Performance Anxiety Changes With Exercise

Study Overview
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Brief Summary
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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
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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.

Official Title
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Clinical, Neuroendocrine and Physiological Effects of Exercise in Patients With Music Performance Anxiety

Conditions
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Performance Anxiety

Intervention / Treatment
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* Other: high-intensive aerobe exercise
* Other: low-intensive aerobe exercise


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: high-intensive aerobe exercise<br>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 | Other: high-intensive aerobe exercise<br>* 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<br>|
| Placebo Comparator: low-intensive aerobe exercise<br>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 | Other: low-intensive aerobe exercise<br>* 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<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Bühnenangstfragebogen | Bühnenangstfragebogen is a questionnaire measuring Music Performance Anxiety. It is the German Version of the PAQ (Performance Anxiety Questionnaire) | Change from Baseline to post therapy (+12 days) and from Baseline to follow-up (+22 days) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Screening für somatoforme Störungen (SOMS-7T) | SOMS-7T is a questionnaire for detecting the changes in somatisation | 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 | 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 | Only one assessment at baseline to assess differences between the two intervention groups | 
| Resilienzskala (RS-13) | A Questionnaire measuring resilience | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | From Baseline to post therapy (+12 days) and during performance situations 1 (Baseline) and 2 (+15 days) | 
| heart rate | Measurement of heart rate | 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 | 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 | 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 | 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 | 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 | Change from Baseline to post therapy (+12 days) and from Baseline to follow-up (+22 days) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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MPA, Music Performance Anxiety, HIIT, Exercise, Cortisol, HRV, Heart Rate