NPPV Added Inspiratory Muscle Training in Severe COPD

NCT ID: NCT01926275

Last Updated: 2013-08-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-07-31

Study Completion Date

2013-12-31

Brief Summary

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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

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Conditions

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Chronic Obstructive Pulmonary Disease Hypercapnic Respiratory Failure

Keywords

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COPD Noninvasive Positive Pressure Ventilation Respiratory Muscle Training

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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NPPV+IMT

noninvasive positive pressure ventilation and inspiratory muscle training

Group Type EXPERIMENTAL

NPPV

Intervention Type DEVICE

noninvasive positive pressure ventilation

IMT

Intervention Type DEVICE

inspiratory muscle training

NPPV

noninvasive positive pressure ventilation

Group Type ACTIVE_COMPARATOR

NPPV+IMT

Intervention Type DEVICE

noninvasive positive pressure ventilation and inspiratory muscle training

IMT

Intervention Type DEVICE

inspiratory muscle training

IMT

inspiratory muscle training

Group Type ACTIVE_COMPARATOR

NPPV+IMT

Intervention Type DEVICE

noninvasive positive pressure ventilation and inspiratory muscle training

NPPV

Intervention Type DEVICE

noninvasive positive pressure ventilation

LTOT

Long time oxygen therapy

Group Type PLACEBO_COMPARATOR

NPPV+IMT

Intervention Type DEVICE

noninvasive positive pressure ventilation and inspiratory muscle training

NPPV

Intervention Type DEVICE

noninvasive positive pressure ventilation

IMT

Intervention Type DEVICE

inspiratory muscle training

Interventions

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NPPV+IMT

noninvasive positive pressure ventilation and inspiratory muscle training

Intervention Type DEVICE

NPPV

noninvasive positive pressure ventilation

Intervention Type DEVICE

IMT

inspiratory muscle training

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

40 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Guangzhou Institute of Respiratory Disease

OTHER

Sponsor Role lead

Responsible Party

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LuQian Zhou

Doctor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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LuQian Zhou, Doctor

Role: PRINCIPAL_INVESTIGATOR

Guangzhou Institute of Respiratory Disease

Locations

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Guangzhou Institute of Respiratory Disease

Guangzhou, Guangdong, China

Site Status RECRUITING

Countries

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China

Central Contacts

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LuQian Zhou, Doctor

Role: CONTACT

Phone: +86-15622236759

Email: [email protected]

Facility Contacts

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LuQian Zhou, Doctor

Role: primary

Other Identifiers

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GZIRD-201308

Identifier Type: -

Identifier Source: org_study_id