Effect of Inspiratory Muscle Training on Physiological Function and Clinical Outcomes After Lung Transplant: A Randomized Controlled Trial
Overview
- Phase
- N/A
- Intervention
- POWERBreathe Plus®
- Conditions
- Post-Lung Transplantation Bronchiectasis
- Sponsor
- Mayo Clinic
- Enrollment
- 30
- Locations
- 1
- Primary Endpoint
- Maximal inspiratory mouth pressure (MIP) measured in cmH2O
- Status
- Recruiting
- Last Updated
- 3 months ago
Overview
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.
Investigators
Bryan Taylor
Principal Investigator
Mayo Clinic
Eligibility Criteria
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.
Arms & Interventions
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.
Intervention: POWERBreathe Plus®
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.
Intervention: Cardiopulmonary rehabilitation post lung transplant
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.
Intervention: POWERBreathe Plus®
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.
Intervention: Cardiopulmonary rehabilitation post lung transplant
Outcomes
Primary Outcomes
Maximal inspiratory mouth pressure (MIP) measured in cmH2O
Time Frame: 12 weeks
The maximal strength generating capacity of the inspiratory muscles.
Secondary Outcomes
- Maximal oxygen uptake (V̇O2max) measured in mL/kg/min(12 weeks)