Cut-off Values of 6-min Walk Test and Sit-to-stand Test for Determining Symptom Burden and Functional Impairment in Atrial Fibrillation
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
- 否
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
Melih Zeren
Assist. Prof. Dr.
Izmir Bakircay University
