BackgroundPatients 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/designSeventy-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.DiscussionThis 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 registrationBrazilian Clinical Trials Registry (ReBec) - RBR-9zgxzd - Registered on 4 Jan. 2017.Electronic supplementary materialThe online version of this article (10.1186/s13063-018-2906-y) contains supplementary material, which is available to authorized users.
O objetivo deste estudo foi verificar dentre os sintomas motores, sintomas não motores e o medo de cair quais seriam os principais preditores de qualidade de vida em indivíduos nos estágios 2 e 3 da doença de Parkinson (DP). Trinta e nove indivíduos com DP (64,1±9,1 anos, 10,3±4,7 duração da DP) avaliados no estado on da medicação participaram do estudo. A disfunção motora foi avaliada por meio dos seguintes testes: parte III da Escala Unificada de Avaliação da Doença de Parkinson (UPDRS-III), teste Timed up and Go (TUG), Teste de Sistema de Avaliação do Equilíbrio (BESTest) e uma repetição máxima dos membros inferiores (1RM no leg press). A disfunção não motora foi avaliada por meio dos seguintes testes: Avaliação Cognitiva de Montreal (MoCA), Inventário de Depressão de Beck (IDB) e o Índice de Qualidade do Sono de Pittsburgh (PSQI). O medo de cair foi avaliado por meio da Escala Internacional de Eficácia de Quedas (FES-I). A qualidade de vida foi avaliada por meio do teste Questionário da Doença de Parkinson (PDQ-39). Uma regressão múltipla linear, método stepwise foi empregada para verificar o principal preditor do escore da PDQ-39. A única variável independente que entrou no modelo de regressão múltipla linear (stepwise) e mostrou uma alta capacidade para explicar o escore de qualidade de vida de indivíduos com DP foi a FES-I (R2 ajustado = 0,73, P<0,0001). Assim, como implicação clínica, é possível sugerir que estratégias de treinamento físico que promovam diminuição no medo de cair podem impactar positivamente na qualidade de vida de indivíduos com DP moderada.
Background Minimal detectable change (MDC) when assessing balance using the Biodex Balance System (BBS) in patients with Parkinson disease (PD) is currently unknown, limiting the interpretability of the scores. Objective To determine the MDC on the Anterior/Posterior Stability Index (APSI), Medial/Lateral Stability Index (MLSI), and Overall Stability Index (OSI) from postural stability and fall risk protocols of the BBS in patients with PD. Design This was a repeated‐measures design (at a 1‐week interval). Setting Strength training laboratory of a public university. Patients 46 patients with PD (men and women) at stages 2 and 3 (67.9 ± 7.4 years old) were assessed in the “on” state (fully medicated). Methods Patients performed three trials of 20 s for each protocol. Main Outcome Measurements Absolute and relative MDC (MDC%) calculated for APSI, MLSI, and OSI from the postural stability (stable condition) and fall risk protocols (unstable condition). Results For the postural stability, the MDC and MDC% were 0.26° and 17% for APSI, 0.41° and 21% for MLSI, and 0.22° and 12% for OSI, respectively. For the fall risk, the MDC and MDC% were 0.51° and 18% for APSI, 0.21° and 15% for MLSI, and 0.41° and 20% for OSI, respectively. These results were considered acceptable, despite indices with high MDC for MLSI (postural stability) and APSI (fall risk). Conclusions Patients with PD have more mediolateral and anteroposterior changes in the stable and unstable conditions, respectively. These abnormal balance strategies can occur principally due to postural instability of PD. However, our results demonstrated acceptable MDCs in both conditions in all of the assessed axes. Thus, BBS should be incorporated into the clinical evaluation to help therapists to determine if intervention‐induced changes in balance are clinically significant or due to measurement error. Level of Evidence II
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