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临床试验/NCT04754360
NCT04754360已完成不适用

Cut-off Values of 6-min Walk Test and Sit-to-stand Test for Determining Symptom Burden and Functional Impairment in Atrial Fibrillation

Izmir Bakircay University1 个研究点 分布在 1 个国家目标入组 125 人开始时间: 2021年2月15日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
125
试验地点
1
主要终点
The European Heart Rhythm Association (EHRA) score

研究概览

简要总结

Cut-off values indicating higher symptom burden and impairment in health status in 6-min walk test and 30-second sit-to-stand test in patients with atrial fibrillation will be determined in the study.

详细描述

The 6-min walk test (6MWT) is the most used field test for measuring functional impairment in cardiopulmonary patients. However, to be able to objectively interpret 6MWT of a patient with specific chronic condition, the distance walked in 6MWT should be compared to either a healthy control group or a cut-off value that was specifically determined for that population. Such cut-off values are present for 6MWT in several cardiopulmonary diseases including COPD (350 m), heart failure (200 m) and pulmonary hypertension (400 m) for identifying patients with high mortality, poor prognosis and/or poor health status, but there is no cut-off value determined for atrial fibrillation (AF). The European Heart Rhythm Association (EHRA) score is a practical measure for assessing symptom burden and functional impairment caused by AF-related symptoms. While EHRA class 1 indicates asymptomatic patients, EHRA class 2, 3 and 4 indicates higher severities of symptom burden and functional impairment. Primary aim of this study is to determine a cut-off value in 6MWT for discriminating between the asymptomatic and symptomatic AF patients according to EHRA classification. In addition, a cut-off value for 30-second sit-to-stand test will be determined in these patients as well, since sit-to-stand tests have gained a lot of interest in the recent literature for practically evaluating functional status in various cardiopulmonary conditions.

研究设计

研究类型
Observational
观察模型
Other
时间视角
Prospective

入排标准

年龄范围
18 Years 至 99 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Diagnosis of paroxysmal, persistant or permanent atrial fibrillation

排除标准

  • Diagnosis of heart failure or any chronic respiratory disease
  • Recent coronary bypass surgery
  • Previous heart valve surgery
  • Rheumatic valvular heart disease
  • Recent acute myocardial infarction
  • Having a pacemaker

结局指标

主要结局

The European Heart Rhythm Association (EHRA) score

时间窗: At baseline

Functional impairment and symptom burden of the patients will be determined according to The European Heart Rhythm Association (EHRA) score. While EHRA class 1 indicates asymptomatic patients, EHRA class 2, 3 and 4 indicates higher severities of symptom burden and functional impairment, respectively.

6-min walk distance

时间窗: At baseline

Distance walked in six minutes will be recorded. Test will be conducted according to the guideline of American Thoracic Society (ATS).

Number of repetitions in 30-second sit-to-stand test

时间窗: At baseline

Participants will be asked to perform sit-to-stand maneuver as fast as possible for 30 seconds and the number of completed repetitions will be recorded.

次要结局

  • Maximum inspiratory pressure (MIP)(At baseline)
  • International Physical Activity Questionnaire - Short Form(At baseline)
  • Maximum expiratory pressure (MEP)(At baseline)
  • Forced Vital Capacity (FVC)(At baseline)
  • Forced Expiratory Volume in 1 second (FEV1)(At baseline)
  • Peak Expiratory Flow (PEF)(At baseline)
  • Short Form-36(At baseline)

研究者

发起方
Izmir Bakircay University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Melih Zeren

Assist. Prof. Dr.

Izmir Bakircay University

研究点 (1)

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