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临床试验/NCT04335760
NCT04335760已完成不适用

Is There a Relationship Between Fear of Activity and Functional Capacity in Patients With Coronary Artery Disease? - A Multi-Center Study From Turkey

Tuğba Atan1 个研究点 分布在 1 个国家目标入组 309 人开始时间: 2016年1月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
309
试验地点
1
主要终点
Fear of activity scale in CAD (FactCAD)

研究概览

简要总结

To identify whether coronary artery disease (CAD) patients have fear of activity, and to assess the relationship between fear of activity and exercise capacity in CAD patients.

详细描述

Cardiac rehabilitation (CR) is a well-known way of secondary prevention in heart diseases. CR is shown to be effective in reducing cardiovascular morbidity and mortality. CR also enhances exercise capacity and quality of life, promotes healthy and active lifestyle and reduces psychosocial stress and depressive symptoms in coronary artery disease (CAD). Exercise is one of the most important component of CR. The positive prognostic effect of the exercise on cardiovascular disease is mediated by mechanisms such as reducing numerous risk factors, enhancing endothelial function, declining arterial inflammation and stiffness, improving diastolic function, remodeling of left ventricle, and stabilization of electrical activity. Each 1 MET increase in functional capacity is known to improve survival by 12 %. Exercise capacity is a more powerful predictor of mortality among men than other established risk factors for cardiovascular disease.

The prevalence of fear of activity in CAD, heart failure and female patients have been studied by several researchers reporting variable results. It ranges from 70% in acute hospitalized CAD patients to 20% in chronic patients in community. Muscle endurance, steps per day measured by pedometer, IPAQ were found to be lower in patients with high level of fear of activity.They did not measure exercise capacity objectively. Research investigating the effect of fear of activity on exercise capacity in patients with CAD is lacking.

The aim of this study is to identify whether coronary artery disease (CAD) patients have fear of activity, and to assess the relationship between fear of activity and exercise capacity in CAD patients. The hypothesis of this study were that CAD patients would have lower exercise capacity than healthy subjects and CAD patients with higher fear of activity would have lower exercise capacity.

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 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Age > 18 years
  • History of diagnosis of CAD and/or cardiac event in the past 1-60 months
  • Being medically stable
  • Cognitive and physical ability to complete the required tests.

排除标准

  • Patients with recent cardiac event sooner than 1 month
  • Musculoskeletal/neurologic problems imparing ambulation or current hospitalization

结局指标

主要结局

Fear of activity scale in CAD (FactCAD)

时间窗: baseline

Fear of activity scale in CAD (FactCAD) was used to assess fear of activity and exercise in subjects with CAD. FactCAD is a novel scale developed specifically for patients with heart disease. Mean time to complete this self-administered scale is 4-7 minutes. The final score of the questionnaire ranges between 0 and 84. High scores indicate higher levels of fear regarding activity or exercise.

Exercise test (Modified Bruce protocol)

时间窗: baseline

Modified Bruce protocol on treadmill was used in institutions where technical equipment and experience was available.

Functional capacity (6MWT)

时间窗: baseline

Functional exercise capacity was assessed by distance walked in 6 minutes (6MWT). The patient was asked to walk as long as possible for 6 minutes on a 30 meters of marked and flat ground, at a self selected speed. 6MWT is a submaximal exercise test and can be used to assess treatment response.

次要结局

未报告次要终点

研究者

发起方
Tuğba Atan
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Tuğba Atan

MD, Physiatrist (Department of Physical Medicine and Rehabilitation)

Hitit University

研究点 (1)

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