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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 12-weeks pulmonary rehabilitation training plus inspiratory muscle training | Experimental | 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 | Placebo Comparator | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| POWERBreathe Plus® | Device | Commercially available pressure-threshold device |
|
| Measure | Description | Time Frame |
|---|---|---|
| Maximal inspiratory mouth pressure (MIP) measured in cmH2O | The maximal strength generating capacity of the inspiratory muscles. | 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Maximal oxygen uptake (V̇O2max) measured in mL/kg/min | Vo2 max is the maximal measured oxygen uptake during a symptom limited exercise test. | 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Six-minute walk test distance (6MWTd) measured in meters (m) | Distance walked during a 6 minute test | 12 weeks |
| Peak work rate (Wpeak) (watts) | The maximal work achieved in watts during a symptom limited exercise test. |
Inclusion Criteria:
- All patients who undergo single- or double-lung transplant at Mayo Clinic Florida.
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Bryan Taylor | Contact | taylor.bryan@mayo.edu |
| Name | Affiliation | Role |
|---|---|---|
| Bryan Taylor, PhD | Mayo Clinic | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mayo Clinic in Florida | Recruiting | Jacksonville | Florida | 32224 | United States |
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| Label | URL |
|---|---|
| Mayo Clinic Clinical Trials | View source |
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| ID | Term |
|---|---|
| D053120 | Respiratory Aspiration |
| ID | Term |
|---|---|
| D012120 | Respiration Disorders |
| D012140 | Respiratory Tract Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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This is a double-blinded, randomized study
| Cardiopulmonary rehabilitation post lung transplant | Other | 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 |
|
| 12 weeks |