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

Zhujiang Hospital

Status: Completed

Conditions: Chronic Obstructive Pulmonary Disease (COPD)

Treatments: Device: Control group; Device: Calibrated cycle ergometer; Device: Calibrated cycle ergometer and threshold loading device; Device: Threshold loading device

Study type: Interventional

Funder types: Other

Identifiers

NCT03082924

CX20160902

Details and patient eligibility

About

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.

Full 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).

Enrollment: 500 patients

Sex: All

Ages: 40 to 80 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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500 participants in 4 patient groups

Control group

Experimental group

Description:

Neither cycle training nor inspiratory muscle training.

Treatment:

Device: Control group

Cycle training group

Experimental group

Description:

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

Treatment:

Device: Calibrated cycle ergometer

Inspiratory training group

Experimental group

Description:

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

Treatment:

Device: Threshold loading device

Combined group

Experimental group

Description:

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.

Treatment:

Device: Calibrated cycle ergometer and threshold loading device