Clinical trial NCT03082924: Surface EMGdi Evaluate the Efficacy of Pulmonary Rehabilitation in Patients With COPD: a Multi Center Prospective Study
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Obstructive Pulmonary Disease (COPD)
Keywords: surface EMGdi
pulmonary rehabilitation
inspiratory muscle training
exercise training
Lead sponsor: Zhujiang Hospital
Sponsor class: OTHER
Collaborators: name: Guangzhou Institute of Respiratory Disease
name: The First Affiliated Hospital of Guangdong Pharmaceutical University
name: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
name: Nanfang Hospital, Southern Medical University
First posted: 2017-03-17
Enrollment: 500
Sex: ALL
Minimum age (years): 40
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).

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.

Primary outcomes:
measure: Diaphragmatic function(composite outcome measure)
timeFrame: Change from baseline in diaphragm electromyogram.(8 weeks later, 26 weeks later, 52 weeks later)
Secondary outcomes:
measure: Inspiratory muscle function(composite outcome measure)
timeFrame: Change from baseline in inspiratory muscle function.(8 weeks later, 26 weeks later, 52 weeks later)
measure: Pulmonary Function(composite outcome measure)
timeFrame: Change from baseline in pulmonary function.(8 weeks later, 26 weeks later, 52 weeks later)
measure: Cardiopulmonary exercise test(composite outcome measure)
timeFrame: Change from baseline in cardiopulmonary exercise test.(8 weeks later, 26 weeks later, 52 weeks later)
measure: Degree of dyspnea(composite outcome measure)
timeFrame: Change from baseline in degree of dyspnea.(8 weeks later, 26 weeks later, 52 weeks later)
measure: Exercise capacity(composite outcome measure)
timeFrame: Change from baseline in exercise performance.(8 weeks later, 26 weeks later, 52 weeks later)
Other outcomes:
measure: Body Composition Monitor(composite outcome measure)
timeFrame: Change from baseline in body composition.(8 weeks later, 26 weeks later, 52 weeks later)
measure: Health-related quality(composite outcome measure)
timeFrame: Change from baseline in Health-related quality.(8 weeks later, 26 weeks later, 52 weeks later)
measure: Symptom Evaluation(composite outcome measure)
timeFrame: Change from baseline in symptom evaluation.(8 weeks later, 26 weeks later, 52 weeks later)
measure: Depression and anxiety evaluation(composite outcome measure)
timeFrame: Change from baseline in depression and anxiety evaluatione.(8 weeks later, 26 weeks later, 52 weeks later)
Locations:
city: Guangzhou
country: China
facility: Zhujiang Hospital,Southern Medical Universtiy
state: Guangdong
Study officials:
affiliation: Zhujiang Hospital,Southern Medical Unversity
name: Xin Chen, Doctor
role: PRINCIPAL_INVESTIGATOR
References: