NCT02662803

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
29

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2015

Longer than P75 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

Study Start

First participant enrolled

January 1, 2015

Completed
1 year until next milestone

First Submitted

Initial submission to the registry

January 11, 2016

Completed
15 days until next milestone

First Posted

Study publicly available on registry

January 26, 2016

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2019

Completed
Last Updated

February 5, 2019

Status Verified

February 1, 2019

Enrollment Period

4 years

First QC Date

January 11, 2016

Last Update Submit

February 3, 2019

Conditions

Generalized Anxiety Disorder (GAD)

Keywords

Generalized Anxiety DisorderGADphysical exerciseaerobe exercisemental disorderhigh-intensive aerobe exercise

Outcome Measures

Primary Outcomes (1)

  • Change in Penn State Worry Questionnaire (PSWQ, german version)

    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 Outcomes (9)

  • Change in Screening für somatoforme Störungen (SOMS)

    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)

    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)

    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)

    From baseline to post therapy (+12 days) and from baseline to follow-up (+30 days)

  • Change in Anxiety Control Questionnaire (ACQ, german version)

    From baseline to post therapy (+12 days) and from baseline to follow-up (+30 days)

  • +4 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

high-intensive aerobe exerciseOTHER

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
low-intensive aerobe exerciseOTHER

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

You may qualify if:

  • 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

You may not qualify if:

  • 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

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

Related Publications (13)

  • Gaudlitz K, Plag J, Dimeo F, Strohle A. Aerobic exercise training facilitates the effectiveness of cognitive behavioral therapy in panic disorder. Depress Anxiety. 2015 Mar;32(3):221-8. doi: 10.1002/da.22337. Epub 2014 Dec 17.

    PMID: 25515221BACKGROUND

  • Ghisolfi ES, Heldt E, Zanardo AP, Strimitzer IM Jr, Prokopiuk AS, Becker J, Cordioli AV, Manfro GG, Lara DR. P50 sensory gating in panic disorder. J Psychiatr Res. 2006 Sep;40(6):535-40. doi: 10.1016/j.jpsychires.2006.02.006. Epub 2006 Apr 17.

    PMID: 16616936BACKGROUND

  • Hegerl U, Juckel G. Intensity dependence of auditory evoked potentials as an indicator of central serotonergic neurotransmission: a new hypothesis. Biol Psychiatry. 1993 Feb 1;33(3):173-87. doi: 10.1016/0006-3223(93)90137-3.

    PMID: 8383545BACKGROUND

  • Clark CR, McFarlane AC, Weber DL, Battersby M. Enlarged frontal P300 to stimulus change in panic disorder. Biol Psychiatry. 1996 May 15;39(10):845-56. doi: 10.1016/0006-3223(95)00288-x.

    PMID: 9172705BACKGROUND

  • Naatanen R. The mismatch negativity: a powerful tool for cognitive neuroscience. Ear Hear. 1995 Feb;16(1):6-18.

    PMID: 7774770BACKGROUND

  • 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.

    PMID: 25085607BACKGROUND

  • Schumacher S, Kirschbaum C, Fydrich T, Strohle A. Is salivary alpha-amylase an indicator of autonomic nervous system dysregulations in mental disorders?--a review of preliminary findings and the interactions with cortisol. Psychoneuroendocrinology. 2013 Jun;38(6):729-43. doi: 10.1016/j.psyneuen.2013.02.003. Epub 2013 Mar 5.

    PMID: 23481259BACKGROUND

  • Burgomaster KA, Hughes SC, Heigenhauser GJ, Bradwell SN, Gibala MJ. Six sessions of sprint interval training increases muscle oxidative potential and cycle endurance capacity in humans. J Appl Physiol (1985). 2005 Jun;98(6):1985-90. doi: 10.1152/japplphysiol.01095.2004. Epub 2005 Feb 10.

    PMID: 15705728BACKGROUND

  • Meyer TJ, Miller ML, Metzger RL, Borkovec TD. Development and validation of the Penn State Worry Questionnaire. Behav Res Ther. 1990;28(6):487-95. doi: 10.1016/0005-7967(90)90135-6.

    PMID: 2076086BACKGROUND

  • Stober J, Bittencourt J. Weekly assessment of worry: an adaptation of the Penn State Worry Questionnaire for monitoring changes during treatment. Behav Res Ther. 1998 Jun;36(6):645-56. doi: 10.1016/s0005-7967(98)00031-x.

    PMID: 9648338BACKGROUND

  • Maier W, Buller R, Philipp M, Heuser I. The Hamilton Anxiety Scale: reliability, validity and sensitivity to change in anxiety and depressive disorders. J Affect Disord. 1988 Jan-Feb;14(1):61-8. doi: 10.1016/0165-0327(88)90072-9.

    PMID: 2963053BACKGROUND

  • Plag J, Schumacher S, Strohle A. [Generalized anxiety disorder]. Nervenarzt. 2014 Sep;85(9):1185-94. doi: 10.1007/s00115-014-4121-8. German.

    PMID: 25119343BACKGROUND

  • Jayakody K, Gunadasa S, Hosker C. Exercise for anxiety disorders: systematic review. Br J Sports Med. 2014 Feb;48(3):187-96. doi: 10.1136/bjsports-2012-091287. Epub 2013 Jan 7.

    PMID: 23299048BACKGROUND

MeSH Terms

Conditions

Generalized Anxiety DisorderMotor ActivityMental Disorders

Condition Hierarchy (Ancestors)

Anxiety DisordersBehavior

Study Officials

  • Plag JP Plag, Dr.

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

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
physician

Study Record Dates

First Submitted

January 11, 2016

First Posted

January 26, 2016

Study Start

January 1, 2015

Primary Completion

January 1, 2019

Study Completion

January 1, 2019

Last Updated

February 5, 2019

Record last verified: 2019-02

Data Sharing

IPD Sharing
Will not share

Locations

DE(1)