Measuring Fear of Physical Activity in Patients With Heart Failure

Chronic Heart Failure Clinical Trial

Official title:

Measuring Fear of Physical Activity in Patients With Heart Failure Using Questionnaires and Physiological Parameters

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03119298
• Other study ID #: 10784
• Status: Completed
• Start date: May 2, 2017
• Est. completion date: December 16, 2019

Study information

• Verified date: December 2019
• Source: University of Trier
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: December 16, 2019
• Est. primary completion date: April 15, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 50 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Chronic Heart Failure
• Fear of Physical Activity
• Heart Failure

Locations

Country	Name	City	State
Germany	Department of Health Psychology, Trier University	Trier	Rhineland-Palatinate

Sponsors (2)

Lead Sponsor	Collaborator
University of Trier	Krankenhaus der Barmherzigen Brüder Trier

Country where clinical trial is conducted

Germany, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Electromyography (EMG) magnitude (in µV) during startle probes	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.	30 minutes, one time point
Primary	Electrocardiography (ECG) measures of interbeat intervals and subjective counts of heart beats	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.	10 minutes, one time point
Secondary	Scores on the Multidimensional Assessment of Interoceptive Awareness (MAIA) scale	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.	5 minutes, one time point