NCT04783155|RecruitingFDA Device
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Sponsor study identifier
interventional
30
1 country
1
Study Start
May 10, 2021
Actual (reported)Primary Completion
December 2026
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
December 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
December 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
February 22, 2021
Actual (reported)March 5, 2021
Actual (reported)May 10, 2021
Actual (reported)December 2026
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
December 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Maximal inspiratory mouth pressure (MIP) measured in cmH2O
The maximal strength generating capacity of the inspiratory muscles.
12 weeks
Maximal oxygen uptake (V̇O2max) measured in mL/kg/min
12 weeks
Six-minute walk test distance (6MWTd) measured in meters (m)
12 weeks
Peak work rate (Wpeak) (watts)
12 weeks
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.
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.
Commercially available pressure-threshold device
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
Mayo Clinic in Florida
Jacksonville, Florida, 32224, United States
Bryan Taylor, PhD
Mayo Clinic
First Submitted
February 22, 2021
First Posted
March 5, 2021
Study Start
May 10, 2021
Actual (reported)Primary Completion
December 2026
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
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Planned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
December 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Last Updated
January 6, 2026
Record last verified: 2026-01
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Source: ClinicalTrials.gov.
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