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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

      • Ankara、火鸡、06500
        • Gazi University
      • Yenimahalle、火鸡
        • Gazi University Faculty of Health Sciences Department of Physical Therapy and Rehabilitation

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
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)
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)

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
Maximal exercise capacity
大体时间:First day
Cardiopulmonary exercise testing (Oxygen consumption measurement during test)
First day

次要结果测量

结果测量
措施说明
大体时间
Functional exercise capacity
大体时间:Second day
Six minute stepper test
Second day
Physical activity
大体时间:Second day
Multi sensor activity monitor
Second day
Pulmonary function
大体时间:First day
Spirometry
First day
Respiratory muscle strength
大体时间:First day
Mouth pressure device
First day
Peripheral muscle strength
大体时间:Second day
Hand held dynamometer
Second day
Respiratory muscle endurance
大体时间:Second day
Incremental threshold loading test
Second day
Depression
大体时间:Second day
Beck depression inventory (Turkish version)
Second day
Life quality
大体时间:Second day
SF-36 Health Survey (Turkish version)
Second day
Intermittent claudication
大体时间:Second day
Walking Impairment Questionnaire (Turkish version)
Second day

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。

赞助

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

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

与本研究相关的术语

其他研究编号

  • Gazi University 9

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)?

药物和器械信息、研究文件

研究美国 FDA 监管的药品

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