Dataset Information

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 (~?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.

SUBMITTER: Neves LM

PROVIDER: S-EPMC6180512 | biostudies-literature | 2018 Oct

REPOSITORIES: biostudies-literature

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Publications

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.

Neves Lucas Melo LM Silva-Batista Carla C Marquesini Raquel R da Cunha Telma Fátima TF Dimateo Elisa E Nascimento Luciana L Moreira-Neto Acácio A de Lima Miliatto Angelo Corrêa AC das Chagas Mendes Sheila S Saad Flavia F Codogno Jamile Sanches JS Nunes Renato Hoffmann RH Ritti-Dias Raphael Mendes RM Juday Valeria V Lafer Beny B Ugrinowitsch Carlos C

Trials 20181010 1

<h4>Background</h4>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, hipp ...[more]

PMID: 30305151

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Project description:Background: Aerobic exercise (AE) may be a non-pharmacological strategy to improve depression treatment and lessen the burden of somatic comorbidity of depression. Only few studies have examined the effect of AE as an add-on treatment for moderate to severe depression in an inpatient setting, and most studies have focused on depression severity and cardiovascular parameters. The purpose of the present article is to present the study protocol, to provide information about the assessed study population, and to perform a manipulation check in order to examine whether the intervention program was properly implemented. Methods: We conducted a randomized controlled trial in two centers comparing 6 weeks of AE to a placebo control intervention (stretching) as an add-on to standardized inpatient treatment of moderate to severe depression. Besides depression severity, several other psychological and biological variables were measured such as salivary cortisol, brain-derived neurotropic factor, cognitive tests, and polysomnography. To evaluate long-term effects of the intervention, we also scheduled a follow-up 6 months after completion of the study intervention. Results: Forty-five patients were randomized to either AE (n = 23) or the placebo intervention (n = 22); 36 patients completed the 6-week intervention. In the AE group, 65% completed all 18 training sessions. Patients who were less physically active prior to admission were less likely to complete the study. With regard to energy expenditure, mean kcal/kg/week was 16.4 kcal/kg/week (range: 13.8-17.7), coming close to the targeted dose of 17.5 kcal/kg/week. Conclusions: Overall, patients showed good adherence to the intervention protocol despite at least moderate depression severity. However, the dropout rate suggests that depressed inpatients may need special support to adhere to a structured exercise intervention program. This study will add evidence on the effects of AE as an add-on to inpatient treatment of moderate to severe depression. Besides antidepressant effects, potentially beneficial effects of AE on a broad array of further variables associated with depression will be evaluated. Clinical Trial Registration: www.ClinicalTrials.gov, identifier NCT02679053.

Project description:BackgroundUnipolar depression is one of the most important mental disorders. Insomnia is a symptom of cardinal importance in depression. It increases the risk to develop depression, negatively affects disease trajectory, is the most common symptom after remission, increases the risk of relapse, and is associated with higher suicide rates. Existing therapies for insomnia in depression have limitations. Further adjuvant therapies are therefore needed. Acute aerobic exercise has been shown to have beneficial effects on sleep in healthy individuals and patients with insomnia. We therefore hypothesize that a single session of aerobic exercise has a positive impact on sleep in patients with unipolar depression. This trial aims to investigate the effects of a single bout of aerobic exercise on the subsequent night's sleep in patients with depression.Methods/designThis is a two-arm parallel group, randomized, outcome assessor blinded, controlled, superiority trial. Patients between 18 and 65 years of age with a primary diagnosis of unipolar depression (without a psychotic episode) are included. Exclusion criteria are regular use of hypnotic agents, opioids, and certain beta-blockers, as well as the presence of factors precluding exercise, history of epilepsy, restless legs syndrome, moderate obstructive sleep apnea, and a BMI > 40. The intervention is a single bout of aerobic exercise, performed for 30 min on a bicycle ergometer at 80% individual anaerobic threshold. The control group sits and reads for 30 min. The primary outcome is sleep efficiency measured by polysomnography. Secondary outcomes include further polysomnographic variables, subjective pre-sleep arousal, nocturnal cardiovascular autonomic modulation, subjective sleep quality, daytime sleepiness, and adverse events. According to the sample size calculation, a total of 92 patients will be randomized using minimization.DiscussionThis trial will add new information to the body of knowledge concerning the treatment of insomnia in patients with depression. Thereby, the results will inform decision makers on the utility of acute aerobic exercise.Trial registrationClinicaltrials.gov, NCT03673397 . Protocol version 1 registered on 17 September 2018.

Project description:Background: Motor learning is impaired in Parkinson's disease (PD), with patients demonstrating deficits in skill acquisition (online learning) and consolidation (offline learning) compared to healthy adults of similar age. Recent studies in young adults suggest that single bouts of aerobic exercise (AEX), performed in close temporal proximity to practicing a new motor task, may facilitate motor skill learning. Thus, we aimed at investigating the effects of a single bout of aerobic cycling on online and offline learning in PD patients. Methods: 17 PD patients (Hoehn and Yahr 1 - 2.5, age: 64.4 ± 6.2) participated in this crossover study. Immediately prior to practicing a novel balance task, patients either performed 30 min of (i) moderate intensity (60-70% VO2max) aerobic cycling, or (ii) seated rest (order counterbalanced). The task required patients to stabilize a balance platform (stabilometer) in a horizontal position for 30 s. For each experimental condition, patients performed 15 acquisition trials, followed by a retention test 24 h later. We calculated time in balance (platform within ± 5° from horizontal) for each trial, and analyzed within- and between-subjects differences in skill acquisition (online learning) and skill retention (offline learning) using mixed repeated-measures ANOVA. Results: We found that the exercise bout had no effect on performance level or online gains during acquisition, despite affecting the time course of skill improvements (larger initial and reduced late skill gains). Aerobic cycling significantly improved offline learning, as reflected by larger 24-h skill retention compared to the rest condition. Conclusion: Our results suggest that a single bout of moderate-intensity AEX is effective in improving motor skill consolidation in PD patients. Thus, acute exercise may represent an effective strategy to enhance motor memory formation in this population. More work is necessary to understand the underlying mechanisms, the optimal scheduling of exercise, and the applicability to other motor tasks. Further, the potential for patients in later disease stages need to be investigated. The study was a priori registered at ClinicalTrials.gov (NCT03245216).

Dataset Information

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.

Background

Methods/design

Discussion

Trial registration

Publications

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.

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