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出境医 / 临床实验 / Effect of Combined IMT and CPAP in Pulmonary Rehabilitation for COPD

Effect of Combined IMT and CPAP in Pulmonary Rehabilitation for COPD

Study Description
Brief Summary:
Inspiratory muscle training(IMT) was one of the widely used pulmonary rehabilitation method in COPD patients.However, when the respiratory muscles are fatigue without sufficient rest, IMT may increase muscle fatigue and aggravate muscle damage. Noninvasive positive pressure ventilation (NPPV) is another important strategy of pulmonary rehabilitation which could overcome airway resistance and reduce respiratory work, improve respiratory muscle fatigue. Therefore, the purpose of this study was to explore the effective of the "IMT - NPPV sequential" rehabilitation method, that is, first inspiratory muscle training, followed by respiratory muscle resting (non-invasive positive pressure ventilation).

Condition or disease Intervention/treatment Phase
Pulmonary Rehabilitation Device: inspiratory pressure threshold device Not Applicable

Detailed Description:
Exploring the effects of the new rehabilitation method of "IMT - NPPV sequential", comparing with the single rehabilitation strategy such as inspiratory muscle training and non-invasive positive pressure ventilation.
Study Design
Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single (Participant)
Primary Purpose: Prevention
Official Title: Effect of Combined Inspiratory Muscle Training and Continuous Positive Airway Pressure in Pulmonary Rehabilitation for Chronic Obstructive Pulmonary Disease.
Estimated Study Start Date : May 1, 2019
Estimated Primary Completion Date : May 1, 2019
Estimated Study Completion Date : May 1, 2019
Arms and Interventions
Arm Intervention/treatment
Experimental: respiratory muscle weakness
Patients with respiratory muscle weakness are performing the inspiratory pressure threshold device, combined CPAP and inspiratory pressure threshold device and continue oxygen therapy randomly.
 Device: inspiratory pressure threshold device
The threshold loading device is composed of a mouth -piece attached to a small plastic cylinder that contains a spring-loaded poppet value. The valve opens to permit inspiratory flow only once the person has generated adequate negative intrathoracic pressure to condense the spring.
Other Name: CPAP
Experimental: normal respiratory muscle
Patients with normal respiratory muscle are performing the inspiratory pressure threshold device, combined CPAP and inspiratory pressure threshold device and continue oxygen therapy randomly.
 Device: inspiratory pressure threshold device
The threshold loading device is composed of a mouth -piece attached to a small plastic cylinder that contains a spring-loaded poppet value. The valve opens to permit inspiratory flow only once the person has generated adequate negative intrathoracic pressure to condense the spring.
Other Name: CPAP
Outcome Measures
Primary Outcome Measures :
  1. Respiratory muscle strength(composite outcome measure) [ Time Frame: Change from baseline to 8 weeks ]
    Currently, the maximal inspiratory pressure (PImax) and maximal expiratory pressures(PEmax) are measured by a digital manometer (AZ-8205, AZ Instrument, Taichung City, Taiwan)and combined to evaluate respiratory muscle function.


Secondary Outcome Measures :
  1. Diaphragmatic function [ Time Frame: Change from baseline to 8 weeks ]
    Diaphragmatic function can be assessed by diaphragm electromyogram (EMGdi) measured by a high-performance data acquisition device (Powerlab 16/35; ADInstruments, Australia), which reflect the physiological activity of the diaphragm and indicate functional status of the central drive.

  2. Symptom Evaluation(composite outcome measure) [ Time Frame: Change from baseline to 8 weeks ]
    Individuals with chronic respiratory disease often have symptoms such as dyspnea, fatigue, cough, weakness, sleeplessness, and psychological distress. Instruments for assessment of multiple symptoms include COPD Assessment Test (CAT) and Modified Medical British Research Council Scale(mMRC).

  3. Pulmonary function(composite outcome measure) [ Time Frame: Change from baseline to 8 weeks ]
    Pulmonary function is measured using a spirometer(PonyFX 229, Cosmed, Rome, Italy) that is calibrated daily.The FEV1 and percent-of-predicted FEV1, FVC and percent-of-predicted FVC which are presented in one report are used to evaluate Pulmonary Function.

  4. Exercise capacity [ Time Frame: Change from baseline to 8 weeks ]
    Exercise capacity is evaluated using the 6-min walking distance (6MWD) according to American Thoracic Society guidelines.


Eligibility Criteria
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Ages Eligible for Study:   40 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Gender Based Eligibility:   Yes
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Patients with pulmonary function test of forced expiratory volume at one second (FEV1)/forced vital capacity(FVC) < 70% after inhalation of bronchial dilation agent. Patients in a clinically stable state.

Exclusion Criteria:

  • Patients were excluded if they had other respiratory diseases ,or evidence of pneumothorax or mediastinal emphysema and pacemaker installed.

Patients with acute cardiovascular event and severe cor pulmonale. Patients with poor compliance. An Other causes of diaphragmatic dysfunction

Contacts and Locations

Locations
Layout table for location information
China, Guangdong
Zhujiang Hospital,Southern Medical Universicity
Guangzhou, Guangdong, China, 510282
Sponsors and Collaborators
Zhujiang Hospital
Investigators
Layout table for investigator information
Principal Investigator: Chen Xin, Doctor Zhujiang Hospital,Southern Medical Unversity
Tracking Information
First Submitted Date  ICMJE April 4, 2019
First Posted Date  ICMJE April 18, 2019
Last Update Posted Date April 18, 2019
Estimated Study Start Date  ICMJE May 1, 2019
Estimated Primary Completion Date May 1, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 15, 2019) 		Respiratory muscle strength(composite outcome measure) [ Time Frame: Change from baseline to 8 weeks ]
Currently, the maximal inspiratory pressure (PImax) and maximal expiratory pressures(PEmax) are measured by a digital manometer (AZ-8205, AZ Instrument, Taichung City, Taiwan)and combined to evaluate respiratory muscle function.
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: April 15, 2019)
  • Diaphragmatic function [ Time Frame: Change from baseline to 8 weeks ]
    Diaphragmatic function can be assessed by diaphragm electromyogram (EMGdi) measured by a high-performance data acquisition device (Powerlab 16/35; ADInstruments, Australia), which reflect the physiological activity of the diaphragm and indicate functional status of the central drive.
  • Symptom Evaluation(composite outcome measure) [ Time Frame: Change from baseline to 8 weeks ]
    Individuals with chronic respiratory disease often have symptoms such as dyspnea, fatigue, cough, weakness, sleeplessness, and psychological distress. Instruments for assessment of multiple symptoms include COPD Assessment Test (CAT) and Modified Medical British Research Council Scale(mMRC).
  • Pulmonary function(composite outcome measure) [ Time Frame: Change from baseline to 8 weeks ]
    Pulmonary function is measured using a spirometer(PonyFX 229, Cosmed, Rome, Italy) that is calibrated daily.The FEV1 and percent-of-predicted FEV1, FVC and percent-of-predicted FVC which are presented in one report are used to evaluate Pulmonary Function.
  • Exercise capacity [ Time Frame: Change from baseline to 8 weeks ]
    Exercise capacity is evaluated using the 6-min walking distance (6MWD) according to American Thoracic Society guidelines.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Effect of Combined IMT and CPAP in Pulmonary Rehabilitation for COPD
Official Title  ICMJE Effect of Combined Inspiratory Muscle Training and Continuous Positive Airway Pressure in Pulmonary Rehabilitation for Chronic Obstructive Pulmonary Disease.
Brief Summary Inspiratory muscle training(IMT) was one of the widely used pulmonary rehabilitation method in COPD patients.However, when the respiratory muscles are fatigue without sufficient rest, IMT may increase muscle fatigue and aggravate muscle damage. Noninvasive positive pressure ventilation (NPPV) is another important strategy of pulmonary rehabilitation which could overcome airway resistance and reduce respiratory work, improve respiratory muscle fatigue. Therefore, the purpose of this study was to explore the effective of the "IMT - NPPV sequential" rehabilitation method, that is, first inspiratory muscle training, followed by respiratory muscle resting (non-invasive positive pressure ventilation).
Detailed Description Exploring the effects of the new rehabilitation method of "IMT - NPPV sequential", comparing with the single rehabilitation strategy such as inspiratory muscle training and non-invasive positive pressure ventilation.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single (Participant)
Primary Purpose: Prevention
Condition  ICMJE Pulmonary Rehabilitation
Intervention  ICMJE Device: inspiratory pressure threshold device
The threshold loading device is composed of a mouth -piece attached to a small plastic cylinder that contains a spring-loaded poppet value. The valve opens to permit inspiratory flow only once the person has generated adequate negative intrathoracic pressure to condense the spring.
Other Name: CPAP
Study Arms  ICMJE
  • Experimental: respiratory muscle weakness
    Patients with respiratory muscle weakness are performing the inspiratory pressure threshold device, combined CPAP and inspiratory pressure threshold device and continue oxygen therapy randomly.
    Intervention: Device: inspiratory pressure threshold device
  • Experimental: normal respiratory muscle
    Patients with normal respiratory muscle are performing the inspiratory pressure threshold device, combined CPAP and inspiratory pressure threshold device and continue oxygen therapy randomly.
    Intervention: Device: inspiratory pressure threshold device
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: April 15, 2019) 		30
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE May 1, 2019
Estimated Primary Completion Date May 1, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Patients with pulmonary function test of forced expiratory volume at one second (FEV1)/forced vital capacity(FVC) < 70% after inhalation of bronchial dilation agent. Patients in a clinically stable state.

Exclusion Criteria:

  • Patients were excluded if they had other respiratory diseases ,or evidence of pneumothorax or mediastinal emphysema and pacemaker installed.

Patients with acute cardiovascular event and severe cor pulmonale. Patients with poor compliance. An Other causes of diaphragmatic dysfunction
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Gender Based Eligibility: Yes
Ages  ICMJE 40 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03919513
Other Study ID Numbers  ICMJE 2018-HXNK-011
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Zhujiang Hospital
Study Sponsor  ICMJE Zhujiang Hospital
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Chen Xin, Doctor Zhujiang Hospital,Southern Medical Unversity
PRS Account Zhujiang Hospital
Verification Date January 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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