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

NCT03500042 | Completed DMC

• 1 other identifier: 2018-HXNK-008
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Obstructive Pulmonary Disease (COPD)

Keywords

Chronic Obstructive Pulmonary Disease; inspiratory muscle training; expiratory muscle training; Neural Respiratory Drive

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Respiratory pressure

  Change from baseline in respiratory pressure at the load of threshold (10 minutes later,20minutes later,30 minutes later, 40 minutes later)

• Respiratory volume

  Change from baseline in respiratory volume at the load of threshold (10 minutes later,20minutes later,30 minutes later, 40 minutes later)

• respiratory work

  Change from baseline in transdiaphragmatic pressure time product at the load of threshold (10 minutes later,20minutes later,30 minutes later, 40 minutes later)

Study Arms (2)

respiratory muscle weakness

EXPERIMENTAL

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

normal respiratory muscle

EXPERIMENTAL

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

Interventions

inspiratory pressure threshold device 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.

Also known as: expiratory pressure threshold device, concurrent inspiratory and expiratory muscle device

normal respiratory muscle; respiratory muscle weakness

Eligibility Criteria

• Age: 40 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Zhujiang Hospital: lead

Study Sites (1)

Zhujiang Hospital,Southern Medical Universtiy

Guangzhou, Guangdong, 510282, China

Location

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Xin Chen, Doctor

  Zhujiang Hospital,Southern Medical Unversity

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 26, 2018
• First Posted: April 17, 2018
• Study Start: March 1, 2018
• Primary Completion: December 1, 2018
• Study Completion: March 1, 2019
• Last Updated: March 13, 2024

Record last verified: 2018-03

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)