Fear of Activity in Situations (FActS) - Study 2016

Fear of Activity in Situations (FActS) - Heart Failure 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.

Study Overview

• Status: Completed
• Conditions: Chronic Heart Failure; Fear of Movement (Fear of Physical Activity)

• Study Type: Observational
• Enrollment (Actual): 187

Contacts and Locations

Study Locations

• Germany
  • Aachen, Germany
    • Universitätsklinikum Aachen
  • Homburg, Germany
    • Universitätsklinikum des Saarlands
  • Trier, Germany, 54290
    • Mutterhaus der Borromäerinnen
  • Trier, Germany
    • Krankenhaus der Barmherzigen Bruder Trier
  • Trier, Germany
    • Geriatrische Rehabilitationsklinik St. Irminen
  • Würselen, Germany, 52146
    • Rhein-Maas-Klinikum

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Cross-Sectional

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Patients with chronic heart failure; 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

Collaborators and Investigators

• Sponsor: University of Trier
• Collaborators: RWTH Aachen University; University Hospital, Saarland; Krankenhaus der Barmherzigen Brüder Trier; Geriatric Rehabilitation Clinic St. Irminen
• Investigators: Principal Investigator: Heike Spaderna, PhD, Trier University

Study record dates

Study Major Dates

• Study Start: November 1, 2016
• Primary Completion (Actual): July 1, 2019
• Study Completion (Actual): July 1, 2019

Study Registration Dates

• First Submitted: September 2, 2016
• First Submitted That Met QC Criteria: September 7, 2016
• First Posted (Estimate): September 13, 2016

Study Record Updates

• Last Update Posted (Actual): September 6, 2019
• Last Update Submitted That Met QC Criteria: September 4, 2019
• Last Verified: September 1, 2019

More Information

Terms related to this study

• Keywords: heart failure; motor activity; fear of physical activity
• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Heart Failure
• Other Study ID Numbers: FActS Study 2016

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No