NCT02898246

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
187

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Nov 2016

Typical duration for all trials

Geographic Reach
1 country

6 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 2, 2016

Completed
11 days until next milestone

First Posted

Study publicly available on registry

September 13, 2016

Completed
2 months until next milestone

Study Start

First participant enrolled

November 1, 2016

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2019

Completed
Last Updated

September 6, 2019

Status Verified

September 1, 2019

Enrollment Period

2.7 years

First QC Date

September 2, 2016

Last Update Submit

September 4, 2019

Conditions

Chronic Heart FailureFear of Movement (Fear of Physical Activity)

Keywords

heart failurefear of physical activitymotor activity

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (3)

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

    6 day assessment, after questionnaire completion

  • Average intensity of physical activity (MET)

    6 day assessment, after questionnaire completion

  • Average relative frequency of activity classes

    6 day assessment, after questionnaire completion

Study Arms (1)

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.

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (6)

Universitätsklinikum Aachen

Aachen, Germany

Location

Universitätsklinikum des Saarlands

Homburg, Germany

Location

Mutterhaus der Borromäerinnen

Trier, 54290, Germany

Location

Geriatrische Rehabilitationsklinik St. Irminen

Trier, Germany

Location

Krankenhaus der Barmherzigen Brüder Trier

Trier, Germany

Location

Rhein-Maas-Klinikum

Würselen, 52146, Germany

Location

Related Publications (2)

  • Luke T, Brandenburg VM, Partetzke TM, Voss F, Spaderna H. Accelerometer-Measured Daily Physical Activity in Adults With Chronic Heart Failure and Associations With Fear of Physical Activity and Coping Dispositions. J Cardiovasc Nurs. 2025 Jul 28. doi: 10.1097/JCN.0000000000001242. Online ahead of print.

    PMID: 40719556DERIVED

  • Spaderna H, Brandenburg VM, Lauterbach M, Partetzke TM, Schwab SU, Voss F, Kindermann I. Associations of fear of physical activity, coping style and self-reported exercise behavior in patients with chronic heart failure. PLoS One. 2024 Sep 5;19(9):e0309952. doi: 10.1371/journal.pone.0309952. eCollection 2024.

    PMID: 39236063DERIVED

MeSH Terms

Conditions

KinesiophobiaHeart FailureMotor Activity

Condition Hierarchy (Ancestors)

Phobic DisordersAnxiety DisordersMental DisordersHeart DiseasesCardiovascular DiseasesBehavior

Study Officials

  • Heike Spaderna, PhD

    Trier University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Head of Department of Health Psychology

Study Record Dates

First Submitted

September 2, 2016

First Posted

September 13, 2016

Study Start

November 1, 2016

Primary Completion

July 1, 2019

Study Completion

July 1, 2019

Last Updated

September 6, 2019

Record last verified: 2019-09

Data Sharing

IPD Sharing
Will not share

Locations

DE(6)