Measuring Fear of Physical Activity in Patients With Heart Failure
NCT ID: NCT03119298
Last Updated: 2019-12-20
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
60 participants
OBSERVATIONAL
2017-05-02
2019-12-16
Brief Summary
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Aim 1: The "startle paradigm" will be used to investigate the physiological component of fear of PA. The startle paradigm is based on empirical observations that the startle reflex is larger after the priming with unpleasant stimuli and inhibited after the priming with pleasant stimuli. The participants will be primed with various words including those words associated with physical activity that are expected to be unpleasant in patients with high fear of PA. The startle reflex will be triggered by air puffs on the eyes (startle probes) and measured via facial electromyography (EMG). We assume that startle responses primed with PA related words are stronger in patients with high fear of PA compared to the other groups.
Aim 2: Interoceptive accuracy will be assessed via the "Schandry test" and interoceptive awareness will be assessed via the "Multidimensional Assessment of Interoceptive Awareness" (MAIA) questionnaire. During the Schandry test the participants will be instructed to subjectively count their heart rate without any aid or tools. The heart rate will be objectively measured at the same time via ECG. A high congruence of the objective and subjective results indicates a high interoception ability, and is assumed to be correlated with fear of physical activity. Additionally, we expect the MAIA and FActS scores to be correlated.
Detailed Description
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Conditions
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Study Design
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CASE_CONTROL
CROSS_SECTIONAL
Study Groups
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High-fear-of-physical-activity group
Group members with high fear of physical activity
No interventions assigned to this group
Low-fear-of-physical-activity group
Group members with low fear of physical activity
No interventions assigned to this group
Control group
Healthy subjects matched for age and sex
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
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
* 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
50 Years
85 Years
ALL
Yes
Sponsors
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Krankenhaus der Barmherzigen Brüder Trier
OTHER
University of Trier
OTHER
Responsible Party
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Prof. Dr. Heike Spaderna
Professor of Health Psychology
Principal Investigators
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Heike Spaderna, Prof. Dr.
Role: STUDY_CHAIR
Trier University
Locations
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Department of Health Psychology, Trier University
Trier, Rhineland-Palatinate, Germany
Countries
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References
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Hoffmann JM, Hellwig S, Brandenburg VM, Spaderna H. Measuring Fear of Physical Activity in Patients with Heart Failure. Int J Behav Med. 2018 Jun;25(3):294-303. doi: 10.1007/s12529-017-9704-x.
Other Identifiers
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10784
Identifier Type: -
Identifier Source: org_study_id