NCT03562312

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

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
28

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started May 2018

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 3, 2018

Completed
Same day until next milestone

Study Start

First participant enrolled

May 3, 2018

Completed
2 months until next milestone

First Posted

Study publicly available on registry

June 19, 2018

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 14, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 14, 2020

Completed
Last Updated

April 15, 2020

Status Verified

April 1, 2020

Enrollment Period

2 years

First QC Date

May 3, 2018

Last Update Submit

April 14, 2020

Conditions

Keywords

MPAMusic Performance AnxietyHIITExerciseCortisolHRVHeart Rate

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

EXPERIMENTAL

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

low-intensive aerobe exercise

PLACEBO COMPARATOR

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

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

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

low-intensive aerobe exercise

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

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

Location

MeSH Terms

Conditions

Motor Activity

Condition Hierarchy (Ancestors)

Behavior

Study Officials

  • Alexander Schmidt

    Charite University, Berlin, Germany

    STUDY CHAIR

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

Locations