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

Charité University Medicine Berlin

Status: Completed

Conditions: Generalized Anxiety Disorder (GAD)

Treatments: Other: high-intensive aerobe exercise; Other: low-intensive aerobe exercise

Study type: Interventional

Funder types: Other

Identifiers

NCT02662803

EA1/217/15

Details and patient eligibility

About

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.

Full 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.

Enrollment: 29 patients

Sex: All

Ages: 18+ years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

29 participants in 2 patient groups, including a placebo group

high-intensive aerobe exercise

Experimental group

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

Treatment:

Other: high-intensive aerobe exercise

low-intensive aerobe exercise

Placebo Comparator group

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

Treatment:

Other: low-intensive aerobe exercise