Inspiratory Muscle Training Immediately After Lung Transplantation

December 16, 2025 updated by: Cristiane Meirelles, PT, PhD, Ohio State University

The Effects of Inspiratory Muscle Training Immediatley After Lung Transplantation: a Randomized Controlled Trial

Following lung transplantation (LTX), patients may exhibit respiratory and skeletal muscle weakness that will affect exercise capacity, increase dyspnea and fatigue, limit activities of daily living (ADL) and decrease quality of life.

Inspiratory muscle training (IMT) has been extensively studied in a variety of non-LTX populations and research has shown that IMT improves exercise capacity, diaphragmatic thickness, and reduced dyspnea during activities of daily living and improved quality of life in patients with advanced lung disease.

The aim of this randomized controlled study is to investigate the benefits of providing inspiratory muscle training via use of an inspiratory muscle trainer device in addition to standard physical therapy in the acute phase of rehabilitation following LTX. Patients targeted for enrollment will be those with any type of advanced lung disease requiring LTX with the objective of demonstrating improvements in respiratory muscle recovery, perceived dyspnea, severity of fatigue, and overall functional status following the transplant procedure.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

90

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 Locations

  • United States
    • Ohio
      • Columbus, Ohio, United States, 43210
        • The Ohio State University Wexner Medical CEnter

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

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Participant has personally signed and dated informed consent form indicating understanding of all pertinent aspects of the study
  • Active on the waiting list for lung transplantation
  • Able to ambulate pre-transplant (not bed/wheelchair bound) with or without assistive device

Exclusion Criteria:

  • Already participating in a regular IMT program
  • Impaired cognition with inability to follow commands

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: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Usual care group
Patients will only participate in standard post-transplant physical therapy.
Experimental: Inspiratory Muscle training- Intervention group
Along with standard post-transplant physical therapy, the intervention group will begin daily respiratory exercise training utilizing the IMT trainer device (POWERbreathe Medic Plus®) with weekly incremental increases in respiratory load. Patients will be asked to use the IMT device twice per day, 7 days per week, for 8 weeks.
Device: IMT- Intervention group
The resistive load will be readjusted weekly to reach 50% of maximal inspiratory pressure (MIP).
Other Names:
  • POWERBreathe Medic Plus®
Sham Comparator: Inspiratory Muscle training - Placebo group
Along with standard post-transplant physical therapy, the placebo group will begin daily respiratory exercise training utilizing the IMT trainer device (POWERbreathe Medic Plus®) with no increase of respiratory load. Patients will be asked to use the IMT device twice per day, 7 days per week, for 8 weeks.
Device: IMT- Placebo group
The inspiratory resistive load will be adjusted to the minimum value of the device (9 cm H2O) during all inspiratory muscle training sessions.
Other Names:
  • POWERBreathe Medic Plus®

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in inspiratory muscle strength: Maximal inspiratory pressure (MIP) measured in cmH2O
Time Frame: The groups will be assessed: Before Lung transplantation, at baseline (immediate post-transplant), 8 weeks, 6 and 12 months after LTX
Inspiratory muscle strength will be measured as maximal inspiratory pressure (MIP) using a POWERbreathe® KH2, International Ltd; UK. The MIP is defined as the greatest negative pressure sustained for at least one second by each patient. The patient will be verbally encouraged to perform three to five inspiratory maneuvers at maximal intensity. The maximum value will be used for the analysis.
The groups will be assessed: Before Lung transplantation, at baseline (immediate post-transplant), 8 weeks, 6 and 12 months after LTX
Change in perceived dyspnea: Modified Medical Research Council Dyspnea Scale
Time Frame: The groups will be assessed: Before Lung transplantation, 8 weeks, 6 and 12 months after LTX
Modified Medical Research Council Dyspnea Scale (mMRC) will measure dyspnea perceptions during the activities of daily living. A score from 0-4 is used to classify the impact of dyspnea on physical function in patients with respiratory limitations. 0 represents a person who suffers from dyspnea only with strenuous exercise. 4 represents a person who are too breathless to leave the house, or breathless when dressing.
The groups will be assessed: Before Lung transplantation, 8 weeks, 6 and 12 months after LTX
Change in fatigue: Fatigue Severity Scale
Time Frame: The groups will be assessed: Before Lung transplantation, 8 weeks, 6 and 12 months after LTX
Fatigue Severity Scale (FSS) evaluates fatigue using a nine-item, self-scored questionnaire, which with a visual ranking format ranging from one to seven that quantifies patient-perceived fatigue. Higher composite scores indicate more severe fatigue. An average score of less than 2.8 indicates no fatigue, and more than 6.1 indicates chronic fatigue syndrome.
The groups will be assessed: Before Lung transplantation, 8 weeks, 6 and 12 months after LTX
Change in functional capacity
Time Frame: The groups will be assessed: Before Lung transplantation, 8 weeks, 6 and 12 months after LTX
Functional capacity will be estimated using the 6-minute walk test according to the American Thoracic Society guidelines. Before and after the test, oxygen saturation (SpO2), heart rate, Modified Dyspnea Borg Scale and walking distance will be recorded
The groups will be assessed: Before Lung transplantation, 8 weeks, 6 and 12 months after LTX

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in lung function: Pulmonary Function Test
Time Frame: The groups will be assessed: Before Lung transplantation, 8 weeks, 6 and 12 months after LTX
Lung function will be measured in accordance with the guidelines of the American Thoracic Society. The following variables will be analyzed: (a) forced vital capacity (FVC, L) and (b) forced expiratory volume in the first second (FEV1, L).
The groups will be assessed: Before Lung transplantation, 8 weeks, 6 and 12 months after LTX
Change in physical performance
Time Frame: The groups will be assessed: Before Lung transplantation, 8 weeks, 6 and 12 months after LTX
Physical performance test will be evaluated using the Short Physical Performance Battery Test (SPPB) to assess standing balance, walking speed, and chair stands. The corresponding score from each section is determined and compiled for an overall score of 0-12.
The groups will be assessed: Before Lung transplantation, 8 weeks, 6 and 12 months after LTX
Change in lower extremity muscle strength
Time Frame: The groups will be assessed: Before Lung transplantation, 8 weeks, 6 and 12 months after LTX
Quadriceps strength will be measured with a hand-held dynamometer (HHD, Microfet®, Hogan Health Industries, Inc., UT, USA). At least three measurements will be obtained and the higher knee extensor muscle strength value will be used for the analysis.
The groups will be assessed: Before Lung transplantation, 8 weeks, 6 and 12 months after LTX
Change in grip strength
Time Frame: The groups will be assessed: Before Lung transplantation, 8 weeks, 6 and 12 months after LTX
Grip strength will be performed using a digital dynamometer. At least three measurements will be obtained and the highest reproducible value will be taken into analysis and related to reference values.
The groups will be assessed: Before Lung transplantation, 8 weeks, 6 and 12 months after LTX
Change in quality of life
Time Frame: The groups will be assessed: Before Lung transplantation, 8 weeks, 6 and 12 months after LTX
Heath related quality of life will be measured using the SF-36 questionnaire. The 36-Item Short Form Health Survey questionnaire (SF-36) is a very popular instrument for evaluating Health-Related Quality of Life. The SF-36 measures eight scales: physical functioning (PF), role physical (RP), bodily pain (BP), general health (GH), vitality (VT), social functioning (SF), role emotional (RE), and mental health (MH).
The groups will be assessed: Before Lung transplantation, 8 weeks, 6 and 12 months after LTX

Collaborators and Investigators

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

Sponsor

Ohio State University

Investigators

  • Principal Investigator: Cristiane Meirelles, PT, PhD, School of Health and Rehabilitation Sciences- Physical Therapy Division

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)

April 20, 2022

Primary Completion (Estimated)

May 1, 2026

Study Completion (Estimated)

May 1, 2026

Study Registration Dates

First Submitted

March 22, 2022

First Submitted That Met QC Criteria

April 1, 2022

First Posted (Actual)

April 4, 2022

Study Record Updates

Last Update Posted (Estimated)

December 18, 2025

Last Update Submitted That Met QC Criteria

December 16, 2025

Last Verified

December 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2021H0310

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

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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