Fear of Activity in Situations (FActS) - Study 2016

Chronic Heart Failure Clinical Trial

Official title:

Fear of Activity in Situations (FActS) - Heart Failure Study 2016

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02898246
• Other study ID #: FActS Study 2016
• Status: Completed
• Start date: November 2016
• Est. completion date: July 2019

Study information

• Verified date: September 2019
• Source: University of Trier
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 187
• Est. completion date: July 2019
• Est. primary completion date: July 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

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

Locations

Country	Name	City	State
Germany	Universitätsklinikum Aachen	Aachen
Germany	Universitätsklinikum des Saarlands	Homburg
Germany	Geriatrische Rehabilitationsklinik St. Irminen	Trier
Germany	Krankenhaus der Barmherzigen Brüder Trier	Trier
Germany	Mutterhaus der Borromäerinnen	Trier
Germany	Rhein-Maas-Klinikum	Würselen

Sponsors (5)

Lead Sponsor	Collaborator
University of Trier	Geriatric Rehabilitation Clinic St. Irminen, Krankenhaus der Barmherzigen Brüder Trier, RWTH Aachen University, University Hospital, Saarland

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	2016-2019
Secondary	Average daily energy expenditure due to physical activity (kcal/d)	Objectively assessed via accelerometry	6 day assessment, after questionnaire completion
Secondary	Average intensity of physical activity (MET)	Objectively assessed via accelerometry	6 day assessment, after questionnaire completion
Secondary	Average relative frequency of activity classes	Relative frequency of activity classes stair climbing, lying down, walking	6 day assessment, after questionnaire completion