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

NCT03082924 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 500

Last updated 2024-03-13

No results posted yet for this study

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)

Interventions

DEVICE

Control group

Neither cycle training nor inspiratory muscle training.

DEVICE

Calibrated cycle ergometer

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

DEVICE

Threshold loading device

Threshold loading device is used to perform inspiratory muscle training.

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.

Sponsors & Collaborators

  • Guangzhou Institute of Respiratory Disease

    collaborator OTHER
  • The First Affiliated Hospital of Guangdong Pharmaceutical University

    collaborator OTHER
  • Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

    collaborator OTHER
  • Nanfang Hospital, Southern Medical University

    collaborator OTHER
  • Zhujiang Hospital

    lead OTHER

Principal Investigators

  • Xin Chen, Doctor · Zhujiang Hospital,Southern Medical Unversity

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
40 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-07-31
Primary Completion
2020-12-31
Completion
2021-06-30

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03082924 on ClinicalTrials.gov