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NCT Number: NCT02898246

Fear of Activity in Situations (FActS) - Study 2016

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.

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Key information

Conditions

Chronic Heart Failure Anxiety Disorders Behavior Cardiovascular Diseases Fear of Movement (Fear of Physical Activity) Heart Diseases Heart Failure Kinesiophobia Mental Disorders Motor Activity Phobic Disorders

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Universitätsklinikum Aachen, Aachen, Germany

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. FActS-HF 15 total score and subscores

    Time frame: 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 outcomes

  1. Average daily energy expenditure due to physical activity (kcal/d)

    Time frame: 6 day assessment, after questionnaire completion

    Objectively assessed via accelerometry

  2. Average intensity of physical activity (MET)

    Time frame: 6 day assessment, after questionnaire completion

    Objectively assessed via accelerometry

  3. Average relative frequency of activity classes

    Time frame: 6 day assessment, after questionnaire completion

    Relative frequency of activity classes stair climbing, lying down, walking

Sponsors and collaborators

Lead sponsor

University of Trier

Other

Collaborators

  • Geriatric Rehabilitation Clinic St. Irminen
  • Krankenhaus der Barmherzigen Brüder Trier
  • RWTH Aachen University
  • University Hospital, Saarland

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2019
Study completion
2019
First posted
Sep 13, 2016
Registry last updated
Sep 6, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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