NPPV Added Inspiratory Muscle Training in Severe COPD

Overview

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.

Full Title of Study: “Noninvasive Positive Pressure Ventilation Added Inspiratory Muscle Training in Severe Chronic Obstructive Pulmonary Disease”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Single (Outcomes Assessor)
  • Study Primary Completion Date: December 2013

Interventions

  • Device: NPPV+IMT
    • noninvasive positive pressure ventilation and inspiratory muscle training
  • Device: NPPV
    • noninvasive positive pressure ventilation
  • Device: IMT
    • inspiratory muscle training

Arms, Groups and Cohorts

  • Experimental: NPPV+IMT
    • noninvasive positive pressure ventilation and inspiratory muscle training
  • Active Comparator: NPPV
    • noninvasive positive pressure ventilation
  • Active Comparator: IMT
    • inspiratory muscle training
  • Placebo Comparator: LTOT
    • Long time oxygen therapy

Clinical Trial Outcome Measures

Primary Measures

  • 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 Measures

  • respiratory muscle strength
    • Time Frame: Change from Baseline in respiratory muscle strength at 8 weeks
  • Dyspnea
    • Time Frame: Change from Baseline in dyspnea at 8 weeks
    • baseline dyspnea index (BDI)and transition dyspnea index(TDI)
  • Walked distance in 6MWT
    • Time Frame: 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
    • Time Frame: 8 week
  • Pulmonary function tests
    • Time Frame: Change from Baseline in pulmonary function tests at 8 weeks
  • Blood gases levels
    • Time Frame: Change from Baseline in blood gases levelsat 8 weeks
  • Sleep quality
    • Time Frame: Change from Baseline in sleep qualityat 8 weeks
    • Epworth´s Sleepiness Scale
  • Length of hospital admission
    • Time Frame: 8 week
  • frequency of of hospital admission
    • Time Frame: 8 week

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 40 Years

Maximum Age: 75 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Guangzhou Institute of Respiratory Disease
  • Provider of Information About this Clinical Study
    • Principal Investigator: LuQian Zhou, Doctor – Guangzhou Institute of Respiratory Disease
  • Overall Official(s)
    • LuQian Zhou, Doctor, Principal Investigator, Guangzhou Institute of Respiratory Disease
  • Overall Contact(s)
    • LuQian Zhou, Doctor, +86-15622236759, zhlx09@163.com

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