Fear of Activity in Situations (FActS) - Study 2016

Study Overview
=================
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.

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

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

Participation Criteria
=================
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: Systolic dysfunction: left ventricular ejection fraction < 45% in the last 6 month 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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 85 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Patients with chronic heart failure<br>Fear of physical activity (exposure) will be assessed in adult outpatients with diagnosed, chronic heart failure (with reduced ejection fraction or with preserved ejection fraction). Hospitals provide medical data to assess patients' disease severity. Additional measures assessed via questionnaire include demographic characteristics, State and Trait depression and anxiety, heart failure related symptom distress, and coping dispositions relevant for coping with physical threat. Fear of physical activity (FActS-HF 15) is reassessed after 4 weeks to evaluate the instrument's retest reliability. After questionnaire completion, a subsample of participants will wear the MOVE III accelerometer for one week to objectively assess everyday physical activity and fill in an activity diary. | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

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

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
heart failure, fear of physical activity, motor activity