An interventional study of Control group and Calibrated cycle ergometer in Chronic Obstructive Pulmonary Disease (COPD), sponsored by Zhujiang Hospital. Completed at 1 site in China. Open to participants aged 40 Years to 80 Years. Per ClinicalTrials.gov, last updated 2024-03-13.
Sponsored by Zhujiang Hospital · Not applicable, Interventional, and Treatment
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.
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:
3,303 studies on the registry are indexed under Lung Diseases; 355 are open to participants now.
This study's enrollment of 500 is above the median of 72 across 2,118 interventional studies indexed under Lung Diseases.
Browse Lung Diseases studies →Zhujiang Hospital is the lead sponsor of 199 studies on the registry; 96 are open to participants now.
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Exclusion Criteria:
Neither cycle training nor inspiratory muscle training.
Device: Control group
A calibrated cycle ergometer is used to do 30-minute cycling training session 3 days a week.
Device: Calibrated cycle ergometer
A threshold loading device is used to perform 21-minute inspiratory muscle training 3 days a week.
Device: Threshold loading device
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
Neither cycle training nor inspiratory muscle training.
The most common device to perform cycle training is calibrated cycle ergometer.
Threshold loading device is used to perform inspiratory muscle training.
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.
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.
Time frame: Change from baseline in diaphragm electromyogram.(8 weeks later, 26 weeks later, 52 weeks later)
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.
Time frame: Change from baseline in inspiratory muscle function.(8 weeks later, 26 weeks later, 52 weeks later)
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.
Time frame: Change from baseline in pulmonary function.(8 weeks later, 26 weeks later, 52 weeks later)
Cardiopulmonary exercise test(composite outcome measure)
Cardiopulmonary exercise test can help to reflect the variables,like maximaloxygen uptake（VO2max）, anaerobic threshold (AT).
Time frame: Change from baseline in cardiopulmonary exercise test.(8 weeks later, 26 weeks later, 52 weeks later)
Degree of dyspnea(composite outcome measure)
Difference in the degree of dyspnea can be measured by Borg index.
Time frame: Change from baseline in degree of dyspnea.(8 weeks later, 26 weeks later, 52 weeks later)
Exercise capacity(composite outcome measure)
Exercise capacity is evaluated using the 6-min walking distance (6MWD) according to American Thoracic Society guidelines.
Time frame: Change from baseline in exercise performance.(8 weeks later, 26 weeks later, 52 weeks later)
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.
Time frame: Change from baseline in body composition.(8 weeks later, 26 weeks later, 52 weeks later)
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.
Time frame: Change from baseline in Health-related quality.(8 weeks later, 26 weeks later, 52 weeks later)
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).
Time frame: Change from baseline in symptom evaluation.(8 weeks later, 26 weeks later, 52 weeks later)
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.
Time frame: Change from baseline in depression and anxiety evaluatione.(8 weeks later, 26 weeks later, 52 weeks later)
Plan to share: Undecided
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Zhujiang Hospital