Efficacy of Early Inspiratory Muscle Training in Lung Transplanted Patients

April 1, 2024 updated by: Laura Muelas Gomez, Puerta de Hierro University Hospital

Efficacy of Early Inspiratory Muscle Training Combined With the Conventional Rehabilitation Programme in Lung Transplanted Patients

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

54

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 78 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: 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.
Experimental: 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.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in respiratory strength: maximal inspiratory pressure (MIP) and maximal expiratory pressure (MEP) measured in water centimeters (cmH2O).
Time Frame: The groups will be assessed at six times:Pre -Lung transplantation (Pre-LT), at baseline, every 15 days and 3 months after LT
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
Time Frame: The groups will be assessed Pre-LT and 3 months after LT
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
Time Frame: The groups will be assessed Pre-LT and 3 months after LT
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)
Time Frame: The groups will be assessed at baseline, every 15 days and 3 months after LT
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)
Time Frame: The groups will be assessed at baseline, every 15 days and 3 months after LT
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Changes in dyspnea measured with the modified borg scale 0-10
Time Frame: The groups will be assessed at baseline, every 15 days and 3 months after LT
Dyspnea perceptions during the activities of daily living and during exert were assessed. Med Sci Sports Exert 1982; 14: 377-81.
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
Time Frame: The patients will be assessed through study completion, an average of 3 months
Registry of Atelectasis is a complete or partial collapse of the whole lung or a part (lobe) of the lung diagnosed by the responsible physician by Chest x-ray report or physician documentation of atelectasis.The postoperative chest radiographs were scored according the following rating (2): 0, no abnormalities; 1, minor atelectasis on one side; 2,minor atelectasis on both sides; 3,major atelectasis on one side; and 4, major atelectasis on both sides. Crit Care Med 2000;28:679-83. Physiotherapy 2011;97(4):278-283
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 %
Time Frame: The groups will be assessed Pre-LT, at baseline and 3 months after LT
the investigators will interpret the data obtained from forced spirometry to evaluate how our patient's pulmonary functions is developing after the surgery. FEV1/FVC: It represents the proportion of a person's vital capacity that they are able to expire in the first second of forced expiration (FEV1) to the full, forced vital capacity (FVC).The result of this ratio is expressed as FEV1%. Spirometry is traditionally and widely used to measure pulmonary function and capacity. This test will be performed with a spirometer according to American Thoracic Society (ATS) guidelines and measured in liters . Am J respi Crit Care Med 2002;166:521-522, Eur respi J 2005; 26: 153-161.
The groups will be assessed Pre-LT, at baseline and 3 months after LT

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Puerta de Hierro University Hospital

Collaborators

Universidad Complutense de Madrid

Investigators

  • Principal Investigator: Laura Muelas Gómez, PT, MSc, Hospital Universitario Puerta de Hierro Majadahonda
  • Study Director: 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 Chair: 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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 4, 2022

Primary Completion (Estimated)

December 15, 2024

Study Completion (Estimated)

April 30, 2025

Study Registration Dates

First Submitted

February 16, 2022

First Submitted That Met QC Criteria

February 26, 2022

First Posted (Actual)

March 8, 2022

Study Record Updates

Last Update Posted (Actual)

April 2, 2024

Last Update Submitted That Met QC Criteria

April 1, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PI 195/21

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

For now I don't want to share information about the study until I have the protocol or some published results of the intervention. At that time, the information will be shared with the other researchers.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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