NPPV Added Inspiratory Muscle Training in Severe COPD

August 18, 2013 updated by: LuQian Zhou, Guangzhou Institute of Respiratory Disease

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

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
80

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.
  • Name: LuQian Zhou, Doctor
  • Phone Number: +86-15622236759
  • Email: zhlx09@163.com

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

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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)
Change from Baseline in quality of life at 8 weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
respiratory muscle strength
Time Frame: Change from Baseline in respiratory muscle strength at 8 weeks
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)
Change from Baseline in dyspnea at 8 weeks
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
Change from Baseline in walked distance at 8 weeks
Frequency of acute exacerbations of COPD
Time Frame: 8 week
8 week
Pulmonary function tests
Time Frame: Change from Baseline in pulmonary function tests at 8 weeks
Change from Baseline in pulmonary function tests at 8 weeks
Blood gases levels
Time Frame: Change from Baseline in blood gases levelsat 8 weeks
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
Change from Baseline in sleep qualityat 8 weeks
Length of hospital admission
Time Frame: 8 week
8 week
frequency of of hospital admission
Time Frame: 8 week
8 week

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Guangzhou Institute of Respiratory Disease

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: LuQian Zhou, Doctor, Guangzhou Institute of Respiratory Disease

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 1, 2013

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2013

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2013

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 14, 2013

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 18, 2013

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 20, 2013

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 20, 2013

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 18, 2013

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • GZIRD-201308

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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