The Effect of Seasonal Variation on Physical Activity in Patients With Heart Failure With Cardiac Implantable Electronic Devices
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- Participant's objective physical activity level
研究概览
简要总结
The aim of this observational study is to determine the effect of seasonal changes on physical activity levels in heart failure patients with cardiac implantable electronic devices.
Patients with heart failure who have a cardiac implantable electronic device will be evaluated throughout the year.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Over 18 years of age,
- •Have a diagnosis of heart failure due to ischemic or non-ischemic cardiomyopathy,
- •Have a cardiac implantable electrical devices,
- •Be in New York Heart Association (NYHA) Class I-II-III.
排除标准
- •Being a New York Heart Association (NYHA) Class IV resident
- •Not living within a 50-mile radius of a weather reporting station,
- •Having documented conditions that limit ambulation, including wheelchair use, serious orthopedic problems, stroke and other neurological disorders, or amputation,
- •Using a left ventricular assist device,
- •Having a history of more than five hospitalizations for any reason,
- •Having recently undergone major cardiovascular or orthopedic surgical procedures, including coronary artery bypass grafting, aortic aneurysm repair, joint replacement, amputation, or spinal surgery,
- •Having a cognitive impairment that impairs cooperation with questionnaires or tests.
研究组 & 干预措施
Patients with Heart Failure with Cardiac Implantable Electronic Devices
干预措施: follow-up study (Other)
结局指标
主要结局
Participant's objective physical activity level
时间窗: Every three months for one year (Patients will be evaluated in all four seasons: spring, summer, autumn, and winter)
Objective measurement of physical activity will be assessed using an accelerometer (Garmin Vivosmart 5). The accelerometer will be placed on the patient's non-dominant wrist for one week, 5 days a week during weekdays and 2 days a week on weekends. The accelerometer can be used day and night, while sleeping or showering, and has enough battery life to collect activity data throughout the day.
Participant's subjective physical activity level
时间窗: Every three months for one year (Patients will be evaluated in all four seasons: spring, summer, autumn, and winter)
Additionally, physical activity will be assessed using International Pyhsical Activity Questionnaire Short Form (IPAQ). The questionnaire examines physical activity in four different groups: vigorous physical activity, moderate physical activity, walking, and sitting. In the results evaluation, the data is converted to metabolic rate (MET) values and calculated accordingly.
次要结局
- Participant's functional capacity(Every three months for one year (Patients will be evaluated in all four seasons: spring, summer, autumn, and winter))
- Participant's motivation for physical activity(Every three months for one year (Patients will be evaluated in all four seasons: spring, summer, autumn, and winter))
研究者
Gamze Nur AHISKALI
PT, MSc. Gamze Nur Ahiskali
Erol Olcok Corum Training and Research Hospital