Performance Anxiety Changes With Exercise (PACE)

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.

Study Overview

• Status: Completed
• Conditions: Performance Anxiety
• Intervention / Treatment: Other: high-intensive aerobe exercise; Other: low-intensive aerobe exercise

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 Type: Interventional
• Enrollment (Actual): 28
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Germany
  • Berlin, Germany, 10117
    • Department of Psychiatry and Psychotherapy, Charité - Universitätsmedizin Berlin, Campus Mitte

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: high-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	Other: high-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
PLACEBO_COMPARATOR: low-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 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

What is the study measuring?

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)

Collaborators and Investigators

• Sponsor: Charite University, Berlin, Germany
• Collaborators: Friede Springer Stiftung, Germany
• Investigators: Study Chair: Alexander Schmidt, Charite University, Berlin, Germany

Study record dates

Study Major Dates

• Study Start (ACTUAL): May 3, 2018
• Primary Completion (ACTUAL): April 14, 2020
• Study Completion (ACTUAL): April 14, 2020

Study Registration Dates

• First Submitted: May 3, 2018
• First Submitted That Met QC Criteria: June 7, 2018
• First Posted (ACTUAL): June 19, 2018

Study Record Updates

• Last Update Posted (ACTUAL): April 15, 2020
• Last Update Submitted That Met QC Criteria: April 14, 2020
• Last Verified: April 1, 2020

More Information

Terms related to this study

• Keywords: Exercise; Cortisol; HRV; HIIT; Heart Rate; MPA; Music Performance Anxiety
• Additional Relevant MeSH Terms: Mental Disorders; Anxiety Disorders
• Other Study ID Numbers: EA114217

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No