Physiotherapy in Patients With Stable Chronic Obstructive Pulmonary Disease
2016年10月30日 更新者：Marie Carmen Valenza、Universidad de Granada
Effects of a Physiotherapy Program in Patients With Stable Chronic Obstructive Pulmonary Disease
Chronic Obstructive Pulmonary Disease (COPD) is a lung disease that is characterized by incompletely reversible airflow obstruction.
It is projected to be the fifth leading burden of disease worldwide by the year 2020.
Pulmonary dysfunction reduces exercise capacity in COPD patients, and it has been previously shown that COPD patients suffer deterioration in their quality of life.
The objective of this study is to examine the effects of a physical therapy intervention in stable patients with COPD.
研究概览
详细说明
Chronic obstructive pulmonary disease (COPD) is one of the leading diseases causing mortality and morbidity, despite advanced pharmacotherapy and therapeutic management. Although COPD primarily affects the lungs, it also implies extrapulmonary manifestations, such as nutritional depletion, skeletal muscle dysfunction, and abnormal respiratory muscles.
Pulmonary rehabilitation is widely used to treat COPD patients and it has been shown that pulmonary rehabilitation should be implemented at all COPD stages, bringing them benefits in terms of improved exercise capacity, symptoms, and quality of life.
研究类型
介入性
注册 (实际的)
40
阶段
- 不适用
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习地点
-
-
-
Granada、西班牙、18071
- Department of Physical Therapy
-
-
参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
40年 及以上 (成人、年长者)
接受健康志愿者
不
有资格学习的性别
全部
描述
Inclusion Criteria:
- COPD diagnosis
- No contraindication of physiotherapy.
- Signed written consent.
- Medical approval for inclusion.
Exclusion Criteria:
- Acute exacerbation in the previous month
- Contraindications of physiotherapy.
- Neurological, orthopedic or heart disease.
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
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：单组作业
- 屏蔽：单身的
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
实验性的：Experimental group
COPD patients with stable disease will be recruited and they will receive physiotherapy added to standard care.
|
The treatment will be based on domiciliary physiotherapy program during 8 weeks, twice a week added to standard care.
The duration of the sessions will be 45-60 minutes.
The physiotherapy treatment includes: breathing exercises, electrostimulation in quadriceps with voluntary contraction and exercises with theraband.
This will be a home-based program supervised by a physiotherapist.
其他名称：
|
|
其他：Control group
COPD patients with stable disease will be recruited and they will receive standard care.
|
The standard care of stable COPD is based on long-acting bronchodilators (LABD).
其他名称：
|
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 |
|---|---|---|
|
Changes in Muscle strength
大体时间：Baseline, 8 weeks
|
Quadriceps strength will be assessed with a portable dynamometer.
|
Baseline, 8 weeks
|
|
Changes in Exercise capacity
大体时间：Baseline, 8 weeks
|
Five times sit to stand test (5STS) will be used to assess exercise capacity, 5STS is a simple assessment tool that is feasible in all healthcare settings, and may be a rapid method of assessing changes in exercise capacity in COPD and screening for poor physical functioning individuals.
|
Baseline, 8 weeks
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Changes in Respiratory function
大体时间：Baseline, 8 weeks
|
Spirometry is regarded as the gold standard measure of respiratory function.
Spirometry will be performed according to the American Thoracic Society (ATS) criteria.
|
Baseline, 8 weeks
|
|
Changes in Dyspnea perception
大体时间：Baseline, 8 weeks
|
Dyspnea perception will be assessed with Borg modified scale.
Patients will classify their breathlessness between 0 and 10.
|
Baseline, 8 weeks
|
|
Changes in Quality of life
大体时间：Baseline, 8 weeks
|
EuroQol-5D (EQ-5D) will be used to assess quality of life.
EQ-5D is a generic questionnaire and consists of two parts, the EQ-5D Visual analogue scale (VAS) and the EQ-5D index.
The EQ-5D VAS consists on a vertical rating scale from 0 to 100 (0 = death/worst possible health state and 100 = best possible health state).
The EQ-5D index is a five-item questionnaire (mobility, self-care, usual activity, pain/discomfort and anxiety/depression).
|
Baseline, 8 weeks
|
|
Changes in Fatigue
大体时间：Baseline, 8 weeks
|
Fatigue will be assessed with the Fatigue Severity Scale (FSS).
The FSS is a nine-item instrument designed to assess fatigue as a symptom of a variety of different chronic conditions and disorders.
The scale addresses fatigue's effects on daily functioning, querying its relationship to motivation, physical activity, work, family, and social life, and asking respondents to rate the ease with which they are fatigued and the degree to which the symptom poses a problem for them.
|
Baseline, 8 weeks
|
|
Impact of COPD
大体时间：Baseline, 8 weeks
|
The impact of COPD in patient's life will be evaluated with COPD Assessment Test (CAT) that is a simple instrument to quantify chronic obstructive pulmonary disease (COPD) impact in routine practice.
|
Baseline, 8 weeks
|
其他结果措施
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Quality of life related to respiratory symptoms
大体时间：Baseline
|
Saint George Respiratory Questionnaire (SGRQ) will be also used to evaluate the quality of life of patients in the previous year.
It includes 50 items, divided into three domains: Symptoms, Activity and Impacts.
A score is calculated for each domain and a total score including all items is also obtained.
Low scores indicate better health related quality of life.
|
Baseline
|
|
Peripheral vascular status
大体时间：Baseline
|
Ankle-brachial index will be used to predict the presence or absence of peripheral arterial disease.
|
Baseline
|
|
Physical activity
大体时间：Baseline
|
Modified Baecke Questionnaire will be used to assess the physical activity levels.
It is a frequently used questionnaire to measure habitual physical activity in the elderly.
|
Baseline
|
|
Cognitive status
大体时间：Baseline
|
Cognitive status will be assessed with Montreal Cognitive Assessment test (MoCA) which is a cognitive screening test designed to assist Health Professionals for detection of mild cognitive impairment.
|
Baseline
|
合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始
2015年9月1日
初级完成 (实际的)
2016年1月1日
研究完成 (实际的)
2016年6月1日
研究注册日期
首次提交
2015年8月2日
首先提交符合 QC 标准的
2015年8月4日
首次发布 (估计)
2015年8月7日
研究记录更新
最后更新发布 (估计)
2016年11月1日
上次提交的符合 QC 标准的更新
2016年10月30日
最后验证
2016年10月1日
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.