NPPV Added Inspiratory Muscle Training in Severe COPD

Not Applicable

• Conditions: Chronic Obstructive Pulmonary Disease; Hypercapnic Respiratory Failure
• Interventions: Device: NPPV; Device: NPPV+IMT; Device: IMT

• Registration Number: NCT01926275
• Lead Sponsor: Guangzhou Institute of Respiratory Disease

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-07
• Status Verified: 2013-08
• Study First Submitted: 2013-08-14
• Study First Submitted QC: 2013-08-18
• Last Update Submitted: 2013-08-18
• Study First Posted: 2013-08-20
• Last Update Posted: 2013-08-20
• Primary Completion: 2013-12
• Study Completion: 2013-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 80

Inclusion Criteria

1. Aged 40-75 years, male or female.
2. 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.
3. 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
4. No treatment with NPPV and respiratory muscle training in the last 8 weeks

Exclusion Criteria

1. Smokers can be excluded;
2. 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
3. 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).
4. Local derangement of the face, skin, tongue, upper airways, larynx and upper oesophagus.
5. Severe chronic diseases except COPD, hindering the patient to follow the schedule of this study

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
NPPV+IMT	NPPV	noninvasive positive pressure ventilation and inspiratory muscle training
NPPV+IMT	IMT	noninvasive positive pressure ventilation and inspiratory muscle training
NPPV	NPPV+IMT	noninvasive positive pressure ventilation
NPPV	IMT	noninvasive positive pressure ventilation
IMT	NPPV+IMT	inspiratory muscle training
IMT	NPPV	inspiratory muscle training
LTOT	NPPV+IMT	Long time oxygen therapy
LTOT	NPPV	Long time oxygen therapy
LTOT	IMT	Long time oxygen therapy

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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

Trial Locations

Locations (1)

Guangzhou Institute of Respiratory Disease; 🇨🇳 Canton, Guangdong, China