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Effects of Different Modes of Respiratory MuscleTraining on Respiratory Mechanics and NRD in Patient With Stable COPD.

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ClinicalTrials.gov Identifier: NCT03500042
Recruitment Status : Recruiting
First Posted : April 17, 2018
Last Update Posted : April 17, 2018
Sponsor:
Information provided by (Responsible Party):
Zhujiang Hospital

Brief Summary:
Chronic Obstructive Pulmonary Disease (COPD) is a chronic respiratory disease characterized by persistent airflow limitation. The patients are suffering dyspnea year by year, resulting in the decreased exercise tolerance and quality of life. Patients with COPD often have both inspiratory muscles and expiratory muscle dysfunction. Respiratory muscle training was one of the widely used pulmonary rehabilitation method in COPD patients. Respiratory muscle training include inspiratory training ,expiratory training and concurrent inspiratory and expiratory muscle training . Both of the training methods are effective. However, the effects of these different types of respiratory muscle training method on the respiratory physiology and neural respiratory drive of COPD are still unclear. Therefore, the purpose of this study was to investigate the different effects of these respiratory muscle training methods on respiratory mechanics and central drive in COPD patients. Besides,the effect of the different respiratory muscle training methods was compared between patients with and without respiratory muscle weakness.

Condition or disease Intervention/treatment Phase
Chronic Obstructive Pulmonary Disease (COPD) Device: inspiratory pressure threshold device Not Applicable

Detailed Description:

The patients with COPD will participate in a rehabilitation program including inspiratory muscle training, expiratory muscle training and concurrent inspiratory and expiratory muscle training.

The outcome measures are the classic respiratory mechanics indicators and respiratory center drive.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Effects of Different Modes of Respiratory Muscular Threshold Loads Training on Respiratory Mechanics and Neural Respiratory Drive(NRD) in Patient With Stable Chronic Obstructive Pulmonary Disease(COPD).
Actual Study Start Date : March 1, 2018
Estimated Primary Completion Date : December 1, 2018
Estimated Study Completion Date : March 1, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: COPD Lung Diseases

Arm Intervention/treatment
Experimental: respiratory muscle weakness
Patients with respiratory muscle weakness are performing the inspiratory pressure threshold device, expiratory pressure threshold device and concurrent inspiratory and expiratory muscle device for one minute 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 Names:
  • expiratory pressure threshold device
  • concurrent inspiratory and expiratory muscle device

Experimental: normal respiratory muscle
Patients with respiratory muscle weakness are performing the inspiratory pressure threshold device, expiratory pressure threshold device and concurrent inspiratory and expiratory muscle device for one minute 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 Names:
  • expiratory pressure threshold device
  • concurrent inspiratory and expiratory muscle device




Primary Outcome Measures :
  1. Diaphragmatic function [ Time Frame: Change from baseline in diaphragm electromyogram at the load of threshold (10 minutes later,20minutes later,30 minutes later, 40 minutes later) ]
    Diaphragmatic function can be assessed by diaphragm electromyogram(EMGdi) which reflect the physiological activity of the diaphragm and indicate functional status of the central drive.


Secondary Outcome Measures :
  1. Respiratory pressure [ Time Frame: Change from baseline in respiratory pressure at the load of threshold (10 minutes later,20minutes later,30 minutes later, 40 minutes later) ]
    Respiratory pressure parameter is transdiaphragmatic pressure ( Pdi) in cmH2O, which reflect the strength of diaphragm.

  2. Respiratory volume [ Time Frame: Change from baseline in respiratory volume at the load of threshold (10 minutes later,20minutes later,30 minutes later, 40 minutes later) ]
    Respiratory volume parameter is minute ventilation (VE) in liter(L).

  3. respiratory work [ Time Frame: Change from baseline in transdiaphragmatic pressure time product at the load of threshold (10 minutes later,20minutes later,30 minutes later, 40 minutes later) ]
    respiratory work is associated with transdiaphragmatic pressure time product



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Ages Eligible for Study:   40 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03500042


Contacts
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Contact: Wang Li Qing, Doctor +86-02062782339 wliqing07@gmail.com
Contact: Xin Chen, Doctor chen_xin1020@163.com

Locations
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China, Guangdong
Zhujiang Hospital,Southern Medical Universtiy Recruiting
Guangzhou, Guangdong, China, 510282
Contact: xin Chen, Doctor       chen_xin1020@163.com   
Sponsors and Collaborators
Zhujiang Hospital
Investigators
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Principal Investigator: Xin Chen, Doctor Zhujiang Hospital,Southern Medical Unversity

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Responsible Party: Zhujiang Hospital
ClinicalTrials.gov Identifier: NCT03500042     History of Changes
Other Study ID Numbers: 2018-HXNK-008
First Posted: April 17, 2018    Key Record Dates
Last Update Posted: April 17, 2018
Last Verified: March 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Zhujiang Hospital:
Chronic Obstructive Pulmonary Disease
inspiratory muscle training
expiratory muscle training
Neural Respiratory Drive

Additional relevant MeSH terms:
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Lung Diseases
Lung Diseases, Obstructive
Pulmonary Disease, Chronic Obstructive
Respiratory Tract Diseases