An interventional study of high-intensive aerobe exercise and low-intensive aerobe exercise in Performance Anxiety, sponsored by Charite University, Berlin, Germany. Completed at 1 site in Germany. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2020-04-15.
Sponsored by Charite University, Berlin, Germany · Not applicable, Interventional, and Treatment
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.
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.
4,868 studies on the registry are indexed under Anxiety Disorders; 1,390 are open to participants now.
This study's enrollment of 28 is below the median of 80 across 4,174 interventional studies indexed under Anxiety Disorders.
Browse Anxiety Disorders studies →Charite University, Berlin, Germany is the lead sponsor of 836 studies on the registry; 129 are open to participants now.
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Exclusion Criteria:
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
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
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
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
Bühnenangstfragebogen
Bühnenangstfragebogen is a questionnaire measuring Music Performance Anxiety. It is the German Version of the PAQ (Performance Anxiety Questionnaire)
Time frame: Change from Baseline to post therapy (+12 days) and from Baseline to follow-up (+22 days)
Screening für somatoforme Störungen (SOMS-7T)
SOMS-7T is a questionnaire for detecting the changes in somatisation
Time frame: 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
Time frame: 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
Time frame: Only one assessment at baseline to assess differences between the two intervention groups
Resilienzskala (RS-13)
A Questionnaire measuring resilience
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: From Baseline to post therapy (+12 days) and during performance situations 1 (Baseline) and 2 (+15 days)
heart rate
Measurement of 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
heart rate variability is a non-invasive method to measure autonomic nervous System function
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)
VAS is a scale measuring an individual's anxiety in a specific situation
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: Change from Baseline to post therapy (+12 days) and from Baseline to follow-up (+22 days)
Plan to share: Undecided
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Charite University, Berlin, Germany