Effect of Inspiratory Muscle Training on Physiological Function and Clinical Outcomes After Lung Transplant

Study Overview
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Brief Summary
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The purpose of this research is to study the effect of training the inspiratory muscles (i.e. the muscle that allow you to breath-in) on exercise capacity, quality of life, and short-term clinical outcomes in patients post lung transplant.

Official Title
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Effect of Inspiratory Muscle Training on Physiological Function and Clinical Outcomes After Lung Transplant: A Randomized Controlled Trial

Conditions
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Post-Lung Transplantation Bronchiectasis

Intervention / Treatment
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* Device: POWERBreathe Plus®
* Other: Cardiopulmonary rehabilitation post lung transplant


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: - All patients who undergo single- or double-lung transplant at Mayo Clinic Florida. Exclusion Criteria: Patients who do not survive the intra-operative period during the transplant surgery. Patients undergoing retransplantation. Patients undergoing multiorgan transplantation. Patients who are not willing to or who are unable to give written informed consent.

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: 12-weeks pulmonary rehabilitation training plus inspiratory muscle training<br>To assess maximum inspiratory pressure, you will be asked to breathe through a device called POWERBreathe Plus®. This device is commercially available and will be provided to you by the study. You will be asked to use this device twice per day, 5 days per week, for 12 weeks. Each session will require you to breathe into the device 30 times. You can use the device at home. | Device: POWERBreathe Plus®<br>* Commercially available pressure-threshold device<br>Other: Cardiopulmonary rehabilitation post lung transplant<br>* Pulmonary function, lung diffusing capacity for carbon monoxide, inspiratory muscle strength, and diaphragm dimensions will be assessed in each patient. Each patient will also undergo a cardiopulmonary exercise test (CPET), 6 minute walk test, and an inspiratory muscle endurance test<br>|
| Placebo Comparator: 12-weeks pulmonary rehabilitation plus placebo (inactive) inspiratory muscle<br>To assess maximum inspiratory pressure with placebo, you will be asked to breathe through a device called POWERBreathe Plus®. This device is commercially available and will be provided to you by the study. You will be asked to use this device twice per day, 5 days per week, for 12 weeks. Each session will require you to breathe into the device 30 times. You can use the device at home. The resistance will be set to about 5% throughout the study. | Device: POWERBreathe Plus®<br>* Commercially available pressure-threshold device<br>Other: Cardiopulmonary rehabilitation post lung transplant<br>* Pulmonary function, lung diffusing capacity for carbon monoxide, inspiratory muscle strength, and diaphragm dimensions will be assessed in each patient. Each patient will also undergo a cardiopulmonary exercise test (CPET), 6 minute walk test, and an inspiratory muscle endurance test<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Maximal inspiratory mouth pressure (MIP) measured in cmH2O | The maximal strength generating capacity of the inspiratory muscles. | 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Maximal oxygen uptake (V̇O2max) measured in mL/kg/min | Vo2 max is the maximal measured oxygen uptake during a symptom limited exercise test. | 12 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Inspiratory muscle training, post lung transplant, exercise capacity, breathing