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Clinical, Neurophysiological and Neuroendocrine Effects of Aerobe Exercise in Generalized Anxiety Disorder (GAD) (GAD_exercise)

Primary Purpose

Generalized Anxiety Disorder (GAD)

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 Generalized Anxiety Disorder (GAD) focused on measuring Generalized Anxiety Disorder, GAD, physical exercise, aerobe exercise, mental disorder, high-intensive aerobe exercise

Eligibility Criteria

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

Inclusion Criteria:

  • Generalized Anxiety Disorder (GAD) according to the 5th edition of the Diagnostic and Statistical Manual of Mental Disorders (DSM-5)
  • Appropriate abilities to communicate and to complete the questionnaires
  • Written informed consent
  • Possibility of regular attendance at the training sessions

Exclusion Criteria:

  • Other severe mental conditions than GAD (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
  • Cardiovascular diseases
  • Start or modification of an anxiolytic pharmacotherapy within the last four weeks
  • Current psychotherapy

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

Change in Penn State Worry Questionnaire (PSWQ, german version)
PSWQ is a questionnaire for detecting the severity of GAD

Secondary Outcome Measures

Change in Screening für somatoforme Störungen (SOMS)
SOMS is a questionnaire for detecting the severity of somatisation
Change in Penn State Worry Questionnaire-past week (PSWQ-PW, german version)
PSWQ-PW is a questionnaire for detecting changes in GAD-severity
Change in Screening für somatoforme Störungen - 7 Tage (SOMS-7T)
SOMS-7T is a questionnaire for detecting changes in somatisation
Change in Hamilton Anxiety Rating Scale (HAM-A, german version)
HAM-A is a questionnaire for detecting the severity and changes of anxiety
Change in Anxiety Control Questionnaire (ACQ, german version)
ACQ is a questionnaire for evaluating the ability to control anxiety
Change in saliva cortisol
Cortisol is an established marker of the psychophysiological stress response
Change in saliva alpha amylase
Alpha amylase is an established marker of the psychophysiological stress response
Change in mismatch negativity
Mismatch negativity is an established correlate of the central information processing
Change in loudness dependence auditory evoked potentials
Loudness dependence auditory evoked potentials are established correlates of the central serotonergic transmission

Full Information

First Posted
January 11, 2016
Last Updated
February 3, 2019
Sponsor
Charite University, Berlin, Germany
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1. Study Identification

Unique Protocol Identification Number
NCT02662803
Brief Title
Clinical, Neurophysiological and Neuroendocrine Effects of Aerobe Exercise in Generalized Anxiety Disorder (GAD)
Acronym
GAD_exercise
Official Title
Clinical, Neurophysiological and Neuroendocrine Effects of Aerobe Exercise in Generalized Anxiety Disorder (GAD)
Study Type
Interventional

2. Study Status

Record Verification Date
February 2019
Overall Recruitment Status
Completed
Study Start Date
January 2015 (undefined)
Primary Completion Date
January 2019 (Actual)
Study Completion Date
January 2019 (Actual)

3. Sponsor/Collaborators

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

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
This study investigate the effect of high-intense aerobe exercise training (HIT) on clinical and physiological parameters (anxiety, somatisation, cortisol, alpha amylase, "mismatch negativity", loudness dependence auditory evoked potentials) in patients with generalized anxiety disorder (GAD). Half of patients will receive HIT, while the other half will receive aerobe exercise of low intensity.
Detailed Description
Generalized anxiety disorder (GAD) is a prevalent psychiatric condition and characterized by worrying of several topics of the daily life as well as stress-induced somatic symptoms (e.g. headache or musculoskeletal pain). Disturbed monoaminergic neurotransmission, changes in central information processing and altered levels of stress markers were reported as to be biological correlates of GAD or other stress-related disorders. Cognitive behavioral therapy is the first-line treatment in GAD, but it seems to be less effective than in other anxiety disorders. There is, however, some evidence for an anxiolytic activity of aerobe exercise. In this context, different forms of aerobe training were found to be associated with significant reduction of clinical symptoms in panic disorder, agoraphobia or social phobia as well as a normalisation of some of its pathophysiological markers. In this study, 20 patients with GAD will receive a high-intensive aerobe training (HIT, 6 HIT-sessions of 20 minutes within a period of 12 days). Additionally, 20 GAD-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 30 days after baseline, symptoms of anxiety and somatisation will assessed by using established questionnaires. Moreover, saliva samples and electroencephalogram (EEG) will performed at the same times of assessment in order to evaluating changes of cortisol, alpha amylase, "mismatch negativity" and loudness dependence auditory evoked potentials. We hypothesize, that GAD-patients which undergo HIT, will show a stronger and more sustained improvement of both, clinical symptoms and formally altered electrophysiological and endocrinological parameters.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Generalized Anxiety Disorder (GAD)
Keywords
Generalized Anxiety Disorder, GAD, physical exercise, aerobe exercise, mental disorder, high-intensive aerobe exercise

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
29 (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
Change in Penn State Worry Questionnaire (PSWQ, german version)
Description
PSWQ is a questionnaire for detecting the severity of GAD
Time Frame
From baseline to post therapy (+12 days) and from baseline to follow-up (+30 days)
Secondary Outcome Measure Information:
Title
Change in Screening für somatoforme Störungen (SOMS)
Description
SOMS is a questionnaire for detecting the severity of somatisation
Time Frame
From baseline to post therapy (+12 days) and from baseline to follow-up (+30 days)
Title
Change in Penn State Worry Questionnaire-past week (PSWQ-PW, german version)
Description
PSWQ-PW is a questionnaire for detecting changes in GAD-severity
Time Frame
From baseline to post therapy (+12 days) and from baseline to follow-up (+30 days)
Title
Change in Screening für somatoforme Störungen - 7 Tage (SOMS-7T)
Description
SOMS-7T is a questionnaire for detecting changes in somatisation
Time Frame
From baseline to post therapy (+12 days) and from baseline to follow-up (+30 days)
Title
Change in Hamilton Anxiety Rating Scale (HAM-A, german version)
Description
HAM-A is a questionnaire for detecting the severity and changes of anxiety
Time Frame
From baseline to post therapy (+12 days) and from baseline to follow-up (+30 days)
Title
Change in Anxiety Control Questionnaire (ACQ, german version)
Description
ACQ is a questionnaire for evaluating the ability to control anxiety
Time Frame
From baseline to post therapy (+12 days) and from baseline to follow-up (+30 days)
Title
Change in saliva cortisol
Description
Cortisol is an established marker of the psychophysiological stress response
Time Frame
From baseline to post therapy (+12 days) and from baseline to follow-up (+30 days)
Title
Change in saliva alpha amylase
Description
Alpha amylase is an established marker of the psychophysiological stress response
Time Frame
From baseline to post therapy (+12 days) and from baseline to follow-up (+30 days)
Title
Change in mismatch negativity
Description
Mismatch negativity is an established correlate of the central information processing
Time Frame
From baseline to post therapy (+12 days) and from baseline to follow-up (+30 days)
Title
Change in loudness dependence auditory evoked potentials
Description
Loudness dependence auditory evoked potentials are established correlates of the central serotonergic transmission
Time Frame
From baseline to post therapy (+12 days) and from baseline to follow-up (+30 days)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Generalized Anxiety Disorder (GAD) according to the 5th edition of the Diagnostic and Statistical Manual of Mental Disorders (DSM-5) Appropriate abilities to communicate and to complete the questionnaires Written informed consent Possibility of regular attendance at the training sessions Exclusion Criteria: Other severe mental conditions than GAD (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 Cardiovascular diseases Start or modification of an anxiolytic pharmacotherapy within the last four weeks Current psychotherapy
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Plag JP Plag, Dr.
Organizational Affiliation
Department of Psychiatry and Psychotherapy, Charité - Universitätsmedizin Berlin, Campus Mitte
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
No
Citations:
PubMed Identifier
25515221
Citation
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25085607
Citation
Plag J, Gaudlitz K, Schumacher S, Dimeo F, Bobbert T, Kirschbaum C, Strohle A. Effect of combined cognitive-behavioural therapy and endurance training on cortisol and salivary alpha-amylase in panic disorder. J Psychiatr Res. 2014 Nov;58:12-9. doi: 10.1016/j.jpsychires.2014.07.008. Epub 2014 Jul 21.
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Clinical, Neurophysiological and Neuroendocrine Effects of Aerobe Exercise in Generalized Anxiety Disorder (GAD)

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