998 resultados para Ensaio controlado randomizado


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Ensaio clínico controlado e aleatorizado que comparou o uso de protocolo de insulina intensivo e convencional na evolução clínica de pacientes em sepse grave e choque séptico, nas primeiras 72 h. Foi conduzido em um hospital universitário na cidade de São Paulo. Os pacientes (n=46) foram alocados em dois grupos: glicêmico intensivo (glicemia entre 80-110mg/dl) e convencional (180-220mg/dl). Utilizaram-se testes t-Student e Qui-Quadrado na análise dos dados. Observou-se diferença estatisticamente significativa (p<0,001) na média glicêmica, mas não houve diferença para as variáveis pressão arterial média mínima (p=0,06) e máxima (p=0,11), creatinina sérica (p=0,33) e na mortalidade (p=0,11). Apesar de não haver diferença entre os grupos quanto à mortalidade, a instabilidade hemodinâmica no grupo convencional foi mais duradoura e somente nele ocorreram óbitos.

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Objective: to investigate the immediate effect of the vibrating platform on the neuromuscular performance of the quadriceps femoris and on the postural oscillation of subjects submitted to Anterior Cruciate Ligament (ACL) reconstruction. Materials and methods: this study is a randomized and blind clinical trial. Forty-four male volunteers (average age of 27,4 ±6,2 IMC of 26,85± 3,8 Kg/m² and post surgery timeframe of 17± 1,4 weeks) were randomized into two groups: OFF platform (n=22, protocol of exercise over the vibrating platform off) and ON platform (n=22 protocol of exercise over the vibrating platform on, 50Hz frequency and 4mm of amplitude). All volunteers were submitted to assessment the isokinetic evaluation of the quadriceps femoris (isometric and isokinetic at 60°/s) and of the electromyography activity of the muscles Vasto Lateralis (VL) and Vasto Medialis (VM), besides the postural oscillation (baropodometry) in two distinct moments: before and immediately after the intervention protocol. The data was analyzed through the SPSS 20.0 software, with a 5% significance level. To verify the homogeneity of the groups it was used an ANOVA one way, and a ANOVA mixed model to compare the intra and inter groups. Results: it was observed differences between the pre and the post, to latero lateral velocity, isometric torque peak and total work in comparison with intragroup. However, it wasn’t verified any difference in comparing the intergroup in the preevaluation and in the post-evaluation protocol over the vibrating platform. Conclusion: the use of the vibrating platform doesn’t change as an immediate manner the isokinetic performance of the quadriceps femoris, the electromyography activity of the VL and the VM, also doesn’t interfere with the postural oscillation of individuals that were submitted to the ACL reconstruction.

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OBJETIVO: avaliar o efeito da isoflavona de soja sobre os sintomas climatéricos e espessura endometrial em mulheres na pós-menopausa. MÉTODOS: ensaio clínico randomizado, duplo-cego e controlado envolvendo 90 mulheres pós-menopausadas, entre 45 e 60 anos, com queixas de fogachos, acompanhados ou não de outros sintomas climatéricos. Foram randomizadas para receber 50 mg de isoflavona a cada 12 horas, diariamente, por 12 semanas (n=42), ou placebo (n=48), e avaliadas antes e ao final do tratamento, pelo índice menopausal de Kupperman (IK), no qual se registrava a intensidade dos sintomas climatéricos, utilizando uma escala visual analógica de 100 mm. Os fogachos foram avaliados separadamente também. Foram submetidas a uma ultra-sonografia transvaginal para a avaliação da espessura do eco endometrial. Para a análise estatística, empregaram-se o teste do chi2, ANOVA ou t de Student e Mann-Whitney, ao nível de significância de 5%. RESULTADOS: não foram observadas diferenças significantes no IK (64 versus 82, p>0,05) nem nos fogachos (20 versus 20, p>0,05), entre os grupos tratados com isoflavona ou placebo, respectivamente. Também não foram observadas diferenças significantes no IK e nos fogachos, antes e após o tratamento, quando os grupos tratados com isoflavona ou placebo foram analisados separadamente. Nenhuma diferença foi observada na espessura do endométrio após o tratamento entre os grupos tratados com isoflavona ou placebo (0,28 versus 0,26 mm, respectivamente, p>0,05). CONCLUSÕES: a isoflavona de soja, na dose de 100 mg/dia, não é mais efetiva que o placebo para a redução das ondas de calor e sintomas do hipoestrogenismo em mulheres na pós-menopausa e não apresenta efeitos sobre a espessura endometrial.

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Introdução: AIDS é uma infecção caracterizada pela disfunção das células imunes - imunodeficiência, e freqüente disfunção intestinal. Probióticos, suplemento alimentar microbiano vivo, que afeta beneficamente o animal hospedeiro através do balanço da microflora intestinal e promoção de efeitos benéficos à saúde. Objetivos: determinar a resposta imunológica (CD4 cels/mm3) e diminuir os episódios de fezes líquidas. Metodologias: estudo randomizado duplo-cego controlado, com crianças infectadas pelo vírus HIV (2 - 12 anos), divididas em dois grupos – um recebendo probióticos (fórmula contendo Bifidobacterium bifidum e Streptococcus thermophilus – 2,5x1010 ufc) e, o outro, fórmula padrão (grupo controle). Os valores de CD4 foram coletados no início e término do estudo. A consistência e o número de episódios de fezes foram acessados através de um questionário, e duas amostras de fezes foram coletadas para cultura de Cândida. Resultados: observamos aumento da media de células totais de CD4 no grupo (791 cels/mm3), e um pequeno declínio no grupo controle (538 cels/mm3); a diferença das médias foi de 118 cels/mm3 vs. -42 cels/mm3 (p 0.049), analisado estatisticamente pelo delta de logaritmo base 10 do CD4 log10. Observamos uma redução na freqüência de fezes líquidas semelhante nos dois grupos (p 0,06), porém com leve melhora no grupo probiótico, porém sem diferença estatística (p 0,522). Também houve uma leve diminuição da freqüência de fezes pastosa (p 0,955), bem como um aumento na freqüência de fezes normais nos dois grupos (p 0.01). Conclusão: Nosso estudo mostrou as propriedades imunomodulatórias dos probióticos, e que estes podem ser úteis para auxiliar no tratamento de crianças infectadas pelo HIV.

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A analgesia pós-operatória eficaz é especialmente importante após cirurgias torácicas, pois, além de aliviar a dor, facilita a retomada de atividades normais, incluindo a deambulação, a respiração e a tosse. Dessa forma, os objetivos deste estudo são: avaliar a eficácia analgésica da associação entre anestesia geral e raquianestesia com morfina e ropivacaína mais esquema multimodal em relação à anestesia geral e esquema multimodal em cirurgia de revascularização do miocárdio; analisar a eficácia analgésica da injeção subcutânea de lidocaína e analgesia multimodal na remoção de tubos torácicos em cirurgia de revascularização do miocárdio. A metodologia consiste em ensaio clínico randomizado, controlado, envolvendo 58 pacientes, de ambos os sexos, com idade média de 59,8  8,9 anos, estado físico ASA II e III. Os participantes foram alocados em dois grupos, sendo o GI composto por indivíduos submetidos à anestesia geral combinada à raquianestesia com morfina 400μg e 6 ml (30mg) a 8 ml (40mg) de ropivacaína a 0,5% e analgesia multimodal; já o GII foi composto por indivíduos submetidos à anestesia geral associada à analgesia multimodal. Foi avaliada a dor, ao despertar, nas primeiras 24 horas, e ao realizar exercício respiratório, ao retirar drenos de torácicos e o tempo para extubação. A análise estatística foi realizada pelos testes do Qui-quadrado e Teste t de Student e o teste de Fisher. O resultado obtido foi o seguinte: o GI apresentou menor intensidade de dor ao despertar (p= 0,001), nas primeiras 24 horas (p= 0,001) e durante a realização dos exercícios respiratórios (p= 0,004). Houve maior necessidade de analgesia complementar no grupo GII, com maior consumo de morfina (p= 0,05), e os efeitos colaterais leves, como náuseas (p= 0,001), vômito (p= 0,002), prurido (p= 0,030), predominaram no GI. Não houve diferença estatisticamente significante entre os grupos (P= 0,47), em relação à intensidade de dor na remoção dos drenos. Após as observações feitas, o estudo sugere que a anestesia geral combinada à raquianestesia com morfina associada à ropivacaína oferece melhor efeito analgésico no pós-operatório de cirurgia cardíaca. Adicionalmente, o estudo sugere que o efeito analgésico da injeção subcutânea de lidocaína 1% associado à analgesia multimodal não é eficaz

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Conselho Nacional de Desenvolvimento Científico e Tecnológico

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Objective:To analyze the immediate effects of the Kinesio Taping® application on the quadriceps neuromuscular performance, postural balance and lower limb function in healthy subjects. Materials andmethods:This is a randomized, controlled, blinded clinical trial. Sixtyfemale volunteers(age: 23.3±2.5 years old, BMI: 22.2±2.1kg/m2)wererandomly assigned intothreegroups with20memberseach,and performedone of these threeprotocols: control -10 minutesof rest,experimental 1- patch application ontherectusfemoris (RF), vastuslateralis(VL) and vastusmedialis(VM) and experimental 2-KT application on the same muscles. Allunderwent an evaluationfor singleand triple hop distance, postural balance (baropodometry), joint position sense(JPS), peak torque (concentric and eccentricevaluation at 60°/s)and electromyographic activityof VL,before andafter intervention.Results: There wasasignificant increasein the jump distanceof thethreestudied groups,with no differencebetween groups.There were nosignificant changesin postural balance,JPS, concentricpeak torqueand RMSof the VLin none of the groups. There was a reduction ineccentricpeak torquein all groups, without differencesbetween groups.Conclusion:The KT application on the RF, VL and VMmusclesis not able tosignificantly improvelower limbfunction and postural balance, as well as the kneeextensor peaktorque, JPSand the VL muscleactivation amplitudeof healthy women.

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Objective: To evaluate the effect of different resting periods, after induced muscle fatigue, in the quadriceps femoris neuromuscular performance, in healthy subjects. Methods: Sixty-four volunteers, of both genders, with an average of 21,8 ± 1,7 years and mean body mass index of 24,2 ± 3,7 Kg/m2 were randomly assigned into 4 groups: control group (was not induced fatigue); Experimental Group 1 (Exp. 1 1 minute of rest after fatigue); Experimental Group 3 (Exp. 3 3 minutes of rest after fatigue) and Experimental Group 5 (Exp. 5 5 minutes of rest after fatigue). The subjects were evaluated to the knee´s joint position sense (JPS), followed by 5 flexion-extension knee concentric isokinetic contractions at 60°/s, with concomitant recording of median frequency (Fmed) of rectus femoris (RF), vastus lateralis (VL) and vastus medialis (VM). Then they underwent a muscle fatigue protocol (30 flexion-extension knee concentric contractions at 60°/s) and were reevaluated on the isokinetic performance, Fmed and JPS. Blood lactate levels were measured before initial assessment, immediately after the fatigue protocol and 5 minutes after the end of the rest period. Results: The adoption of 3 minutes of rest was sufficient to restore the initial conditions for the peak torque normalized by body weight and the VL and VM Fmed. The joint position sense returned to its initial values with 1 minute rest. The lactate concentration remained high regardless of the adopted rest period. Conclusion: The use of 3-minute rest period is sufficient for the reestablishment of the neuromuscular parameters to the pre fatigue values.

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Among the therapeutic approaches that can be used to achieve this goal is the gait training on sloping surfaces, but there are few scientific findings that elucidate the results of this practice. OBJECTIVE: To evaluate the effects of training on sloping surfaces on the gait of subjects with chronic hemiparesis. MATERIALS AND METHODS: A controlled, randomized, blinded clinical trial was conducted. Concluded the study twenty-four subjects with age between 40 and 70 years (54,91±9,3). Their neurological function, functional independence, motor function and balance assessed, besides the gait evaluation through kinemetry. The subjects were allocated into two groups: control group (CG) underwent gait training on treadmill with partial body weight support (PBWS) without inclination; and the experimental group (EG) submitted to gait training on treadmill with PBWS and inclination of 10%. Twelve training sessions were performed. The paired t Student test and Wilcoxon test were used in statistical analysis to compare findings before and after training for each group, and the t student test for independent samples and Mann-Whitney.test were used to compare the to groups. RESULTS: After training within-group changes were observed on balance recovery, motor function and functionality, in both experimental conditions. The EG showed changes after training on speed, stride length, step length of paretic and non-paretic side, paretic single support, double support time and non-paretic swing time. The CG the differences were detected on double support, paretic single support and hip range of movement. The EG showed better results when compared to CG on the variables: speed (p=0,034), non-paretic single support (p=0,02) and paretic swing time (p=0,02). CONCLUSION: gait training on sloping surfaces represents a promising strategy for gait training of subjects with chronic hemiparesis since it is can influence a greater number of gait variables, when compared with gait training on flat surface

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Introduction: The intrinsic gait disorders in individuals with Parkinson's disease (PD) are one of the most disabling motor symptoms. Among the therapeutic approaches used in attempts to improve the motor function, especially the gait pattern of individuals, stands out the treadmill gait training associated with the addition of load. However, there are few findings that elucidate the benefits arising from such practice. Objective: To assess the effects of adding load on the treadmill gait training in individuals with PD. Material and Methods: A controlled, randomized and blinded clinical trial, was performed with a sample of 27 individuals (18 men and 9 women) with PD, randomly assigned to three experimental conditions, namely: treadmill gait training (n=9), treadmill gait training associated with addition of 5% load (n=9) and treadmill gait training associated with addition of 10% load (n=9). All volunteers were assessed, during phase on of Parkinson's medication, regarding to demographic, clinical and anthropometric (identification form) data, level of disability (Hoehn and Yahr Modified Scale), cognitive function (Mini Mental State Examination), clinical functional - in those areas activity of daily living and motor examination (Unified Parkinson's Disease Rating Scale - UPDRS) and gait cinematic analysis was performed through Qualisys Motion Capture System®. The intervention protocol consisted of gait training in a period of 4 consecutive weeks, with three weekly sessions, lasting 30 minutes each. The post-intervention assessment occurred the next day after the last training session, which was performed cinematic analysis of gait and the UPDRS. Data analysis was performed using the software Statistical Package for Social Sciences® (SPSS) 17.0. Results: The age of volunteers ranged from 41 to 75 years old (62,26 ± 9,07) and the time of clinical diagnosis of PD between 2 to 9 years (4,56 ± 2,42). There was a reduction regarding the score from motor exam domain (p=0,005), only when training with the addition of a 5% load. As for the space-time variables there was no significant difference between groups (p>0,120); however, the training with addition of 5% load presented the following changes: increase in stride length (p=0,028), in step length (p=0,006), in time balance of the most affected member (p=0,006) and reduction in support time of the referred member (p=0,007). Regarding angular variables significant differences between groups submitted to treadmill gait training without addition load and with 5% of load were observed in angle of the ankle at initial contact (p=0,019), in plantar flexion at toe-off (p=0,003) and in the maximum dorsiflexion in swing (p=0,005). While within groups, there was a reduction in amplitude of motion of the ankle (p=0,048), the only workout on the treadmill. Conclusion: The treadmill gait training with addition of 5% load proved to be a better experimental condition than the others because it provided greater gains in a number of variables (space-time and angular gait) and in the motion function, becoming a therapy capable of effectively improving the progress of individuals with PD

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Background: The Pilates Method is a modality of exercise that has been growing in recent decades, but few researches has been conducted with elderly and little is known about its benefits in this population. Objective: To evaluate the effect of a program of Mat Pilates exercises in muscle performance and postural balance in elderly women. Materials and Method: This is a randomized controlled trial that evaluated the muscle performance (isokinetic dynamometer Biodex System 3 Pro®) and postural balance (Balance Master System®) of 33 women aged 65-80 years. The experimental group (EG) participated of a 12-week program of Mat Pilates exercises with two weekly sessions. Data normality was verified by the Shapiro - Wilk test and were adopted p value < 0.05 as significance level. Results: There were no differences between groups after training. However, the EG showed an increase in the values of extension and flexion average power to 60 ° / s after training (32.19 W to 37.04 W and 14.48 W to 17.56 W, respectively). Conclusion: The proposed exercise program was not effective in the total work and average power of flexor and extensor of the knee, as well as static and dynamic balance of participants