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

Not Applicable

Recruiting

• Conditions: Post-Lung Transplantation Bronchiectasis
• Interventions: Device: POWERBreathe Plus®; Other: Cardiopulmonary rehabilitation post lung transplant

• Registration Number: NCT04783155
• Lead Sponsor: Mayo Clinic

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-02-22
• Study First Submitted QC: 2021-03-02
• Study First Posted: 2021-03-05
• Study Start: 2021-05-10
• Status Verified: 2024-12
• Last Update Submitted: 2024-12-10
• Last Update Posted: 2024-12-13
• Primary Completion: 2025-12
• Study Completion: 2025-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 30

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
12-weeks pulmonary rehabilitation plus placebo (inactive) inspiratory muscle	POWERBreathe Plus®	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.
12-weeks pulmonary rehabilitation training plus inspiratory muscle training	POWERBreathe Plus®	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.
12-weeks pulmonary rehabilitation training plus inspiratory muscle training	Cardiopulmonary rehabilitation post lung transplant	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.
12-weeks pulmonary rehabilitation plus placebo (inactive) inspiratory muscle	Cardiopulmonary rehabilitation post lung transplant	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.

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

Mayo Clinic in Florida; 🇺🇸 Jacksonville, Florida, United States