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

February 3, 2019 updated by: Dr. Jens Plag, Charite University, Berlin, Germany
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

29

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Berlin, Germany, 10117
        • Department of Psychiatry and Psychotherapy, Charité - Universitätsmedizin Berlin, Campus Mitte

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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
Other: 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
Placebo Comparator: 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
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Penn State Worry Questionnaire (PSWQ, german version)
Time Frame: From baseline to post therapy (+12 days) and from baseline to follow-up (+30 days)
PSWQ is a questionnaire for detecting the severity of GAD
From baseline to post therapy (+12 days) and from baseline to follow-up (+30 days)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Screening für somatoforme Störungen (SOMS)
Time Frame: From baseline to post therapy (+12 days) and from baseline to follow-up (+30 days)
SOMS is a questionnaire for detecting the severity of somatisation
From baseline to post therapy (+12 days) and from baseline to follow-up (+30 days)
Change in Penn State Worry Questionnaire-past week (PSWQ-PW, german version)
Time Frame: From baseline to post therapy (+12 days) and from baseline to follow-up (+30 days)
PSWQ-PW is a questionnaire for detecting changes in GAD-severity
From baseline to post therapy (+12 days) and from baseline to follow-up (+30 days)
Change in Screening für somatoforme Störungen - 7 Tage (SOMS-7T)
Time Frame: From baseline to post therapy (+12 days) and from baseline to follow-up (+30 days)
SOMS-7T is a questionnaire for detecting changes in somatisation
From baseline to post therapy (+12 days) and from baseline to follow-up (+30 days)
Change in Hamilton Anxiety Rating Scale (HAM-A, german version)
Time Frame: From baseline to post therapy (+12 days) and from baseline to follow-up (+30 days)
HAM-A is a questionnaire for detecting the severity and changes of anxiety
From baseline to post therapy (+12 days) and from baseline to follow-up (+30 days)
Change in Anxiety Control Questionnaire (ACQ, german version)
Time Frame: From baseline to post therapy (+12 days) and from baseline to follow-up (+30 days)
ACQ is a questionnaire for evaluating the ability to control anxiety
From baseline to post therapy (+12 days) and from baseline to follow-up (+30 days)
Change in saliva cortisol
Time Frame: From baseline to post therapy (+12 days) and from baseline to follow-up (+30 days)
Cortisol is an established marker of the psychophysiological stress response
From baseline to post therapy (+12 days) and from baseline to follow-up (+30 days)
Change in saliva alpha amylase
Time Frame: From baseline to post therapy (+12 days) and from baseline to follow-up (+30 days)
Alpha amylase is an established marker of the psychophysiological stress response
From baseline to post therapy (+12 days) and from baseline to follow-up (+30 days)
Change in mismatch negativity
Time Frame: From baseline to post therapy (+12 days) and from baseline to follow-up (+30 days)
Mismatch negativity is an established correlate of the central information processing
From baseline to post therapy (+12 days) and from baseline to follow-up (+30 days)
Change in loudness dependence auditory evoked potentials
Time Frame: From baseline to post therapy (+12 days) and from baseline to follow-up (+30 days)
Loudness dependence auditory evoked potentials are established correlates of the central serotonergic transmission
From baseline to post therapy (+12 days) and from baseline to follow-up (+30 days)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Charite University, Berlin, Germany

Investigators

  • Study Chair: Plag JP Plag, Dr., Department of Psychiatry and Psychotherapy, Charité - Universitätsmedizin Berlin, Campus Mitte

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2015

Primary Completion (Actual)

January 1, 2019

Study Completion (Actual)

January 1, 2019

Study Registration Dates

First Submitted

January 11, 2016

First Submitted That Met QC Criteria

January 21, 2016

First Posted (Estimate)

January 26, 2016

Study Record Updates

Last Update Posted (Actual)

February 5, 2019

Last Update Submitted That Met QC Criteria

February 3, 2019

Last Verified

February 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EA1/217/15

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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