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The aim of this study is to determine whether noninvasive positive pressure ventilation with inspiratory muscle training can improve quality of life and respiratory muscle strength than noninvasive positive pressure ventilation or inspiratory muscle training alone.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| NPPV+IMT | Experimental | noninvasive positive pressure ventilation and inspiratory muscle training |
|
| NPPV | Active Comparator | noninvasive positive pressure ventilation |
|
| IMT | Active Comparator | inspiratory muscle training |
|
| LTOT | Placebo Comparator | Long time oxygen therapy |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| NPPV+IMT | Device | noninvasive positive pressure ventilation and inspiratory muscle training |
|
| Measure | Description | Time Frame |
|---|---|---|
| Quality of life | Severe Respiratory Insufficiency (SRI) Questionnaire and chronic obstructive pulmonary disease assessment test(CAT) | Change from Baseline in quality of life at 8 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| respiratory muscle strength | Change from Baseline in respiratory muscle strength at 8 weeks | |
| Dyspnea | baseline dyspnea index (BDI)and transition dyspnea index(TDI) | Change from Baseline in dyspnea at 8 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| LuQian Zhou, Doctor | Contact | +86-15622236759 | zhlx09@163.com |
| Name | Affiliation | Role |
|---|---|---|
| LuQian Zhou, Doctor | Guangzhou Institute of Respiratory Disease | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Guangzhou Institute of Respiratory Disease | Recruiting | Guangzhou | Guangdong | 510120 | China |
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| ID | Term |
|---|---|
| D029424 | Pulmonary Disease, Chronic Obstructive |
| D012131 | Respiratory Insufficiency |
| ID | Term |
|---|---|
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D002908 | Chronic Disease |
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| NPPV | Device | noninvasive positive pressure ventilation |
|
| IMT | Device | inspiratory muscle training |
|
| Walked distance in 6MWT | Change from baseline in distance walked test 6-minute walk test at 8 week | Change from Baseline in walked distance at 8 weeks |
| Frequency of acute exacerbations of COPD | 8 week |
| Pulmonary function tests | Change from Baseline in pulmonary function tests at 8 weeks |
| Blood gases levels | Change from Baseline in blood gases levelsat 8 weeks |
| Sleep quality | Epworth´s Sleepiness Scale | Change from Baseline in sleep qualityat 8 weeks |
| Length of hospital admission | 8 week |
| frequency of of hospital admission | 8 week |
| D020969 |
| Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D012120 | Respiration Disorders |