Effect of Inspiratory Muscle Training on Physiological Function and Clinical Outcomes After Lung Transplant
Part of paid clinical trials in Jacksonville, Florida.
- Sponsor
- Mayo Clinic
- Study ID
- NCT04783155
- Status
- Recruiting
Conditions
- Post-Lung Transplantation Bronchiectasis
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
- POWERBreathe Plus® — DEVICECommercially available pressure-threshold device
- Cardiopulmonary rehabilitation post lung transplant — OTHERPulmonary 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
Study Details
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.
Key Dates
- Start date
- May 10, 2021
- Status verified
- Jan 2026
- Primary completion
- Dec 31, 2026
- Completion
- Dec 31, 2027
Study Design
- Enrollment
- 30 participants (estimated)
- Allocation
- RANDOMIZED
- Intervention model
- PARALLEL
- Primary purpose
- SUPPORTIVE_CARE
Arms
- Experimental: 12-weeks pulmonary rehabilitation training plus inspiratory muscle trainingTo 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.
- Placebo Comparator: 12-weeks pulmonary rehabilitation plus placebo (inactive) inspiratory muscleTo 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 Measure
Maximal inspiratory mouth pressure (MIP) measured in cmH2O [ Time Frame: 12 weeks ]
Central Contacts
- Bryan Taylor
Locations (1)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| Mayo Clinic in Florida | Jacksonville | Florida | 32224 |
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