Clinical trial NCT02898246: Fear of Activity in Situations (FActS) - Study 2016
Official title: Fear of Activity in Situations (FActS) - Heart Failure Study 2016
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Chronic Heart Failure
Fear of Movement (Fear of Physical Activity)
Keywords: heart failure
fear of physical activity
motor activity
Lead sponsor: University of Trier
Sponsor class: OTHER
Collaborators: name: Krankenhaus der Barmherzigen Brüder Trier
name: Geriatric Rehabilitation Clinic St. Irminen
name: RWTH Aachen University
name: University Hospital, Saarland
First posted: 2016-09-13
Enrollment: 187
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study population will consist of adult patients with diagnosed chronic heart failure of all underlying diagnoses. Patients have to be outpatients at time of study participation. They will be recruted in primary care clinics, and heart failure outpatient clinics in Germany.

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.


Eligibility criteria: 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

Primary outcomes:
measure: FActS-HF 15 total score and subscores
timeFrame: 2016-2019
Secondary outcomes:
measure: Average daily energy expenditure due to physical activity (kcal/d)
timeFrame: 6 day assessment, after questionnaire completion
measure: Average intensity of physical activity (MET)
timeFrame: 6 day assessment, after questionnaire completion
measure: Average relative frequency of activity classes
timeFrame: 6 day assessment, after questionnaire completion
Other outcomes:
Locations:
city: Aachen
country: Germany
facility: Universitätsklinikum Aachen
city: Homburg
country: Germany
facility: Universitätsklinikum des Saarlands
city: Trier
country: Germany
facility: Mutterhaus der Borromäerinnen
city: Trier
country: Germany
facility: Geriatrische Rehabilitationsklinik St. Irminen
city: Trier
country: Germany
facility: Krankenhaus der Barmherzigen Brüder Trier
city: Würselen
country: Germany
facility: Rhein-Maas-Klinikum
Study officials:
affiliation: Trier University
name: Heike Spaderna, PhD
role: PRINCIPAL_INVESTIGATOR
References: