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

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).

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.

Study Overview

• Status: Completed
• Conditions: Chronic Obstructive Pulmonary Disease (COPD)
• Intervention / Treatment: Device: inspiratory pressure threshold device

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.

• Study Type: Interventional
• Enrollment (Actual): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Guangdong
    • Guangzhou, Guangdong, China, 510282
      • Zhujiang Hospital,Southern Medical Universtiy

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Change from baseline in diaphragm electromyogram at the load of threshold (10 minutes later,20minutes later,30 minutes later, 40 minutes later)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Respiratory pressure	Respiratory pressure parameter is transdiaphragmatic pressure ( Pdi) in cmH2O, which reflect the strength of diaphragm.	Change from baseline in respiratory pressure at the load of threshold (10 minutes later,20minutes later,30 minutes later, 40 minutes later)
Respiratory volume	Respiratory volume parameter is minute ventilation (VE) in liter(L).	Change from baseline in respiratory volume at the load of threshold (10 minutes later,20minutes later,30 minutes later, 40 minutes later)
respiratory work	respiratory work is associated with transdiaphragmatic pressure time product	Change from baseline in transdiaphragmatic pressure time product at the load of threshold (10 minutes later,20minutes later,30 minutes later, 40 minutes later)

Collaborators and Investigators

• Sponsor: Zhujiang Hospital
• Investigators: Principal Investigator: Xin Chen, doctor, Zhujiang Hospital,Southern Medical Unversity

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2018
• Primary Completion (Actual): December 1, 2018
• Study Completion (Actual): March 1, 2019

Study Registration Dates

• First Submitted: March 26, 2018
• First Submitted That Met QC Criteria: April 8, 2018
• First Posted (Actual): April 17, 2018

Study Record Updates

• Last Update Posted (Actual): March 13, 2024
• Last Update Submitted That Met QC Criteria: March 12, 2024
• Last Verified: March 1, 2018

More Information

Terms related to this study

• Keywords: Chronic Obstructive Pulmonary Disease; inspiratory muscle training; expiratory muscle training; Neural Respiratory Drive
• Additional Relevant MeSH Terms: Pathologic Processes; Respiratory Tract Diseases; Disease Attributes; Chronic Disease; Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive
• Other Study ID Numbers: 2018-HXNK-008

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No