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

Chronic Obstructive Pulmonary Disease (COPD) Clinical Trial

Official title:

Surface Diaphragm EMG Evaluate the Clinical Efficacy of Pulmonary Rehabilitation in Patients With Chronic Obstructive Pulmonary Disease: a Multi Center Prospective Randomized Controlled Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03082924
• Other study ID #: CX20160902
• Status: Completed
• Phase: N/A
• Start date: July 2016
• Est. completion date: June 2021

Study information

• Verified date: March 2017
• Source: Zhujiang Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 500
• Est. completion date: June 2021
• Est. primary completion date: December 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Chronic Obstructive Pulmonary Disease (COPD)
• Lung Diseases
• Lung Diseases, Obstructive
• Pulmonary Disease, Chronic Obstructive

Intervention

Device:
• Control group
Neither cycle training nor inspiratory muscle training.
• Calibrated cycle ergometer
The most common device to perform cycle training is calibrated cycle ergometer.
• Threshold loading device
Threshold loading device is used to perform inspiratory muscle training.
• 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.

Locations

Country	Name	City	State
China	Zhujiang Hospital,Southern Medical Universtiy	Guangzhou	Guangdong

Sponsors (5)

Lead Sponsor	Collaborator
Zhujiang Hospital	Guangzhou Institute of Respiratory Disease, Nanfang Hospital, Southern Medical University, Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University, The First Affiliated Hospital of Guangdong Pharmaceutical University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Body Composition Monitor(composite outcome measure)	Body composition abnormalities are prevalent in COPD.Human body composition analyzer can detect various elements of human body and analyze human health status.	Change from baseline in body composition.(8 weeks later, 26 weeks later, 52 weeks later)
Other	Health-related quality(composite outcome measure)	Health-related quality is a component of the broader concept of quality of life and is defined as satisfaction with health.The St. George's Respiratory Questionnaire (SGRQ) and Chronic Respiratory Disease Questionnaire (CRQ);and its self-reported version are the most widely used disease-specific questionnaires.	Change from baseline in Health-related quality.(8 weeks later, 26 weeks later, 52 weeks later)
Other	Symptom Evaluation(composite outcome measure)	Individuals with chronic respiratory disease often have symptoms such as dyspnea, fatigue, cough, weakness,sleeplessness,and psychological distress.Instruments for assessment of multiple symptoms include COPD Assessment Test (CAT) and Modified Medical British Research Council Scale(mMRC).	Change from baseline in symptom evaluation.(8 weeks later, 26 weeks later, 52 weeks later)
Other	Depression and anxiety evaluation(composite outcome measure)	Hospital Anxiety and Depression Scale (HADS) was found to perform well in assessing the symptom severity and caseness of anxiety disorders and depression in both somatic, psychiatric and primary care patients and in the general population.	Change from baseline in depression and anxiety evaluatione.(8 weeks later, 26 weeks later, 52 weeks later)
Primary	Diaphragmatic function(composite outcome measure)	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.(8 weeks later, 26 weeks later, 52 weeks later)
Secondary	Inspiratory muscle function(composite outcome measure)	Currently, the maximal inspiratory pressure (PImax) and maximal expiratory pressures(PEmax) are measured by a digital manometer (AZ-8205, AZ Instrument, Taichung City, Taiwan)and combined to evaluate inspiratory muscle function.	Change from baseline in inspiratory muscle function.(8 weeks later, 26 weeks later, 52 weeks later)
Secondary	Pulmonary Function(composite outcome measure)	Pulmonary function is measured using a spirometer(PonyFX 229, Cosmed, Rome, Italy) that is calibrated daily.The FEV1 and percent-of-predicted FEV1, FVC and percent-of-predicted FVC which are presented in one report are used to evaluate Pulmonary Function.	Change from baseline in pulmonary function.(8 weeks later, 26 weeks later, 52 weeks later)
Secondary	Cardiopulmonary exercise test(composite outcome measure)	Cardiopulmonary exercise test can help to reflect the variables,like maximaloxygen uptake(VO2max), anaerobic threshold (AT).	Change from baseline in cardiopulmonary exercise test.(8 weeks later, 26 weeks later, 52 weeks later)
Secondary	Degree of dyspnea(composite outcome measure)	Difference in the degree of dyspnea can be measured by Borg index.	Change from baseline in degree of dyspnea.(8 weeks later, 26 weeks later, 52 weeks later)
Secondary	Exercise capacity(composite outcome measure)	Exercise capacity is evaluated using the 6-min walking distance (6MWD) according to American Thoracic Society guidelines.	Change from baseline in exercise performance.(8 weeks later, 26 weeks later, 52 weeks later)