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Acute Effects of Incremental Inspiratory Loads on Respiratory Mechanics and NRD in Patient With Stable COPD.

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ClinicalTrials.gov Identifier: NCT03532243
Recruitment Status : Recruiting
First Posted : May 22, 2018
Last Update Posted : May 22, 2018
Sponsor:
Information provided by (Responsible Party):
Zhujiang Hospital

Brief Summary:
Inspiratory muscle training has been an important part of pulmonary rehabilitation program directed at patients with COPD. It can increase respiratory muscle strength, relieve dyspnea ,improve the quality of life in COPD patients. However, there is no uniform standard for the intensity of inspiratory muscle training. By comparing a series of indexes, such as maximal inspiratory pressure, maximal expiratory pressure, degree of dyspnea and exercise capacity before and after the training under different intensity, a large number of literatures have explored the appropriate intensity of inspiratory muscle training. But to date, there are few studies about the effects of different intensity of inspiratory muscle training on respiratory physiological mechanism. It has been shown that inspiratory muscle training may be more beneficial to improve the pulmonary rehabilitation effect of COPD patients with inspiratory muscle weakness. So it is not clear whether there is a difference in respiratory physiology between patients with normal inspiratory muscle strength and those with lower inspiratory muscle strength. Respiratory central drive, as an important physiological index, which can be reflected by minute ventilation volume, mouth pressure, mean inspiratory flow and diaphragm electromyography,is closely related to the symptoms and the severity of the disease.Therefore,the purpose of this study was to investigate the changes of respiratory mechanics and central drive in COPD patients at different inspiratory loads, and at the same loads between patients with and without respiratory muscle weakness.That can provide more evidential evidence for setting up the intensity of inspiratory muscle training.

Condition or disease Intervention/treatment Phase
Chronic Obstructive Pulmonary Disease Procedure: incremental inspiratory load Not Applicable

Detailed Description:
The patients with COPD will be admitted in one intervention groups(performing on threshold loading device).Before using threshold loading device, we will measure the relevant parameters of lung volume, respiratory flow,diaphragm electromyogram, central drive mechanical and other baseline index.Then incremental inspiratory load will be applied to investigate the effects of inspiratory load on the above mentioned respiratory mechanics parameters.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Acute Effects of Incremental Inspiratory Loads on Respiratory Mechanics and Neural Respiratory Drive(NRD) in Patient With Stable Chronic Obstructive Pulmonary Disease(COPD).
Actual Study Start Date : April 1, 2018
Estimated Primary Completion Date : October 1, 2018
Estimated Study Completion Date : February 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 threshold loading device with incremental inspiratory load.
Procedure: incremental inspiratory load
inspiratory load ranges between 10 and 40 cm water column (cmH2O)or intolerable to the patient, each load increment for 5cm water column.

Experimental: normal respiratory muscle
Patients with normal respiratory muscle are performing the threshold loading device with incremental inspiratory load.
Procedure: incremental inspiratory load
inspiratory load ranges between 10 and 40 cm water column (cmH2O)or intolerable to the patient, each load increment for 5cm water column.




Primary Outcome Measures :
  1. Diaphragmatic function [ Time Frame: Change from baseline in diaphragm electromyogram at the load of 10cm water column (cmH2O).(1 minutes later,3 minutes later,5 minutes later,7 minutes later,9 minutes later,11 minutes later, 13 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 10cm water column (cmH2O).(1 minutes later,3 minutes later,5 minutes later,7 minutes later,9 minutes later,11 minutes later, 13 minutes later) ]
    Respiratory pressure can be assessed by transdiaphragmatic pressure ( Pdi).

  2. Respiratory volume [ Time Frame: Change from baseline in respiratory volume at the load of 10cm water column (cmH2O).(1 minutes later,3 minutes later,5 minutes later,7 minutes later,9 minutes later,11 minutes later, 13 minutes later) ]
    Respiratory volume can be assessed by Tidal volume (VT).

  3. Degree of dyspnea [ Time Frame: Change from baseline in degree of dyspnea at the load of 10cm water column (cmH2O).(1 minutes later,3 minutes later,5 minutes later,7 minutes later,9 minutes later,11 minutes later, 13 minutes later) ]
    Difference in the degree of dyspnea can be measured by Borg index.


Other Outcome Measures:
  1. Pulse oxygen saturation (SpO2) [ Time Frame: Change from baseline in pulse oxygen saturation at the load of 10cm water column (cmH2O).(1 minutes later,3 minutes later,5 minutes later,7 minutes later,9 minutes later,11 minutes later, 13 minutes later) ]
    Change in SpO2 can be recorded by noninvasive monitoring instruments.



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Ages Eligible for Study:   40 Years to 75 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): NCT03532243


Contacts
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Contact: Wang Liqing, 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: NCT03532243     History of Changes
Other Study ID Numbers: 2018-HXNK-007
First Posted: May 22, 2018    Key Record Dates
Last Update Posted: May 22, 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
Product Manufactured in and Exported from the U.S.: Yes

Keywords provided by Zhujiang Hospital:
Chronic Obstructive Pulmonary Disease
inspiratory muscle training
Central Drive

Additional relevant MeSH terms:
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Lung Diseases
Lung Diseases, Obstructive
Pulmonary Disease, Chronic Obstructive
Respiratory Aspiration
Respiratory Tract Diseases
Respiration Disorders
Pathologic Processes