Chronic Heart FailureNCT02898246
Fear of Activity in Situations (FActS) - Study 2016
An observational study of Chronic Heart Failure and Fear of Movement (Fear of Physical Activity), run by University of Trier at 6 sites in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Chronic Heart Failure, Fear of Movement (Fear of Physical Activity)
- How many people
- 187 participants
- Where
- 6 sitesGermany
- Study dates
- Nov 2016to Jul 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
Germany6 sites
Universitätsklinikum Aachen
Aachen
Universitätsklinikum des Saarlands
Homburg
Mutterhaus der Borromäerinnen
Trier, 54290
Geriatrische Rehabilitationsklinik St. Irminen
Trier
Krankenhaus der Barmherzigen Brüder Trier
Trier
Rhein-Maas-Klinikum
Würselen, 52146
About this study
Official title: 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.
- Keywords
- heart failure, fear of physical activity, motor activity
- Medical subject headings
- Kinesiophobia, Heart Failure, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 2016-2019
Secondary outcomes (3)
Average daily energy expenditure due to physical activity (kcal/d)
Objectively assessed via accelerometry
Measured: 6 day assessment, after questionnaire completion
Average intensity of physical activity (MET)
Objectively assessed via accelerometry
Measured: 6 day assessment, after questionnaire completion
Average relative frequency of activity classes
Relative frequency of activity classes stair climbing, lying down, walking
Measured: 6 day assessment, after questionnaire completion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Sep 2016 (estimated)
- Study startNov 2016
- Primary completionJul 2019
- Study completionJul 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Chronic Heart FailureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 187 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Trier
- Sponsor type
- University, hospital or other
- Collaborators
- Krankenhaus der Barmherzigen Brüder Trier, Geriatric Rehabilitation Clinic St. Irminen, RWTH Aachen University, University Hospital, Saarland
- Responsible party
- Principal investigator, Prof. Dr. Heike Spaderna, University of Trier
- Investigators
- Heike Spaderna, PhD, Principal investigator, Trier University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02898246
- Sponsor's protocol ID
- FActS Study 2016
- Status last verified
- Sep 2019
- First submitted
- 2 Sep 2016
- Last updated
- 6 Sep 2019
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
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. 2026 May-Jun 01;41(3):165-173. doi: 10.1097/JCN.0000000000001242. Epub 2025 Jul 28.
PubMed 40719556Spaderna 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.
PubMed 39236063
Study at a glance
From the registry record, last updated by the sponsor on 6 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Fear of Activity in Situations (FActS) - Heart Failure Study 2016
- ClinicalTrials.gov ID
- NCT02898246
- Acronym / sponsor ID
- FActS Study 2016
- Keywords
- heart failure, fear of physical activity, motor activity
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 187 participants (actual)
- Lead sponsor
- University of TrierUniversity, hospital or other
- Collaborators
- Krankenhaus der Barmherzigen Brüder Trier, Geriatric Rehabilitation Clinic St. Irminen, RWTH Aachen University, University Hospital, Saarland
- Study start
- Nov 2016
- Primary completion
- Jul 2019 (actual)
- Study completion
- Jul 2019 (actual)
- First posted
- 13 Sep 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- Clinical diagnosis of heart failure stage B or C (Hunt et al., 2005), or: New York Heart Failure classification II to IIIb:
Key exclusion criteria (7 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
3 secondary outcomes
Average daily energy expenditure due to physical activity (kcal/d)
Time frame: 6 day assessment, after questionnaire completion
Average intensity of physical activity (MET)
Time frame: 6 day assessment, after questionnaire completion
Average relative frequency of activity classes
Time frame: 6 day assessment, after questionnaire completion
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Sep 2019.
- Derived from this study: PubMed 40719556Luke 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. 2026 May-Jun 01;41(3):165-173. doi: 10.1097/JCN.0000000000001242. Epub 2025 Jul 28.
- Derived from this study: PubMed 39236063Spaderna 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Heike Spaderna, PhD principal investigator
Trier University
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Heart Failure and Fear of Movement (Fear of Physical Activity), run by University of Trier at 6 sites in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Sep 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
FActS-HF 15 total score and subscores (time frame: 2016-2019). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02898246, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Sep 2019.