Effects of Combined Cycle Training and Inspiratory Muscle Training in Patients With COPD
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)
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.
研究概览
地位
详细说明
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:
- Cycle training program alone (performing on calibrated stationary cycle ergometer).
- Combined cycle training and inspiratory muscle training(performing on calibrated stationary cycle ergometer and threshold loading device).
- Neither cycle training nor inspiratory muscle training.
研究类型
注册 (实际的)
阶段
- 不适用
联系人和位置
学习地点
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Guangdong
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Guangzhou、Guangdong、中国、510282
- Zhujiang Hospital,Southern Medical Universtiy
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
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.
学习计划
研究是如何设计的?
设计细节
- 主要用途:治疗
- 分配:随机化
- 介入模型:并行分配
- 屏蔽:无(打开标签)
武器和干预
参与者组/臂 |
干预/治疗 |
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实验性的:控制组
既不是循环训练也不是吸气肌训练。
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既不是循环训练也不是吸气肌训练。
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实验性的:Cycle training group
A 30-minute cycling training session is performed 3 days a week using calibrated cycle ergometer.
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The most common device to proform cycle training is calibrated cycle ergometer.
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实验性的:Combined group
A 30-minute Combined training session is performed 3 days a week using calibrated cycle ergometer and threshold loading device.
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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.
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研究衡量的是什么?
主要结果指标
结果测量 |
措施说明 |
大体时间 |
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Exercise Performance (composite outcome measure)
大体时间:The groups will be assessed at baseline (time zero) and at the end of the training protocol (week 8)
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Exercise performance tests include field walking tests and cycle ergometer tests.
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The groups will be assessed at baseline (time zero) and at the end of the training protocol (week 8)
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
---|---|---|
Health-related quality (composite outcome measure)
大体时间:The groups will be assessed at baseline (time zero) and at the end of the training protocol (week 8)
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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.
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The groups will be assessed at baseline (time zero) and at the end of the training protocol (week 8)
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inspiratory muscle function (composite outcome measure)
大体时间:The groups will be assessed at baseline (time zero) and at the end of the training protocol (week 8)
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Currently, a variety of methods can be used to evaluate respiratory muscle function, including maximal inspiratory (PImax),expiratory pressures(PEmax) and inspiratory muscle endurance.
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The groups will be assessed at baseline (time zero) and at the end of the training protocol (week 8)
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Symptom Evaluation (composite outcome measure)
大体时间:The groups will be assessed at baseline (time zero) and at the end of the training protocol (week 8)
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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).
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The groups will be assessed at baseline (time zero) and at the end of the training protocol (week 8)
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其他结果措施
结果测量 |
措施说明 |
大体时间 |
---|---|---|
Depression and anxiety evaluation
大体时间:The groups will be assessed at baseline (time zero) and at the end of the training protocol (week 8)
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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.
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The groups will be assessed at baseline (time zero) and at the end of the training protocol (week 8)
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Composite outcomes
大体时间:The groups will be assessed at baseline (time zero) and at the end of the training protocol (week 8)
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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.
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The groups will be assessed at baseline (time zero) and at the end of the training protocol (week 8)
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Body Composition Monitor
大体时间:The groups will be assessed at baseline (time zero) and at the end of the training protocol (week 8)
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Body composition abnormalities are prevalent in COPD.Human body composition analyzer can detect various elements of human body and analyze human health status.
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The groups will be assessed at baseline (time zero) and at the end of the training protocol (week 8)
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合作者和调查者
研究记录日期
研究主要日期
学习开始
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.
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