Chronic Obstructive Pulmonary Disease (COPD) Clinical Trial
Official title:
Effects of Combined Cycle Training and Inspiratory Muscle Training on Exercise Performance ,Health-related Quality,Dyspnoea ,Body Composition,Depressive Symptomatology in Patients With Chronic Obstructive Pulmonary Disease(COPD)
Verified date | March 2016 |
Source | Zhujiang Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 90 |
Est. completion date | January 2017 |
Est. primary completion date | January 2017 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 40 Years to 75 Years |
Eligibility |
Inclusion Criteria: - Patients between 40 and 75 years of age were eligible if they met the following criteria: - moderate to severe airflow obstruction (30= Forced Expiratory Volume At One Second(FEV1) <80% predicted and Forced Expiratory Volume At One Second/Forced Vital Capacity(FEV1/FVC)<70%) - Complaints of dyspnea on exertion - Clinically stable condition - No participation in a pulmonary rehabilitation program in the last year. Exclusion Criteria: - Patients were excluded if they had evidence of asthma and/or had experienced a major exacerbation in the 2 months before enrollment - Required home oxygen therapy or experienced oxyhemoglobin desaturation below 85% with exercise - And/or had other health problems that would interfere with exercise. |
Country | Name | City | State |
---|---|---|---|
China | Zhujiang Hospital,Southern Medical Universtiy | Guangzhou | Guangdong |
Lead Sponsor | Collaborator |
---|---|
Zhujiang Hospital |
China,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | 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) | |
Other | 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) | |
Other | 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) | |
Primary | 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) | |
Secondary | 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) | |
Secondary | 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) | |
Secondary | 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) |
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