Surface EMGdi Evaluate the Efficacy of Pulmonary Rehabilitation in Patients With COPD: a Multi Center Prospective Study

NCT ID: NCT03082924

Last Updated: 2024-03-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 500 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-07-31
• Study Completion Date: 2021-06-30

Brief Summary

Pulmonary rehabilitation is recognized as a core component of the management of individuals with chronic obstructive respiratory disease, which has become first-line treatment besides drug therapy. However, in the current clinical evaluation system of pulmonary rehabilitation, there is still a lack of simple, objective index,which can be monitored at any time.Neural respiratory drive , as an important physiological index, is closely related to the symptoms and the severity of the disease. It may be a sensitive indicator to evaluate the effectiveness of pulmonary rehabilitation. Surface EMGdi can accurately evaluate neural respiratory drive , its detection is non-invasive, simple and safety . In recent years, with the development of signal detection and analysis technology, EMG recording is more stable, but as the related research samples were low, surface diaphragm EMG has not yet the establishment of standardization. Therefore, based on the previous work, the project was carried out in a multicenter randomized controlled study,in which the stable stage of COPD patients were included in different ways of pulmonary rehabilitation training, a comprehensive clinical assessment will be conducted before and after training. Compared with the traditional evaluation methods and standard esophageal diaphragmatic electromyography, surface EMGdi detect the changes of neural respiratory drive in patients with COPD,that can help to explore the application value of surface EMGdi in the assessment of chronic obstructive pulmonary disease with pulmonary rehabilitation, to provide a basis for the promotion of the diaphragm and the optimization of pulmonary rehabilitation program.

Detailed Description

The patients with COPD will participate in a rehabilitation program for 52 weeks.

Participants in the proposed study will be randomly programmed into one of four intervention groups:

1. Neither cycle training nor inspiratory muscle training.

2. Cycle training program alone (performing on calibrated stationary cycle ergometer).

3. Inspiratory muscle training alone (performing on threshold loading device).

4. Combined cycle training and inspiratory muscle training(performing on calibrated stationary cycle ergometer and threshold loading device).

Conditions

Chronic Obstructive Pulmonary Disease (COPD)

Study Design

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

Study Groups

Control group

Neither cycle training nor inspiratory muscle training.

Group Type: EXPERIMENTAL

Control group

Intervention Type: DEVICE

Neither cycle training nor inspiratory muscle training.

Cycle training group

A calibrated cycle ergometer is used to do 30-minute cycling training session 3 days a week.

Group Type: EXPERIMENTAL

Calibrated cycle ergometer

Intervention Type: DEVICE

The most common device to perform cycle training is calibrated cycle ergometer.

Inspiratory training group

A threshold loading device is used to perform 21-minute inspiratory muscle training 3 days a week.

Group Type: EXPERIMENTAL

Threshold loading device

Intervention Type: DEVICE

Threshold loading device is used to perform inspiratory muscle training.

Combined group

Calibrated cycle ergometer and threshold loading device are applied.A 30-minute cycle training is performed using calibrated cycle ergometer and a 21-minute inspiratory muscle training using threshold loading device 3 days a week.

Group Type: EXPERIMENTAL

Calibrated cycle ergometer and threshold loading device

Intervention Type: DEVICE

Combined cycle training and inspiratory muscle training.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.

Interventions

Control group

Neither cycle training nor inspiratory muscle training.

Intervention Type: DEVICE

Calibrated cycle ergometer

The most common device to perform cycle training is calibrated cycle ergometer.

Intervention Type: DEVICE

Threshold loading device

Threshold loading device is used to perform inspiratory muscle training.

Intervention Type: DEVICE

Calibrated cycle ergometer and threshold loading device

Combined cycle training and inspiratory muscle training.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.

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• Patients aged over 40 years old.
• Patients with pulmonary function test of forced expiratory volume at one second(FEV1)/forced vital capacity(FVC) < 70%.
• Patients in a clinically stable state
• Patients who signed informed consent.
• No participation in other pulmonary rehabilitation program within the previous 2 months.

Exclusion Criteria

• Patients with signs of an airway infection.
• Patients with metabolic disease and serious cardiovascular disease.
• Patients with Multiple pulmonary bulla.
• Patients with poor compliance.

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Guangzhou Institute of Respiratory Disease

OTHER

Sponsor Role: collaborator

The First Affiliated Hospital of Guangdong Pharmaceutical University

OTHER

Sponsor Role: collaborator

Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

OTHER

Sponsor Role: collaborator

Nanfang Hospital, Southern Medical University

OTHER

Sponsor Role: collaborator

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

CX20160902

Identifier Type: -

Identifier Source: org_study_id