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Active, Not Recruiting

NCT Number: NCT05309551

Inspiratory Muscle Training Immediately After Lung Transplantation

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Lung Transplantation Chronic Lung Disease Muscle Weakness Muscular Diseases Musculoskeletal Diseases Nervous System Diseases Neurologic Manifestations Neuromuscular Manifestations Pathologic Processes Pathological Conditions, Signs and Symptoms Rehabilitation Signs and Symptoms

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The Ohio State University Wexner Medical Center

Columbus, Ohio, 43210, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

IMT- Intervention group

Device

The resistive load will be readjusted weekly to reach 50% of maximal inspiratory pressure (MIP).

Other names: POWERBreathe Medic Plus®

IMT- Placebo group

Device

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®

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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

Secondary outcomes

  1. 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).

  2. 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.

  3. 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.

  4. 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.

  5. 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).

Sponsors and collaborators

Lead sponsor

Ohio State University

Other

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2026
Study completion
2026
First posted
Apr 4, 2022
Registry last updated
Dec 18, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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