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Published in: Trials 1/2018

Open Access 01-12-2018 | Study protocol

Effects of a 6-week, whole-body vibration strength-training on depression symptoms, endocrinological and neurobiological parameters in adolescent inpatients experiencing a major depressive episode (the “Balancing Vibrations Study”): study protocol for a randomized placebo-controlled trial

Authors: Max Oberste, Nicola Großheinrich, Heidrun-Lioba Wunram, Johannes Levin Graf, Alischa Ziemendorff, Axel Meinhardt, Oliver Fricke, Esther Mahabir, Stephan Bender

Published in: Trials | Issue 1/2018

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Abstract

Background

Moderate to vigorous endurance and strength-training exercise was suggested as a treatment option for major depression. However, there is little evidence to support this suggestion in adolescent patients. The present study investigates the effects of a whole-body vibration strength-training intervention on symptoms in medication-naïve adolescent inpatients experiencing a major depressive episode. Potential underlying endocrinological and neurobiological mechanisms are explored.

Methods/design

A double-blinded randomized controlled trial is conducted at the University Hospital of Cologne in Germany, comparing a 6-week, whole-body vibration strength-training with a 6-week placebo-intervention, as add-on therapy to inpatient treatment as usual. Forty-one subjects (13–18 years of age) will be included in each of the two groups. The study is powered to detect (α = .05, β = .2) a medium effect size difference between the two groups (d = .5) in terms of patients’ change in the Children’s Depression Rating Scale raw-score, from baseline until the end of the intervention. As secondary endpoints, the effects of exercise treatment on patients’ cortisol awakening response as well as on brain-derived neurotrophic factor, insulin-like growth factor 1 and inflammatory markers (tumor necrosis factor-alpha, interleukin-6 and C-reactive protein) serum levels will be assessed.

Discussion

This study will provide evidence on the effectiveness of whole-body vibration strength-training as an add-on therapy in adolescent inpatients experiencing a major depressive episode. After completion of data collection, the present study will be the largest randomized controlled trial so far to investigate the effectiveness of an exercise intervention in inpatient adolescents suffering from a major depressive episode. Moreover, the present study may help to determine the underlying mechanisms of potential anti-depressant effects of exercise in depressed adolescent inpatients.

Trial registration

DRKS.de, German Clinical Trials Register (DRKS), Identifier: DRKS00011772. Registered on 20 March 2017.
Appendix
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Metadata
Title
Effects of a 6-week, whole-body vibration strength-training on depression symptoms, endocrinological and neurobiological parameters in adolescent inpatients experiencing a major depressive episode (the “Balancing Vibrations Study”): study protocol for a randomized placebo-controlled trial
Authors
Max Oberste
Nicola Großheinrich
Heidrun-Lioba Wunram
Johannes Levin Graf
Alischa Ziemendorff
Axel Meinhardt
Oliver Fricke
Esther Mahabir
Stephan Bender
Publication date
01-12-2018
Publisher
BioMed Central
Published in
Trials / Issue 1/2018
Electronic ISSN: 1745-6215
DOI
https://doi.org/10.1186/s13063-018-2747-8

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