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
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 (~…
How strong is the evidence?
Evidence Hub reads this as a randomized trial, done in people. Its evidence level is 2 of 5 (High · randomized trial). Randomized trials of a reasonable size are the strongest single-study design.
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