NPPV Added Inspiratory Muscle Training in Severe COPD

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

Sponsors

Lead Sponsor: Guangzhou Institute of Respiratory Disease

Source 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.

Overall Status Unknown status
Start Date July 2013
Completion Date December 2013
Primary Completion Date December 2013
Phase N/A
Study Type Interventional
Primary Outcome
Measure Time Frame
Quality of life Change from Baseline in quality of life at 8 weeks
Secondary Outcome
Measure Time Frame
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
Enrollment 80
Condition
Intervention

Intervention Type: Device

Intervention Name: NPPV+IMT

Description: noninvasive positive pressure ventilation and inspiratory muscle training

Intervention Type: Device

Intervention Name: NPPV

Description: noninvasive positive pressure ventilation

Intervention Type: Device

Intervention Name: IMT

Description: inspiratory muscle training

Eligibility

Criteria:

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: All

Minimum Age: 40 Years

Maximum Age: 75 Years

Healthy Volunteers: No

Overall Official
Last Name Role Affiliation
LuQian Zhou, Doctor Principal Investigator Guangzhou Institute of Respiratory Disease
Overall Contact

Last Name: LuQian Zhou, Doctor

Phone: +86-15622236759

Email: [email protected]

Location
Facility: Status: Contact: Investigator: Guangzhou Institute of Respiratory Disease LuQian Zhou, Doctor +86-15622236759 [email protected] LuQian Zhou, Doctor Principal Investigator
Location Countries

China

Verification Date

August 2013

Responsible Party

Type: Principal Investigator

Investigator Affiliation: Guangzhou Institute of Respiratory Disease

Investigator Full Name: LuQian Zhou

Investigator Title: Doctor

Keywords
Has Expanded Access No
Condition Browse
Number Of Arms 4
Arm Group

Label: NPPV+IMT

Type: Experimental

Description: noninvasive positive pressure ventilation and inspiratory muscle training

Label: NPPV

Type: Active Comparator

Description: noninvasive positive pressure ventilation

Label: IMT

Type: Active Comparator

Description: inspiratory muscle training

Label: LTOT

Type: Placebo Comparator

Description: Long time oxygen therapy

Study Design Info

Allocation: Randomized

Intervention Model: Parallel Assignment

Primary Purpose: Treatment

Masking: Single (Outcomes Assessor)

Source: ClinicalTrials.gov