NPPV Added Inspiratory Muscle Training in Severe COPD

Sponsor

Guangzhou Institute of Respiratory Disease (Other)

Overall Status

Unknown status

CT.gov ID

NCT01926275

Collaborator

(none)

Enrollment

Location

Arms

Duration (Months)

15.9

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Chronic Obstructive Pulmonary Disease Hypercapnic Respiratory Failure	Device: NPPV+IMT Device: NPPV Device: IMT	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

80 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Jul 1, 2013

Anticipated Primary Completion Date :

Dec 1, 2013

Anticipated Study Completion Date :

Dec 1, 2013

Arms and Interventions

Arm	Intervention/Treatment
Experimental: NPPV+IMT noninvasive positive pressure ventilation and inspiratory muscle training	Device: NPPV noninvasive positive pressure ventilation Device: IMT inspiratory muscle training
Active Comparator: NPPV noninvasive positive pressure ventilation	Device: NPPV+IMT noninvasive positive pressure ventilation and inspiratory muscle training Device: IMT inspiratory muscle training
Active Comparator: IMT inspiratory muscle training	Device: NPPV+IMT noninvasive positive pressure ventilation and inspiratory muscle training Device: NPPV noninvasive positive pressure ventilation
Placebo Comparator: LTOT Long time oxygen therapy	Device: NPPV+IMT noninvasive positive pressure ventilation and inspiratory muscle training Device: NPPV noninvasive positive pressure ventilation Device: IMT inspiratory muscle training

Outcome Measures

Primary Outcome Measures

Quality of life [Change from Baseline in quality of life at 8 weeks]
Severe Respiratory Insufficiency (SRI) Questionnaire and chronic obstructive pulmonary disease assessment test(CAT)

Secondary Outcome Measures

respiratory muscle strength [Change from Baseline in respiratory muscle strength at 8 weeks]
Dyspnea [Change from Baseline in dyspnea at 8 weeks]
baseline dyspnea index (BDI)and transition dyspnea index(TDI)
Walked distance in 6MWT [Change from Baseline in walked distance at 8 weeks]
Change from baseline in distance walked test 6-minute walk test at 8 week
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 [Change from Baseline in sleep qualityat 8 weeks]
Epworth´s Sleepiness Scale
Length of hospital admission [8 week]
frequency of of hospital admission [8 week]

Eligibility Criteria

Criteria

Ages Eligible for Study:

40 Years to 75 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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