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Fear of Activity in Situations (FActS) - Study 2016

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02898246
Enrollment
187
Registered
2016-09-13
Start date
2016-11-30
Completion date
2019-07-31
Last updated
2019-09-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Keywords

heart failure, fear of physical activity, motor activity

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.

Interventions

None listed

Sponsors

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

Study design

Observational model
COHORT
Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
FActS-HF 15 total score and subscores2016-2019The 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

MeasureTime frameDescription
Average daily energy expenditure due to physical activity (kcal/d)6 day assessment, after questionnaire completionObjectively assessed via accelerometry
Average intensity of physical activity (MET)6 day assessment, after questionnaire completionObjectively assessed via accelerometry
Average relative frequency of activity classes6 day assessment, after questionnaire completionRelative frequency of activity classes stair climbing, lying down, walking

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 5, 2026