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

NCT03082924 | Completed DMC

• 1 other identifier: CX20160902
• Study Type: interventional
• Target: 500
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Obstructive Pulmonary Disease (COPD)

Keywords

surface EMGdi; pulmonary rehabilitation; inspiratory muscle training; exercise training

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Inspiratory muscle function(composite outcome measure)

  Change from baseline in inspiratory muscle function.(8 weeks later, 26 weeks later, 52 weeks later)

• Pulmonary Function(composite outcome measure)

  Change from baseline in pulmonary function.(8 weeks later, 26 weeks later, 52 weeks later)

• Cardiopulmonary exercise test(composite outcome measure)

  Change from baseline in cardiopulmonary exercise test.(8 weeks later, 26 weeks later, 52 weeks later)

• Degree of dyspnea(composite outcome measure)

  Change from baseline in degree of dyspnea.(8 weeks later, 26 weeks later, 52 weeks later)

• Exercise capacity(composite outcome measure)

  Change from baseline in exercise performance.(8 weeks later, 26 weeks later, 52 weeks later)

Other Outcomes (4)

• Body Composition Monitor(composite outcome measure)

  Change from baseline in body composition.(8 weeks later, 26 weeks later, 52 weeks later)

• Health-related quality(composite outcome measure)

  Change from baseline in Health-related quality.(8 weeks later, 26 weeks later, 52 weeks later)

• Symptom Evaluation(composite outcome measure)

  Change from baseline in symptom evaluation.(8 weeks later, 26 weeks later, 52 weeks later)

Study Arms (4)

Control group

EXPERIMENTAL

Neither cycle training nor inspiratory muscle training.

Device: Control group

Cycle training group

EXPERIMENTAL

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

Device: Calibrated cycle ergometer

Inspiratory training group

EXPERIMENTAL

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

Device: Threshold loading device

Combined group

EXPERIMENTAL

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.

Device: Calibrated cycle ergometer and threshold loading device

Interventions

Control group DEVICE

Neither cycle training nor inspiratory muscle training.

Control group

Calibrated cycle ergometer DEVICE

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

Cycle training group

Threshold loading device DEVICE

Threshold loading device is used to perform inspiratory muscle training.

Inspiratory training group

Calibrated cycle ergometer and threshold loading device 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.

Combined group

Eligibility Criteria

• Age: 40 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Zhujiang Hospital: lead
• Guangzhou Institute of Respiratory Disease: collaborator
• The First Affiliated Hospital of Guangdong Pharmaceutical University: collaborator
• Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University: collaborator
• Nanfang Hospital, Southern Medical University: collaborator

Study Sites (1)

Zhujiang Hospital,Southern Medical Universtiy

Guangzhou, Guangdong, 510282, China

Location

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Interventions

Control Groups

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Study Officials

• Xin Chen, Doctor

  Zhujiang Hospital,Southern Medical Unversity

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 27, 2016
• First Posted: March 17, 2017
• Study Start: July 1, 2016
• Primary Completion: December 1, 2020
• Study Completion: June 1, 2021
• Last Updated: March 13, 2024

Record last verified: 2017-03

Locations

CN (1)