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

NCT03532243 | Completed DMC

• 1 other identifier: 2018-HXNK-007
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Obstructive Pulmonary Disease

Keywords

Chronic Obstructive Pulmonary Disease; inspiratory muscle training; Central 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 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 Outcomes (3)

• Respiratory pressure

  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 volume

  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)

• Degree of dyspnea

  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 Outcomes (1)

• Pulse oxygen saturation (SpO2)

  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)

Study Arms (2)

respiratory muscle weakness

EXPERIMENTAL

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

Procedure: incremental inspiratory load

normal respiratory muscle

EXPERIMENTAL

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

Procedure: incremental inspiratory load

Interventions

incremental inspiratory load PROCEDURE

inspiratory load ranges between 10 and 40 cm water column (cmH2O)or intolerable to the patient, each load increment for 5cm water column.

normal respiratory muscle; respiratory muscle weakness

Eligibility Criteria

• Age: 40 Years - 75 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: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 26, 2018
• First Posted: May 22, 2018
• Study Start: April 1, 2018
• Primary Completion: October 1, 2018
• Study Completion: February 1, 2019
• Last Updated: March 13, 2024

Record last verified: 2018-03

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)