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
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 30
Inclusion Criteria
- All patients who undergo single- or double-lung transplant at Mayo Clinic Florida.
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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.
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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