Micro-RPM® . Ever since Black and Hyatt (1969) reported this technique, it is used in healthy control subjects across all ages and athletes. Pressure is recorded at the mouth during quasi-static short (few seconds) maximal breathing according to American Thoracic Society (ATS) guidelines.The maximum value will be obtained. Am J respi Crit Care Med 2002;166:531-535.

  The groups will be assessed at six times:Pre -Lung transplantation (Pre-LT), at baseline, every 15 days and 3 months after LT

• Change in functional capacity: 6 minutes walk test (6MWT) measured in meters

  6MWT is a submaximal exercise test that entails measurement of distance walked during 6 minutes. The 6MWT provides information regarding functional capacity, response to therapy and prognosis. The test will be in line with American Thoracic Society (ATS) guidelines Statement Guidelines for the Six Minutes Walk Test. Am J respi Crit Care Med 2002;166(1):111-117

  The groups will be assessed Pre-LT and 3 months after LT

• Change in Quality of life related with Health(SF-36) measured with a score from 0 to100

  The SF-36 consists of 36 topics that explore eight dimensions of health status: physical function, physical role, bodily pain, general health, vitality, social function, emotional role, and mental health.The SF-36 was previously validated in chronic obstructive pulmonary disease (COPD) patients and has been used in patients before and after lung transplantation (LT). Respiration 2000;67:159-65. Chest 2000;118:408-16.

  The groups will be assessed Pre-LT and 3 months after LT

• Change in Respiratory mechanics parameters: respiratory work measured in Joules (J)

  Respiratory mechanics parameters will be analyzed using a POWERbreathe electronic device: the work of breathing is the area for total external inspiratory work as integrated from mouth pressure (cmH2O) and volume (L) signals over time. Physical Therapy 2015;95(9):1264-1273

  The groups will be assessed at baseline, every 15 days and 3 months after LT

• Change in Inspiratory muscle endurance (Tlim) measure in seconds (s)

  Inspiratory muscle endurance is the time the patient breathe against a submaximal inspiratory load provided by device (POWERbreathe) until task failure due to the symptom limitation. Physical Therapy 2015;95(9):1264-1273.

  The groups will be assessed at baseline, every 15 days and 3 months after LT

Secondary Outcomes (3)

• Changes in dyspnea measured with the modified borg scale 0-10

  The groups will be assessed at baseline, every 15 days and 3 months after LT

• Incidence of atelectasis measured with a score from 0 to 4

  The patients will be assessed through study completion, an average of 3 months

• Change in Pulmonary Function measured with Spirometry Test. FEV1/FVC measured in %

  The groups will be assessed Pre-LT, at baseline and 3 months after LT

Study Arms (2)

Control group: Conventional Rehabilitation Program

NO INTERVENTION

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.

Experimental group: Conventional Rehabilitation Program + Inspiratory Muscle Training (IMT)

EXPERIMENTAL

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.

Device: Threshold load device

Interventions

Threshold load device 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.

Experimental group: Conventional Rehabilitation Program + Inspiratory Muscle Training (IMT)

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Alert or able to cooperate with treatment.
• Able to give Informed Consent and sign it.
• Haemodynamically stable clinical situation or requiring minimal ventilatory support.

You may not qualify if:

• 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

Sponsors & Collaborators

• Puerta de Hierro University Hospital: lead
• Universidad Complutense de Madrid: collaborator

Study Sites (1)

Laura Muelas Gómez

Majadahonda, Madrid, 28222, Spain

RECRUITING

Related Publications (10)

• 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.

  PMID: 29843525 BACKGROUND

• 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.

  BACKGROUND

• 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)

  BACKGROUND

• 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.

  PMID: 21282809 BACKGROUND

• 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.

  PMID: 31429627 BACKGROUND

• 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.

  PMID: 28093920 BACKGROUND

• 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.

  PMID: 22390625 BACKGROUND

• 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.

  PMID: 31241521 BACKGROUND

• 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.

  PMID: 34290002 BACKGROUND

• 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.

  PMID: 19481017 BACKGROUND

MeSH Terms

Conditions

Muscle Weakness; Respiratory Insufficiency

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases; Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Respiration Disorders; Respiratory Tract Diseases

Study Officials

• Laura Muelas Gómez, PT, MSc

  Hospital Universitario Puerta de Hierro Majadahonda

  PRINCIPAL INVESTIGATOR

• Maria de los Angeles Atín Arratibel, MD, PhD

  Universidad Complutense de Madrid

  STUDY DIRECTOR

• Maria A Cebria i Iranzo, PT, PhD

  Hospital Universitario y Politécnico La Fe,Valencia

  STUDY DIRECTOR

• Ignacio Latorre-Marco, DUE

  Hospital Universitario Puerta de Hierro Majadahonda

  STUDY CHAIR

• Montserrat Solis Muñoz, DUE, PhD

  Hospital Universitario Puerta de Hierro Majadahonda

  STUDY CHAIR

• Ana Royuela Vicente, Phd

  Hospital Universitario Puerta de Hierro Majadahonda

  STUDY CHAIR

• Cristina Ruiz González, PT

  Hospital Universitario Puerta de Hierro Majadahonda

  STUDY CHAIR

• Silvia Herguedas Cristobal, PT

  Hospital Universitario Puerta de Hierro Majadahonda

  STUDY CHAIR

• Sofia González López, MD

  Hospital Universitario Puerta de Hierro Majadahonda

  STUDY CHAIR

Central Study Contacts

Laura Muelas Gómez, PT, MSc

CONTACT

+0034 656605303; laura.muelas@salud.madrid.org

Montserrat Solis Muñoz, PhD

CONTACT

+0034 911917457; montserrat.solis@salud.madrid.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Neither the professionals in charge of measuring the pre- and post-intervention outcomes nor the statistician are aware of the assignment.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical physiotherapist

Model Details: Parallel assignment

Study Record Dates

• First Submitted: February 16, 2022
• First Posted: March 8, 2022
• Study Start: February 4, 2022
• Primary Completion: December 15, 2024
• Study Completion: April 30, 2025
• Last Updated: April 2, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)