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

Primary Purpose

Chronic Obstructive Pulmonary Disease

Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
incremental inspiratory load
Sponsored by
Zhujiang Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Obstructive Pulmonary Disease focused on measuring Chronic Obstructive Pulmonary Disease, inspiratory muscle training, Central Drive

Eligibility Criteria

40 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Zhujiang Hospital,Southern Medical UniverstiyRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

respiratory muscle weakness

normal respiratory muscle

Arm Description

Patients with respiratory muscle weakness are performing the threshold loading device with incremental inspiratory load.

Patients with normal respiratory muscle are performing the threshold loading device with incremental inspiratory load.

Outcomes

Primary Outcome Measures

Diaphragmatic function
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

Respiratory pressure
Respiratory pressure can be assessed by transdiaphragmatic pressure ( Pdi).
Respiratory volume
Respiratory volume can be assessed by Tidal volume (VT).
Degree of dyspnea
Difference in the degree of dyspnea can be measured by Borg index.

Full Information

First Posted
March 26, 2018
Last Updated
May 9, 2018
Sponsor
Zhujiang Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT03532243
Brief Title
Acute Effects of Incremental Inspiratory Loads on Respiratory Mechanics and NRD in Patient With Stable COPD.
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).
Study Type
Interventional

2. Study Status

Record Verification Date
March 2018
Overall Recruitment Status
Unknown status
Study Start Date
April 1, 2018 (Actual)
Primary Completion Date
October 1, 2018 (Anticipated)
Study Completion Date
February 1, 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Zhujiang Hospital

4. Oversight

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
Data Monitoring Committee
Yes

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Obstructive Pulmonary Disease
Keywords
Chronic Obstructive Pulmonary Disease, inspiratory muscle training, Central Drive

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
respiratory muscle weakness
Arm Type
Experimental
Arm Description
Patients with respiratory muscle weakness are performing the threshold loading device with incremental inspiratory load.
Arm Title
normal respiratory muscle
Arm Type
Experimental
Arm Description
Patients with normal respiratory muscle are performing the threshold loading device with incremental inspiratory load.
Intervention Type
Procedure
Intervention Name(s)
incremental inspiratory load
Intervention Description
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 Measure Information:
Title
Diaphragmatic function
Description
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.
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)
Secondary Outcome Measure Information:
Title
Respiratory pressure
Description
Respiratory pressure can be assessed by transdiaphragmatic pressure ( Pdi).
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)
Title
Respiratory volume
Description
Respiratory volume can be assessed by Tidal volume (VT).
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)
Title
Degree of dyspnea
Description
Difference in the degree of dyspnea can be measured by Borg index.
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)
Other Pre-specified Outcome Measures:
Title
Pulse oxygen saturation (SpO2)
Description
Change in SpO2 can be recorded by noninvasive monitoring instruments.
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)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Wang Liqing, Doctor
Phone
+86-02062782339
Email
wliqing07@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Xin Chen, Doctor
Email
chen_xin1020@163.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Xin Chen, Doctor
Organizational Affiliation
Zhujiang Hospital,Southern Medical Unversity
Official's Role
Principal Investigator
Facility Information:
Facility Name
Zhujiang Hospital,Southern Medical Universtiy
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510282
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
xin Chen, Doctor
Email
chen_xin1020@163.com

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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