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

NCT ID: NCT03532243

Last Updated: 2024-03-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-04-01
• Study Completion Date: 2019-02-01

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.

Conditions

Chronic Obstructive Pulmonary Disease

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

respiratory muscle weakness

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

Group Type: EXPERIMENTAL

incremental inspiratory load

Intervention Type: 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

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

Group Type: EXPERIMENTAL

incremental inspiratory load

Intervention Type: PROCEDURE

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

Interventions

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.

Intervention Type: PROCEDURE

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

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Zhujiang Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Xin Chen, Doctor

Role: PRINCIPAL_INVESTIGATOR

Zhujiang Hospital,Southern Medical Unversity

Locations

Zhujiang Hospital,Southern Medical Universtiy

Guangzhou, Guangdong, China

Countries

China

Other Identifiers

2018-HXNK-007

Identifier Type: -

Identifier Source: org_study_id