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Published in: Trials 1/2018

Open Access 01-12-2018 | Study protocol

Aerobic exercise program with or without motor complexity as an add-on to the pharmacological treatment of depression – study protocol for a randomized controlled trial

Authors: Lucas Melo Neves, Carla Silva-Batista, Raquel Marquesini, Telma Fátima da Cunha, Elisa Dimateo, Luciana Nascimento, Acácio Moreira-Neto, Angelo Corrêa de Lima Miliatto, Sheila das Chagas Mendes, Flavia Saad, Jamile Sanches Codogno, Renato Hoffmann Nunes, Raphael Mendes Ritti-Dias, Valeria Juday, Beny Lafer, Carlos Ugrinowitsch

Published in: Trials | Issue 1/2018

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Abstract

Background

Patients with major depression disorder presents increased rates of cognitive decline, reduced hippocampal volume, poor sleep quality, hypertension, obesity, suicidal ideation and behavior, and decreased functionality. Although continuous aerobic exercise (CAE) improves some of the aforementioned symptoms, comorbidities, and conditions, recent studies have suggested that performing aerobic exercise with motor complexity (AEMC) may be more beneficial for cognitive decline, hippocampal volume, and functionality. Therefore, this randomized controlled trial will compare the effects of CAE and AEMC on depression score, cognitive function, hippocampal volume, brain-derived neurotrophic factor expression, sleep parameters, cardiovascular risk parameters, suicidal behavior, functionality, and treatment costs in patients with depression.

Methods/design

Seventy-five medicated patients with depression will be recruited from a Basic Healthcare Unit to participate in this prospective, parallel group, single blinded, superiority, randomized controlled trial. Patients with depression according to DSM-V criteria will be balanced and randomly assigned (based on depression scores and number of depressive episodes) to a non-exercising control (C), CAE, and AEMC groups. The CAE and AEMC groups will exercise for 60 min, twice a week for 24 weeks (on non-consecutive days). Exercise intensity will be maintained between 12 and 14 points of the rating of perceived exertion scale (~ 70–80% of the maximum heart rate). The CAE group will perform a continuous aerobic exercise while the AEMC group will perform exercises with progressively increased motor complexity. Blinded raters will assess patients before and after the intervention period. The primary outcome measure will be the change in depression score measured by the Montgomery-Asberg Depression Rating Scale. Secondary outcomes will include measures of cognitive function, hippocampal volume, brain-derived neurotrophic factor expression, sleep parameters, cardiovascular risk parameters, suicidal behavior, functionality, and treatment costs.

Discussion

This study was selected in the call of public policy programs for the Brazilian Unified National Health System – “PPSUS 2015”. To our knowledge, this is the first pragmatic trial to test the effect of adding AEMC to the pharmacological treatment of patients with depression and to evaluate the possible reductions in depression symptoms and healthcare costs.

Trial registration

Brazilian Clinical Trials Registry (ReBec) - RBR-9zgxzd - Registered on 4 Jan. 2017.
Appendix
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Metadata
Title
Aerobic exercise program with or without motor complexity as an add-on to the pharmacological treatment of depression – study protocol for a randomized controlled trial
Authors
Lucas Melo Neves
Carla Silva-Batista
Raquel Marquesini
Telma Fátima da Cunha
Elisa Dimateo
Luciana Nascimento
Acácio Moreira-Neto
Angelo Corrêa de Lima Miliatto
Sheila das Chagas Mendes
Flavia Saad
Jamile Sanches Codogno
Renato Hoffmann Nunes
Raphael Mendes Ritti-Dias
Valeria Juday
Beny Lafer
Carlos Ugrinowitsch
Publication date
01-12-2018
Publisher
BioMed Central
Published in
Trials / Issue 1/2018
Electronic ISSN: 1745-6215
DOI
https://doi.org/10.1186/s13063-018-2906-y

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