Performance Anxiety Changes With Exercise

NCT ID: NCT03562312

Last Updated: 2020-04-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 28 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-05-03
• Study Completion Date: 2020-04-14

Brief 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). 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.

Conditions

Performance Anxiety

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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

Group Type: EXPERIMENTAL

high-intensive aerobe exercise

Intervention Type: OTHER

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 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

Group Type: PLACEBO_COMPARATOR

low-intensive aerobe exercise

Intervention Type: OTHER

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

Interventions

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

Intervention Type: 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

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Friede Springer Stiftung, Germany

UNKNOWN

Sponsor Role: collaborator

Charite University, Berlin, Germany

OTHER

Sponsor Role: lead

Responsible Party

Dr. Jens Plag

MD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Alexander Schmidt

Role: STUDY_CHAIR

Charite University, Berlin, Germany

Locations

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

Berlin, , Germany

Countries

Germany

Other Identifiers

EA114217

Identifier Type: -

Identifier Source: org_study_id