NPPV Added Inspiratory Muscle Training in Severe COPD

Study Overview
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Brief Summary
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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.

Official Title
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Noninvasive Positive Pressure Ventilation Added Inspiratory Muscle Training in Severe Chronic Obstructive Pulmonary Disease

Conditions
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Chronic Obstructive Pulmonary Disease, Hypercapnic Respiratory Failure

Intervention / Treatment
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* Device: NPPV+IMT
* Device: NPPV
* Device: IMT


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Aged 40-75 years, male or female. Have spirometric evidence of COPD with an FEV1 of < 50% predicted and FEV1/FVC < 0.70, measured within the last 6 months (GOLD stage III and IV). Stable disease since 4 weeks or more prior to randomisation. PCO2 of 7 kPa, combined with a pH of 7.35 or above. These gases must be measured after 30 minutes breathing room air in sitting position No treatment with NPPV and respiratory muscle training in the last 8 weeks Exclusion Criteria: Smokers can be excluded; Diseases of the lung or thorax besides COPD: OSA Advanced pulmonary fibrosis, advanced bronchiectases, active tuberculosis, post tuberculosis syndrome, pneumonia, severe kyphoscoliosis, tracheostoma, neuromuscular diseases, or any other disorder, which might result in elevated PCO2 Body mass index of 35 kg/m² or above. Severe cardiac disease, NYHA IV, instable angina, severe cardiac arrhythmia, especially of ventricular origin (atrial fibrillation is not an exclusion criterion). Local derangement of the face, skin, tongue, upper airways, larynx and upper oesophagus. Severe chronic diseases except COPD, hindering the patient to follow the schedule of this study

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: NPPV+IMT<br>noninvasive positive pressure ventilation and inspiratory muscle training | Device: NPPV<br>* noninvasive positive pressure ventilation<br>Device: IMT<br>* inspiratory muscle training<br>|
| Active Comparator: NPPV<br>noninvasive positive pressure ventilation | Device: NPPV+IMT<br>* noninvasive positive pressure ventilation and inspiratory muscle training<br>Device: IMT<br>* inspiratory muscle training<br>|
| Active Comparator: IMT<br>inspiratory muscle training | Device: NPPV+IMT<br>* noninvasive positive pressure ventilation and inspiratory muscle training<br>Device: NPPV<br>* noninvasive positive pressure ventilation<br>|
| Placebo Comparator: LTOT<br>Long time oxygen therapy | Device: NPPV+IMT<br>* noninvasive positive pressure ventilation and inspiratory muscle training<br>Device: NPPV<br>* noninvasive positive pressure ventilation<br>Device: IMT<br>* inspiratory muscle training<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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COPD, Noninvasive Positive Pressure Ventilation, Respiratory Muscle Training