Trial document




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  DRKS00005120

Trial Description

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Title

Endurance Exercise versus Whole Body Vibration as adjuvant therapy in depressed adolescents:
effects on clinical outcome, neurocognitive and humoral parameters and morphological changes of the hippocampus and other brain regions

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Trial Acronym

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URL of the Trial

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Brief Summary in Lay Language

The present study combines fundamental and therapeutic-clinical research, comparing two adjuvant sport-therapies in their neurobiological and neurocognitive as well as clinical effects and feasibility. Non-medication treatment options are of enhanced importance in adolescent psychiatry, considering the limited clinical effects of drug-treatment and its side-effects. Especially physical exercise, in its right practice, shows various positive effects on physical and psychological well-being and is in addition a low-cost option.

In a longitudinal study we want to investigate the feasibility and acceptance of an exercise treatment with depressed adolescents (age 14-18 years), comparing the effects of bicycle ergometry and whole body vibration. Highly innovative and to our knowledge not yet investigated, are the effects of whole body vibration therapy (WBV). WBV-treatment is broadly used in neuropediatrics, and more and more known as so called “power plates” in fitness studios. The supposed advantage of vibration plate treatment is the lower subjective impression of effort, and shorter training periods for equivalent training effects.

The measured outcomes of our study are the clinical, neurobiological (humoral as well as brain-morphological) and neurocognitive effects of the two training forms in depressed adolescents. The intervention group (N=36) is recruited from in-patients of our department for adolescent and child psychiatry, regardless gender and randomized in the two intervention arms. Those adolescents who do not want to participate in the trainings are recruited as control group “treatment as usual”. The clinical outcomes are measured by an improvement in the DIKJ-Scores (i.e. Depression Inventory for Children and Adolescents). The neurocognitive effects are assessed by the CANTAB®. The morphological changes in the brain will be measured using voxel guided morphometry on native brain MRI. The training will be held on 3 to 5 days a week for 6 weeks. The period of observation will continue 8 weeks after the sport intervention is completed.

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Brief Summary in Scientific Language

The present study combines fundamental and therapeutic-clinical research, comparing two adjuvant sport-therapies in their neurobiological and neurocognitive as well as clinical effects and feasibility.

In a longitudinal study we want to investigate the feasibility and acceptance of an exercise treatment with depressed adolescents (age 14-18 years), comparing the effects of bicycle ergometry and whole body vibration. WBV-treatment is broadly used in neuropediatrics, and to our knowledge the effects on psychiatric disorders not yet investigated.

The measured outcomes of our study are the clinical, neurobiological (humoral as well as brain-morphological) and neurocognitive effects of the two training forms in depressed adolescents. The intervention group (N=36) is recruited from in-patients of our department for adolescent and child psychiatry, regardless gender and randomized in the two intervention arms. Those adolescents who do not want to participate in the trainings are recruited as control group “treatment as usual”. The clinical outcomes are measured by an improvement in the DIKJ-Scores (i.e. Depression Inventory for Children and Adolescents). The neurocognitive effects are assessed by the CANTAB®. The morphological changes in the brain will be measured using voxel guided morphometry on native brain MRI. As underlying influencing humoral parameters on neurogenesis and depression improvement we analyze IL-6, TNF-alpha, IGF-1, BDNF. The training will be held on 3 to 5 days a week for 6 weeks. The period of observation will continue 8 weeks after the sport intervention is completed.

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Organizational Data

  •   DRKS00005120
  •   2013/07/10
  •   [---]*
  •   yes
  •   Approved
  •   11-099, Ethik-Kommission der Medizinischen Fakultät der Universität zu Köln
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Secondary IDs

  •   U1111-1145-1854 
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Health Condition or Problem studied

  •   Depressive Episode (F32 ff. ICD 10)
    Major Depression (296.20 ff. DSM IV)
  •   F32 -  Depressive episode
  •   F32.1 -  Moderate depressive episode
  •   F32.2 -  Severe depressive episode without psychotic symptoms
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Interventions/Observational Groups

  •   Bicycle Ergometer Training 3 to 5 days a week for 6 weeks
  •   Whole Body Vibration 3 to 5 days a week for 6 weeks
  •   Controlgroup "treatment as usual", i.e. those patients who have all the inclusion criteria but do not want to participate in the sports intervention can get only the measurements on the three measurement points
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Characteristics

  •   Interventional
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  •   Randomized controlled trial
  •   Blinded
  •   investigator/therapist, assessor, data analyst
  •   Active control (effective treament of control group), Control group receives no treatment
  •   Other
  •   Parallel
  •   N/A
  •   N/A
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Primary Outcome

Physical exercise improves depressive symptoms in adolescents, measured by a significant decrease in the DIKJ-Scores (Depression Inventory for Children and Adolescents) under a T-Score of 60 (PR 86,2). Whole Body Vibration shows equivalent or superior effects compared to bicycle ergometer.
Measurement points: t0 baseline, t1 after 6 weeks intervention, t2 8-weeks post intervention

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Secondary Outcome

2. Physical exercise improves in adolescents with depression cognitive functions of the episodic memory measured by an improvement in relevant subtest of the CANTAB® test battery. Whole Body Vibration shows equal or superior effects to bicycle ergometer-training.
Measurement points: t0 baseline, t1 after 6 weeks intervention, t2 8-weeks post intervention

3. Physical exercise in adolescents with depression leads to morphological changes in brain regions important for emotion processing and episodic memory and enhances hippocampal volume. Whole Body Vibration shows equal or superior effects to bicycle ergometer-training.
Measurement points: t0 baseline, t1 after 6 weeks intervention, t2 8-weeks post intervention

4. Physical exercise in adolescents with depression influences TNF-alpha, IL-6, BDNF and IGF-1. We expect a decrease of TNF-alpha and IGF-1 and an increase of IL-6 and BDNF. Whole Body Vibration shows equal or superior effects to bicycle ergometer-training.
Measurement points: t0 baseline, t1 after 6 weeks intervention, t2 8-weeks post intervention

5. Whole Body Vibration shows equal or superior effects to bicycle ergometer-training in the improvement of physical fitness (VO2max and maximum force) in depressed adolecents.
Measurement points: t0 baseline, t1 after 6 weeks intervention, t2 8-weeks post intervention

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • University Medical Center 
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Recruitment

  •   Actual
  •   2013/07/12
  •   36
  •   Monocenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   14   Years
  •   18   Years
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Additional Inclusion Criteria

Subjects are in-patients of the department of child and adolescent psychiatry, university of Cologne. Age 14-18 years, regardless gender, IQ>70, with normal sports ability. Current depressive disorder has to be diagnosed according to ICD 10 and DSM IV criteria and a baseline score of the DIKJ equal 18.

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Exclusion Criteria

Psychiatric comorbidities are allowed except of: psychotic disorders, serious personality disorders, serious pervasive developmental disorders, psychosis in the past, current substance abuse, BMI< 16 kg/qm, sports disability, malignant diseases, ongoing medication (with anticonvulsants, steroids, methylphenidate, anti-depressants, neuroleptics, benzodiazepines, mood-stabilizing drugs), Addison’s disease, untreated hypothyreoidism

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Addresses

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    • Uniklinik Köln, Klinik für Kinder- und Jugendpsychiatrie
    • Mr.  Prof. Dr. med. Dipl. Psych.  Gerd  Lehmkuhl 
    • Robert-Koch-Str. 10
    • 50931  Köln
    • Germany
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    • Uniklinik Köln, Klinik für Kinder- und Jugendpsychiatrie
    • Ms.  Dr.  Heidrun Lioba  Wunram 
    • Robert-Koch-Str. 10
    • 50931  Köln
    • Germany
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    • Uniklinik Köln, Klinik für Kinder- und Jugendpsychiatrie
    • Ms.  Dr.  Heidrun Lioba  Wunram 
    • Robert-Koch-Str. 10
    • 50937  Köln
    • Germany
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Sources of Monetary or Material Support

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    • Marga und Walter Boll-Stiftung
    • Marie-Curie-Str. 8
    • 50170  Kerpen
    • Germany
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Status

  •   Recruiting complete, follow-up complete
  •   2015/05/31
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Trial Publications, Results and other Documents

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