Fear of Activity in Situations (FActS) - Heart Failure Study 2016
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 187
- 试验地点
- 6
- 主要终点
- FActS-HF 15 total score and subscores
研究概览
简要总结
The aim of the study is to evaluate the psychometric properties of the newly developed Fear of Activity in Situations - Heart Failure (FActS-HF 15) scale. The FActS-HF 15 is a questionnaire assessing fear of physical activity (fear of movement) in patients with chronic heart failure. FActS-HF 15 assesses cognitions and emotions that can occur during physical activity, independent of avoidance behavior. Firstly, the study aims at evaluating the instrument's reliability and validity and to investigate associations of fear of physical activity with demographic, medical, and psychosocial patient characteristics. Secondly, the study aims at assessing everyday physical activity using accelerometric measures to test the hypothesis that fear of physical activity in patients with heart failure is related with lower actual physical activity.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Clinical diagnosis of heart failure stage B or C (Hunt et al., 2005), or: New York Heart Failure classification II to IIIb:
- •Systolic dysfunction: left ventricular ejection fraction < 45% in the last 6 month
- •Diastolic dysfunction: left ventricular ejection fraction >= 45% in the last 6 month
排除标准
- •complex ventricular arrhythmias
- •acute myocarditis
- •symptomatic cardiac valve stenosis
- •instable angina pectoris
- •other severe diseases, that impair physical activity (e.g., advanced stages of cancer)
- •insufficient language skills in German to answer the questionnaires
- •insufficient cognitive skills to answer the questionnaires
结局指标
主要结局
FActS-HF 15 total score and subscores
时间窗: 2016-2019
The psychometric properties of FActS-HF 15 are assessed in terms of item analysis, reliability (internal consistency, test-retest reliability), convergent and discriminant validity (correlations with other questionnaires) as well as confirmatory factor analysis (assessing the dimensionality). Associations with demographic, medical, and psychosocial variables will be evaluated.
次要结局
- Average relative frequency of activity classes(6 day assessment, after questionnaire completion)
- Average daily energy expenditure due to physical activity (kcal/d)(6 day assessment, after questionnaire completion)
- Average intensity of physical activity (MET)(6 day assessment, after questionnaire completion)
研究者
Prof. Dr. Heike Spaderna
Head of Department of Health Psychology
University of Trier