Maximal Exercise Capacity, Physical Activity and Respiratory Muscle Strength in Peripheral Artery Disease
2020年11月23日 更新者：Meral Boşnak Güçlü、Gazi University
Assessment of Exercise Capacity, Physical Activity, Pulmonary Function, Peripheric and Respiratory Muscle Strength, Respiratory Muscle Endurance in Patient With Peripheral Artery Disease
The primary aim of the study is to evaluate the maximal and submaximal exercise capacity in patients with peripheral artery disease (PAD).
The secondary aim of the study is assessment of physical activity level, respiratory function, peripheral and respiratory muscle strength, respiratory muscle endurance, depression, quality of life, intermittent claudication and cardiovascular risk factors in patients with PAD.
研究概览
地位
完全的
条件
详细说明
Peripheral artery disease is characterized by reduced exercise capacity, physical activity level and intermittent claudication.
The number of studies investigating maximal and submaximal exercise capacity and physical activity level in PAD is limited.
There is also no study investigated pulmonary functions, respiratory muscle strength and endurance in this patient population.
According to the sample size analysis 15 patients and 15 healthy individuals with similar demographic characteristics will be included the study.
Patients and healthy individuals will be selected according to predetermined inclusion and exclusion criteria.
The assessments will be completed in two days.Maximal exercise capacity will be assessed using cardiopulmonary exercise testing (CPET), functional exercise capacity using six minute stepper test, physical activity using multi-sensor activity monitor, pulmonary function using spirometry, respiratory muscle strength using mouth pressure device, peripheral muscle strength using hand held dynamometer, respiratory muscle endurance using incremental threshold loading test, depression using Beck depression inventory (Turkish version), life quality using SF-36 Health Survey (Turkish version), intermittent claudication using Walking Impairment Questionnaire (Turkish version)
研究类型
观察性的
注册 (实际的)
35
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
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Ankara、火鸡、06500
- Gazi University
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Yenimahalle、火鸡
- Gazi University Faculty of Health Sciences Department of Physical Therapy and Rehabilitation
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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
18年 至 80年 (成人、年长者)
接受健康志愿者
是的
有资格学习的性别
全部
取样方法
非概率样本
研究人群
At least 15 patients with PAD will be included in patients group and 15 healthy individuals will be included in control group
描述
Inclusion Criteria:
Patients;
- Diagnosed with peripheral artery disease
- Ankle brachial index (ABI)≤ 1,5 or calcified vessel response
- Clinically stable and under standard medication patients will be included
Exclusion Criteria:
Patients with;
- Ischemic amputation
- Any pulmonary disease
- Unstable coronary artery disease
- Orthopedic and neurological problems
- Acute infection
- Myocardial infarction or major surgery in the last 3 months will be excluded
Healthy controls: Ages 18-80 years will be included
- With any diagnosed disease and smoking more than 10 packsyears will be excluded
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
队列和干预
团体/队列 |
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Patients
Maximal exercise capacity will be assessed using cardiopulmonary exercise testing (CPET), functional exercise capacity using six minute stepper test, physical activity using multi-sensor activity monitor, pulmonary function using spirometry, respiratory muscle strength using mouth pressure device, peripheral muscle strength using hand held dynamometer, respiratory muscle endurance using incremental threshold loading test, depression using Beck depression inventory (Turkish version), life quality using SF-36 Health Survey (Turkish version), intermittent claudication using Walking Impairment Questionnaire (Turkish version)
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Healthy controls
Maximal exercise capacity will be assessed using cardiopulmonary exercise testing (CPET), functional exercise capacity using six minute stepper test, physical activity using multi-sensor activity monitor, pulmonary function using spirometry, respiratory muscle strength using mouth pressure device, peripheral muscle strength using hand held dynamometer, respiratory muscle endurance using incremental threshold loading test, depression using Beck depression inventory (Turkish version), life quality using SF-36 Health Survey (Turkish version), intermittent claudication using Walking Impairment Questionnaire (Turkish version)
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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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Maximal exercise capacity
大体时间：First day
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Cardiopulmonary exercise testing (Oxygen consumption measurement during test)
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First day
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Functional exercise capacity
大体时间：Second day
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Six minute stepper test
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Second day
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Physical activity
大体时间：Second day
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Multi sensor activity monitor
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Second day
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Pulmonary function
大体时间：First day
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Spirometry
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First day
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Respiratory muscle strength
大体时间：First day
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Mouth pressure device
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First day
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Peripheral muscle strength
大体时间：Second day
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Hand held dynamometer
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Second day
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Respiratory muscle endurance
大体时间：Second day
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Incremental threshold loading test
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Second day
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Depression
大体时间：Second day
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Beck depression inventory (Turkish version)
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Second day
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Life quality
大体时间：Second day
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SF-36 Health Survey (Turkish version)
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Second day
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Intermittent claudication
大体时间：Second day
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Walking Impairment Questionnaire (Turkish version)
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Second day
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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。
调查人员
- 研究主任：Meral Boşnak Güçlü, Assoc. Prof、Gazi University
- 学习椅：İnci Hazal Ayas, MSc、Gazi University
- 首席研究员：Burcu Camcıoğlu, PhD、Gazi University
- 首席研究员：Dilek Erer, MD、Gazi University
- 首席研究员：Abdullah Özer, MD、Gazi University
出版物和有用的链接
负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。
一般刊物
- Leeper NJ, Myers J, Zhou M, Nead KT, Syed A, Kojima Y, Caceres RD, Cooke JP. Exercise capacity is the strongest predictor of mortality in patients with peripheral arterial disease. J Vasc Surg. 2013 Mar;57(3):728-33. doi: 10.1016/j.jvs.2012.07.051. Epub 2012 Oct 6.
- Pande RL, Perlstein TS, Beckman JA, Creager MA. Secondary prevention and mortality in peripheral artery disease: National Health and Nutrition Examination Study, 1999 to 2004. Circulation. 2011 Jul 5;124(1):17-23. doi: 10.1161/CIRCULATIONAHA.110.003954. Epub 2011 Jun 20.
- Nordanstig J, Broeren M, Hensater M, Perlander A, Osterberg K, Jivegard L. Six-minute walk test closely correlates to "real-life" outdoor walking capacity and quality of life in patients with intermittent claudication. J Vasc Surg. 2014 Aug;60(2):404-9. doi: 10.1016/j.jvs.2014.03.003. Epub 2014 Mar 29.
- Colas-Ribas C, Signolet I, Henni S, Feuillloy M, Gagnadoux F, Abraham P. High prevalence of known and unknown pulmonary diseases in patients with claudication during exercise oximetry: A retrospective analysis. Medicine (Baltimore). 2016 Oct;95(40):e4888. doi: 10.1097/MD.0000000000004888.
- Sieminski DJ, Gardner AW. The relationship between free-living daily physical activity and the severity of peripheral arterial occlusive disease. Vasc Med. 1997 Nov;2(4):286-91. doi: 10.1177/1358863X9700200402.
- Gardner AW, Montgomery PS, Scott KJ, Blevins SM, Afaq A, Nael R. Association between daily ambulatory activity patterns and exercise performance in patients with intermittent claudication. J Vasc Surg. 2008 Nov;48(5):1238-44. doi: 10.1016/j.jvs.2008.06.062. Epub 2008 Sep 4.
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 (实际的)
2018年1月1日
初级完成 (实际的)
2018年12月31日
研究完成 (实际的)
2019年3月31日
研究注册日期
首次提交
2018年3月2日
首先提交符合 QC 标准的
2018年3月2日
首次发布 (实际的)
2018年3月8日
研究记录更新
最后更新发布 (实际的)
2020年11月24日
上次提交的符合 QC 标准的更新
2020年11月23日
最后验证
2020年11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.
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