Performance Anxiety Changes With Exercise
PACE
Clinical, Neuroendocrine and Physiological Effects of Exercise in Patients With Music Performance Anxiety
1 other identifier
interventional
28
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started May 2018
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 3, 2018
CompletedStudy Start
First participant enrolled
May 3, 2018
CompletedFirst Posted
Study publicly available on registry
June 19, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 14, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
April 14, 2020
CompletedApril 15, 2020
April 1, 2020
2 years
May 3, 2018
April 14, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (19)
Screening für somatoforme Störungen (SOMS-7T)
Change from Baseline to post therapy (+12 days) and from Baseline to follow-up (+22 days)
Screening für somatoforme Störungen (SOMS-2)
Only one assessment at baseline to assess differences between the two intervention groups
NEO-FFI personality inventory
Only one assessment at baseline to assess differences between the two intervention groups
Resilienzskala (RS-13)
Change from Baseline to post therapy (+12 days) and from Baseline to follow-up (+22 days)
Trierer Inventar zum chronischen Stress (TICS)
Only one assessment at baseline to assess differences between the two intervention groups
- +14 more secondary outcomes
Study Arms (2)
high-intensive aerobe exercise
EXPERIMENTALAerobe 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 COMPARATORAerobe 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
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
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Department of Psychiatry and Psychotherapy, Charité - Universitätsmedizin Berlin, Campus Mitte
Berlin, 10117, Germany
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Alexander Schmidt
Charite University, Berlin, Germany
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- MD
Study Record Dates
First Submitted
May 3, 2018
First Posted
June 19, 2018
Study Start
May 3, 2018
Primary Completion
April 14, 2020
Study Completion
April 14, 2020
Last Updated
April 15, 2020
Record last verified: 2020-04