NPPV Added Inspiratory Muscle Training in Severe COPD

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

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.

Study Overview

• Status: Unknown
• Conditions: Chronic Obstructive Pulmonary Disease; Hypercapnic Respiratory Failure
• Intervention / Treatment: Device: NPPV; Device: IMT; Device: NPPV+IMT

• Study Type: Interventional
• Enrollment (Anticipated): 80
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Guangdong
    • Canton, Guangdong, China, 510120
      • Recruiting
      • Guangzhou Institute of Respiratory Disease
      • Contact: LuQian Zhou, Doctor; Phone Number: +86-15622236759; Email: zhlx09@163.com
      • Principal Investigator: LuQian Zhou, Doctor

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

4

Arms and Interventions

Participant Group / 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: IMT; inspiratory muscle training; Device: NPPV+IMT; noninvasive positive pressure ventilation and inspiratory muscle training
Active Comparator: IMT; inspiratory muscle training	Device: NPPV; noninvasive positive pressure ventilation; Device: NPPV+IMT; noninvasive positive pressure ventilation and inspiratory muscle training
Placebo Comparator: LTOT; Long time oxygen therapy	Device: NPPV; noninvasive positive pressure ventilation; Device: IMT; inspiratory muscle training; Device: NPPV+IMT; noninvasive positive pressure ventilation and inspiratory muscle training

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Guangzhou Institute of Respiratory Disease
• Investigators: Principal Investigator: LuQian Zhou, Doctor, Guangzhou Institute of Respiratory Disease

Study record dates

Study Major Dates

• Study Start: July 1, 2013
• Primary Completion (Anticipated): December 1, 2013
• Study Completion (Anticipated): December 1, 2013

Study Registration Dates

• First Submitted: August 14, 2013
• First Submitted That Met QC Criteria: August 18, 2013
• First Posted (Estimate): August 20, 2013

Study Record Updates

• Last Update Posted (Estimate): August 20, 2013
• Last Update Submitted That Met QC Criteria: August 18, 2013
• Last Verified: August 1, 2013

More Information

Terms related to this study

• Keywords: COPD; Noninvasive Positive Pressure Ventilation; Respiratory Muscle Training
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Respiration Disorders; Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive; Respiratory Insufficiency
• Other Study ID Numbers: GZIRD-201308