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

Sponsor

Mayo Clinic (Other)

Overall Status

Recruiting

CT.gov ID

NCT04783155

Collaborator

(none)

Enrollment

Location

Arms

16.7

Anticipated Duration (Months)

1.8

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Post-Lung Transplantation Bronchiectasis	Device: POWERBreathe Plus® Other: Cardiopulmonary rehabilitation post lung transplant	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

30 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Investigator)

Masking Description:

This is a double-blinded, randomized study

Primary Purpose:

Supportive Care

Official Title:

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

Actual Study Start Date :

May 10, 2021

Anticipated Primary Completion Date :

Oct 1, 2022

Anticipated Study Completion Date :

Oct 1, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 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.	Device: POWERBreathe Plus® Commercially available pressure-threshold device Other: 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
Placebo Comparator: 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.	Device: POWERBreathe Plus® Commercially available pressure-threshold device Other: 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

Arm

Intervention/Treatment

Experimental: 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.

Device: POWERBreathe Plus®

Commercially available pressure-threshold device

Other: 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

Placebo Comparator: 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.

Device: POWERBreathe Plus®

Commercially available pressure-threshold device

Other: Cardiopulmonary rehabilitation post lung transplant

Outcome Measures

Primary Outcome Measures

Maximal inspiratory mouth pressure (MIP) measured in cmH2O [12 weeks]
The maximal strength generating capacity of the inspiratory muscles.

Secondary Outcome Measures

Maximal oxygen uptake (V̇O2max) measured in mL/kg/min [12 weeks]
Vo2 max is the maximal measured oxygen uptake during a symptom limited exercise test.

Other Outcome Measures

Six-minute walk test distance (6MWTd) measured in meters (m) [12 weeks]
Distance walked during a 6 minute test
Peak work rate (Wpeak) (watts) [12 weeks]
The maximal work achieved in watts during a symptom limited exercise test.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.