Fear of Activity in Situations (FActS) - Study 2016

Completed

• Conditions: Fear of Movement (Fear of Physical Activity); Chronic Heart Failure

• Registration Number: NCT02898246
• Lead Sponsor: University of Trier

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2016-09-02
• Study First Submitted QC: 2016-09-07
• Study First Posted: 2016-09-13
• Study Start: 2016-11
• Primary Completion: 2019-07
• Study Completion: 2019-07
• Status Verified: 2019-09
• Last Update Submitted: 2019-09-04
• Last Update Posted: 2019-09-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 187

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
FActS-HF 15 total score and subscores	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.

Secondary Outcome Measures

Name	Time	Method
Average intensity of physical activity (MET)	6 day assessment, after questionnaire completion	Objectively assessed via accelerometry
Average relative frequency of activity classes	6 day assessment, after questionnaire completion	Relative frequency of activity classes stair climbing, lying down, walking
Average daily energy expenditure due to physical activity (kcal/d)	6 day assessment, after questionnaire completion	Objectively assessed via accelerometry

Trial Locations

Locations (6)

Universitätsklinikum Aachen; 🇩🇪 Aachen, Germany

Mutterhaus der Borromäerinnen; 🇩🇪 Trier, Germany

Universitätsklinikum des Saarlands; 🇩🇪 Homburg, Germany

Geriatrische Rehabilitationsklinik St. Irminen; 🇩🇪 Trier, Germany

Krankenhaus der Barmherzigen Brüder Trier; 🇩🇪 Trier, Germany

Rhein-Maas-Klinikum; 🇩🇪 Würselen, Germany