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临床试验/NCT03458754
NCT03458754已完成不适用

Assessment of Exercise Capacity, Physical Activity, Pulmonary Function, Peripheric and Respiratory Muscle Strength, Respiratory Muscle Endurance in Patient With Peripheral Artery Disease

Gazi University2 个研究点 分布在 1 个国家目标入组 35 人开始时间: 2018年1月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
35
试验地点
2
主要终点
Maximal exercise capacity

研究概览

简要总结

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.

详细描述

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)

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Cross Sectional

入排标准

年龄范围
18 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • 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

结局指标

主要结局

Maximal exercise capacity

时间窗: First day

Cardiopulmonary exercise testing (Oxygen consumption measurement during test)

次要结局

  • Life quality(Second day)
  • Intermittent claudication(Second day)
  • Functional exercise capacity(Second day)
  • Pulmonary function(First day)
  • Respiratory muscle strength(First day)
  • Peripheral muscle strength(Second day)
  • Depression(Second day)
  • Physical activity(Second day)
  • Respiratory muscle endurance(Second day)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Meral Boşnak Güçlü

Assoc. Prof

Gazi University

研究点 (2)

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