Performance AnxietyPACENCT03562312
Performance Anxiety Changes With Exercise
A study testing high-intensive aerobe exercise and low-intensive aerobe exercise in people with Performance Anxiety, run by Charite University, Berlin, Germany at 1 site in Germany.
Trial summary
This study investigates the effect of high-intense aerobe exercise training (HIIT) and aerobe exercise of low intensity on clinical and physiological parameters (anxiety, activity, cortisol, alpha amylase, heart rate, heart rate variability, spiroergometry) in patients with Music Performance Anxiety (MPA). Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Performance Anxiety
- What is being tested?
- high-intensive aerobe exercise and low-intensive aerobe exercise
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 28 participants
- Where
- 1 siteGermany
- Study dates
- 3 May 2018to 14 Apr 2020
- Phase
- Interventional
- 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 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of social anxiety disorder, Performance only subtype due to DSM-5
- Appropriate abilities to communicate and to complete the questionnaires
- Written informed consent
- Possibility of regular attendance at the training sessions
- Participant is a classical instrumentalist
Who cannot join
- Other severe mental conditions than MPA (e.g. schizophrenia, severe depressive episode, addiction)
- Acute suicidality
- Epilepsy or other disorders of the central nervous system (e.g. tumor, encephalitis)
- Contraindications to aerobe exercise Training
- Start or modification of an anxiolytic pharmacotherapy or other therapy within the last four weeks
- Current psychotherapy
- no sufficient capability to consent to trial
Trial locations and contacts
1 site in 1 country.
Germany1 site
Department of Psychiatry and Psychotherapy, Charité - Universitätsmedizin Berlin, Campus Mitte
Berlin, 10117
About this study
Official title: Clinical, Neuroendocrine and Physiological Effects of Exercise in Patients With Music Performance Anxiety
This study investigates the effect of high-intense aerobe exercise training (HIIT) and aerobe exercise of low intensity on clinical and physiological parameters (anxiety, activity, cortisol, alpha amylase, heart rate, heart rate variability, spiroergometry) in patients with Music Performance Anxiety (MPA). Half of the patients will receive HIIT, while the other half will receive aerobe exercise of low intensity.
Read the detailed description
In this study, 20 patients with MPA will receive a high-intensive aerobe training (HIIT, 6 HIIT-sessions of 20 minutes within a period of 12 days). Additionally, 20 MPA-patients will undergo a less intense aerobe training matched regarding frequency and duration of sessions. Prior to the first training session, after completing the training (day 12) and 10 days after the Training (day 22), symptoms of anxiety and will be assessed by using questionnaires. Moreover, heart rate and heart rate variability will be obtained and activity level is measured using accelerometers. Before and after the training there will be an assessment of saliva samples for measuring cortisol and alpha amylase.
Furthermore, a standardized performance situation is established before and after the Training. Before, during and after the performance anxiety ratings, cortisol, alpha amylase, heart rate and heart rate variability are assessed.
The investigators hypothesize, that patients with MPA which undergo HIIT, will show a stronger and more sustained improvement of both, clinical symptoms and physiological measures. Specifically, a decreased heart rate, higher heart rate variability and decreased endocrinological parameters.
- Conditions
- Performance Anxiety
- Being tested
- high-intensive aerobe exercise, low-intensive aerobe exercise
- Keywords
- MPA, Music Performance Anxiety, HIIT, Exercise, Cortisol, HRV, Heart Rate
- Medical subject headings
- Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
high-intensive aerobe exerciseOther
Aerobe bicycle ergometer training within 77-95% of maximum oxygen consumption; duration of each training session: 20 minutes; frequency of training: 6 sessions within 12 days
low-intensive aerobe exerciseOther
Aerobe training below 70% of maximum oxygen consumption (including light stretching and simple exercises adapted from yoga figures); duration of training session: 20 minutes; frequency of training: 6 sessions within 12 days
| Study group | Role | What they receive |
|---|---|---|
| high-intensive aerobe exercise | Experimental | Aerobe bicycle ergometer training within 77-95% of maximum oxygen consumption; duration of each training session: 20 minutes; frequency of training: 6 sessions within 12 days Receives: Other: high-intensive aerobe exercise |
| low-intensive aerobe exercise | Placebo comparator | Aerobe training below 70% of maximum oxygen consumption (including light stretching and simple exercises adapted from yoga figures); duration of training session: 20 minutes; frequency of training: 6 sessions within 12 days Receives: Other: low-intensive aerobe exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Bühnenangstfragebogen
Bühnenangstfragebogen is a questionnaire measuring Music Performance Anxiety. It is the German Version of the PAQ (Performance Anxiety Questionnaire)
Measured: Change from Baseline to post therapy (+12 days) and from Baseline to follow-up (+22 days)
Secondary outcomes (19)
Screening für somatoforme Störungen (SOMS-7T)
SOMS-7T is a questionnaire for detecting the changes in somatisation
Measured: Change from Baseline to post therapy (+12 days) and from Baseline to follow-up (+22 days)
Screening für somatoforme Störungen (SOMS-2)
SOMS-2 is a questionnaire for detecting the severity of somatisation
Measured: Only one assessment at baseline to assess differences between the two intervention groups
NEO-FFI personality inventory
personality inventory measuring neuroticism, extraversion, openness to experience, agreeableness, conscientiousness
Measured: Only one assessment at baseline to assess differences between the two intervention groups
Resilienzskala (RS-13)
A Questionnaire measuring resilience
Measured: Change from Baseline to post therapy (+12 days) and from Baseline to follow-up (+22 days)
Trierer Inventar zum chronischen Stress (TICS)
TICS is an inventory measuring chronic stress
Measured: Only one assessment at baseline to assess differences between the two intervention groups
Angstkontrollfragebogen (AKF)
AKF is the German Version of the Anxiety Control Questionnaire
Measured: Change from Baseline to post therapy (+12 days) and from Baseline to follow-up (+22 days)
Anxiety Sensitivity Index (ASI)
ASI is a Questionnaire measuring anxiety sensitivity
Measured: Change from Baseline to post therapy (+12 days) and from Baseline to follow-up (+22 days)
Beck Anxiety Inventory (BAI)
BAI is a questionnaire measuring anxiety
Measured: Change from Baseline to post therapy (+12 days) and from Baseline to follow-up (+22 days)
Beck Depression Inventory (BDI)
BDI is a questionnaire measuring depression
Measured: Change from Baseline to post therapy (+12 days) and from Baseline to follow-up (+22 days)
Liebowitz Social Anxiety Scale (LSAS)
LSAS is a questionnaire measuring social anxiety
Measured: Change from Baseline to post therapy (+12 days) and from Baseline to follow-up (+22 days)
Fragebogen zu sozialphobischen Kognitionen (SPK)
SPK is the German Version of the social cognitions questionnaire. It measures cognitions in social situations
Measured: Change from Baseline to post therapy (+12 days) and from Baseline to follow-up (+22 days)
saliva cortisol hormone
Cortisol is an established marker of the psychophysiological stress response and obtained with help of Salivettes absorbing saliva
Measured: Change from Baseline to post therapy (+12 days) and in performance situations 1 and 2 (+15 days)
saliva alpha Amylase hormone
Alpha amylase is an established marker of the psychophysiological stress Response and obtained with help of Salivettes absorbing saliva
Measured: From Baseline to post therapy (+12 days) and during performance situations 1 (Baseline) and 2 (+15 days)
heart rate
Measurement of heart rate
Measured: Change from Baseline to post therapy (+12 days), from Baseline to Follow-up and during performance situations 1 (Baseline) and 2 (+15 days)
heart rate variability
heart rate variability is a non-invasive method to measure autonomic nervous System function
Measured: Change from Baseline to post therapy (+12 days), from Baseline to follow-up (+22 days) and during performance situations 1 (Baseline) and 2 (+15 days)
visual analogue scale for anxiety (VAS)
VAS is a scale measuring an individual's anxiety in a specific situation
Measured: Change during performance situations 1 (baseline) and 2 (+15 days)
Accelerometer
With help of an accelerometer the activity level of a person can be measured
Measured: Change from Baseline to post therapy (+12 days) and from Baseline to follow-up (+22 days)
International Physical Activity Questionnaire (IPAQ-SF)
With the IPAQ-SF the physical activity of an individual during the last 7 days can be measured
Measured: Change from Baseline to post therapy (+12 days) and from Baseline to follow-up (+22 days)
K-MPAI
Kenny Music Performance Anxiety Inventory is a questionnaire measuring Music Performance Anxiety
Measured: Change from Baseline to post therapy (+12 days) and from Baseline to follow-up (+22 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jun 2018
- Study start3 May 2018
- Primary completion14 Apr 2020
- Study completion14 Apr 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Performance AnxietyStudies of the same condition, open and under way.
- More trials run by Charite University, Berlin, GermanyThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- Charite University, Berlin, Germany
- Sponsor type
- University, hospital or other
- Collaborators
- Friede Springer Stiftung, Germany
- Responsible party
- Principal investigator, Dr. Jens Plag, Charite University, Berlin, Germany
- Investigators
- Alexander Schmidt, Study chair, Charite University, Berlin, Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03562312
- Sponsor's protocol ID
- EA114217
- Acronym
- PACE
- Status last verified
- Apr 2020
- First submitted
- 3 May 2018
- Last updated
- 15 Apr 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 15 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical, Neuroendocrine and Physiological Effects of Exercise in Patients With Music Performance Anxiety
- ClinicalTrials.gov ID
- NCT03562312
- Acronym / sponsor ID
- PACE / EA114217
- Conditions
- Performance Anxiety
- Keywords
- MPA, Music Performance Anxiety, HIIT, Exercise, Cortisol, HRV, Heart Rate
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- Charite University, Berlin, GermanyUniversity, hospital or other
- Collaborators
- Friede Springer Stiftung, Germany
- Study start
- 3 May 2018 (actual)
- Primary completion
- 14 Apr 2020 (actual)
- Study completion
- 14 Apr 2020 (actual)
- First posted
- 19 Jun 2018 (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.
This study investigates the effect of high-intense aerobe exercise training (HIIT) and aerobe exercise of low intensity on clinical and physiological parameters (anxiety, activity, cortisol, alpha amylase, heart rate, heart rate variability, spiroergometry) in patients with Music Performance Anxiety (MPA). Half of the patients will receive HIIT, while the other half will receive aerobe exercise of low intensity.
Detailed description
In this study, 20 patients with MPA will receive a high-intensive aerobe training (HIIT, 6 HIIT-sessions of 20 minutes within a period of 12 days). Additionally, 20 MPA-patients will undergo a less intense aerobe training matched regarding frequency and duration of sessions. Prior to the first training session, after completing the training (day 12) and 10 days after the Training (day 22), symptoms of anxiety and will be assessed by using questionnaires. Moreover, heart rate and heart rate variability will be obtained and activity level is measured using accelerometers. Before and after the training there will be an assessment of saliva samples for measuring cortisol and alpha amylase.
Furthermore, a standardized performance situation is established before and after the Training. Before, during and after the performance anxiety ratings, cortisol, alpha amylase, heart rate and heart rate variability are assessed.
The investigators hypothesize, that patients with MPA which undergo HIIT, will show a stronger and more sustained improvement of both, clinical symptoms and physiological measures. Specifically, a decreased heart rate, higher heart rate variability and decreased endocrinological parameters.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| high-intensive aerobe exercise | Experimental | Other: high-intensive aerobe exerciseAerobe bicycle ergometer training within 77-95% of maximum oxygen consumption; duration of each training session: 20 minutes; frequency of training: 6 sessions within 12 days |
| low-intensive aerobe exercise | Placebo comparator | Other: low-intensive aerobe exerciseAerobe training below 70% of maximum oxygen consumption (including light stretching and simple exercises adapted from yoga figures); duration of training session: 20 minutes; frequency of training: 6 sessions within 12 days |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Diagnosis of social anxiety disorder, Performance only subtype due to DSM-5
- Appropriate abilities to communicate and to complete the questionnaires
- Written informed consent
- Possibility of regular attendance at the training sessions
- Participant is a classical instrumentalist
Key exclusion criteria (7 listed)
- Other severe mental conditions than MPA (e.g. schizophrenia, severe depressive episode, addiction)
- Acute suicidality
- Epilepsy or other disorders of the central nervous system (e.g. tumor, encephalitis)
- Contraindications to aerobe exercise Training
- Start or modification of an anxiolytic pharmacotherapy or other therapy within the last four weeks
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| high-intensive aerobe exerciseAerobe bicycle ergometer training within 77-95% of maximum oxygen consumption; duration of each training session: 20 minutes; frequency of training: 6 sessions within 12 days | Other | high-intensive aerobe exercise |
| low-intensive aerobe exerciseAerobe training below 70% of maximum oxygen consumption (including light stretching and simple exercises adapted from yoga figures); duration of training session: 20 minutes; frequency of training: 6 sessions within 12 days | Other | low-intensive aerobe exercise |
Primary outcome
Bühnenangstfragebogen
Time frame: Change from Baseline to post therapy (+12 days) and from Baseline to follow-up (+22 days)
Bühnenangstfragebogen is a questionnaire measuring Music Performance Anxiety. It is the German Version of the PAQ (Performance Anxiety Questionnaire)
19 secondary outcomes
Screening für somatoforme Störungen (SOMS-7T)
Time frame: Change from Baseline to post therapy (+12 days) and from Baseline to follow-up (+22 days)
Screening für somatoforme Störungen (SOMS-2)
Time frame: Only one assessment at baseline to assess differences between the two intervention groups
NEO-FFI personality inventory
Time frame: Only one assessment at baseline to assess differences between the two intervention groups
Resilienzskala (RS-13)
Time frame: Change from Baseline to post therapy (+12 days) and from Baseline to follow-up (+22 days)
Trierer Inventar zum chronischen Stress (TICS)
Time frame: Only one assessment at baseline to assess differences between the two intervention groups
Angstkontrollfragebogen (AKF)
Time frame: Change from Baseline to post therapy (+12 days) and from Baseline to follow-up (+22 days)
Anxiety Sensitivity Index (ASI)
Time frame: Change from Baseline to post therapy (+12 days) and from Baseline to follow-up (+22 days)
Beck Anxiety Inventory (BAI)
Time frame: Change from Baseline to post therapy (+12 days) and from Baseline to follow-up (+22 days)
Beck Depression Inventory (BDI)
Time frame: Change from Baseline to post therapy (+12 days) and from Baseline to follow-up (+22 days)
Liebowitz Social Anxiety Scale (LSAS)
Time frame: Change from Baseline to post therapy (+12 days) and from Baseline to follow-up (+22 days)
Fragebogen zu sozialphobischen Kognitionen (SPK)
Time frame: Change from Baseline to post therapy (+12 days) and from Baseline to follow-up (+22 days)
saliva cortisol hormone
Time frame: Change from Baseline to post therapy (+12 days) and in performance situations 1 and 2 (+15 days)
saliva alpha Amylase hormone
Time frame: From Baseline to post therapy (+12 days) and during performance situations 1 (Baseline) and 2 (+15 days)
heart rate
Time frame: Change from Baseline to post therapy (+12 days), from Baseline to Follow-up and during performance situations 1 (Baseline) and 2 (+15 days)
heart rate variability
Time frame: Change from Baseline to post therapy (+12 days), from Baseline to follow-up (+22 days) and during performance situations 1 (Baseline) and 2 (+15 days)
visual analogue scale for anxiety (VAS)
Time frame: Change during performance situations 1 (baseline) and 2 (+15 days)
Accelerometer
Time frame: Change from Baseline to post therapy (+12 days) and from Baseline to follow-up (+22 days)
International Physical Activity Questionnaire (IPAQ-SF)
Time frame: Change from Baseline to post therapy (+12 days) and from Baseline to follow-up (+22 days)
K-MPAI
Time frame: Change from Baseline to post therapy (+12 days) and from Baseline to follow-up (+22 days)
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 15 Apr 2020.
- Individual participant dataSharing planned: Undecided
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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.
Alexander Schmidt study chair
Charite University, Berlin, Germany
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing high-intensive aerobe exercise and low-intensive aerobe exercise in people with Performance Anxiety, run by Charite University, Berlin, Germany 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 5 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 15 Apr 2020. 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. Some participants in this study may receive a placebo. 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?
Bühnenangstfragebogen (time frame: Change from Baseline to post therapy (+12 days) and from Baseline to follow-up (+22 days)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 15 Apr 2020.