Inspiratory Muscle Training Immediately After Lung Transplantation

Study Overview
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Brief Summary
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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.

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

Conditions
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Lung Transplantation, Chronic Lung Disease, Muscle Weakness, Rehabilitation

Intervention / Treatment
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* Device: IMT- Intervention group
* Device: IMT- Placebo group


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Inspiratory Muscle training- Intervention group<br>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<br>* The resistive load will be readjusted weekly to reach 50% of maximal inspiratory pressure (MIP).<br>* Other names: POWERBreathe Medic Plus®;|
| Sham Comparator: Inspiratory Muscle training - Placebo group<br>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<br>* The inspiratory resistive load will be adjusted to the minimum value of the device (9 cm H2O) during all inspiratory muscle training sessions.<br>* Other names: POWERBreathe Medic Plus®;|
| No Intervention: Usual care group<br>Patients will only participate in standard post-transplant physical therapy. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in inspiratory muscle strength: Maximal inspiratory pressure (MIP) measured in cmH2O | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 |