search
Back to results

Performance Anxiety Changes With Exercise (PACE)

Primary Purpose

Performance Anxiety

Status
Completed
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
high-intensive aerobe exercise
low-intensive aerobe exercise
Sponsored by
Charite University, Berlin, Germany
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Performance Anxiety focused on measuring MPA, Music Performance Anxiety, HIIT, Exercise, Cortisol, HRV, Heart Rate

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

high-intensive aerobe exercise

low-intensive aerobe exercise

Arm Description

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

Outcomes

Primary Outcome Measures

Bühnenangstfragebogen
Bühnenangstfragebogen is a questionnaire measuring Music Performance Anxiety. It is the German Version of the PAQ (Performance Anxiety Questionnaire)

Secondary Outcome Measures

Screening für somatoforme Störungen (SOMS-7T)
SOMS-7T is a questionnaire for detecting the changes in somatisation
Screening für somatoforme Störungen (SOMS-2)
SOMS-2 is a questionnaire for detecting the severity of somatisation
NEO-FFI personality inventory
personality inventory measuring neuroticism, extraversion, openness to experience, agreeableness, conscientiousness
Resilienzskala (RS-13)
A Questionnaire measuring resilience
Trierer Inventar zum chronischen Stress (TICS)
TICS is an inventory measuring chronic stress
Angstkontrollfragebogen (AKF)
AKF is the German Version of the Anxiety Control Questionnaire
Anxiety Sensitivity Index (ASI)
ASI is a Questionnaire measuring anxiety sensitivity
Beck Anxiety Inventory (BAI)
BAI is a questionnaire measuring anxiety
Beck Depression Inventory (BDI)
BDI is a questionnaire measuring depression
Liebowitz Social Anxiety Scale (LSAS)
LSAS is a questionnaire measuring social anxiety
Fragebogen zu sozialphobischen Kognitionen (SPK)
SPK is the German Version of the social cognitions questionnaire. It measures cognitions in social situations
saliva cortisol hormone
Cortisol is an established marker of the psychophysiological stress response and obtained with help of Salivettes absorbing saliva
saliva alpha Amylase hormone
Alpha amylase is an established marker of the psychophysiological stress Response and obtained with help of Salivettes absorbing saliva
heart rate
Measurement of heart rate
heart rate variability
heart rate variability is a non-invasive method to measure autonomic nervous System function
visual analogue scale for anxiety (VAS)
VAS is a scale measuring an individual's anxiety in a specific situation
Accelerometer
With help of an accelerometer the activity level of a person can be measured
International Physical Activity Questionnaire (IPAQ-SF)
With the IPAQ-SF the physical activity of an individual during the last 7 days can be measured
K-MPAI
Kenny Music Performance Anxiety Inventory is a questionnaire measuring Music Performance Anxiety

Full Information

First Posted
May 3, 2018
Last Updated
April 14, 2020
Sponsor
Charite University, Berlin, Germany
Collaborators
Friede Springer Stiftung, Germany
search

1. Study Identification

Unique Protocol Identification Number
NCT03562312
Brief Title
Performance Anxiety Changes With Exercise
Acronym
PACE
Official Title
Clinical, Neuroendocrine and Physiological Effects of Exercise in Patients With Music Performance Anxiety
Study Type
Interventional

2. Study Status

Record Verification Date
April 2020
Overall Recruitment Status
Completed
Study Start Date
May 3, 2018 (Actual)
Primary Completion Date
April 14, 2020 (Actual)
Study Completion Date
April 14, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Charite University, Berlin, Germany
Collaborators
Friede Springer Stiftung, Germany

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Performance Anxiety
Keywords
MPA, Music Performance Anxiety, HIIT, Exercise, Cortisol, HRV, Heart Rate

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
28 (Actual)

8. Arms, Groups, and Interventions

Arm Title
high-intensive aerobe exercise
Arm Type
Experimental
Arm Description
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
Arm Title
low-intensive aerobe exercise
Arm Type
Placebo Comparator
Arm Description
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
Intervention Name(s)
high-intensive aerobe exercise
Intervention Description
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
Intervention Name(s)
low-intensive aerobe exercise
Intervention Description
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
Primary Outcome Measure Information:
Title
Bühnenangstfragebogen
Description
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)
Secondary Outcome Measure Information:
Title
Screening für somatoforme Störungen (SOMS-7T)
Description
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)
Title
Screening für somatoforme Störungen (SOMS-2)
Description
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
Title
NEO-FFI personality inventory
Description
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
Title
Resilienzskala (RS-13)
Description
A Questionnaire measuring resilience
Time Frame
Change from Baseline to post therapy (+12 days) and from Baseline to follow-up (+22 days)
Title
Trierer Inventar zum chronischen Stress (TICS)
Description
TICS is an inventory measuring chronic stress
Time Frame
Only one assessment at baseline to assess differences between the two intervention groups
Title
Angstkontrollfragebogen (AKF)
Description
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)
Title
Anxiety Sensitivity Index (ASI)
Description
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)
Title
Beck Anxiety Inventory (BAI)
Description
BAI is a questionnaire measuring anxiety
Time Frame
Change from Baseline to post therapy (+12 days) and from Baseline to follow-up (+22 days)
Title
Beck Depression Inventory (BDI)
Description
BDI is a questionnaire measuring depression
Time Frame
Change from Baseline to post therapy (+12 days) and from Baseline to follow-up (+22 days)
Title
Liebowitz Social Anxiety Scale (LSAS)
Description
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)
Title
Fragebogen zu sozialphobischen Kognitionen (SPK)
Description
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)
Title
saliva cortisol hormone
Description
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)
Title
saliva alpha Amylase hormone
Description
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)
Title
heart rate
Description
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)
Title
heart rate variability
Description
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)
Title
visual analogue scale for anxiety (VAS)
Description
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)
Title
Accelerometer
Description
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)
Title
International Physical Activity Questionnaire (IPAQ-SF)
Description
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)
Title
K-MPAI
Description
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)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Alexander Schmidt
Organizational Affiliation
Charite University, Berlin, Germany
Official's Role
Study Chair
Facility Information:
Facility Name
Department of Psychiatry and Psychotherapy, Charité - Universitätsmedizin Berlin, Campus Mitte
City
Berlin
ZIP/Postal Code
10117
Country
Germany

12. IPD Sharing Statement

Plan to Share IPD
Undecided

Learn more about this trial

Performance Anxiety Changes With Exercise

We'll reach out to this number within 24 hrs