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

Guangzhou Institute of Respiratory Disease1 site in 1 country80 target enrollmentJuly 2013

ConditionsChronic Obstructive Pulmonary Disease Hypercapnic Respiratory Failure

Overview

Phase: N/A
Intervention: Not specified
Conditions: Chronic Obstructive Pulmonary Disease
Sponsor: Guangzhou Institute of Respiratory Disease
Enrollment: 80
Locations: 1
Primary Endpoint: Quality of life
Last Updated: 12 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

July 2013

End Date

December 2013

Last Updated

12 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Guangzhou Institute of Respiratory Disease

Responsible Party

Principal Investigator

LuQian Zhou

Doctor

Guangzhou Institute of Respiratory Disease

Eligibility Criteria

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

Outcomes

Primary Outcomes

Quality of life

Time Frame: Change from Baseline in quality of life at 8 weeks

Severe Respiratory Insufficiency (SRI) Questionnaire and chronic obstructive pulmonary disease assessment test(CAT)

Secondary Outcomes

respiratory muscle strength(Change from Baseline in respiratory muscle strength at 8 weeks)
Dyspnea(Change from Baseline in dyspnea at 8 weeks)
Walked distance in 6MWT(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(Change from Baseline in sleep qualityat 8 weeks)
Length of hospital admission(8 week)
frequency of of hospital admission(8 week)