Chronic Heart FailureNCT03119298
Measuring Fear of Physical Activity in Patients With Heart Failure
An observational study of Chronic Heart Failure and Fear of Physical Activity, run by University of Trier at 1 site in Germany.
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. Read more about this study
- Who is it for?
- Ages 50 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Chronic Heart Failure, Fear of Physical Activity
- How many people
- 60 participants
- Where
- 1 siteGermany
- Study dates
- 2 May 2017to 16 Dec 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 85 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Germany1 site
Department of Health Psychology, Trier University
Trier, Rhineland-Palatinate, 54296
About this study
Official title: Measuring Fear of Physical Activity in Patients With Heart Failure Using Questionnaires and Physiological Parameters
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
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 10 minutes, one time point
Secondary outcomes (1)
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.
Measured: 5 minutes, one time point
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Apr 2017
- Study start2 May 2017
- Primary completion15 Apr 2019
- Study completion16 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Chronic Heart FailureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Trier
- Sponsor type
- University, hospital or other
- Collaborators
- Krankenhaus der Barmherzigen Brüder Trier
- Responsible party
- Principal investigator, Prof. Dr. Heike Spaderna, University of Trier
- Investigators
- Heike Spaderna, Prof. Dr., Study chair, Trier University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03119298
- Sponsor's protocol ID
- 10784
- Status last verified
- Dec 2019
- First submitted
- 10 Apr 2017
- Last updated
- 20 Dec 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 29230643
Study at a glance
From the registry record, last updated by the sponsor on 20 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Measuring Fear of Physical Activity in Patients With Heart Failure Using Questionnaires and Physiological Parameters
- ClinicalTrials.gov ID
- NCT03119298
- Acronym / sponsor ID
- 10784
- Conditions
- Chronic Heart Failure, Fear of Physical Activity
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- University of TrierUniversity, hospital or other
- Collaborators
- Krankenhaus der Barmherzigen Brüder Trier
- Study start
- 2 May 2017 (actual)
- Primary completion
- 15 Apr 2019 (actual)
- Study completion
- 16 Dec 2019 (actual)
- First posted
- 18 Apr 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 50 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- Clinical diagnosis of Heart Failure stage B or C (Hunt et al., 2005), or: New York Heart Failure classification II to IIIb
Key exclusion criteria (7 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
1 secondary outcome
Scores on the Multidimensional Assessment of Interoceptive Awareness (MAIA) scale
Time frame: 5 minutes, one time point
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Dec 2019.
- Background: PubMed 29230643Hoffmann 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Heike Spaderna, Prof. Dr. study chair
Trier University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Heart Failure and Fear of Physical Activity, run by University of Trier at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Dec 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Electromyography (EMG) magnitude (in µV) during startle probes (time frame: 30 minutes, one time point). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03119298, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Dec 2019.