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1.
Zhen Ci Yan Jiu ; 46(5): 431-8, 2021 May 25.
Artigo em Chinês | MEDLINE | ID: mdl-34085469

RESUMO

OBJECTIVE: To systematically evaluate the efficacy and safety of thrombolysis combined with acupuncture therapy in the treatment of acute cerebral infarction (ACI) in the light of evidence-based medicine. METHODS: Randomized controlled trials (RCT) for acupuncture and thrombolysis treatment of acute cerebral infarction published from the inception of databa-ses to March 2020 were searched from PubMed, Cochrane Library, Embase, Web of science, CNKI, Wanfang, VIP, and CBM Database. According to the inclusion and exclusion criteria, two reviewers independently screened the RCTs and extracted the data. The quality of the included literature was evaluated, and the Meta-analysis was performed by using Revman 5.3 software. RESULTS: A total of 330 studies were identified, and 14 RCTs (including 604 cases of the treatment group, 598 cases of the control group) met the inclusion criteria. The Meta-analysis showed that the thrombolysis combined with acupuncture therapy was better than acupuncture therapy alone in the clinical effective rate (risk ratio ï¼»RRï¼½=1.19, 95% confidence interval ï¼»CIï¼½ ï¼»1.13, 1.25ï¼½), NIHSS score (mean difference ï¼»MDï¼½=-3.51, 95% CI ï¼»-4.54, -2.48ï¼½), BI index (MD=12.26, 95% CI ï¼»8.07, 16.46ï¼½), and in lowering C-reaction protein levels (MD=-3.99, 95% CI ï¼»-4.35, -3.63ï¼½). The rate of complete recanalization (RR = 1.20, 95% CI ï¼»1.00, 1.44ï¼½), adverse reaction (RR = 0.76, 95% CI ï¼»0.41, 1.41ï¼½) and hemorrhagic conversion (RR = 0.72, 95% CI ï¼»0.14, 3.62ï¼½) was not statistically significant. CONCLUSION: The current effective evidence shows that acupuncture has certain advantages in improving the therapeutic effect and safety of thrombolysis in the treatment of ACI patients.


Assuntos
Terapia por Acupuntura , Acidente Vascular Cerebral , Infarto Cerebral/terapia , Humanos , Ensaios Clínicos Controlados Aleatórios como Assunto , Acidente Vascular Cerebral/terapia , Terapia Trombolítica , Resultado do Tratamento
2.
No Shinkei Geka ; 49(3): 588-596, 2021 May.
Artigo em Japonês | MEDLINE | ID: mdl-34092564

RESUMO

Chemotherapeutic treatment of malignant gliomas is extremely challenging. Tumor accumulation of systemically-administrated chemotherapy is always hindered by the blood-brain barrier(BBB). Although temozolomide administered orally or intravenously represents the standard of care for malignant gliomas, its efficacy is unsatisfactory. Local chemotherapy bypasses the BBB and, therefore, achieves a high drug concentration at the site the drug is administered. Carmustine wafers are clinically available local chemotherapeutic agents. However, their efficacy is limited because of limited drug penetration into the tumor. Combined with the highly chemoresistant features of glioma itself, ongoing chemotherapy is far from satisfactory in terms of efficacy. This review covers several important issues regarding temozolomide chemotherapy, including the reactivation of hepatitis B virus, assessment of MGMT promoter methylation, and pseudo-progression. Local chemotherapy for newly diagnosed resectable glioblastoma cases using carmustine wafers is currently under investigation with a randomized phase 3 trial (JCOG 1703), which will also be discussed. In addition, recent progress in convection-enhanced delivery of chemotherapeutics against gliomas has also been reported. Development of an alternative strategy to effectively deliver drugs to the tumor site may improve the efficacy of chemotherapy against gliomas in the near future.


Assuntos
Antineoplásicos , Neoplasias Encefálicas , Glioblastoma , Glioma , Antineoplásicos/uso terapêutico , Protocolos de Quimioterapia Combinada Antineoplásica , Neoplasias Encefálicas/tratamento farmacológico , Ensaios Clínicos Fase III como Assunto , Glioblastoma/tratamento farmacológico , Glioma/tratamento farmacológico , Humanos , Ensaios Clínicos Controlados Aleatórios como Assunto
3.
Trials ; 22(1): 403, 2021 Jun 16.
Artigo em Inglês | MEDLINE | ID: mdl-34134736

RESUMO

BACKGROUND: Almost all Aboriginal children in remote communities have persistent bilateral otitis media affecting hearing and learning throughout early childhood and school years, with consequences for social and educational outcomes, and later employment opportunities. Current primary health care and specialist services do not have the resources to meet the complex needs of these children. METHOD/DESIGN: This stepped-wedge cluster randomised trial will allocate 18 communities to one of five 6-monthly intervention start dates. Stratification will be by region and population size. The intervention (Hearing for Learning Initiative, HfLI) consists of six 20-h weeks of training (delivered over 3 months) that includes Certificate II in Aboriginal Primary Health Care (3 modules) and competencies in ear and hearing data collection (otoscopy, tympanometry and hearScreen), plus 3 weeks of assisted integration into the health service, then part-time employment as Ear Health Facilitators to the end of the trial. Unblinding will occur 6 months prior to each allocated start date, to allow Community Reference Groups to be involved in co-design of the HfLI implementation in their community. Relevant health service data will be extracted 6-monthly from all 18 communities. The primary outcome is the difference in proportion of children (0 to 16 years of age) who have at least one ear assessment (diagnosis) documented in their medical record within each 6-month period, compared to control periods (no HfLI). Secondary outcomes include data on sustainability, adherence to evidence-based clinical guidelines for otitis media, including follow-up and specialist referrals, and school attendance. Structured interviews with staff working in health and education services, Ear Health Trainees, Ear Health Facilitators and families will assess process outcomes and the HfLI broader impact. DISCUSSION: The impact of training and employment of Ear Health Facilitators on service enhancement will inform the health, education and employment sectors about effectiveness of skills and job creation that empowers community members to contribute to addressing issues of local importance, in this instance ear and hearing health of children. TRIAL REGISTRATION: ClinicalTrials.gov NCT03916029 . Registered on 16 April 2019.


Assuntos
Serviços de Saúde Comunitária , Atenção Primária à Saúde , Criança , Pré-Escolar , Emprego , Audição , Humanos , Northern Territory , Ensaios Clínicos Controlados Aleatórios como Assunto
4.
Trials ; 22(1): 401, 2021 Jun 16.
Artigo em Inglês | MEDLINE | ID: mdl-34134744

RESUMO

BACKGROUND: Up to two-thirds of dementia care is provided by family caregivers who often experience high burden, little support and adverse health outcomes. Enabling and supporting family caregivers to provide care at home prevents early institutionalisation of the person with dementia and alleviates the economic burden of dementia in the long term. General practitioners (GPs), as the first point of contact, have a key role in identifying and managing burden and care needs of family caregivers. However, in routine care, this opportunity is often limited by time constraints and even if caregiver needs are recognised, detailed information about regionally available support and advice on healthcare services is often lacking. METHODS: This is a cluster randomised, controlled trial investigating the clinical use and cost-effectiveness of a digitally supported care management programme for caregivers of people with dementia (PwD). Five hundred family caregivers will be randomised at GP offices, specialist practices and memory clinics, with about n=250 participants per arm. Participants are eligible if they are the primary family caregiver of a PwD, are at least 18 years of age and provide informed consent. Participants in the intervention group will receive an individualised care management plan, which will be carried out by qualified study nurses in collaboration with the treating GP. All participants will receive a baseline assessment and a 6-months follow-up assessment. Participants in the wait-list control group will receive usual care. Starting at the 6 months' follow-up, the former controls will also receive an individualised management plan. Primary outcomes are the number of unmet needs (incl. the Camberwell Assessment of Need for the Elderly, CANE) and health-related quality of life (EQ-5D-5L) at 6 months. Secondary outcomes include caregiver burden (Zarit Burden Interview, ZBI), social support (Lubben Social Network Scale, LSNS), the use of medical and non-medical services (Questionnaire for the Use of Medical and Non-Medical Services, FIMA) and resource utilisation (Resource Utilisation in Dementia, RUD). The primary analysis will be based on intention-to-treat. Between- and within-group analyses and a cost-effectiveness analysis will be conducted to estimate the effect of the tablet PC-based care management programme. This trial is funded by the German Federal Joint Committee (G-BA) Innovation Fund. DISCUSSION: The findings of this trial will be useful in informing and improving current healthcare system structures and processes to support family dementia caregivers within routine care practices. TRIAL REGISTRATION: ClinicalTrials.gov NCT04037501 . Registered on 30 July 2019.


Assuntos
Cuidadores , Demência , Idoso , Análise Custo-Benefício , Demência/diagnóstico , Demência/terapia , Humanos , Qualidade de Vida , Ensaios Clínicos Controlados Aleatórios como Assunto , Apoio Social , Inquéritos e Questionários
5.
BMJ Open ; 11(6): e045537, 2021 06 16.
Artigo em Inglês | MEDLINE | ID: mdl-34135038

RESUMO

INTRODUCTION: Career firefighters experience chronic circadian rhythm disruption, increasing their risk of cardiometabolic disease. The recent discovery that eating patterns regulate circadian rhythmicity in metabolic organs has raised the hypothesis that maintaining a consistent daily cycle of eating and fasting can support circadian rhythms and reduce disease risks. Preclinical animal studies and preliminary clinical trials have shown promising effects of time-restricted eating (TRE) to reduce disease risk without compromising physical performance. However, there is a lack of research on TRE in shift workers including firefighters. This study aims to investigate the feasibility and efficacy of 10-hour TRE on health parameters that contribute to cardiometabolic disease risks among career firefighters who work on a 24-hour shift schedule. METHODS AND ANALYSES: The Healthy Heroes Study is a randomised controlled parallel open-label clinical trial with 150 firefighters over 1 year. Firefighters are randomised with a 1:1 ratio to either the control or intervention group. The control group receives Mediterranean diet nutritional counselling (standard of care, 'SOC'). The intervention group receives the same SOC and a self-selected 10-hour TRE window. After the 2-week baseline, participants enter a 3-month monitored intervention, followed by a 9-month self-guided period with follow-up assessments. The impact of TRE on blood glucose, body weight, body composition, biomarkers (neuroendocrine, inflammatory and metabolic), sleep and mood is evaluated. These assessments occur at baseline, at the end of intervention and at 6, 9 and 12-month follow-ups. Temporal calorie intake is monitored with the smartphone application myCircadianClock throughout the study. Continuous glucose monitors, wrist-worn actigraphy device and questionnaires are used to monitor glucose levels, activity, sleep and light exposure. ETHICS AND DISSEMINATION: The study was approved by the Institutional Review Boards of the University of California San Diego and the Salk Institute for Biological Studies. Results will be disseminated through peer-reviewed manuscripts, reports and presentations. TRIAL REGISTRATION NUMBER: NCT03533023; Pre result.


Assuntos
Doenças Cardiovasculares , Bombeiros , Jornada de Trabalho em Turnos , Doenças Cardiovasculares/prevenção & controle , Ritmo Circadiano , Estudos de Viabilidade , Humanos , Ensaios Clínicos Controlados Aleatórios como Assunto
6.
BMJ Open ; 11(6): e046628, 2021 06 16.
Artigo em Inglês | MEDLINE | ID: mdl-34135047

RESUMO

INTRODUCTION: Early medical abortion (EMA) is a two-stage process of terminating pregnancy using oral mifepristone (a progesterone-receptor antagonist) followed usually 1-2 days later by sublingual, vaginal or buccal misoprostol (a prostaglandin analogue). There are no published randomised controlled trials (RCTs) on the use of telemedicine for EMA. Our proposed research will determine if telephone consultations for EMA (the most common method of abortion in the UK) is non-inferior to standard face-to-face consultations with regard to the efficacy of EMA. METHODS AND ANALYSIS: This study will be conducted as an RCT. The recruitment target is 1222 participants.The primary outcome is success of EMA (complete abortion rate). This will be determined based on a negative low-sensitivity urine pregnancy test result (2 weeks after misoprostol use) and absence of surgical intervention or diagnosis of ongoing pregnancy (within 6 weeks of misoprostol).Secondary outcomes include total time spent at a clinic appointment to receive EMA, self-reported preparedness for EMA, level of satisfaction with consultation and effective contraception uptake compared with when women attend for a face-to-face consultation.The main analysis will be a modified intention-to-treat analysis. This will include all randomised women (with a viable pregnancy) using EMA and follow-up for the main outcome. The study initiated on 13 January 2020 and is anticipated to finish in late 2021. ETHICS AND DISSEMINATION: Ethical approval was given by the South East Scotland NHS Research Ethics Committee, reference: 19/SS/0111. Results will be published in peer-reviewed journals, presented at clinical and academic meetings, and shared with participants via the clinic website. TRIAL REGISTRATION NUMBER: NCT04139382.


Assuntos
Aborto Induzido , Telemedicina , Feminino , Humanos , Gravidez , Ensaios Clínicos Controlados Aleatórios como Assunto , Encaminhamento e Consulta , Escócia , Telefone , Utah
7.
BMJ Open ; 11(6): e050541, 2021 06 16.
Artigo em Inglês | MEDLINE | ID: mdl-34135055

RESUMO

INTRODUCTION: Approximately 7.2% of children in the world suffer from attention-deficit/hyperactivity disorder (ADHD). Due to the availability of the osmotic-release oral-system methylphenidate, ADHD currently has a remission rate of up to 30.72%. Nevertheless, it has been reported that patients with ADHD tend to exhibit vitamin A and vitamin D deficiency, which may aggravate the symptoms of ADHD. This study aims to determine the effect of vitamin A and vitamin D supplementation as adjunctive therapy to methylphenidate on the symptoms of ADHD. METHODS AND ANALYSIS: This is a parallel, prospective, interventional multicentric study. Patients will be enrolled from the southern, central and northern parts of China. A target of 504 patients will be followed for 8 weeks. They will be allocated into three groups (vitamin AD, vitamin D and placebo) and administered the interventions accordingly. Data on changes in the symptoms of ADHD as well as changes in the serum concentrations of vitamin A and vitamin D will be recorded. Both responders and nonresponders based on the sociodemographic and clinical data will also be described to mitigate selection bias. ETHICS AND DISSEMINATION: This study is performed in accordance with the Declaration of Helsinki and was approved by the Institutional Review Board of Children's Hospital of Chongqing Medical University, China (approval number: (2019) IRB (STUDY) number 262). The results of the trial will be reported in peer-reviewed scientific journals and academic conferences regardless of the outcomes. TRIAL REGISTRATION NUMBER: NCT04284059.


Assuntos
Transtorno do Deficit de Atenção com Hiperatividade , Estimulantes do Sistema Nervoso Central , Metilfenidato , Transtorno do Deficit de Atenção com Hiperatividade/tratamento farmacológico , Estimulantes do Sistema Nervoso Central/uso terapêutico , Criança , China , Suplementos Nutricionais , Método Duplo-Cego , Humanos , Metilfenidato/uso terapêutico , Estudos Multicêntricos como Assunto , Estudos Prospectivos , Ensaios Clínicos Controlados Aleatórios como Assunto , Resultado do Tratamento , Vitamina A , Vitamina D/uso terapêutico
8.
BMJ Open ; 11(6): e051374, 2021 06 16.
Artigo em Inglês | MEDLINE | ID: mdl-34135056

RESUMO

INTRODUCTION: Surgical site infection (SSI) is one of the most common complications after gastrointestinal surgery, with a reported incidence of approximately 10%-25%, which is higher than the rates after other types of surgery. Intraoperative wound irrigation (IOWI) is a simple intervention for SSI prevention, and recent studies have reported that IOWI with aqueous povidone-iodine (PVP-I) is significantly more effective at reducing the incidence of SSI than saline. However, the evidence level of previous trials evaluating the efficacy of aqueous PVP-I solution for preventing SSI has been low. METHODS AND ANALYSES: We propose a single-institute, prospective, randomised, blinded-endpoint trial to assess the superiority of IOWI with aqueous 10% PVP-I solution compared with normal saline for reducing SSI in clean-contaminated wounds after elective gastrointestinal surgery. In the study group, IOWI with 40 mL of aqueous 10% PVP-I solution is performed for 1 min before skin suture, and in the control group, IOWI with 100 mL of saline is performed for 1 min before skin suture. We hypothesise that IOWI with aqueous 10% PVP-I solution will achieve a 50% reduction in the incidence of SSIs. The target number of cases is set at 950. The primary outcome is the incidence of incisional SSI up to postoperative day 30 and will be analysed in the modified intention-to-treat set. ETHICS AND DISSEMINATION: This trial was designed and is being conducted by Saitama Medical Center, Jichi Medical University, with approval from the Bioethics Committee for Clinical Research, Saitama Medical Center, Jichi Medical University. Participant recruitment began in June 2019. The final results will be reported in international peer-reviewed journals immediately after trial completion. TRIAL REGISTRATION NUMBER: UMIN000036889.


Assuntos
Anti-Infecciosos Locais , Procedimentos Cirúrgicos do Sistema Digestório , Procedimentos Cirúrgicos do Sistema Digestório/efeitos adversos , Humanos , Povidona-Iodo , Estudos Prospectivos , Ensaios Clínicos Controlados Aleatórios como Assunto , Solução Salina , Infecção da Ferida Cirúrgica/epidemiologia , Infecção da Ferida Cirúrgica/prevenção & controle
9.
J Pak Med Assoc ; 71(6): 1556-1560, 2021 Jun.
Artigo em Inglês | MEDLINE | ID: mdl-34111071

RESUMO

OBJECTIVE: To evaluate the sensitivity of the modified Brief Form of Bruininks Oseretsky Test in identifying motor differences secondary to malnutrition and poverty. METHODS: This longitudinal cohort study was conducted at Nowshero Feroze, Sindh from 2013 to 2014 and comprised data drawn from children who participated in a randomised controlled trial, that assessed responsive stimulation and nutrition interventions in the first two years of life. Outcome measures included motor development assessed using Brief Form of Bruininks Oseretsky Test, child anthropometry and household economic and demographic information. Data was analysed using SPSS 15 and STATA 12. RESULTS: Of the 1058 children, 570(53%) were boys. Moderate-severe stunting was reported in 171(16.12%) subjects, while moderate-severe underweight was reported in 117(11.1%). Also, 591(56%) subjects belonged to poor families, 343(32%) had illiterate mothers, and 392(37%) were food-insecure. Malnutrition, socio-economic status and maternal literacy were significantly associated with a 6-item motor composite of the Brief Form of Bruininks Oseretsky Test (p<0.05). CONCLUSIONS: The 6-item motor composite of the Brief Form of Bruininks Oseretsky Test was found to be a reliable tool to measure motor performance in Pakistani pre-school children.


Assuntos
Desnutrição , Destreza Motora , Criança , Feminino , Transtornos do Crescimento , Humanos , Estudos Longitudinais , Masculino , Paquistão , Ensaios Clínicos Controlados Aleatórios como Assunto
10.
J Trop Pediatr ; 67(2)2021 05 17.
Artigo em Inglês | MEDLINE | ID: mdl-34089322

RESUMO

OBJECTIVE: To evaluate the efficacy and safety of levetiracetam (LEV) in comparison to phenytoin (PHT) as second line antiseizure medication (ASM) for Pediatric convulsive status epilepticus (SE). DATA SOURCE: PubMed, Embase, Google scholar/Google, Scopus, Cumulative Index to Nursing and Allied Health Literature (CINAHL), Cochrane Database of Systematic Reviews and Cochrane Central Register of Controlled Trials. STUDY SELECTION: Randomized controlled trials (RCTs) assessing LEV and PHT as second line agent for convulsive SE in children <18 years published between 1 January 2000 and 30 November 2020. DATA EXTRACTION: The data were pooled regarding the proportion of children achieving seizure cessation within 5-60 min of completion of study drug infusion (primary outcome); and seizure cessation within 5 min, time to achieve seizure cessation, seizure recurrence between 1 to 24 h, intubation and cardiovascular instability (secondary outcomes). Data were analyzed using RevMan version 5.4 and quality analysis was done using Cochrane risk-of-bias tool. The study protocol was registered with PROSPERO. DATA SYNTHESIS: Twelve RCTs with 2293 children were included. Seizure cessation within 5-60 min was similar with both the drugs [82% in LEV vs. 77.5% in PHT, risk ratio (RR) = 1.04, 95% confidence interval (95% CI) 0.97-1.11, p = 0.30]. Seizure recurrences within 1-24 h was higher with PHT in comparison to LEV (16.6% vs. 9.7%, RR = 0.63, 95% CI 0.44-0.90, p = 0.01). Higher proportion of children in PHT group required intubation and mechanical ventilation (21.4% vs. 14.2%, RR = 0.54, 95% CI 0.30-0.98, p = 0.04). Seizure cessation within 5 min, time to achieve seizure cessation, and cardiovascular instability were similar with both the drugs. Three RCTs were at low risk of bias and nine were at high risk of bias. CONCLUSION: The efficacy of LEV is similar to PHT as second line ASM for Pediatric convulsive SE. Seizure recurrences between 1 to24 h and requirement of intubation and mechanical ventilation were significantly higher with PHT in comparison to LEV.


Assuntos
Fenitoína , Estado Epiléptico , Anticonvulsivantes/uso terapêutico , Criança , Humanos , Levetiracetam/uso terapêutico , Fenitoína/uso terapêutico , Ensaios Clínicos Controlados Aleatórios como Assunto , Estado Epiléptico/tratamento farmacológico
11.
JAMA ; 325(22): 2294-2306, 2021 06 08.
Artigo em Inglês | MEDLINE | ID: mdl-34100866

RESUMO

Importance: General health checks, also known as general medical examinations, periodic health evaluations, checkups, routine visits, or wellness visits, are commonly performed in adult primary care to identify and prevent disease. Although general health checks are often expected and advocated by patients, clinicians, insurers, and health systems, others question their value. Observations: Randomized trials and observational studies with control groups reported in prior systematic reviews and an updated literature review through March 2021 were included. Among 19 randomized trials (906 to 59 616 participants; follow-up, 1 to 30 years), 5 evaluated a single general health check, 7 evaluated annual health checks, 1 evaluated biannual checks, and 6 evaluated health checks delivered at other frequencies. Twelve of 13 observational studies (240 to 471 415 participants; follow-up, cross-sectional to 5 years) evaluated a single general health check. General health checks were generally not associated with decreased mortality, cardiovascular events, or cardiovascular disease incidence. For example, in the South-East London Screening Study (n = 7229), adults aged 40 to 64 years who were invited to 2 health checks over 2 years, compared with adults not invited to screening, experienced no 8-year mortality benefit (6% vs 5%). General health checks were associated with increased detection of chronic diseases, such as depression and hypertension; moderate improvements in controlling risk factors, such as blood pressure and cholesterol; increased clinical preventive service uptake, such as colorectal and cervical cancer screening; and improvements in patient-reported outcomes, such as quality of life and self-rated health. In the Danish Check-In Study (n = 1104), more patients randomized to receive to a single health check, compared with those randomized to receive usual care, received a new antidepressant prescription over 1 year (5% vs 2%; P = .007). In a propensity score-matched analysis (n = 8917), a higher percentage of patients who attended a Medicare Annual Wellness Visit, compared with those who did not, underwent colorectal cancer screening (69% vs 60%; P < .01). General health checks were sometimes associated with modest improvements in health behaviors such as physical activity and diet. In the OXCHECK trial (n = 4121), fewer patients randomized to receive annual health checks, compared with those not randomized to receive health checks, exercised less than once per month (68% vs 71%; difference, 3.3% [95% CI, 0.5%-6.1%]). Potential adverse effects in individual studies included an increased risk of stroke and increased mortality attributed to increased completion of advance directives. Conclusions and Relevance: General health checks were not associated with reduced mortality or cardiovascular events, but were associated with increased chronic disease recognition and treatment, risk factor control, preventive service uptake, and improved patient-reported outcomes. Primary care teams may reasonably offer general health checks, especially for groups at high risk of overdue preventive services, uncontrolled risk factors, low self-rated health, or poor connection or inadequate access to primary care.


Assuntos
Exame Físico , Atenção Primária à Saúde , Prevenção Primária , Adulto , Idoso , Doenças Cardiovasculares/diagnóstico , Doenças Cardiovasculares/prevenção & controle , Doença Crônica , Neoplasias Colorretais/diagnóstico , Depressão/diagnóstico , Exercício Físico , Feminino , Comportamentos Relacionados com a Saúde , Humanos , Hipertensão/diagnóstico , Masculino , Pessoa de Meia-Idade , Mortalidade , Estudos Observacionais como Assunto/estatística & dados numéricos , Exame Físico/efeitos adversos , Serviços Preventivos de Saúde/estatística & dados numéricos , Ensaios Clínicos Controlados Aleatórios como Assunto/estatística & dados numéricos , Fatores de Risco , Acidente Vascular Cerebral/epidemiologia
12.
Front Public Health ; 9: 554291, 2021.
Artigo em Inglês | MEDLINE | ID: mdl-34113593

RESUMO

Introduction: Fibromyalgia (FM) is characterized by multiple symptoms including pain, fatigue, and sleep disorders, altering patient's quality of life. In the absence of effective pharmacological therapy, the last European guidelines recommend a multidisciplinary management based on exercise and education. Thus, our main objective was to measure the effectiveness of a healthcare organization offering a specific program of adapted physical activity combined with a therapeutic education program for FM patients. Methods and Analysis: The From Intent To Move (FIMOUV) study will recruit 330 FM patients randomized into two groups: test and control. The test group will benefit from a 1-month mixed exercise training program supervised at the hospital, followed by 2 months in a community-based relay in a health-sport structure. In addition, each of the two groups will benefit from therapeutic patient education sessions. The main endpoint is the measurement of the level of physical activity by accelerometry at 1 year. The secondary endpoints concern adherence to the practice of physical activity, impact on lifestyle, state of health, and physical capacity, as well as an estimate of the budgetary impact of this management strategy. Discussion: This interventional research will allow us to assess the evolution of behaviors in physical activity after an FM syndrome management based solely on patient education or based on a supervised and adapted practice of physical activity associated with this same therapeutic education program. It seems to be the first study evaluating the impact of its intervention on objective data for measuring physical activity and sedentary behavior via accelerometry among FM patients. Trial registration: ClinicalTrials.gov NCT04107948.


Assuntos
Fibromialgia , Exercício Físico , Terapia por Exercício , Fibromialgia/terapia , Humanos , Intenção , Qualidade de Vida , Ensaios Clínicos Controlados Aleatórios como Assunto
13.
Trials ; 22(1): 400, 2021 Jun 14.
Artigo em Inglês | MEDLINE | ID: mdl-34127032

RESUMO

BACKGROUND: Stroke is a leading cause of disability, injury, and death in elderly people and represents a major public health problem with substantial medical and economic consequences. The incidence of stroke rapidly increases with age, doubling for each decade after age 55 years. Gait impairment is one of the most important problems after stroke, and improving walking function is often a key component of any rehabilitation program. To achieve this goal, a robotic gait trainer seems to be promising. In fact, some studies underline the efficacy of robotic gait training based on end-effector technology, for different diseases, in particular in stroke patients. In this randomized controlled trial, we verify the efficacy of the robotic treatment in terms of improving the gait and reducing the risk of falling and its long-term effects. METHODS: In this single-blind randomized controlled trial, we will include 152 elderly subacute stroke patients divided in two groups to receive a traditional rehabilitation program or a robotic rehabilitation using G-EO system, an end-effector device for the gait rehabilitation, in addition to the traditional therapy. Twenty treatment sessions will be conducted, divided into 3 training sessions per week, for 7 weeks. The control group will perform traditional therapy sessions lasting 50 min. The technological intervention group, using the G-EO system, will carry out 30 min of traditional therapy and 20 min of treatment with a robotic system. The primary outcome of the study is the evaluation of the falling risk. Secondary outcomes are the assessment of the gait improvements and the fear of falling. Further evaluations, such as length and asymmetry of the step, walking and functional status, and acceptance of the technology, will be carried. DISCUSSION: The final goal of the present study is to propose a new approach and an innovative therapeutic plan in the post-stroke rehabilitation, focused on the use of a robotic device, in order to obtain the beneficial effects of this treatment. TRIAL REGISTRATION: ClinicalTrials.gov NCT04087083 . Registered on September 12, 2019.


Assuntos
Reabilitação do Acidente Vascular Cerebral , Acidente Vascular Cerebral , Acidentes por Quedas , Idoso , Terapia por Exercício , Medo , Marcha , Humanos , Pessoa de Meia-Idade , Ensaios Clínicos Controlados Aleatórios como Assunto , Método Simples-Cego , Acidente Vascular Cerebral/diagnóstico , Acidente Vascular Cerebral/terapia , Resultado do Tratamento
14.
Trials ; 22(1): 394, 2021 Jun 14.
Artigo em Inglês | MEDLINE | ID: mdl-34127029

RESUMO

BACKGROUND: There remains no effective intervention capable of reversing most cases of dementia. Current research is focused on prevention by addressing risk factors that are shared between cardiovascular disease and dementia (e.g., hypertension) before the cognitive, functional, and behavioural symptoms of dementia manifest. A promising preventive treatment is exercise. This study describes the methods of a randomized controlled trial (RCT) that assesses the effects of aerobic exercise and behavioural support interventions in older adults at increased risk of dementia due to genetic and/or cardiovascular risk factors. The specific aims are to determine the effect of aerobic exercise on cognitive performance, explore the biological mechanisms that influence cognitive performance after exercise training, and determine if changes in cerebrovascular physiology and function persist 1 year after a 6-month aerobic exercise intervention followed by a 1-year behavioural support programme (at 18 months). METHODS: We will recruit 264 participants (aged 50-80 years) at elevated risk of dementia. Participants will be randomly allocated into one of four treatment arms: (1) aerobic exercise and health behaviour support, (2) aerobic exercise and no health behaviour support, (3) stretching-toning and health behaviour support, and (4) stretching-toning and no health behaviour support. The aerobic exercise intervention will consist of three supervised walking/jogging sessions per week for 6 months, whereas the stretching-toning control intervention will consist of three supervised stretching-toning sessions per week also for 6 months. Following the exercise interventions, participants will receive either 1 year of ongoing telephone behavioural support or no telephone support. The primary aim is to determine the independent effect of aerobic exercise on a cognitive composite score in participants allocated to this intervention compared to participants allocated to the stretching-toning group. The secondary aims are to examine the effects of aerobic exercise on a number of secondary outcomes and determine whether aerobic exercise-related changes persist after a 1-year behavioural support programme (at 18 months). DISCUSSION: This study will address knowledge gaps regarding the underlying mechanisms of the pro-cognitive effects of exercise by examining the potential mediating factors, including cerebrovascular/physiological, neuroimaging, sleep, and genetic factors that will provide novel biologic evidence on how aerobic exercise can prevent declines in cognition with ageing. TRIAL REGISTRATION: ClinicalTrials.gov NCT03035851 . Registered on 30 January 2017.


Assuntos
Demência , Terapia por Exercício , Idoso , Encéfalo , Cognição , Demência/prevenção & controle , Exercício Físico , Humanos , Ensaios Clínicos Controlados Aleatórios como Assunto , Resultado do Tratamento
15.
Trials ; 22(1): 398, 2021 Jun 14.
Artigo em Inglês | MEDLINE | ID: mdl-34127039

RESUMO

BACKGROUND: Degenerative lumbar instability (DLI) is a common disease that causes low back pain (LBP) in clinic. It is difficult to completely recover from DLI, and it occurs repeatedly, which seriously affects the quality of life of patients. The epidemiological survey showed that 20-30% of low back pain was related to lumbar instability. Increasing evidence shows that seated lumbar rotation manipulation can effectively improve the clinical symptoms of patients with low back pain. The primary aim of this clinical trial is to observe the intervention effect of seated lumbar rotation manipulation on DLI patients. METHOD/DESIGN: A total of 60 participants with DLI will be recruited and randomly allocated into the seated lumbar rotation manipulation group (the intervention group) or lumbar traction in supine position group (the control group) in this prospective, outcome assessor-blind, two-arm randomized controlled clinical trial. The treatment of the two groups lasted for 3 weeks, and the manipulation of the intervention group would be carried out once every other day, three times a week, a total of 9 times; the control group would be given lumbar traction once a day, five times a week, a total of 15 times. JOA (Japanese Orthopaedic Association) and VAS (Visual Analogue Scales) scores will be recorded as the primary outcomes before the treatment and at the 1st, 3rd, 5th, 8th, 10th, 12th, 15th, 17th, and 19th days after treatment and follow-up visit at the first, third, and sixth months. JOA efficacy evaluation standard will be used to evaluate the overall efficacy as the secondary outcomes. DISCUSSION: The results of this prospective, randomized controlled trial will provide a clinical evidence for the treatment of DLI with seated lumbar rotation manipulation. TRIAL REGISTRATION: Chinese Clinical Trial Registry ChiCTR2000032017 . Registered on 18 April 2020, Prospective registration.


Assuntos
Vértebras Lombares , Qualidade de Vida , Humanos , Estudos Prospectivos , Ensaios Clínicos Controlados Aleatórios como Assunto , Rotação , Resultado do Tratamento
16.
Trials ; 22(1): 392, 2021 Jun 14.
Artigo em Inglês | MEDLINE | ID: mdl-34127040

RESUMO

BACKGROUND: Non-invasive ventilation (NIV) has been recommended as the best respiratory support for preterm infants with respiratory distress syndrome (RDS). However, the best NIV technique to be used as first intention in RDS management has not yet been established. Nasal intermittent positive pressure ventilation (NIPPV) may be synchronized (SNIPPV) or non-synchronized to the infant's breathing efforts. The aim of the study is to evaluate the short-term effects of SNIPPV vs. NIPPV on the cardiorespiratory events, trying to identify the best ventilation modality for preterm infants at their first approach to NIV ventilation support. METHODS: An unmasked randomized crossover study with three treatment phases was designed. All newborn infants < 32 weeks of gestational age with RDS needing NIV ventilation as first intention or after extubation will be consecutively enrolled in the study and randomized to the NIPPV or SNIPPV arm. After stabilization, enrolled patients will be alternatively ventilated with two different techniques for two time frames of 4 h each. NIPPV and SNIPPV will be administered with the same ventilator and the same interface, maintaining continuous assisted ventilation without patient discomfort. During the whole duration of the study, the patient's cardiorespiratory data and data from the ventilator will be simultaneously recorded using a polygraph connected to a computer. The primary outcome is the frequency of episodes of oxygen desaturation. Secondary outcomes are the number of the cardiorespiratory events, FiO2 necessity, newborn pain score evaluation, synchronization index, and thoracoabdominal asynchrony. The calculated sample size was of 30 patients. DISCUSSION: It is known that NIPPV produces a percentage of ineffective acts due to asynchronies between the ventilator and the infant's breaths. On the other hand, an ineffective synchronization could increase work of breathing. Our hypothesis is that an efficient synchronization could reduce the respiratory work and increase the volume per minute exchanged without interfering with the natural respiratory rhythm of the patient with RDS. The results of this study will allow us to evaluate the effectiveness of the synchronization, demonstrating whether SNIPPV is the most effective non-invasive ventilation mode in preterm infants with RDS at their first approach to NIV ventilation. TRIAL REGISTRATION: ClinicalTrials.gov NCT03289936 . Registered on September 21, 2017.


Assuntos
Ventilação com Pressão Positiva Intermitente , Síndrome do Desconforto Respiratório do Recém-Nascido , Pressão Positiva Contínua nas Vias Aéreas , Estudos Cross-Over , Humanos , Lactente , Recém-Nascido , Recém-Nascido Prematuro , Respiração com Pressão Positiva , Ensaios Clínicos Controlados Aleatórios como Assunto , Síndrome do Desconforto Respiratório do Recém-Nascido/diagnóstico , Síndrome do Desconforto Respiratório do Recém-Nascido/terapia
17.
Trials ; 22(1): 396, 2021 Jun 14.
Artigo em Inglês | MEDLINE | ID: mdl-34127042

RESUMO

AIM: To quantify recruitment, retention and differential retention rates and associated trial, participant and intervention characteristics in randomised controlled trials (RCTs) evaluating the effect of exercise therapy in people with multimorbidity. DATA SOURCES: MEDLINE, EMBASE, CINAHL and CENTRAL from 1990 to April 20, 2020. STUDY SELECTION: RCTs including people with multimorbidity comparing exercise therapy with a non-exposed comparator group reporting at least one of the following outcomes: physical function, health-related quality of life, depression symptoms, or anxiety symptoms. DATA EXTRACTION AND SYNTHESIS: Recruitment rates (proportion of people randomised/proportion of people eligible), retention rates (proportion of people providing the outcomes of interest/proportion randomised) and differential retention rates (difference in proportion of people providing the outcomes in the intervention group and comparator group) were calculated. Meta-analysis using a random-effects model was used to estimate pooled proportions. Methodological quality was assessed using Cochrane ´Risk of Bias tool 2.0´ for individual studies, and the GRADE approach was used to assess the overall quality of the evidence. RESULTS: Twenty-three RCTs with 3363 people were included. The pooled prevalence for recruitment rate was 75% (95%CI 66 to 84%). The pooled prevalence for retention rate was 90% (95%CI 86 to 94%) at the end of the intervention (12 weeks; interquartile range (IQR) (12 to 12)). Meta-regression analyses showed that increasing age and including a higher proportion of people with hypertension was associated with lower retention rates. Retention rates did not differ between the intervention and comparator groups. The overall quality of the evidence was deemed very low. CONCLUSION: Three in four eligible people with multimorbidity were randomised to RCTs using exercise therapy, of which nine out of 10 provided end of treatment outcomes with no difference seen between the intervention and comparison groups. However, the results must be interpreted with caution due to large differences between the included studies. TRIAL REGISTRATION: ClinicalTrials.gov CRD42020161329 . Registered on 28 April 2020.


Assuntos
Terapia por Exercício , Multimorbidade , Ansiedade , Humanos , Terapias Mente-Corpo , Qualidade de Vida , Ensaios Clínicos Controlados Aleatórios como Assunto
18.
Trials ; 22(1): 393, 2021 Jun 14.
Artigo em Inglês | MEDLINE | ID: mdl-34127045

RESUMO

OBJECTIVE: Bone grafting is an important surgical procedure to restore missing bone in patients with alveolar cleft lip/palate, aiming to stabilize either sides of the maxillary segments by inducing new bone formation, and in bilateral cleft cases also to stabilize the pre-maxilla. Polyphosphate (PolyP), a physiological polymer composed of orthophosphate units linked together with high-energy phosphate bonds, is a naturally existing compound in platelets which, when complexed with calcium as Ca-polyP microparticles (Ca-polyP MPs), was proven to have osteoinductive properties in preclinical studies. AIM: To evaluate the feasibility, safety, and osteoinductivity of Ca-polyP MPs as a bone-inducing graft material in humans. METHODS: This prospective non-blinded first-in-man clinical pilot study shall consist of 8 alveolar cleft patients of 13 years or older to evaluate the feasibility and safety of Ca-PolyP MPs as a bone-inducing graft material. Patients will receive Ca-polyP graft material only or Ca-polyP in combination with biphasic calcium phosphate (BCP) as a bone substitute carrier. During the trial, the participants will be investigated closely for safety parameters using radiographic imaging, regular blood tests, and physical examinations. After 6 months, a hollow drill will be used to prepare the implantation site to obtain a biopsy. The radiographic imaging will be used for clinical evaluation; the biopsy will be processed for histological/histomorphometric evaluation of bone formation. DISCUSSION: This is the first-in-man study evaluating the safety and feasibility of the polyP as well as the potential regenerative capacity of polyP using an alveolar cleft model. TRIAL REGISTRATION: Indonesian Trial Registry INA-EW74C1N . Registered on 12 June 2020.


Assuntos
Fenda Labial , Fissura Palatina , Fenda Labial/diagnóstico por imagem , Fenda Labial/cirurgia , Fissura Palatina/diagnóstico por imagem , Fissura Palatina/cirurgia , Humanos , Indonésia , Projetos Piloto , Polifosfatos/efeitos adversos , Estudos Prospectivos , Ensaios Clínicos Controlados Aleatórios como Assunto
19.
Trials ; 22(1): 399, 2021 Jun 14.
Artigo em Inglês | MEDLINE | ID: mdl-34127059

RESUMO

BACKGROUND: As it has been recorded in ancient Chinese classics, Yanglingquan (GB34) and Dannangxue (EX-LE6) are two important acupoints that can regulate the function of the gallbladder. Acupuncture at these two acupoints is considered particularly effective for gallbladder disease treatment, especially for alleviating gallbladder stone disease (GSD) symptoms that can be aggravated after intaking high-fat food. However, the superior effect between the two acupoints still needs to be further explored, as well as the underlying central mechanism has never been investigated to date. METHODS AND DESIGN: Ninety participants diagnosed with GSD will be randomly divided into group A (acupuncture at GB34), group B (acupuncture at EX-LE6), and group C (acupuncture at non-acupoint) in a ratio of 1:1:1. All of them will receive a 30-min acupuncture treatment with fatty-food cues being presented before and after acupuncture. During the task, participants will be scanned by MRI and required to rate their desire for high-/low-fat food with an 11-point Likert scale. Additionally, the participants' pain/discomfort sensation will be evaluated using the Numeric Rating Scale (NRS) at four timepoints, including before the 1st task fMRI scan, before and after acupuncture, and after the 2nd task fMRI scan. For both behavior and fMRI data, the ANOVA analysis will be conducted among three groups to testify the immediate effect of GB34 and EX-LE6. The post hoc t-test will be employed to further explore the superiority between acupuncture with GB34 and EX-LE6. Furthermore, correlation analyses will be conducted to investigate a possible correlation between neural changes and clinical data. DISCUSSION: In comparison to the non-acupoint, the results will firstly explore the superior effect between acupuncture with GB34 and EX-LE6 on GSD patients by observing their behavioral and neural response change to fatty-food cue, and then to investigate the underlying central mechanism. TRIAL REGISTRATION: Chinese Clinical Trial Registry ChiCTR2000034368 . Registered on 3 July 2020.


Assuntos
Pontos de Acupuntura , Terapia por Acupuntura , Terapia por Acupuntura/efeitos adversos , Vesícula Biliar/diagnóstico por imagem , Humanos , Imageamento por Ressonância Magnética , Ensaios Clínicos Controlados Aleatórios como Assunto
20.
Medicine (Baltimore) ; 100(22): e25605, 2021 Jun 04.
Artigo em Inglês | MEDLINE | ID: mdl-34087820

RESUMO

INTRODUCTION: Several studies reported that traditional Chinese mind-body exercises showed beneficial effects on improving anxiety and depression of patients with low back pain (LBP) in recent years. However, the effects of traditional Chinese mind-body exercises on improving psychological disorders of patients with LBP remain controversial. Most previous reviews only focused on the effects of traditional Chinese mind-body exercises for LBP on pain and dysfunction. Therefore, the present systematic review and meta-analysis will be conducted to evaluate the evidence on psychological effects of traditional Chinese mind-body exercises for LBP. METHODS AND ANALYSIS: The electronic databases (PubMed, Embase, MEDLINE, Cochrane Central Register of Controlled Trials, Web of Science, China Knowledge Resource Integrated Database, and Wanfang Data) will be searched. The search will include all documents from their inception to February 2021. The Physiotherapy Evidence Database scale will be used for quality assessment of eligible studies. Risk of bias of eligible studies will also be assessed by Cochrane tool. The meta-analysis will be conducted using the Review Manager Version 5.3 software. The Higgins I2 statistic will be performed to examine for heterogeneity. The subgroup analysis will be conducted based on different types of traditional Chinese mind-body exercises, different intervention time, and different outcomes. Quality of evidence will be assessed using the Grades of Recommendation, Assessment, Development and Evaluation. ETHICS AND DISSEMINATION: No ethical statement will be required for the performance of this review and meta-analysis. The results of this review will be published in an international peer-reviewed journal. INPLASY REGISTRATION NUMBER: INPLASY202130075.


Assuntos
Dor Lombar/psicologia , Dor Lombar/terapia , Saúde Mental , Terapias Mente-Corpo/métodos , Terapias Mente-Corpo/psicologia , Ansiedade/etiologia , Ansiedade/terapia , China , Depressão/etiologia , Depressão/terapia , Humanos , Dor Lombar/complicações , Medicina Tradicional Chinesa/métodos , Ensaios Clínicos Controlados Aleatórios como Assunto , Projetos de Pesquisa
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