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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-05-10

Study Completion Date

2027-12-31

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.

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Detailed Description

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Conditions

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Post-Lung Transplantation Bronchiectasis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

DOUBLE

Participants Investigators

This is a double-blinded, randomized study

Study Groups

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12-weeks pulmonary rehabilitation training plus inspiratory muscle training

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.

Group Type EXPERIMENTAL

POWERBreathe Plus®

Intervention Type DEVICE

Commercially available pressure-threshold device

Cardiopulmonary rehabilitation post lung transplant

Intervention Type OTHER

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

12-weeks pulmonary rehabilitation plus placebo (inactive) inspiratory muscle

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.

Group Type PLACEBO_COMPARATOR

POWERBreathe Plus®

Intervention Type DEVICE

Commercially available pressure-threshold device

Cardiopulmonary rehabilitation post lung transplant

Intervention Type OTHER

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

Interventions

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POWERBreathe Plus®

Commercially available pressure-threshold device

Intervention Type DEVICE

Cardiopulmonary rehabilitation post lung transplant

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

Intervention Type OTHER

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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No