Measuring Fear of Physical Activity in Patients With Heart Failure

NCT03119298 | Completed DMC

• 1 other identifier: 10784
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Heart Failure; Fear of Physical Activity

Outcome Measures

Primary Outcomes (2)

• 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

• 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 Outcomes (1)

• Scores on the Multidimensional Assessment of Interoceptive Awareness (MAIA) scale

  5 minutes, one time point

Study Arms (3)

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

Eligibility Criteria

• Age: 50 Years - 85 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Trier: lead
• Krankenhaus der Barmherzigen Brüder Trier: collaborator

Study Sites (1)

Department of Health Psychology, Trier University

Trier, Rhineland-Palatinate, 54296, Germany

Location

Related 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.

  PMID: 29230643 BACKGROUND

Study Officials

• Heike Spaderna, Prof. Dr.

  Trier University

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Health Psychology

Study Record Dates

• First Submitted: April 10, 2017
• First Posted: April 18, 2017
• Study Start: May 2, 2017
• Primary Completion: April 15, 2019
• Study Completion: December 16, 2019
• Last Updated: December 20, 2019

Record last verified: 2019-12

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)