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Chronic Obstructive Pulmonary Disease (COPD) ,the fourth leading cause of death in the world, represents an important public health challenge. It is also a major cause of chronic morbidity, mortality and disability throughout the world, leading to a heavy social and economic burden. For a long time, treatment of COPD mainly focus on drug therapy. Recently, pulmonary rehabilitation is recognized as a core component of the management of individuals with chronic respiratory disease, which has been clearly demonstrated to reduce dyspnea, increase exercise capacity, and improve quality of life.
Exercise training, widely regarded as the cornerstone of pulmonary rehabilitation , is one of the best available means of improving muscle function in COPD.The most commonly form is cycle training. Inspiratory Muscle Training (IMT) as an adjunct to exercise training has an additional benefit on inspiratory muscle strength, endurance and exercise capacity in patient with COPD.
There is insufficient evidence demonstrate greater benefits from combined inspiratory muscle training and cycle training. This study will evaluate the effects of combined inspiratory muscle training and cycle training in patients with COPD.
The patients with COPD will participate in a rehabilitation program for 8 weeks. Participants in the proposed study will be randomly programmed into one of three intervention groups:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control group | Experimental | Neither cycle training nor inspiratory muscle training. |
|
| Cycle training group | Experimental | A 30-minute cycling training session is performed 3 days a week using calibrated cycle ergometer. |
|
| Combined group | Experimental | A 30-minute Combined training session is performed 3 days a week using calibrated cycle ergometer and threshold loading device. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Control group | Device | Neither cycle training nor inspiratory muscle training. |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Exercise Performance (composite outcome measure) | Exercise performance tests include field walking tests and cycle ergometer tests. | The groups will be assessed at baseline (time zero) and at the end of the training protocol (week 8) |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | The groups will be assessed at baseline (time zero) and at the end of the training protocol (week 8) |
| Measure | Description | Time Frame |
|---|---|---|
| Depression and anxiety evaluation | 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. | The groups will be assessed at baseline (time zero) and at the end of the training protocol (week 8) |
Inclusion Criteria:
Patients between 40 and 75 years of age were eligible if they met the following criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Xin Chen, Doctor | Zhujiang Hospital,Southern Medical Unversity | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Zhujiang Hospital,Southern Medical Universtiy | Guangzhou | Guangdong | 510282 | China |
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| ID | Term |
|---|---|
| D029424 | Pulmonary Disease, Chronic Obstructive |
| ID | Term |
|---|---|
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D002908 | Chronic Disease |
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| ID | Term |
|---|---|
| D035061 | Control Groups |
| ID | Term |
|---|---|
| D015340 | Epidemiologic Research Design |
| D004812 | Epidemiologic Methods |
| D008919 | Investigative Techniques |
| D012107 | Research Design |
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| calibrated cycle ergometer |
| Device |
The most common device to proform cycle training is calibrated cycle ergometer. |
|
| 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. |
|
| inspiratory muscle function (composite outcome measure) | Currently, a variety of methods can be used to evaluate respiratory muscle function, including maximal inspiratory (PImax),expiratory pressures(PEmax) and inspiratory muscle endurance. | The groups will be assessed at baseline (time zero) and at the end of the training protocol (week 8) |
| 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). | The groups will be assessed at baseline (time zero) and at the end of the training protocol (week 8) |
| Composite outcomes | Among patients with COPD there is increasing interest in the use of multidimensional indices to characterize the severity of the disease and better predict outcomes.Arguably the most well-known of these indices is the BODE Index. | The groups will be assessed at baseline (time zero) and at the end of the training protocol (week 8) |
| Body Composition Monitor | Body composition abnormalities are prevalent in COPD.Human body composition analyzer can detect various elements of human body and analyze human health status. | The groups will be assessed at baseline (time zero) and at the end of the training protocol (week 8) |
| D020969 |
| Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D008722 | Methods |