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article 2012 10 pages

DEMO-II Trial. Aerobic Exercise versus Stretching Exercise in Patients with Major Depression—A Randomised Clinical Trial

Jesper Krogh, Poul Videbech, Carsten Thomsen, Christian Gluud, Merete Nordentoft

Journal
PLOS ONE
DOI
10.1371/journal.pone.0048316
Publication type
Research Article
Study type
randomised clinical trial
Population
patients with major depression
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Abstract

Background

The effect of referring patients from a clinical setting to a pragmatic exercise intervention for depressive symptoms, cognitive function, and metabolic variables has yet to be determined.

Methods

Outpatients with major depression (DSM-IV) were allocated to supervised aerobic or stretching exercise groups during a three months period. The primary outcome was the Hamilton depression score (HAM-D17). Secondary outcomes were cognitive function, cardiovascular risk markers, and employment related outcomes.

Results

56 participants were allocated to the aerobic exercise intervention versus 59 participants to the stretching exercise group. Post intervention the mean difference between groups was −0.78 points on the HAM-D17 (95% CI −3.2 to 1.6; P = .52). At follow-up, the participants in the aerobic exercise group had higher maximal oxygen uptake (mean difference 4.4 l/kg/min; 95% CI 1.7 to 7.0; P = .001) and visuospatial memory on Rey’s Complex Figure Test (mean difference 3.2 points; 95% CI 0.9 to 5.5; P = .007) and lower blood glucose levels (mean difference 0.2 mmol/l; 95% CI 0.0 to 0.5; P = .04) and waist circumference (mean difference 2.2 cm; 95% CI 0.3 to 4.1; P = .02) compared with the stretching exercise group.

Conclusions

The results of this trial does not support any antidepressant effect of referring patients with major depression to a three months aerobic exercise program. Due to lower recruitment than anticipated, the trial was terminated prior to reaching the pre-defined sample size of 212 participants; therefore the results should be interpreted in that context. However, the DEMO-II trial does suggest that an exercise program for patients with depression offer positive short-term effects on maximal oxygen uptake, visuospatial memory, fasting glucose levels, and waist circumference.

Trial Registration

ClinicalTrials.gov NCT00695552

Citation: Krogh J, Videbech P, Thomsen C, Gluud C, Nordentoft M (2012) DEMO-II Trial. Aerobic Exercise versus Stretching Exercise in Patients with Major Depression—A Randomised Clinical Trial. PLoS ONE 7(10):
e48316.

https://doi.org/10.1371/journal.pone.0048316

Editor: Conrad P. Earnest,
University of Bath, United Kingdom

Received: May 21, 2012; Accepted: September 14, 2012; Published: October 31, 2012

Copyright: © 2012 Krogh et al. This is an open-access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.

Funding: Trygfonden (an insurance company), Nordea-Danmark fonden (a bank), Helsefonden (public fund), and Åse and Ejnar Danielsen’s fond (a family foundation) funded this trial. The funders had no role in study design, data collection and analysis, decision to publish, or preparation of the manuscript.

Competing interests: Two of the funders (Trygfonden and Nordea-Danmark fonden) are commercial funders. However, none of the authors have any declarations relating to employment, consultancy, patents, products in development or marketed products relating to the commercial funders. Co-author CG is an editor at PLOS ONE. None of the above alters the authors’ adherance to all the PLOS ONE policies on sharing data and materials. Otherwise, the authors have declared that no competing interests exist.

Description

This trial compares aerobic and stretching exercises in patients with major depression.