Measuring Fear of Physical Activity in Patients With Heart Failure
|ClinicalTrials.gov Identifier: NCT03119298|
Recruitment Status : Completed
First Posted : April 18, 2017
Last Update Posted : December 20, 2019
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|
|Study Type :||Observational|
|Actual Enrollment :||60 participants|
|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|
Group members with high fear of physical activity
Group members with low fear of physical activity
Healthy subjects matched for age and sex
- 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.
- 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.
- 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.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03119298
|Department of Health Psychology, Trier University|
|Trier, Rhineland-Palatinate, Germany, 54296|
|Study Chair:||Heike Spaderna, Prof. Dr.||Trier University|