Does Transcranial Direct Current Stimulation reduce central and peripheral muscle fatigue in recreational runners? A triple-blind, sham-controlled, randomized, crossover clinical study.

BACKGROUND: Runners seek health benefits and performance improvement. However, fatigue might be considered a limiting factor. Transcranial Direct Current Stimulation (tDCS) has been investigated to improve performance and reduce fatigue in athletes. While some studies showing that tDCS may improve a variety of physical measures, other studies failed to show any benefit. OBJECTIVE: To evaluate the acute effects of tDCS on central and peripheral fatigue compared to a sham intervention in recreational runners. METHODS: This is a triple-blind, controlled, crossover study of 30 recreational runners who were randomized to receive one of the two interventions, anodal or sham tDCS, after the fatigue protocol. The interventions were applied to the quadriceps muscle hotspot for 20 min. Peak torque, motor-evoked potential, and perceived exertion rate were assessed before and after the interventions, and blood lactate level was assessed before, during, and after the interventions. A generalized estimated equation was used to analyze the peak torque, motor-evoked potential, and blood lactate data, and the Wilcoxon test was used for perceived exertion rate data. RESULTS: Our findings showed no difference between anodal tDCS and sham tDCS on peak torque, motor-evoked potential, blood lactate, and perceived exertion rate. CONCLUSION: The tDCS protocol was not effective in improving performance and reducing fatigue compared to a sham control intervention. BRAZILIAN CLINICAL TRIALS REGISTRY: RBR-8zpnxz.

Effect of transcranial direct current stimulation combined with pelvic muscle training in women: Randomized, controlled, double-blind, and clinical trial.

BACKGROUND: Pelvic floor muscle training (PFMT) is widely used for pelvic floor muscle (PFM) weakness in women; however, it has no prolonged effects. OBJECTIVE: To evaluate the effect of Transcranial Direct Current Stimulation (tDCS) associated with PFMT on PFM contraction, sexual function and quality of life (QoL) in healthy women. STUDY DESIGN: 32 nulliparous women, aged 22.7 ± 0.42 years, were randomized into two groups: G1 (active tDCS combined with PFMT) and G2 (sham tDCS combined with PFMT). The treatment was performed three times a week for 4 weeks, totaling 12 sessions. PFM function was assessed using the PERFECT scheme (P = power, E = endurance, R = repetitions, F = rapid contractions, ECT = each timed contraction) and the perineometer (cmH2O). Sexual function was assessed by The Female Sexual Function Index, and QoL by the SF-36 questionnaire. These assessments were performed before and after the 12nd treatment session and after 30-day follow-up. RESULTS: There was a significant increase (p = 0.037) in the power of G2 compared to G1; repetitions and fast contraction increased in the G1 group, and the resistance increased in both groups, however, without statistical difference between the groups. ECT increased in the G1 group (p = 0.0). CONCLUSION: Active tDCS combined with PFMT did not potentiate the effect of the PFMT to increase the PFM function, QoL, and sexual function in healthy women. However, adjunctive tDCS to PFMT improved the time of contractions, maintaining it during follow-up.

Predictors of the Social Participation of Adults with Down Syndrome: An Analysis Based on the Biopsychosocial Model of the International Classification of Functioning, Disability, and Health.

OBJECTIVE: The aim of the study is to identify the predictors of social participation in Down syndrome adults from the biopsychosocial model of the International Classification of Functioning, Disability, and Health. METHODS: An exploratory, analytical, cross-sectional study was conducted with Down syndrome adults. The social participation was assessed using the Life Habits Assessment. The independent variables were determined using the International Classification of Functioning, Disability, and Health biopsychosocial model: body functions were assessed by body mass index, cognition function (Mini-Mental State Examination), and lower limbs muscle strength (Sit-to-Stand Test). Activities were assessed by the 8-Foot Up and Go Test. Environmental factors were assessed by the measure of the quality of the environment, and personal factors were assessed by age, sex, and education level. RESULTS: The total Life Habits Assessment score indicates that individuals show moderate restriction in social participation, with major restriction in the education, employment, and responsibilities domains. The 8-Foot Up and Go Test was the best social participation predictor variable, followed by Mini-Mental State Examination, and the Sit-to-Stand Test. Contextual factors were not predictors of participation. CONCLUSIONS: It was concluded that individuals with Down syndrome present the most restrictions to social participation in activities that involve social roles. The predictors influencing social participation are functional mobility, cognition, and lower limb muscle strength.

Effects of Transcranial Direct Current Stimulation and Pelvic Floor Muscle Training in Women: protocol for a controlled, randomized, double-blind clinical trial / Efectos de la estimulación transcraneal por corriente directa y del entrenamiento muscular del suelo pélvico en mujeres: protocolo de un ensayo clínico controlado, aleatorizado y doble ciego / Efeitos da estimulação transcraniana por corrente contínua e treinamento muscular do assoalho pélvico em mulheres: protocolo para um ensaio clínico controlado, randomizado e duplo-cego

ABSTRACT Pelvic floor muscle weakness can lead to urinary incontinence, pelvic organ prolapse, and sexual dysfunction. Although it can be minimized by pelvic floor muscle training (PFMT), its effects are not lasting. Therefore, using combination therapy seems promising. This study aims to evaluate the effect of transcranial direct current stimulation (tDCS) combined with PFMT on intravaginal pressure, pelvic floor muscle strength (PFMS), sexual function (SF), and quality of life (QoL) in healthy women. A total of 32 women, aged from 18 to 45 years, will undergo PFMT (with perineal contractions and relaxation) with the aid of pressure biofeedback associated with active tDCS or sham tDCS. Sessions will last 20 minutes, three times per week, for four weeks, totaling 12 sessions. During the protocol, participants will be instructed to also perform the home-based PFMT daily. The tDCS anodal electrode will be positioned over the supplementary motor area of the dominant cortical hemisphere, whereas the cathodal will be over the contralateral supraorbital region, with a 2mA intensity for 20 minutes. Intravaginal pressure (pressure gauge), PFM strength (measured by digital palpation and the PERFECT scheme), FSFI (Female Sexual Function Index), and QoL (SF-36 questionnaire) will be evaluated before and after the 12 sessions and after a 30-day follow-up.

RESUMEN La debilidad de la musculatura del suelo pélvico puede provocar incontinencia urinaria, prolapso de órganos pélvicos y disfunción sexual, y puede minimizarse mediante el entrenamiento de la musculatura del suelo pélvico (EMSP). Sin embargo, este efecto no es duradero. En este contexto, una terapia combinada puede ser prometedora para mejorar la situación. Este estudio tiene por objetivo evaluar el efecto de la estimulación transcraneal por corriente directa (ETCC) combinada con EMSP sobre la presión intravaginal, la fuerza muscular del suelo pélvico (FMSP), la función sexual (FS) y la calidad de vida (CV) en mujeres sanas. Participarán 32 mujeres, de entre 18 y 45 años, que se someterán a EMSP (contracciones y relajación del perineo) y a Biofeedback asociado a ETCC activa o ETCC sham durante 20 minutos, tres veces por semana, durante 4 semanas, con un total de 12 sesiones. Durante el protocolo, las participantes también se someterán diariamente a EMSP en casa. El electrodo anodal de la ETCC se colocará sobre el área motora suplementaria del hemisferio cortical dominante, y el electrodo catodal sobre la región supraorbital contralateral, a una intensidad de 2 mA, durante 20 minutos. Se evaluarán la presión intravaginal (manómetro), la FMSP (palpación digital, esquema Perfect), la FS (Índice de Función Sexual Femenina) y la CV (cuestionario SF-36) antes y después de las 12 sesiones, así como tras un seguimiento de 30 días.

RESUMO A fraqueza muscular do assoalho pélvico pode gerar incontinência urinária, prolapso de órgãos pélvicos e disfunção sexual, e pode ser minimizada pelo treinamento muscular do assoalho pélvico (TMAP). No entanto, este efeito não é duradouro. Assim, terapia combinada parece ser promissora para a melhora deste quadro. Dessa forma, objetiva-se avaliar o efeito da estimulação transcraniana por corrente contínua (ETCC), combinada ao TMAP, sobre a pressão intravaginal, força muscular do assoalho pélvico (FMAP), função sexual (FS) e qualidade de vida (QV) em mulheres saudáveis. Serão 32 mulheres, entre 18 e 45 anos, que realizaram TMAP (contrações e relaxamento do períneo) e Biofeedback associados a ETCC ativa ou ETCC sham por 20 minutos, três vezes por semana, por 4 semanas, totalizando 12 sessões. Durante o protocolo, as participantes também realizarão diariamente, em domicílio, o TMAP. O eletrodo anodal da ETCC será posicionado sobre a área motora suplementar do hemisfério cortical dominante, e o catodal sobre a região supraorbital contralateral, com intensidade de 2mA, por 20 minutos. A pressão intravaginal (manômetro de pressão), FMAP (palpação digital, esquema Perfect), FS (Índice de Função Sexual Feminina) e QV (questionário SF-36) foram avaliadas antes e depois das 12 sessões, bem como após acompanhamento de 30 dias.

Effect of osteopathic visceral manipulation for individuals with functional constipation and chronic nonspecific low back pain: Randomized controlled trial.

OBJECTIVE: To investigate the effect of osteopathic visceral manipulation (OVM) on disability and pain intensity in individuals with functional constipation and chronic nonspecific low back pain. METHODS: This study is a randomized controlled trial with a blinded assessor. Seventy-six volunteers with functional constipation and chronic nonspecific low back pain were randomized to two groups: OVM and sham OVM. The primary clinical outcome was pain intensity measured using a numeric rating scale (NRS) and disability measured using the Oswestry Disability Index (ODI). The secondary outcomes were electromyographic signals measured during the flexion-extension cycle, the finger-to-floor distance during complete flexion of the trunk and the Fear-Avoidance Beliefs Questionnaire (FABQ). All outcomes were determined after six weeks of treatment as well as three months after randomization. RESULTS: The OVM group reported a reduction in pain intensity after six weeks of treatment and at the three-month evaluation (p < .0002) and the sham group reported a reduction in pain intensity after three-month evaluation (p < .007). For the ODI was also found in the OVM group six weeks after the end of treatment (treatment effect = -6.59, 95% CI: -12.01 to -1.17, p = .01) and at the three-month evaluation (treatment effect = -6.02, 95% CI: -11.55 to -0.49, p = .03). Significant differences were also found for paravertebral muscle activity during the dynamic phases (flexion and extension) six-week evaluations. CONCLUSIONS: The OVM group demonstrated a reduction in pain intensity and improvement in disability after six-weeks and three-month follow-up while the sham group reduction in pain three-month follow-up.

Adverse effects after vaccination against SARS-CoV-2 (COVID-19) in Down syndrome adults / Efeito adverso pós-vacinação contra a Covid-19 em adultos com síndrome de down

Introduction: Comorbidities in adults with Down syndrome are common making them a risk group for COVID-19. Thus, vaccinating against COVID-19 becomes necessary, but requires care against possible side effects. Objective: To investigate possible adverse effects after vaccination against COVID-19 in adults with Down Syndrome (DS). Methodology: Descriptive study in which ninety-seven adults diagnosed with DS were interviewed using a questionnaire containing seventeen questions related to personal and historical data, and seven questions related to vaccination. Results: The most applied vaccine was AstraZeneca (94%), Pfizer (4%), and CoronaVac (2%); 74% of the subjects had adverse effects, the most frequent after the first dose being pain at the injection site (65.3%), fever (37.9%), muscle pain (37.8%), malaise (29.5%); in the second dose there was a decrease in these adverse effects; 95% of symptoms disappeared after the first 24 hours following application. Conclusion: More than half of the individuals interviewed had adverse effects after the application of the first dose of the vaccine, decreasing with the second dose; the most frequent was pain at the site of application.

Introdução: Comorbidades em adultos com síndrome de Down são comuns tornando-os um grupo de risco para COVID-19. Dessa forma, vacinar contra a COVID-19 torna-se necessária, mas requer cuidados contra possíveis efeitos colaterais. Objetivo: Pesquisar possíveis efeitos adversos após vacinação contra COVID-19 em adultos com Síndrome de Down (SD). Metodologia: Estudo descritivo no qual 97 adultos diagnosticados com SD foram entrevistados por meio de um questionário contendo dezessete questões relacionadas a dados pessoais e histórico, e sete questões relacionadas à vacinação. Resultados: A vacina mais aplicada foi a AstraZeneca (94%), Pfizer (4%) e CoronaVac (2%); 74% dos sujeitos apresentaram efeitos adversos, sendo os mais frequentes após a primeira dose: dor no local da injeção (65,3%), febre (37,9%), dores musculares (37,8%), mal-estar (29,5%); na segunda dose houve diminuição desses efeitos adversos; 95% dos sintomas desapareceram após as primeiras 24 horas após a aplicação. Conclusão: Mais da metade dos indivíduos entrevistados apresentou efeitos adversos após a aplicação da primeira dose da vacina, diminuindo com a segunda dose; a mais frequente foi a dor no local de aplicação.

Influência da inatividade física na capacidade funcional de idosos saudáveis durante a pandemia da Covid-19 / Influence of physical inactivity on the functional capacity of healthy older people during the Covid-19 pandemic

Resumo Introdução: A pandemia da COVID-19 contribuiu para a diminuição das atividades habituais dos idosos, o que pode interferir na capacidade funcional (CF) dos mesmos. Objetivo: Verificar o impacto da inatividade física durante a pandemia da COVID-19 na CF de idosos e associar o nível de atividade física com a CF dos mesmos. Métodos: Participaram do estudo 20 idosos que frequentavam um programa de atividade física antes da pandemia da COVID-19. Foi avaliada a capacidade funcional pelo teste AVD-Glittre, teste de caminhada de 6 minutos (TC6) e Time Up and Go (TUG); os resultados foram comparados com os resultados dos testes obtidos em 2019 (antes da pandemia da COVID-19). Para verificar o nível de atividade física, foi aplicado o Questionário Internacional de Nível de Atividade Física (IPAQ). Os dados foram analisados pelo teste t pareado de Wilcoxon e teste de correlação de Pearson. Resultados: Houve um aumento do tempo da execução do teste de AVD-Glittre de 171.90 ± 35.56 para 272.00 ± 344.77 segundos, no TUG teste de 6.27 ± 119 para 6.92 ± 1.53 segundos, e no TC6 houve uma diminuição de 564.97 ± 85.22 para 464.65 ± 105.95 metros, com p<0.001 em todas as análises. A correlação entre IPAQ e o teste de AVD-Glittre foi fraca (r=0.11, p<0.63), fraca com TC6 (r= -0.10, p>0.001) e moderada com TUG (r=0.59, p>0.001). Conclusão: Houve diminuição da CF dos idosos durante a pandemia da COVID-19, o nível de atividade física influenciou no TUG.

Introduction: The COVID-19 pandemic contributed to a decrease in the usual activities of older adults, which may interfere with their functional capacity (FC). Objective: To verify the impact of physical inactivity during the COVID-19 pandemic on the older adults' FC and associate the level of older adults' physical activity with the FC. Methods: The study included 20 older people who attended a physical activity program before the COVID-19 pandemic. Functional capacity was evaluated by the ADL-Glittre test, 6-minute walk test (6MWT) and Time Up and Go (TUG) test. The tests' results were compared to the tests obtained in 2019 (before the COVID-19 pandemic). The International Physical Activity Level Questionnaire (IPAQ) was applied to verify the physical activity level. Data were analyzed using Wilcoxon's paired t-test and Pearson's correlation test. Results: There was an increase in the execution time of the ADL-Glittre test from 171.90 ± 35.56 to 272.00 ± 344.77 seconds, in the TUG test from 6.27 ± 119 to 6.92 ± 1.53 seconds, and in the 6MWT there was a decrease from 564.97 ± 85.22 to 464.65 ± 105.95 meters, with p<0.001 in all analyses. The correlation between IPAQ and the ADL-Glittre test was weak (r=0.11, p<0.63), weak with 6MWT (r= -0.10, p>0.001) and moderate with TUG (r=0.59, p>0.001). Conclusion: There was a decrease in the FC of older adults during the COVID-19 pandemic; the level of physical activity influenced the TUG.

Associação entre diabetes mellitus e evolução para intubação ou morte para os indivíduos hospitalizados com Covid-19 / Association between diabetes mellitus and evolution to intubation or death for individuals hospitalized with Covid-19

Introdução: Pacientes infectados com COVID-19 parecem manifestar evolução mais grave quando apresentam comorbidades, como a Diabetes Mellitus (DM). No entanto, dados da população brasileira ainda são pouco disponíveis. Objetivo: Analisar a associação entre DM e evolução para intubação e óbito em indivíduos internados com COVID-19. Metodologia: Estudo transversal, observacional, quantitativo com dados dos prontuários de 74 participantes adultos internados no Hospital Professora Lydia Storópoli, com diagnóstico de COVID-19. O Comitê de Ética em Pesquisa Humana aprovou este estudo e os participantes assinaram o termo de consentimento do estudo. Resultados: Dos 74 pacientes, 18 apresentavam DM, dos quais seis evoluíram para intubação e cinco evoluíram para óbito. Não houve associação significativa (p>0,05) entre DM e intubação e óbito. Conclusão: Na presente amostra a DM não foi associada com a evolução clínica para intubação e óbito.

Introduction: Patients infected with COVID-19 seem to manifest a more severe evolution when they have comorbidities, such as Diabetes Mellitus (DM). However, data on the Brazilian population are still scarcely available. Objective: To analyze the association between DM and evolution to intubation and death in individuals hospitalized with COVID-19. Methodology: Cross-sectional, observational, quantitative study with data from the medical records of 74 adult participants admitted to Professora Lydia Storópoli Hospital, diagnosed with COVID-19. The Human Research Ethics Committee approved this study, and participants signed the study consent form. Results: 74 patients with Covid-19, 18 had DM, of which six evolved to intubation, and five evolved to death. There was no significant association (p>0.05) between DM and intubation and death. Conclusion: In the present study, DM was not associated with clinical evolution to intubation and death.

Translation and cross-cultural adaptation of the Brazilian version of the PM-Scale: A specific measure of participation after stroke.

BACKGROUND: The PM-Scale was developed specifically to assess participation in individuals after stroke based on the concepts contained in the International Classification of Functioning, Disability and Health. However, this measure is only available in English and French. OBJECTIVE: To translate and cross-culturally adapt the PM-Scale to Brazilian Portuguese, followed by the validation and testing of reliability of the translated version. METHODS: The translation process followed standard guidelines. Preliminary test-retest reliability was determined using the intraclass correlation coefficient (ICC2,1). The Rasch model was employed to analyse the validity, unidimensionality, invariance, and internal consistency of the Brazilian version of the PM-Scale. RESULTS: The final translated version of the PM-Scale presented appropriate semantic, idiomatic, cultural, and conceptual equivalence. The preliminary analysis revealed excellent intra-observer and inter-observer reliability (ICC2,1 = 0.91; 95%CI: 0.83, 0.95 and ICC2,1 = 0.81; 95%CI: 0.64, 0.89, respectively). The analysis of the Rasch model revealed only one erratic item. An excellent overall fit was found for items (mean ± SD = 0.01 ± 1.02) and adequate fit was found for persons (mean ± SD = 1.16 ± 0.88). Internal consistency was considered adequate (person separation index = 1.77, reliability = 0.76). No significant invariance was found with regards to the personal characteristics of the sample (p > 0.05). CONCLUSION: The Brazilian version of the PM-Scale is a valid, unidimensional, linear, reliable scale for measuring participation in stroke survivors and can be administered in less than five minutes.

Outcome measures for adults with Down Syndrome based on the International Classification of Functioning, Disability, and Health Model: A Systematic Review

Introduction: Adults with Down syndrome (DS) have functional disabilities due to the extra presence of chromosome 21. Objective: To identify the functionality and disability assessment instruments used in research involving adults with DS and associate them with the components of the International Classification of Functioning (ICF). Methods: Two independent researchers analyzed articles from PubMed, Lilacs, SciELO, Science Direct, and Cochrane databases, including cross sectional and clinical studies whose results involved functionality and disability for individuals with DS (≥18 years), with no publication date limit for the studies. The methodological quality of the studies was analyzed by the Downs & Black Checklist; descriptive analysis was used for the results. This review was registered in PROSPERO (CRD42021234012). Results: 15 articles were analyzed in which 48 instruments were identified for the assessment of adults with DS (36.42±10.62 years); the quality of the articles was considered "good". Of these 48 instruments, 41 were associated with bodily function, 5 instruments were associated with the activity component, one instrument was associated with social participation and one instrument was associated with the environment. Conclusion: Of the 48 instruments identified to assess adults with DS, most were for the Body Function and Structure component; only the 6MWT and CAMDEX-SD have been validated for this population. LIFE-H and MQE were used to assess Social Participation and the Environment, but they cannot be considered dependable, as they have not been confirmed for individuals with DS.

Validation and reliability of the Glittre-ADL test to evaluate functional capacity in older adults

INTRODUCTION: The decline in functional capacity (FC) interferes with the functional independence of older adults, so it is important to assess the FC and use appropriate instruments for this. OBJECTIVE: To investigate the Glittre Activities of Daily Living (ADL) test's validity and reliability for assessing functional capacity in older adults. METHODS: Cross-sectional study with a sample of 100 elderly (68 ± 5.16 years). To assess the convergent validity, the Six-Minute Walk Test (6MWT) and the Timed Up and Go Test (TUG) were performed. The intra-examiner test-retest of the Glittre-ADL test was performed on the same day with a 30-minute interval between repetitions and inter-examiner reliability with an interval of seven days. RESULTS: There was a strong correlation between the Glittre-ADL test and the 6MWT (r=-0,75; p<0.001) and the TUG (r=0.77; p<0.001). The intra-examiner and inter-examiner reliability was excellent (ICC)=0.91 and 95% CI=0.14-0.97; p<0.001 and ICC=0.91; 95% CI: 0.86-0.94; p<0.001, respectively). CONCLUSION: The Glittre-ADL test demonstrated that it is valid and that its reliability is adequate to assess functional capacity in older adults.

Transcutaneous auricular vagus nerve stimulation effects on inflammatory markers and clinical evolution of patients with COVID-19: a pilot randomized clinical trial.

OBJECTIVE: To evaluate the effects of transcutaneous auricular vagus nerve stimulation (taVNS) on inflammatory markers and clinical outcomes in patients with COVID-19. METHODS: A randomized blinded pilot study was carried out with 21 individuals hospitalized with COVID-19 who received 14 sessions of active (a-taVNS) or sham taVNS (s-taVNS). The level of interleukin-6 (IL-6), interleukin-10 (IL-10), cortisol, and C-reactive protein (CRP) in plasma and clinical evolution pre- and post-intervention were evaluated. The memory and attention levels were evaluated 14 days after the end of the treatment. RESULTS: After treatment, significant intragroup differences were found in the CRP (p = 0.01), IL-6 (p = 0.01), and cortisol (p = 0.01) levels; however, in the comparison between the groups, only the CRP level was statistically lower for the a-taVNS (p = 0.04). The impression of improvement in memory and attention was greater in the a-taVNS than in the s-taVNS (p = 0.01, p = 0.04, respectively). There was no difference between the other clinical outcomes. CONCLUSIONS: taVNS is a viable and safe intervention in the acute care of patients with COVID-19, which can modulate their inflammatory profile and improve cognitive symptoms. However, improvements in overall clinical outcomes were not detected. Larger sample sizes and longer follow-ups are needed to confirm the anti-inflammatory and clinical effects of taVNS in patients with COVID-19. TRIALS REGISTRY: The Brazilian Registry of Clinical Trials (RBR-399t4g5).

Transcutaneous Auricular Vagus Nerve Stimulation Improves Inflammation but Does Not Interfere with Cardiac Modulation and Clinical Symptoms of Individuals with COVID-19: A Randomized Clinical Trial.

Transcranial auricular vagus nerve stimulation (taVNS) has shown effectiveness in reducing inflammation and depression. Thus, this study evaluated its effect on inflammation, cardiac autonomic modulation, and clinical symptoms in individuals affected by COVID-19. Methods: There were 52 randomized participants hospitalized with COVID-19 diagnosis who were to receive active (a-taVNS) or sham taVNS (s-taVNS) for 90 min twice a day for seven consecutive days. Interleukin 6 (IL-6), 10 (IL-10), cortisol, C-reactive protein (CRP), heart rate variability (HRV), and clinical symptoms were assessed before and after seven days of treatment. There were also seven- and fourteen-day follow-ups for clinical symptoms, including anxiety and depression levels, as well as a six-month follow-up for memory and attention levels. Results: There was significant reduction in CRP −23.9%, (95% CI −46.3 to −1.4) and IL-6 −37.7%, (95% CI −57.6 to −17.7) for the a-taVNS group. There were no changes in IL-10, cortisol levels, or in HRV results (p > 0.05) in both groups. There were no changes regarding clinical symptoms, except for a significant decrease in depression level (−2.85, 95% CI −5.44 to −0.27) in the a-taVNS group. Conclusion: taVNS showed effects on CRP, IL-6, and depression levels; however, it did not affect other clinical symptoms.

Efeito da estimulação elétrica transcutânea do nervo vago na inflamação, modulação autonômica cardíaca e evolução clínica dos pacientes com COVID-19: estudo de protocolo para um ensaio clínico, controlado, randomizado e cego / Efecto de la estimulación eléctrica transcutánea del nervio vago sobre la inflamación, la modulación autonómica cardiac y la evolución clínica de pacientes con COVID-19: estudio de protocolo para un ensayo clínico, controlado, aleatorizado y ciego / Effects of transcutaneous auricular vagus nerve stimulation on inflammation, cardiac autonomic modulation, and clinical evolution of patients with COVID-19: protocol for a clinical, controlled, randomized, and blind trial

RESUMO O objetivo deste estudo é avaliar o efeito da estimulação elétrica transcutânea do nervo vago (EETNV) na inflamação, modulação autonômica cardíaca e evolução clínica dos pacientes com COVID-19. Trata-se de um ensaio clínico, controlado por sham, randomizado e cego, no qual participarão 52 indivíduos hospitalizados com diagnóstico de COVID-19, que serão randomizados em dois grupos de tratamento: grupo experimental (tratamento médico usual associado à EETNV ativa) ou grupo-controle (tratamento médico usual associado à EETNV sham). A EETNV será realizada por meio de um estimulador elétrico neuromuscular (modelo Dualpex 071 da Quark Medical Products), com o eletrodo de estimulação posicionado sobre o tragus esquerdo, com corrente alternada, frequência de 30Hz e variação de 50%, intensidade ajustada para o limiar sensorial do paciente, com duração de 90 minutos cada sessão de estimulação, duas vezes ao dia, durante sete dias consecutivos, totalizando 14 sessões. Serão avaliados pré e pós-intervenção o nível de interleucina-6 (IL-6) e interleucina-10 (IL-10), cortisol e proteína C reativa (PCR), pressão arterial, variabilidade da frequência cardíaca pelos parâmetros de baixa frequência (BF), alta frequência (AF) e pela razão da baixa e alta frequência (BF/AF), além de evolução clínica dos pacientes, incluindo o nível de ansiedade e depressão, cujos dados serão obtidos por meio de prontuários e questionários. Será realizado também um acompanhamento 7 e 14 dias após o término das intervenções para verificar a evolução clínica, incluindo nível de ansiedade e depressão, e durante seis meses serão avaliadas memória e atenção.

RESUMEN El objetivo de este estudio es evaluar el efecto de la estimulación eléctrica transcutánea del nervio vago (EETNV) sobre la inflamación, la modulación autonómica cardíaca y la evolución clínica de pacientes con COVID-19. Se trata de un ensayo clínico, controlado por simulado, aleatorizado y ciego, en el que participarán 52 individuos hospitalizados diagnosticados de COVID-19, que serán aleatorizados en dos grupos de tratamiento: grupo experimental (tratamiento médico habitual asociado a la EETNV activa) o grupo control (tratamiento médico habitual asociado a la EETNV simulada). La EETNV se realizará mediante un estimulador eléctrico neuromuscular (modelo Dualpex 071 de Quark Medical Products), con el electrodo de estimulación colocado en el trago izquierdo, con corriente alterna, frecuencia de 30Hz y 50% de variación, intensidad ajustada al umbral sensorial del paciente, con una duración de 90 minutos cada sesión de estimulación, dos veces al día, durante siete días consecutivos, lo que totaliza 14 sesiones. Se evaluarán antes y después de la intervención la interleucina-6 (IL-6) y la interleucina-10 (IL-10), el cortisol y la proteína C reactiva (PCR), la presión arterial, la variabilidad de la frecuencia cardíaca por los parámetros de baja frecuencia (BF), alta frecuencia (AF) y razón de baja y alta frecuencia (BF/AF), así como la evolución clínica de los pacientes, incluidos los parámetros de ansiedad y depresión cuyos datos se obtendrán de historias clínicas y cuestionarios. También se realizará un seguimiento de 7 y 14 días tras finalizadas las intervenciones para verificar la evolución clínica, incluidos el nivel de ansiedad y de depresión, y durante seis meses se evaluará la memoria y la atención.

ABSTRACT This study aims to evaluate the effect of transcutaneous auricular vagus nerve stimulation (taVNS) on inflammation, cardiac autonomic modulation, and clinical evolution of patients with COVID-19. This is a clinical, sham-controlled, randomized, and blind trial, in which 52 hospitalized individuals diagnosed with COVID-19 will participate. They will be randomized into: experimental group (usual medical treatment associated with active taVNS) and control group (usual medical treatment associated with sham taVNS). The taVNS will be performed by a neuromuscular electric stimulator (Dualpex model 071 of Quark Medical Products), with the stimulation electrode positioned on the left tragus, with alternating current, at a 30Hz frequency with 50% variation. Intensity will be adjusted to the patient's sensory threshold, with 90-minutes-long stimulation sessions, happening twice per day for seven consecutive days, totaling 14 sessions. Interleukin-6 (IL-6) and interleukin-10 (IL-10), cortisol and C-reactive protein (CRP), blood pressure, heart rate variability (HRV) by low frequency (LF), high frequency (HF) and low and high frequency ratio (LF/HF) parameters will be evaluated before and after the intervention, as well as patients' clinical evolution-including anxiety and depression levels-whose data will be obtained through medical records and questionnaires. A follow-up will also be performed seven and 14 days after the end of the interventions to verify the clinical evolution, including anxiety and depression levels. Memory and attention levels will be evaluated for six months.

Clinimetric properties of the SATIS-Stroke questionnaire in the Brazilian population: A satisfaction assessment measure addressing activities and participation after a stroke.

BACKGROUND: SATIS-Stroke questionnaire has been translated and adapted for use in the Brazilian population, however, it is necessary to test the measurement properties in Brazilian population. OBJECTIVE: To test the reliability, agreement, concurrent validity, and diagnostic accuracy of the SATIS-Stroke. METHODS: Chronic stroke survivors were included. The calculations were made using scores in logits (Rasch Model). Reliability was tested using the intraclass correlation coefficient (ICC2,1), standard error of measurement (SEM), minimal detectable change (MDC), and Bland-Altman plots. Concurrent validity was analyzed using Spearman's correlation coefficient. For such, the correlation between SATIS-Stroke and Stroke Specific Quality of Life (SS-QOL) questionnaires was determined. Diagnostic accuracy was estimated based on the area under the receiver operating characteristic (ROC) curve with a 95% confidence interval and considering the sensitivity and specificity of SATIS-Stroke in differentiating different types of activity and participation. RESULTS: Eighty stroke survivors were analyzed. Mean age was 57.98±13.85 years and 45.2% had severe impairment. Excellent reliability was found (intra-observer ICC2,1 = 0.90; 95% CI: 0.84, 0.93; inter-observer ICC2,1 = 0.89; 95% CI: 0.83, 0.93). The Bland-Altman plot demonstrated satisfactory agreement. In the analysis of concurrent validity, a strong, positive, significant correlation was found between SATIS-Stroke and SS-QOL (rs = 0.74; p <0.001 with an r2=0.44; p=0.001). Diagnostic accuracy was satisfactory, with 80.8% sensitivity and 85.2% specificity. CONCLUSION: The Brazilian version of the SATIS-Stroke questionnaire exhibited adequate reliability, concurrent validity, and diagnostic accuracy. Therefore, this is a valid, reproducible measure for the assessment of satisfaction with regard to activities and participation following a stroke.

Associação entre a classificação da deambulação funcional com a velocidade da marcha após acidente vascular cerebral / Association between the classification of functional ambulation classification and gait speed after stroke

A escolha do instrumento adequado é decisiva para o sucesso da avaliação funcional e reabilitação. Diante disto, é necessário que o profissional tenha amplo conhecimento dos instrumentos disponíveis para que possa optar pela avaliação mais eficaz, menos onerosa e mais rápida. Objetivo: Analisar se a classificação da deambulação obtida pela Functional Ambulation Classification (FAC) se associa com o desempenho obtido no Teste de Caminhada de 10 metros (TC10M). Métodos: Estudo transversal no qual foram avaliados 61 indivíduos acometidos pelo Acidente Vascular Cerebral (AVC). Utilizou-se o TC10M e a FAC. Para verificar a normalidade dos dados foi utilizado teste Kolmogorov ­ Smirnov. Foi utilizado o ANOVA de uma via para verificar se houve diferença dos deambuladores dependentes e independentes conforme a FAC com a velocidade da marcha por meio do TC10M. Foi realizado um teste post hoc e o método de Scheffe, considerando p≤0,05. Para analisar a associação da categorização da deambulação com a velocidade da marcha, foi o utilizado o teste do qui-quadrado de independência. Resultados: Houve diferença significante de cada nível da FAC em relação a velocidade da marcha. Houve associação entre as classificações obtidas pela FAC e pelo TC10m [x2(9) = 145,335; p=0,001]; sendo que em 48% as variáveis estão corretamente associadas. Conclusão: Os achados indicaram que os níveis da FAC apresentaram associação com a velocidade da marcha. Este achada amplia os conhecimentos sobre medidas de avaliação da marcha e auxilia a prática clínica, considerando que facilita a escolha do melhor instrumento para avaliar a marcha após AVC

The choice of the appropriate instrument is decisive for the success of functional assessment and rehabilitation. In view of this, it is necessary that the professional has extensive knowledge of the instruments available so that he can choose the most effective, least costly and quickest assessment. Objective: To analyze whether the classification of ambulation obtained by the Functional Ambulation Classification (FAC) is associated with the performance obtained in the 10-meter walk test (TC10m). Methods: Cross-sectional study in which 61 individuals affected by stroke were evaluated. TC10m and FAC were used. To verify the normality of the data, a Kolmogorov-Smirnov test was used. One-way ANOVA was used to check whether there was a difference between dependent and independent walkers according to FAC with gait speed using the TC10m. A post hoc test and the Scheffe method were performed, considering p≤0.05. To analyze the association between the categorization of walking and gait speed, the chi-square test of independence was used. Results: There was a significant difference at each FAC level in relation to gait speed. There was an association between the classifications obtained by the FAC and by the TC10m [x2(9) = 145.335; p= 0.001]; and in 48% the variables are correctly associated. Conclusion: The findings indicated that the FAC levels were associated with walking speed. This finding expands the knowledge about gait assessment measures and helps clinical practice, considering that it facilitates the choice of the best instrument to assess gait after stroke

Effect of transcranial direct current stimulation and multicomponent training on functional capacity in older adults: protocol for a randomized, controlled, double-blind clinical trial.

INTRODUCTION: When physical activity contains training of at least three components such as balance, coordination and strength, among others, it is called multicomponent training. This type of training is recommended for improving the functional capacity in elderly individuals but has no lasting effects. The association of transcranial direct current stimulation (tDCS) with other types of therapy has been shown to facilitate the enhancement and prolongation of therapy outcomes. AIM: The objective of this study is to evaluate the effect of multicomponent training associated with active or sham tDCS on the performance of functional capacity in the elderly before treatment, after treatment and 30 days after the end of treatment. The secondary objective will be to correlate the performance of the primary outcome (functional capacity assessed by the Glittre Daily Life Activity Test) with walking capacity (by 6-min walk test), balance (with the mini-Balance Evaluation Systems Test), functional independence (by the Functional Independence Measure) and quality of life (with the World Health Organization Quality of Life Instrument). METHODS: Twenty-eight elderly people from the community will participate in the study, and will be randomized into two groups: 1) multicomponent training associated with active tDCS; and 2) multicomponent training associated with sham tDCS. The multicomponent training sessions will be held twice a week for 12 weeks, totaling 24 sessions. The tDCS will be administered over the dominant dorsolateral prefrontal cortex at the same time as multicomponent training, with an intensity of 2 mA, for 20 min. The evaluations will be made pretraining, after 24 training sessions and 30 days after the end of the training. DISCUSSION: We hypothesize that tDCS, when associated with multicomponent training, can potentiate and prolong the effects of this training on the functional capacity of the elderly. If this hypothesis is confirmed, this protocol may contribute to a longer-lasting physical rehabilitation of the elderly, encouraging them to maintain their independent daily activities for longer. TRIAL REGISTRATION: The study was registered in the Brazilian Clinical Trial Registry (RBR-2crd42) and received approval from the Human Research Ethics Committee of University Nove de Julho, São Paulo, Brazil (process number 3.077.953).

Protocol for a controlled, randomized, blind, clinical trial to assess the effects of anodal transcranial direct current stimulation dorsolateral prefrontal cortex associated with balance training using games in the postural balance of older people.

Aims: This study aims to evaluate the additional effect of anodal transcranial direct current stimulation (a-tDCS) applied on dorsolateral pré-frontal cortex on training postural balance with the use of video games in the aged. Methods: This is a blinded, randomized, controlled clinical trial protocol, with older people of both genders. Participants will be randomized into three training groups: Group 1 (videogame balance training), group 2 (videogame balance training associated with anodal tDCS), group 3 (videogame balance training associated with sham tDCS). The training will be carried out twice a week for four weeks, totaling eight sessions, and will be performed with the Nintendo Wii videogame console, using games that stimulate the postural balance associated with tDCS, with anode applied over the left dorsolateral prefrontal cortex and cathode on the contralateral supraorbital region at 2 mA for 20 minutes. The postural balance will be assessed using the Mini Test of the Balance Assessment System and posturography. Evaluations will be carried out before and after eight training sessions and 30 days after the end of treatment. Discussion: Some studies show favorable results from the use of video games in improving postural balance in older people; however, their effect does not remain long-term. TDCS associated with other therapies can potentiate and prolong the effects of these therapies owing to its ability to stimulate neurotrophins important for neurogenesis, facilitating tasks that require attention, and helping to consolidate learning and memory. The effect of the two associated techniques on balance has not yet been tested in this population. Registration: Brazilian Registry of Clinical Trials ID U1111-1213-4266; registered on 15 October 2018.

Translation and Cross-Cultural Adaptation of SATIS-Stroke for Use in Brazil: A Satisfaction Measure of Activities and Participation in Stroke Survivors.

INTRODUCTION: SATIS-Stroke was developed to measure satisfaction regarding activities and participation among stroke survivors based on the concepts contained in the International Classification of Functioning, Disability, and Health. However, this measure is only available in English and French. OBJECTIVE: Perform the translation and cross-cultural adaptation of SATIS-Stroke to Brazilian Portuguese and test the preliminary reliability of this measure. METHODS: The translation process followed standardized guidelines and consisted of six phases: initial translation, back-translation, analysis of expert committee, test of final version, submission, and assessment of all written reports. To test the preliminary test-retest reliability, the measure was administered by a single observer on two occasions with an interval of 7 to 14 days for the determination of intraobserver agreement and administered again by a second observer for the determination of interobserver agreement. Reliability was analyzed using the intraclass correlation coefficient (ICC2,1) and respective 95% confidence intervals (CI). RESULTS: All stages of the cross-cultural adaptation process were respected and the final translated version of SATIS-Stroke exhibited semantic, idiomatic, cultural, and conceptual equivalence to the original version. The preliminary analysis revealed excellent intraobserver and interobserver reliability (ICC = 0.93; 95% CI: 0.83-0.97, p = 0.001 and ICC = 0.90; 95% CI: 0.74-0.96; p = 0.001, respectively). The items demonstrated adequate internal consistency, although ceiling and floor effects were considered beyond acceptable standards for some items. In the exploratory factor analysis, three factors were extracted that aggregated more than one construct to each component, but all were related to the "Activities and Participation" component of the International Classification of Functioning, Disability, and Health. CONCLUSION: The final version of the SATIS-Stroke scale in Brazilian Portuguese proved to be adequate and reliable for use on the Brazilian population. Further studies are underway to give continuity to the validation process and analyze the others measurement properties of the scale in the Brazilian population.

Effects of transcranial direct current stimulation on the rehabilitation of painful shoulder following a stroke: protocol for a randomized, controlled, double-blind, clinical trial.

BACKGROUND: Shoulder pain is reported to be one of the major challenges faced in the functional recovery of patients in rehabilitation following a stroke. In such cases, transcranial direct current stimulation (tDCS) has been used as an additional therapeutic tool for improvements in central and peripheral pain. The aim of the proposed study is to evaluate the effect of tDCS when combined with upper limb physical therapy on pain intensity and functional improvement in stroke survivors with shoulder pain in the hemiplegic limb. METHODS: A randomized, placebo-controlled, double-blind, clinical trial is proposed. The volunteers will be randomly allocated to receive passive movement on the upper limb, which will be performed by the therapist for 20 min followed by either active tDCS or sham tDCS (current stimulation for 30 s) during simultaneous physical activity of the upper limb ("mini-bike") for 20 min, totaling 40 min of intervention performed in 10 consecutive sessions. The anode electrode will be positioned over the primary motor cortex with a current of 2 mA and the cathode electrode will be positioned in the supraorbital region contralateral to the anode. The primary outcome will be shoulder pain intensity, which will be measured using the visual analog scale (VAS) on three occasions: 1) pre-intervention; 2) after 10 interventions (5 weekly sessions, for 2 weeks); and 3) 30 days after the end of the interventions. The secondary outcomes will be motor performance, upper limb function, and quality of life. TRIAL REGISTRATION: Brazilian Registry of Clinical Trials, RBR-8F5MNY . Registered on June 2, 2017.