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Measuring Fear of Physical Activity in Patients With Heart Failure

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03119298
Recruitment Status : Completed
First Posted : April 18, 2017
Last Update Posted : December 20, 2019
Sponsor:
Collaborator:
Krankenhaus der Barmherzigen Brüder Trier
Information provided by (Responsible Party):
Prof. Dr. Heike Spaderna, University of Trier

Brief Summary:

The study's aims are twofold: First, to examine physiological correlates of fear of physical activity (PA) and second, to examine correlates between fear of PA and interoceptive abilities in patients with chronic heart failure and healthy persons. Patients' fear of PA will be assessed via the "Fear of Activity in Situations - Heart Failure" (FActS-HF) questionnaire. The patient group will be split into two subgroups: One with high fear of PA and the second with low fear of PA based on FActS-HF scores. Fear of PA will be assessed via an adapted version of FActS-HF in a sample of healthy persons (control group). Each member of the high-fear-of-PA group will be individually age- and sex-matched with one member of the low-fear-of-PA group and control group. The participants of all three groups undergo the same experimental trials.

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.


Condition or disease
Chronic Heart Failure Fear of Physical Activity

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Study Type : Observational
Actual Enrollment : 60 participants
Observational Model: Case-Control
Time Perspective: Cross-Sectional
Official Title: Measuring Fear of Physical Activity in Patients With Heart Failure Using Questionnaires and Physiological Parameters
Actual Study Start Date : May 2, 2017
Actual Primary Completion Date : April 15, 2019
Actual Study Completion Date : December 16, 2019

Resource links provided by the National Library of Medicine


Group/Cohort
High-fear-of-physical-activity group
Group members with high fear of physical activity
Low-fear-of-physical-activity group
Group members with low fear of physical activity
Control group
Healthy subjects matched for age and sex



Primary Outcome Measures :
  1. Electromyography (EMG) magnitude (in µV) during startle probes [ Time Frame: 30 minutes, one time point ]
    The startle reflex will be triggered by air puffs (startle probes) and its modulation in response to a set of verbal stimuli related to physical activity will be measured with the EMG during a time window of 30 minutes. Thereby physiological (EMG magnitude) correlates of fear of physical activity will be assessed.

  2. Electrocardiography (ECG) measures of interbeat intervals and subjective counts of heart beats [ Time Frame: 10 minutes, one time point ]
    Interoceptive accuracy will be assessed as the congruence of subjective heart beat counts and objectively measured ECG interbeat intervals (Schandry test) during specified time intervals.


Secondary Outcome Measures :
  1. Scores on the Multidimensional Assessment of Interoceptive Awareness (MAIA) scale [ Time Frame: 5 minutes, one time point ]
    The MAIA scale assesses the interoceptive awareness using the subscales emotional awareness, body listening, etc. Each item is rated on a continuous scale from 0 (never) to 5 (always). Sum scores of the subscales will be calculated.



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Ages Eligible for Study:   50 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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 recruited in primary care clinics, and heart failure outpatient clinics in Germany. For the control group healthy volunteers without a chronic heart failure are recruited.
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03119298


Locations
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Germany
Department of Health Psychology, Trier University
Trier, Rhineland-Palatinate, Germany, 54296
Sponsors and Collaborators
University of Trier
Krankenhaus der Barmherzigen Brüder Trier
Investigators
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Study Chair: Heike Spaderna, Prof. Dr. Trier University
Publications:
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Responsible Party: Prof. Dr. Heike Spaderna, Professor of Health Psychology, University of Trier
ClinicalTrials.gov Identifier: NCT03119298    
Other Study ID Numbers: 10784
First Posted: April 18, 2017    Key Record Dates
Last Update Posted: December 20, 2019
Last Verified: December 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Heart Failure
Heart Diseases
Cardiovascular Diseases