Fear of Activity in Situations (FActS) - Study 2016

University of Trier187 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

187

Conditions

Chronic Heart Failure Fear of Movement (Fear of Physical Activity)

Eligibility

Sex: ALLMin age: 18 YearsMax age: 85 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Clinical diagnosis of heart failure stage B or C (Hunt et al., 2005), or: New York Heart Failure classification II to IIIb: 1. Systolic dysfunction: left ventricular ejection fraction \< 45% in the last 6 month 2. Diastolic dysfunction: left ventricular ejection fraction \>= 45% in the last 6 month Exclusion Criteria: * 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

Locations (6)

Universitätsklinikum Aachen

Aachen, Germany

Universitätsklinikum des Saarlands

Homburg, Germany

Mutterhaus der Borromäerinnen

Trier, Germany

Geriatrische Rehabilitationsklinik St. Irminen

Trier, Germany

Krankenhaus der Barmherzigen Brüder Trier

Trier, Germany

Rhein-Maas-Klinikum

Würselen, Germany

Outcomes

Primary Outcomes

FActS-HF 15 total score and subscores

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.

Time frame: 2016-2019

Secondary Outcomes

Average daily energy expenditure due to physical activity (kcal/d)

Objectively assessed via accelerometry

Time frame: 6 day assessment, after questionnaire completion

Average intensity of physical activity (MET)

Objectively assessed via accelerometry

Time frame: 6 day assessment, after questionnaire completion

Average relative frequency of activity classes

Relative frequency of activity classes stair climbing, lying down, walking

Time frame: 6 day assessment, after questionnaire completion