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The objective was to compare the color match and color stability behavior of single- and multi-shade resin-based composites (RBCs) used for direct restorations. This review was conducted according to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines. Randomized clinical trials evaluating the shade performance of single-shade RBCs in direct restorations were included. A search of the scientific literature was performed in five databases (April 2024). The meta-analysis was performed using RevMan 5.4, calculating the risk difference (RD) and 95% confidence interval (CI) of the dichotomous outcome using a random effects model. Bias was assessed using the RoB 2.0 tool, and certainty of evidence was assessed using the GRADEpro tool. Four studies were selected, with 263 restorations analyzed. The results showed comparable performance between single-shade RBCs and multi-shade RBCs in terms of color match and color stability over 12 months. Three studies had a low risk of bias with all expected results, and one study had some concerns. The certainty of evidence for color stability was considered low for all follow-up periods due to the small number of events and sample size. According to the United States Public Health Service Evaluation (USPHS) and the World Dental Federation (FDI), there is comparable clinical color performance between single-shade and multi-shade RBCs over 12 months.
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BACKGROUND: The vegan diet (VEGD) has gained popularity in recent years for ecological and ethical reasons, as well as for its health benefits. In addition to the type of diet, the resistance training program (RTP) plays a fundamental role as one of the main natural anabolic stimuli to increase musculoskeletal mass and reduce fat mass. METHODS: The study was a 16-week non-randomized controlled clinical trial consisting of three RTP sessions per week. The sample included 70 Chilean individuals, aged between 18 and 59 years, who had been following a VEGD or omnivorous diet (OMND) for the past 6 months. Four groups were established: Vegan Diet Resistance Training Program (VEGD-RTP), Vegan Diet Control (VEGD-C), Omnivorous Diet Resistance Training Program (OMND-RTP), and Omnivorous Diet Control (OMND-C). RESULTS: The sample consisted of 47 women and 23 men, with a mean age of 30.1 (±8.6) years. A reduction of 1.20% in the percentage of fat mass (%FM) was observed in the VEGD-RTP group (r = 0.554, p = 0.016), as well as a reduction of 0.70 kg in kilograms of fat mass (KFM) (r = 0.480, p = 0.036). The OMND-RTP group decreased %FM by 0.90% (r = 0.210, p = 0.432) and KFM by 0.50 kg (r = 0.109, p = 0.683). CONCLUSIONS: RTP combined with VEGD or OMND significantly reduced the percentage of fat mass, although its effect was more significant in the VEGD-RTP participants.
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Composição Corporal , Dieta Vegana , Treinamento Resistido , Humanos , Feminino , Adulto , Masculino , Treinamento Resistido/métodos , Adulto Jovem , Pessoa de Meia-Idade , Adolescente , Chile , DietaRESUMO
INTRODUCTION AND HYPOTHESIS: Transcranial direct current stimulation (tDCS) can enhance muscle function in healthy individuals. However, it is unknown if tDCS associated with pelvic floor muscle training (PFMT) can improve pelvic floor muscle function (PFMF) in healthy women. The aim of this study was to investigate the acute effect of a single session of tDCS in PFMF compared with sham-tDCS in healthy women. METHODS: A double-blind, cross-over, randomized clinical trial was conducted with healthy, nulliparous and sexually active women. PFMF was assessed by bidigital palpation (PERFECT scale) and intravaginal pressure by a manometer (Peritron™). Participants randomly underwent two tDCS sessions (active and sham) 7 days apart. The electrode was positioned equal for both protocols, the anode electrode in the supplementary motor area (M1) and the cathode electrode in the right supraorbital frontal cortex (Fp2). The current was applied for 20 min at 2 mA in active stimulation and for 30 s in sham-tDCS. The tDCS applications were associated with verbal instructions to PFMT in a seated position. After each tDCS session PFMF was reevaluated. RESULTS: Twenty young healthy women (aged 23.4 ± 1.7 years; body mass index 21.7 ± 2.2 kg/m2) were included. No difference was observed in power, endurance, and intravaginal pressure of PFMF (p > 0.05). The number of sustained contractions improved from 3.0 (2.0-3.5) to 4.0 (3.0-5.0) after active-tDCS (p = 0.0004) and was superior to sham-tDCS (p = 0.01). CONCLUSION: The number of sustained contractions of PFM improved immediately after a single active-tDCS session, with a difference compared with the post-intervention result of sham-tDCS in healthy young women.
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Estudos Cross-Over , Diafragma da Pelve , Estimulação Transcraniana por Corrente Contínua , Humanos , Feminino , Diafragma da Pelve/fisiologia , Método Duplo-Cego , Adulto Jovem , Estimulação Transcraniana por Corrente Contínua/métodos , Adulto , Voluntários Saudáveis , Contração Muscular/fisiologiaRESUMO
INTRODUCTION: Impairments in bottom-up perceptual processing have been associated to the age-related cognitive decline. Digital cognitive training focusing on bottom-up and/or top-down processes have been studied as a tool to remediate age-related cognitive decline. However, the most effective training type and order of application remain unclear. METHODS: One hundred and fifteen older adults were randomly assigned to 40 h of bottom-up then top-down or top-down then bottom-up digital cognitive training or an active control group. We evaluated cognition at baseline, after 20 h and 40 h of training and at follow-up using a mixed-model analysis. RESULTS: Global cognition improved, for the top-down group, after 20 h of training (p = 0.04; d = 0.7) and for all three groups after 40 h. The improvement in global cognition remained five months after the bottom-up/ top-down training (p = 0.009; d = 4.0). There were also improvements in the recall cognitive domain, after 20 h of training, for the bottom-up group and, after 40 h, for all three groups. Gains were observed in verbal fluency after 40 h of training for both therapeutic groups. Processing speed was significantly slower, after 20 h of training, for the control and bottom-up groups and, after 40 h, only for the control group. Emotion recognition improved, after 20 h, for the control group as compared to the therapeutic groups. CONCLUSIONS: These results indicate that the bottom-up/top-down training has the most endurable effects, which reveals the importance of the order of application of the exercises for gains in cognition in older adults.
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Cognição , Disfunção Cognitiva , Humanos , Masculino , Feminino , Idoso , Disfunção Cognitiva/terapia , Cognição/fisiologia , Terapia Cognitivo-Comportamental/métodos , Testes Neuropsicológicos , Idoso de 80 Anos ou mais , Treino CognitivoRESUMO
BACKGROUND: The purpose of this study was to review and summarize the association between preoperative magnetic resonance imaging (MRI) and surgical outcomes in women with newly diagnosed invasive breast cancer from published randomized controlled trials (RCT). MATERIALS AND METHODS: Two independent researchers conducted a systematic review through a comprehensive search of electronic databases, including PubMed, Medline, Embase, Ovid, Cochrane Library, and Web of Science. If there was disagreement between the two reviewers, a third reviewer assessed the manuscript to determine whether it should be included for data extraction. The quality of the papers was assessed using the risk of bias tool, and the evidence was analyzed using GRADE. Meta-analyses using a fixed-effects model were used to estimate the pooled risk ratio (RR) and 95% confidence interval (CI). RESULTS: Initially, 21 studies were identified, 15 of which were observational comparative studies. A total of five RCTs were included, and they suggested that preoperative MRI significantly reduced the rate of immediate breast-conserving surgery and increased the risk for mastectomy. CONCLUSIONS: From the RCT perspective, preoperative MRI for newly diagnosed invasive breast cancer did not improve surgical outcomes and may increase the risk of mastectomy.
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Neoplasias da Mama , Imageamento por Ressonância Magnética , Cuidados Pré-Operatórios , Humanos , Neoplasias da Mama/cirurgia , Neoplasias da Mama/diagnóstico por imagem , Neoplasias da Mama/patologia , Feminino , Imageamento por Ressonância Magnética/métodos , Prognóstico , Mastectomia , Ensaios Clínicos Controlados Aleatórios como Assunto , Tomada de Decisão Clínica , Mastectomia Segmentar/métodosRESUMO
INTRODUCTION: Obesity has become a worldwide public health problem and is directly linked to loss of quality of life, complications and comorbidities. One of them is chronic pain, especially in the knees, which increases significantly and proportionally with weight gain. In patients with severe obesity, with indication for bariatric surgery, the presence of chronic pain disables and often prevents their participation in a pre-surgical rehabilitation programme. As an analgesic therapy, photobiomodulation (PBM) has been studied with safety, efficacy, well-tolerated used and low costs. Thus, this study aims to evaluate the use of PBM for the treatment of chronic knee pain in obese patients undergoing a pre-surgical rehabilitation programme for bariatric surgery. METHODS AND ANALYSES: This is a double-blinded, randomised, placebo-controlled clinical, superiority, trial protocol. The PBM will be applied in bilateral knees and lumbar paraspinal points levels referring to the roots of innervation of the knee. The outcomes evaluated will be pain intensity, functionality, quality of life and clinical signs of neurological sensitization of chronic knee pain pathways. ETHICS AND DISSEMINATION: This protocol has already been approved by the Comitê de Ética em Pesquisa do Hospital das Clínicas da Universidade Federal de Goiás/EBSERH-Ethics Committee and it is following SPIRIT guidelines. The results will be statistically analysed and subsequently published in peer-reviewed journals. TRIAL REGISTRATION NUMBER: Clinical Trials Platform (https://clinicaltrials.gov/) with the number NCT05816798.
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Cirurgia Bariátrica , Dor Crônica , Terapia com Luz de Baixa Intensidade , Ensaios Clínicos Controlados Aleatórios como Assunto , Humanos , Método Duplo-Cego , Dor Crônica/etiologia , Dor Crônica/terapia , Terapia com Luz de Baixa Intensidade/métodos , Obesidade/complicações , Qualidade de Vida , Articulação do Joelho , Medição da Dor , Adulto , Artralgia/etiologia , Artralgia/terapiaRESUMO
BACKGROUND: Vaginal laxity (VL) is a complaint of excessive vaginal looseness with a prevalence ranging from 24% to 38% across studies. AIM: The study sought to compare the effect of radiofrequency (RF) and pelvic floor muscle training (PFMT) on the treatment of women with VL. METHODS: From February 2020 to December 2021, a prospective, parallel, noninferiority, randomized clinical trial was carried out in women ≥18 years of age and complaining of VL in a tertiary hospital. Two groups (RF and PFMT) were evaluated at the beginning of the study and 30 days and 6 months postintervention. A total of 42 participants per arm was sufficient to demonstrate a difference in sexual function on the Female Sexual Function Index at 90% power, 1-sided type 1 error of 0.025 with a noninferiority margin of 4 on the FSFI total score. Analysis was intention-to-treat and per-protocol based. OUTCOMES: The primary endpoint was the change of FSFI score after treatment, and the secondary outcomes were improvement in symptoms of VL and changes in questionnaire scores of sexual distress, vaginal symptoms, and urinary incontinence, in the quantification of pelvic organ prolapse, and pelvic floor muscle (PFM) contraction. RESULTS: Of 167 participants recruited, 87 were included (RF: n = 42; PFMT: n = 45). All questionnaires improved (P < .05) their total scores and subscales in both groups and during the follow-ups. After 30 days of treatment, RF was noninferior to PFMT to improving FSFI total score (mean difference -0.08 [95% confidence interval, -2.58 to 2.42]) in the per-protocol analysis (mean difference -0.46 [95% confidence interval, -2.92 to 1.99]) and in the intention-to-treat analysis; however, this result was not maintained after 6 months of treatment. PFM contraction improved significantly in both groups (RF: P = .006, 30 days; P = .049, 6 months; PFMT: P < .001, 30 days and 6 months), with better results in the PFMT group. CLINICAL IMPLICATIONS: Sexual, vaginal, and urinary symptoms were improved after 30 days and 6 months of treatment with RF and PFMT; however, better results were observed in the PFMT group after 6 months. STRENGTHS & LIMITATIONS: The present randomized clinical trial used several validated questionnaires evaluating quality of life, sexual function and urinary symptoms, in addition to assessing PFM contraction and classifying the quantification of pelvic organ prolapse aiming at anatomical changes in two follow-up periods. The limitations were the lack of a sham-controlled group (third arm) and the difficulty of blinding researchers to assess treatments due to the COVID-19 pandemic. CONCLUSION: After 30 days and 6 months of treatment, sexual, vaginal, and urinary symptoms improved with RF and PFMT; however, better results were observed in the PFMT group after 6 months. RF was noninferior to PFMT in improving FSFI total score after 30 days; however, this result was not maintained after 6 months of treatment.
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Terapia por Exercício , Diafragma da Pelve , Vagina , Humanos , Feminino , Diafragma da Pelve/fisiopatologia , Pessoa de Meia-Idade , Vagina/fisiopatologia , Estudos Prospectivos , Terapia por Exercício/métodos , Adulto , Disfunções Sexuais Fisiológicas/terapia , Prolapso de Órgão Pélvico/terapia , Incontinência Urinária/terapia , Incontinência Urinária/fisiopatologia , Resultado do TratamentoRESUMO
Several randomized controlled trials (RCTs) have investigated the potential benefits of green tea on the inflammatory process in metabolic syndrome (MetS). However, the results are inconclusive and inconsistent. In the present study, we performed a literature review and meta-analysis to evaluate the effect of green tea supplementation on inflammatory markers [e.g., tumor necrosis factor-α (TNF-α), C-reactive protein (CRP), and interleukin-6 (IL-6)] among patients with MetS and related disorders. We systematically searched for relevant publications up to March 2022 in the PubMed, Scopus, Web of Science, and SciELO databases. The review was registered with PROSPERO (CRD42022320345). Mean differences with 95% confidence intervals were pooled on the basis of the random effects model to compare the effects of green tea with placebo. We used meta-regression and subgroup analyses to determine the cause of heterogeneity and performed study quality assessment using the Grading of Recommendations Assessment, Development, and Evaluation method. We assessed publication bias using funnel plots and Egger's tests. Out of the total 15 RCTs that were included in this systematic review, 12 were chosen for the meta-analysis. The results revealed that green tea significantly decreased TNF-α levels but did not affect CRP and IL-6 levels. Subgroup analysis showed that green tea supplementation in studies lasting ≤8 weeks significantly increased CRP levels. Furthermore, meta-regression analysis demonstrated a significant association between increasing IL-6 concentration and treatment duration. According to our meta-analysis, green tea was shown to considerably lower circulating TNF-α levels. To confirm these findings, carefully planned trials are required.
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BACKGROUND: There is general agreement that sexuality is a central aspect of human development; it is key in sexual health and reproductive education during adolescence. However, in spite of the existing interventions on this topic and the evidence generated, the inclusion of a gender focus in sexuality is relatively recent and there is little evidence available, thus structured and corroborated interventions with a gender-transforming perspective in sexuality are required. METHODS: We will use a mixed method experimental design with a parallel cluster-randomized trial (GRTs) that will evaluate the effectiveness of a comprehensive gender-transformative intervention of sexual education (ENFOCATE -Focus-on-), which will be complemented with qualitative studies to understand the implementation process. The participants will be 609 10th and 11th-grade students. The randomization will be by grade, and the data will be collected at three moments (pre-intervention, post-intervention, and a 3-month follow-up). DISCUSSION: Comprehensive, gender-focused, and culturally pertinent interventions in sexuality are needed for adolescents of countries with high, middle, and low incomes. These produce better results in terms of sexual health, and including a gender-transformative focus contributes to equity in health. Focus-on is unique since it uses a comprehensive gender-transformative intervention in sexual education that will allow putting into practice a program based both on international evidence and that which arises from the object population. It also uses a culturally-sensitive focus, since it is designed based on the characteristics of the object population; it will allow adapting some activities to the needs of the context in which it is developed. TRIAL REGISTRATION: The study was prospectively registered on June 6, 2023, at ClinicalTrials.gov ID: NCT05896540. Protocol version number 1.0. May 22, 2023.
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Ensaios Clínicos Controlados Aleatórios como Assunto , Serviços de Saúde Escolar , Educação Sexual , Saúde Sexual , Humanos , Adolescente , Educação Sexual/métodos , Feminino , Masculino , Comportamento do Adolescente , Comportamento Sexual , Fatores Sexuais , Conhecimentos, Atitudes e Prática em Saúde , Fatores de TempoRESUMO
OBJECTIVE: To determine in the long term whether supervised physiotherapy is more effective than a home exercise program for functional improvement and pain relief in patients with distal radius fracture (DRF). DESIGN: Randomized controlled trial. SETTING: Rehabilitation hospital. PARTICIPANTS: A total of 74 patients older than 60 years with extra-articular DRF were randomly allocated into two groups. INTERVENTIONS: The experimental group received 6 weeks of supervised physiotherapy (nâ¯=â¯37) and the control group received 6 weeks of home exercise program (nâ¯=â¯37). MAIN OUTCOME MEASURES: The primary outcome was wrist/hand function assessed using the Patient-Rated Wrist Evaluation (PRWE) questionnaire; secondary outcomes were the pain visual analogue scale (VAS), grip strength and wrist flexion-extension active range of motion. RESULTS: All patients completed the trial. For the primary outcome, at 6-weeks and 1-year follow-up, the PRWE questionnaire showed a mean difference between groups of 18.6 (95% CI 12.8 to 24.3) and 18.5 points (95% CI 12.7 to 24.2) respectively, these differences are clinically important. Conversely, at 2-year follow-up this effect decreases to 3.3 points (95% CI -2.4 to 9.0). For secondary outcomes, at 6-weeks and 1-year follow-up, in all measurements the effect size range from medium to large. Conversely, at 2-year follow-up only grip strength showed large effect size in favor of supervised physiotherapy, the rest of outcomes did not show difference between groups. CONCLUSION: At the 6-week and 1-year follow-up, supervised physiotherapy was more effective for functional improvement and pain relief compared with a home exercise program in patients older than 60 years with extra-articular DRF. However, this effect decreases over time, at the 2-year follow-up, only grip strength showed a difference in favor of supervised physiotherapy. TRIAL REGISTRATION: Brazilian registry of clinical trials UTN no. U1111- 1249-2492. Registered 17 March 2020. CONTRIBUTION OF THE PAPER.
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Terapia por Exercício , Força da Mão , Modalidades de Fisioterapia , Fraturas do Rádio , Amplitude de Movimento Articular , Humanos , Masculino , Feminino , Idoso , Fraturas do Rádio/reabilitação , Terapia por Exercício/métodos , Pessoa de Meia-Idade , Seguimentos , Medição da Dor , Serviços de Assistência Domiciliar , Fraturas do PunhoRESUMO
INTRODUCTION: New therapies for resistant hypertension (RH), including renal denervation (RDN), have been studied. AIM: Access the safety and effectiveness of radiofrequency-based RDN vs pharmacological treatment for RH. METHODS: A thorough literature search was conducted across PubMed, EMBASE, and the Cochrane databases, focusing on studies that compared the effects of radiofrequency-based RDN versus pharmacological treatment for RH. Treatment effects for binary and continuous endpoints were pooled and used, respectively, odds-ratio (OR) and mean differences (MD) with 95% confidence intervals (CI) to analyze continuous outcomes. RESULTS: In the 10 included studies, involving 1.182 patients, 682 received radiofrequency-based RDN. The follow-up period ranged from 6 to 84 months. Analysis revealed that the RDN group had a significant reduction in office systolic blood pressure (BP) (MD - 9.5 mmHg; 95% CI - 16.81 to - 2.29; P = 0.01), office diastolic BP (MD - 5.1 mmHg; 95% CI - 8.42 to - 2.80; P < 0.001), 24 h systolic BP (MD - 4.8 mmHg; 95% CI - 7.26 to - 2.42; P < 0.001). For 24 h diastolic BP RDN did not have a significant reduction (MD - 2.3 mmHg; 95% CI - 4.19 to - 0.52; P = 0.012). The heterogeneity between the studies was high, visible in the funnel and Baujat plots. The OR was non-significant for non-serious adverse events, but also clinically significant for hypertensive crises and strokes for the RDN group. CONCLUSIONS: While the pharmacological regimen of 3 or more anti-hypertensive, including a diuretic, still be the first-line option for RH treatment, our results support that radiofrequency-based RDN is superior in reducing global BP and is safe.
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Anti-Hipertensivos , Pressão Sanguínea , Ablação por Cateter , Resistência a Medicamentos , Hipertensão , Rim , Simpatectomia , Humanos , Resultado do Tratamento , Hipertensão/fisiopatologia , Hipertensão/cirurgia , Hipertensão/diagnóstico , Hipertensão/tratamento farmacológico , Pressão Sanguínea/efeitos dos fármacos , Anti-Hipertensivos/uso terapêutico , Anti-Hipertensivos/efeitos adversos , Ablação por Cateter/efeitos adversos , Rim/inervação , Pessoa de Meia-Idade , Simpatectomia/efeitos adversos , Simpatectomia/métodos , Feminino , Masculino , Idoso , Fatores de Risco , Artéria Renal/inervação , Artéria Renal/cirurgia , Fatores de Tempo , AdultoRESUMO
INTRODUCTION: This study reports the evaluation of the short-term effects of the Strengthening Families Program (SFP 10-14), adapted as Famílias Fortes (Strong Families) in Brazil, on preventing adolescent drug use and improving parenting behaviors. METHODS: A two-arm, parallel cluster randomized controlled trial was conducted in 60 Social Assistance Reference Centers (SARC) from 12 Brazilian municipalities. In each city, the SARC were randomly assigned to the intervention or control group. A total of 805 families participated in the study, each contributing data from one parent or legal guardian and one adolescent totaling 1,610 participants. Data collection occurred before intervention implementation and 6 months after baseline collection. Data were analyzed using multilevel mixed-effects modeling with repeated measures in two different paradigms: Intention to Treat (ITT) and Per protocol (PP). The study was registered in the Brazilian Ministry of Health Register of Clinical Trials (REBEC), under protocol no. RBR-5hz9g6z. RESULTS: Considering the ITT paradigm, the program reduced the chance of parents and legal guardians being classified as negligent by 60% (95%CI 0.21; 0.78), increased the use of nonviolent discipline by caregivers (Coef 0.33, 95%CI 0.01; 0.64) and decreased the chance of adults exposing adolescents to their drunken episodes by 80% (95%CI 0.06; 0.54). No program effects were observed on outcomes related to adolescent drug use. Similar results were found for the PP paradigm. CONCLUSION: The positive effects on family outcomes suggest preventive potential of the program among the Brazilian population. Long-term evaluations are necessary to verify if the program can also achieve the drug use reduction goals not observed in the short term.
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PURPOSE: Limited high-quality studies have compared robot-assisted laparoscopic prostatectomy (RALP) vs open retropubic radical prostatectomy. We sought to compare their postoperative outcomes in a randomized setting. MATERIALS AND METHODS: In a single center, 354 men with newly diagnosed prostate cancer were assessed for eligibility; 342 were randomized (1:1). The primary outcome was 90-day complication rates. Functional outcomes and quality of life were assessed over 18 months, and oncological outcomes, biochemical recurrence-free survival, and additional treatment over 36 months. RESULTS: From 2014 to 18, 327 patients underwent surgery (retropubic radical prostatectomy = 156, RALP = 171). Complications occurred in 27 (17.3%) vs 19 (11.1%; P = .107). Patients undergoing RALP experienced lower median bleeding (250.0 vs 719.5 mL; P < .001) and shorter hospitalization time. Urinary EPIC (Expanded Prostate Cancer Index Composite) median scores were better for RALP over 18 months, with higher continence rate at 3 months (80.5% vs 64.7%; P = .002), 6 months (90.1% vs 81.6%; P = .036) and 18 months (95.4% vs 78.8%; P < .001). Sexual EPIC and Sexual Health Inventory for Men median scores were higher with RALP up to 12 months, while the potency rate was superior at 3 months (23.9% vs 5.3%; P = .001) and 6 months (30.6% vs 6.9%; P < .001). Quality of life over the 18 months and oncological outcomes over 36 months were not significantly different between arms. CONCLUSIONS: Complications at 90 days were similar. RALP showed superior sexual outcomes at 1 year, improved urinary outcomes at 18 months, and comparable oncological outcomes at 36 months. TRIAL REGISTRATION: Prospective Analysis of Robot-Assisted Surgery; NCT02292914. https://clinicaltrials.gov/ct2/show/NCT02292914?cond=NCT02292914&draw=2&rank=1.
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Laparoscopia , Complicações Pós-Operatórias , Prostatectomia , Neoplasias da Próstata , Qualidade de Vida , Procedimentos Cirúrgicos Robóticos , Humanos , Masculino , Prostatectomia/métodos , Prostatectomia/efeitos adversos , Procedimentos Cirúrgicos Robóticos/efeitos adversos , Procedimentos Cirúrgicos Robóticos/métodos , Neoplasias da Próstata/cirurgia , Laparoscopia/métodos , Laparoscopia/efeitos adversos , Pessoa de Meia-Idade , Idoso , Complicações Pós-Operatórias/epidemiologia , Complicações Pós-Operatórias/etiologia , Resultado do TratamentoRESUMO
BACKGROUND: The excess neonatal adiposity is considered a risk factor for the development of childhood obesity and the birth weight is a marker of health throughout life. AIMS: To evaluate the effect of a lifestyle intervention conducted among pregnant women with overweight on neonatal adiposity and birth weight. METHODS: A total of 350 pregnant women were recruited and randomly allocated into the control (CG) and intervention (IG) groups. Pregnant women in the IG were invited to participate in three nutritional counselling sessions based on encouraging the consumption of unprocessed and minimally processed foods, rather than ultra-processed foods, following the NOVA food classification system, which categorizes foods according to the extent and purpose of industrial processing, and the regular practice of physical activity. Neonatal adiposity was estimated using a previously validated anthropometric model. Adjusted linear regression models were used to measure the effect. RESULTS: Adopting the modified intention-to-treat principle, data from 256 neonates were analyzed for birth weight, and data from 163 for body composition estimation. The treatment had no effect on the proportion of fat mass [ß 0.52 (95 % CI -1.03, 2.06); p = .51], fat-free mass [ß -0.50 (95 % CI -2.45, 1.45); p = .61] or birth weight [ß 53.23 (95 % CI -87.19, 193.64); p = .46]. CONCLUSIONS: In the present study, the lifestyle counselling used had no effect on neonatal adiposity or birth weight. Future studies should investigate the effect of more intensive interventions.
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Adiposidade , Peso ao Nascer , Sobrepeso , Humanos , Feminino , Gravidez , Recém-Nascido , Adulto , Sobrepeso/terapia , Estilo de Vida , Exercício Físico , Complicações na Gravidez/terapiaRESUMO
BACKGROUND: Understanding the influence of contextual factors (CFs) on interventions for mechanical neck pain (MNP) is essential for evidence-based practice in physical therapy. However, the specific effects and synergies of combining different CFs remain unclear. OBJECTIVE: The primary purpose of this study will be to determine if a CFs-Enriched Standard Care (SC) approach is an effective treatment for MNP in terms of reducing pain and improving function. METHODS: This will be an assessor-blinded, 2-group (1:1) randomised clinical trial (RCT) aiming to enrol 94 participants with neck pain persisting for more than 4 weeks. Both groups will undergo 4 weeks of SC twice weekly, following established clinical practice guidelines. In the intervention group, CFs will be enhanced, encompassing the physical, psychological, and social elements inherent in the clinical encounter, based on existing evidence. The primary outcomes will encompass changes in pain and disability after 4 weeks of treatment, with a follow-up reassessment at week 12 post-treatment. Secondary outcomes will include changes in Active Range of Motion, Global Rating of Change, and Satisfaction with treatment. The change between groups after treatment and at the 12-week follow-up will be reported for all outcomes, considering the difference from scores recorded at baseline. RESULTS: We hypothesise that a 4-week CFs-Enriched SC approach will be superior to SC alone in terms of patient-reported disability and pain, with measurements conducted using the Northwick Park Neck Pain Questionnaire and the Numeric Pain Rating Scale, respectively. CONCLUSION: This RCT rigorously assesses the effect of purposeful manipulation of CFs during MNP treatment. By elucidating the role of these factors, our findings have the potential to significantly refine clinical practice in managing MNP, thereby enhancing patient care, and advancing the fields of physical therapy and rehabilitation.
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Cervicalgia , Humanos , Cervicalgia/terapia , Medição da Dor , Modalidades de Fisioterapia , Ensaios Clínicos Controlados Aleatórios como AssuntoRESUMO
Background: Chile faces a significant postpartum depression prevalence and treatment gap, necessitating accessible interventions. While cognitive-behavioral internet-based interventions have proven effective in high-income countries, this field is underdeveloped in Chile. Based on the country's widespread use of digital technology, a guided 8-week cognitive-behavioral web app intervention named "Mamá, te entiendo" was developed. Objective: This study aimed to assess the acceptability and feasibility of "Mamá, te entiendo", for reducing depressive symptomatology in postpartum women. Methods: Sixty-five postpartum women with minor or major depression were randomly assigned to either intervention or waitlist. Primary outcomes centered on study feasibility, intervention feasibility, and acceptability. Semi-structured interviews with a sub-sample enriched the understanding of participants' experiences. Secondary outcomes included mental health variables assessed at baseline, post-intervention, and 1-month follow-up. Results: Chilean women displayed great interest in the intervention. 44.8 % of participants completed the intervention. Participants reported high satisfaction and engagement levels, with interviewees highlighting the value of the intervention's content, exercises, and therapist's feedback. However, preliminary efficacy analysis didn't reveal a significant interaction between group and time for outcome measures. Discussion: This research represents a pioneering effort in Chile to evaluate an internet-based intervention for postpartum depression symptoms. The demonstrated feasibility and acceptability highlight the potential of integrating technology-driven approaches into mental health interventions. However, the intervention did not demonstrate superiority, as both groups exhibited similar positive progress in several outcomes. Therefore, the following research phase should involve a larger and more diverse sample to assess the intervention's effectiveness, identify influencing factors, and determine the individuals who benefit the most.
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Background: After antiretroviral therapy (ART) initiation, people with HIV (PWH) treated for tuberculosis (TB) may develop TB-associated immune reconstitution inflammatory syndrome (TB-IRIS). Integrase inhibitors, by providing a faster HIV-RNA decline than efavirenz, might increase the risk for this complication. We sought to assess incidence and determinants of TB-IRIS in PWH with TB on raltegravir- or efavirenz-based ART. Methods: We conducted a secondary analysis of the Reflate TB 2 trial, which randomized ART-naive PWH on standard TB treatment, to receive raltegravir- or efavirenz-based ART. The primary objective was to evaluate the incidence of TB-IRIS. Incidence rate ratio comparing TB-IRIS incidence in each arm was calculated. Kaplan-Meier curves were used to compare TB-IRIS-free survival probabilities by ART arm. Cox regression models were fitted to analyze baseline characteristics associated with TB-IRIS. Results: Of 460 trial participants, 453 from Brazil, Côte d'Ivoire, Mozambique, and Vietnam were included in this analysis. Baseline characteristics were median age 35 years (interquartile range [IQR], 29-43), 40% female, 69% pulmonary TB only, median CD4, 102 (IQR, 38-239) cells/mm³, and median HIV RNA, 5.5 (IQR, 5.0-5.8) log copies/mL. Forty-eight participants developed TB-IRIS (incidence rate, 24.7/100 PY), 19 cases in the raltegravir arm and 29 in the efavirenz arm (incidence rate ratio 0.62, 95% confidence interval .35-1.10). Factors associated with TB-IRIS were: CD4 ≤ 100 cells/µL, HIV RNA ≥500 000â copies/mL, and extrapulmonary/disseminated TB. Conclusions: We did not demonstrate that raltegravir-based ART increased the incidence of TB-IRIS compared with efavirenz-based ART. Low CD4 counts, high HIV RNA, and extrapulmonary/disseminated TB at ART initiation were associated with TB-IRIS.
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INTRODUCTION AND HYPOTHESIS: Internal vaginal pessary is among the leading treatments for pelvic organ prolapse (POP); however, it has a high adverse event rate. An external pessary was recently developed as an alternative. The study's objective was to compare the efficacy of external and internal pessaries in treating POP in postmenopausal women. METHODS: This parallel randomized (1:1 ratio) open-blind study included 40 symptomatic women with stage 2 or 3 POP. They were randomized into two groups: group 1 (internal pessary) and group 2 (external pessary) (n = 20 in each); and evaluated at the start of and 3 months after the treatment. Statistical analysis was performed to compare the results within and between the groups before and after the 3-month treatment. RESULTS: The groups were homogeneous, except for the variables previous pregnancies (p = 0.030) and POP-Q score of apical prolapse (p = 0.023) whose values were higher in group 2. A significant improvement in quality of life was observed in both groups after 3 months of follow-up; however, internal pessaries were found to be more effective (p < 0.001). In group 1 there were differences between the initial and final POP-Q scores of anterior (0.004) and apical prolapse (p = 0.005). The complication rate associated with internal pessary use was high (p = 0.044). CONCLUSIONS: The present data suggested that external pessaries have a similar effect to internal ones for the treatment of POP and improvement of the quality of life of postmenopausal women.
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Prolapso de Órgão Pélvico , Pessários , Feminino , Humanos , Pessoa de Meia-Idade , Prolapso de Órgão Pélvico/terapia , Pessários/efeitos adversos , Projetos Piloto , Pós-Menopausa , Qualidade de Vida , Resultado do Tratamento , IdosoRESUMO
During the COVID-19 outbreak, there was a sharp increase in generalized anxiety disorder (GAD). Acupuncture therapy has the advantages of accurate clinical efficacy, safety and reliability, few adverse reactions, and no dependence, and is gradually becoming one of the emerging therapies for treating GAD. We present a study protocol for a randomized clinical trial with the aim of exploring the mechanism of brain plasticity in patients with GAD and evaluate the effectiveness and reliability of acupuncture treatment. Transcranial magnetic stimulation (TMS) will be used to assess cortical excitability in GAD patients and healthy people. Sixty-six GAD patients meeting the inclusion criteria will be randomly divided into two groups: TA group, (treatment with acupuncture and basic western medicine treatment) and SA group (sham acupuncture and basic western medicine treatment). Twenty healthy people will be recruited as the control group (HC). The parameters that will be evaluated are amplitude of motor evoked potentials (MEPs), cortical resting period (CSP), resting motor threshold (RMT), and Hamilton Anxiety Scale (HAMA) score. Secondary results will include blood analysis of γ-aminobutyric acid (GABA), glutamate (Glu), glutamine (Gln), serotonin (5-HT), and brain-derived nerve growth factor (BDNF). Outcomes will be assessed at baseline and after the intervention (week 8). This study protocol is the first clinical trial designed to detect differences in cerebral cortical excitability between healthy subjects and patients with GAD, and the comparison of clinical efficacy and reliability before and after acupuncture intervention is also one of the main contents of the protocol. We hope to find a suitable non-pharmacological alternative treatment for patients with GAD.
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OBJECTIVE: To ascertain whether sociodemographic and health-related characteristics known from previous research to have a substantive impact on recovery from depression modified the effect of a digital intervention designed to improve depressive symptoms (CONEMO). METHODS: The CONEMO study consisted of two randomized controlled trials, one conducted in Lima, Peru, and one in São Paulo, Brazil. As a secondary trial plan analysis, mixed logistic regression was used to explore interactions between the treatment arm and subgroups of interest defined by characteristics measured before randomization - suicidal ideation, race/color, age, gender, income, type of mobile phone, alcohol misuse, tobacco use, and diabetes/hypertension - in both trials. We estimated interaction effects between the treatment group and these subgroup factors for the secondary outcomes using linear mixed regression models. RESULTS: Increased effects of the CONEMO intervention on the primary outcome (reduction of at least 50% in depressive symptom scores at 3-month follow-up) were observed among older and wealthier participants in the Lima trial (p = 0.030 and p = 0.001, respectively). CONCLUSION: There was no evidence of such differential effects in São Paulo, and no evidence of impact of any other secondary outcomes in either trial. CLINICAL TRIAL REGISTRATION: NCT02846662 (São Paulo, Brazil - SP), NCT03026426 (Lima, Peru - LI).