796 resultados para randomized controlled study


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Background and Purpose: The evidence of the benefits from regular physical activity to hypertensives is based on dry land training studies. Therefore, the aim of this study is to compare the effect of aquatic exercise with dry land training on hypertensive women. Methods: This is a randomized controlled study with 52 post-menopausal hypertensive women. The patients were randomly allocated in three groups: water aerobic training group (n=19), dry land aerobic training group (n=19) and a non-intervention control group (n=14). The training protocol was performed by 12weeks. Results: There were no differences among the three groups concerning basal blood pressure (BP) and biochemical variables. In water group, there was a statistically significant reduction of systolic BP from 136±16mmHg at zero week to 124±18mm Hg at 11th week and 124±15mmHg at 12th week. In dry land training group, there was a statistically significant reduction of systolic BP from 138±15mmHg at zero week to 125±10mmHg at 7th week, 127±10mmHg at 10th week and 126±9mmHg at 12th week. The control group presented no change in any of the assessed variables. No changes were carried out in any antihypertensive medications during study. Discussion: This is a randomized controlled study that demonstrates the antihypertensive efficacy of aerobic aquatic exercise. © 2013 John Wiley & Sons, Ltd.

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L’ictus è un importante problema di salute pubblica, è causa di morte e disabilità nella popolazione anziana. La necessità di strategie di prevenzione secondaria e terziaria per migliorare il funzionamento post-ictus e prevenire o ritardare altre condizioni disabilitanti, ha portato l’Italia a sviluppare un intervento di Attività Fisica Adattata (AFA) per l’ictus, che permettesse di migliorare gli esiti della riabilitazione. Obiettivo dello studio è di valutare se l’AFA unita all’Educazione Terapeutica (ET), rispetto al trattamento riabilitativo standard, migliora il funzionamento e la qualità di vita in pazienti con ictus. Studio clinico non randomizzato, in cui sono stati valutati 229 pazienti in riabilitazione post-ictus, 126 nel gruppo sperimentale (AFA+ET) e 103 nel gruppo di controllo. I pazienti sono stati valutati al baseline, a 4 e a 12 mesi di follow-up. Le misure di esito sono il cambiamento a 4 mesi di follow-up (che corrisponde a 2 mesi post-intervento nel gruppo sperimentale) di: distanza percorsa, Berg Balance Scale, Short Physical Performance Battery, e Motricity Index. Le variabili misurate a 4 e a 12 mesi di follow-up sono: Barthel Index, Geriatric Depression Scale, SF-12 e Caregiver Strain Index. La distanza percorsa, la performance fisica, l’equilibrio e il punteggio della componente fisica della qualità di vita sono migliorate a 4 mesi nel gruppo AFA+ET e rimasti stabili nel gruppo di controllo. A 12 mesi di follow-up, il gruppo AFA+ET ottiene un cambiamento maggiore, rispetto al gruppo di controllo, nell’abilità di svolgimento delle attività giornaliere e nella qualità di vita. Infine il gruppo AFA+ET riporta, nell’ultimo anno, un minor numero di fratture e minor ricorso a visite riabilitative rispetto al gruppo di controllo. I risultati confermano che l’AFA+ET è efficace nel migliorare le condizioni cliniche di pazienti con ictus e che gli effetti, soprattutto sulla riabilitazione fisica, sono mantenuti anche a lungo termine.

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Unilateral damage to the labyrinth and the vestibular nerve cause rotational vertigo, postural imbalance, oculomotor disorders and spatial disorientation. Electrophysiological investigations in animals revealed that such deficits are partly due to imbalanced spontaneous activity and sensitivity to motion in neurons located in the ipsilesional and contralesional vestibular nuclei. Neurophysiological reorganizations taking place in the vestibular nuclei are the basis of the decline of the symptoms over time, a phenomenon known as vestibular compensation. Vestibular compensation is facilitated by motor activity and sensory experience, and current rehabilitation programs favor physical activity during the acute stage of a unilateral vestibular loss. Unfortunately, vestibular-defective patients tend to develop strategies in order to avoid movements causing imbalance and nausea (in particular body movements towards the lesioned side), which impedes vestibular compensation. Neuroanatomical evidence suggests a cortical control of postural and oculomotor reflexes based on corticofugal projections to the vestibular nuclei and, therefore, the possibility to manipulate vestibular functions through top-down mechanisms. Based on evidence from neuroimaging studies showing that imagined whole-body movements can activate part of the vestibular cortex, we propose that mental imagery of whole-body rotations to the lesioned and to the healthy side will help rebalancing the activity in the ipsilesional and contralesional vestibular nuclei. Whether imagined whole-body rotations can improve vestibular compensation could be tested in a randomized controlled study in such patients beneficiating, or not, from a mental imagery training. If validated, this hypothesis will help developing a method contributing to reduce postural instability and falls in vestibular-defective patients. Imagined whole-body rotations thus could provide a simple, safe, home-based and self-administered therapeutic method with the potential to overcome the inconvenience related to physical movements.

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BACKGROUND: Resistance training (RT) is safe and practicable in low-risk populations with coronary artery disease. In patients with left ventricular (LV) dysfunction after an acute ischaemic event, few data exist about the impact of RT on LV remodelling. METHODS: In this prospective, randomized, controlled study, 38 patients, after a first myocardial infarction and a maximum ejection fraction (EF) of 45%, were assigned either to combined endurance training (ET)/RT (n=17; 15 men; 54.7+/-9.4 years and EF: 40.3+/-4.5%) or to ET alone (n=21; 17 men; 57.0+/-9.6 years and EF: 41.9+/-4.9%) for 12 weeks. ET was effectuated at an intensity of 70-85% of peak heart rate; RT, between 40 and 60% of the one-repetition maximum. LV remodelling was assessed by MRI. RESULTS: No statistically significant differences between the groups in the changes of end-diastolic volume (P=0.914), LV mass (P=0.885) and EF (P=0.763) were observed. Over 1 year, the end-diastolic volume increased from 206+/-41 to 210+/-48 ml (P=0.379) vs. 183+/-44 to 186+/-52 ml (P=0.586); LV mass from 149+/-28 to 155+/-31 g (P=0.408) vs. 144+/-36 to 149+/-42 g (P=0.227) and EF from 49.1+/-12.3 to 49.3+/-12.0% (P=0.959) vs. 51.5+/-13.1 to 54.1% (P=0.463), in the ET/RT and ET groups, respectively. Peak VO2 and muscle strength increased significantly in both groups, but no difference between the groups was noticed. CONCLUSION: RT with an intensity of up to 60% of the one-repetition maximum, after an acute myocardial infarction, does not lead to a more pronounced LV dilatation than ET alone. A combined ET/RT, or ET alone, for 3 months can both increase the peak VO2 and muscle strength significantly.

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Introduction Injured individuals face a high risk for the development of psychological symptoms such as depression or anxiety, which influences early return to work after an accident. So far, it is unclear to which extent early psychological interventions can improve the ability to return to work. Purpose of the study The aim of the study was to investigate whether an improvement of the treatment-triage (by the screening questionnaire work and health [FAB]) influences early return to work and well being in injured individuals. Methods The study sample consists of injured individuals with different mental health-related or work-related disabilities after an accident. Participants are included eight weeks after an accident. Participants are randomly assigned to the intervention or to the control group. The intervention is an individualized psychotherapy consisting of cognitive-behavioral therapy and work related topics in an individual setting. Well being and work related actors are assessed at baseline and after six months. Results The recruitment is still ongoing. The preliminary results of this randomized controlled study will be presented at the conference. Conclusion An individualized psychotherapy might have the potential to improve the rehabilitation process in injured individuals and improve the ability to return to work.

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Aim: Injured individuals face a high risk for the development of psychological symptoms such as depression or anxiety, which influences early return to work after an accident. So far, it is unclear to which extent early psychological interventions can improve the ability to return to work. The aim of the study was to investigate whether an improvement of the treatment‐triage influences early return to work and well being in injured individuals. Method: The study sample consists of injured individuals with different mental health-related or work-related disabilities after an accident. Participants are included eight weeks after an accident. Participants are randomly assigned to the intervention or to the control group. The intervention is an individualized psychotherapy consisting of cognitive‐behavioral therapy and work related topics in an individual setting. Wellbeing and work related factors are assessed at baseline and after six months. Result: The recruitment is still ongoing. The preliminary results of this randomized controlled study will be presented at the conference. Discussion: An individualized psychotherapy might have the potential to improve the rehabilitation process in injured individuals and improve the ability to return to work.

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Introducción. El aumento de la obesidad y el sedentarismo en niños es un problema social grave. La adopción de hábitos activos contribuye a la prevención de estos trastornos. Objetivos. Medir el efecto de un programa escolar de promoción de actividad física (AF). Material y método. Estudio de intervención controlado no aleatorizado. Participaron 123 niños de ambos sexos, 32 en el grupo intervención (I) y 92 en el grupo control (C). El nivel de AF se obtuvo por cuestionario. Se ponderó el grado de asociación conceptual entre AF y salud mediante test relacional. El grupo I participó de talleres durante 8 semanas durante una hora semanal en horario escolar. Resultados. La práctica deportiva creció 10 en grupo I y 2,9 en C, la diferencia entre medias fue 7.1. (p menor a 0.05). El grupo I aumentó la cantidad de veces que usan la bicicleta por semana 2,88 a 3,56. En el grupo I el tiempo de pedaleo aumentó 30.57 min./sem y disminuyó las horas frente al TV en 1.40 min/día. El grupo I aumentó la importancia que los niños asignan a la AF relación a la salud en forma significativa. Conclusiones. Implementar estrategias de promoción de AF puede favorecer cambios de hábitos y conductas hacia un estilo de vida saludable cuando se trabaja sistemáticamente en talleres mediante la participación activa de niños y maestros.

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Introducción. El aumento de la obesidad y el sedentarismo en niños es un problema social grave. La adopción de hábitos activos contribuye a la prevención de estos trastornos. Objetivos. Medir el efecto de un programa escolar de promoción de actividad física (AF). Material y método. Estudio de intervención controlado no aleatorizado. Participaron 123 niños de ambos sexos, 32 en el grupo intervención (I) y 92 en el grupo control (C). El nivel de AF se obtuvo por cuestionario. Se ponderó el grado de asociación conceptual entre AF y salud mediante test relacional. El grupo I participó de talleres durante 8 semanas durante una hora semanal en horario escolar. Resultados. La práctica deportiva creció 10 en grupo I y 2,9 en C, la diferencia entre medias fue 7.1. (p menor a 0.05). El grupo I aumentó la cantidad de veces que usan la bicicleta por semana 2,88 a 3,56. En el grupo I el tiempo de pedaleo aumentó 30.57 min./sem y disminuyó las horas frente al TV en 1.40 min/día. El grupo I aumentó la importancia que los niños asignan a la AF relación a la salud en forma significativa. Conclusiones. Implementar estrategias de promoción de AF puede favorecer cambios de hábitos y conductas hacia un estilo de vida saludable cuando se trabaja sistemáticamente en talleres mediante la participación activa de niños y maestros.

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Introducción. El aumento de la obesidad y el sedentarismo en niños es un problema social grave. La adopción de hábitos activos contribuye a la prevención de estos trastornos. Objetivos. Medir el efecto de un programa escolar de promoción de actividad física (AF). Material y método. Estudio de intervención controlado no aleatorizado. Participaron 123 niños de ambos sexos, 32 en el grupo intervención (I) y 92 en el grupo control (C). El nivel de AF se obtuvo por cuestionario. Se ponderó el grado de asociación conceptual entre AF y salud mediante test relacional. El grupo I participó de talleres durante 8 semanas durante una hora semanal en horario escolar. Resultados. La práctica deportiva creció 10 en grupo I y 2,9 en C, la diferencia entre medias fue 7.1. (p menor a 0.05). El grupo I aumentó la cantidad de veces que usan la bicicleta por semana 2,88 a 3,56. En el grupo I el tiempo de pedaleo aumentó 30.57 min./sem y disminuyó las horas frente al TV en 1.40 min/día. El grupo I aumentó la importancia que los niños asignan a la AF relación a la salud en forma significativa. Conclusiones. Implementar estrategias de promoción de AF puede favorecer cambios de hábitos y conductas hacia un estilo de vida saludable cuando se trabaja sistemáticamente en talleres mediante la participación activa de niños y maestros.

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Fever has both beneficial and detrimental effects. There is evidence that antipyretics and physical cooling methods, when used in combination, are more effective than antipyretics alone. This randomized controlled study examined 45 acutely ill adults with fever ${\ge}102.5\sp\circ\rm F$ where three nursing interventions were used. Group I received acetaminophen 650 mgs., Group II received acetaminophen 650 mgs. and tepid sponging, and Group III received acetaminophen 650 mgs. and hypothermia blanket. The purpose of this study was to evaluate which nursing intervention reduced temperature most effectively with respect to eight biobehavioral variables. Research hypotheses were tested statistically using the chi-square test and repeated measures analysis of variance. The study found statistically significant results for fever reduction overall, but no difference for the groups. Therefore, we suggest that acetaminophen alone be used in the treatment of fever in order to decrease cost, nursing time, and increase patient comfort. ^

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As morbid obesity increasingly affects Hispanic-Americans, the incidence of Roux-en-Y gastric bypass procedures (RYGB) among this population rises. Prospective research on the impact of postoperative educational interventions focused on Hispanic- Americans is needed to prevent premature weight loss plateau, weight regain, nutritional deficiencies, and relapse of obesity-related comorbidities. This randomized-controlled study evaluated the impact of a comprehensive nutrition and lifestyle education intervention (6 biweekly postoperative sessions that incorporated motivational strategies for behavioral change) as compared to a non-comprehensive approach (printed guidelines for healthy lifestyle). The variables to consider are body weight, obesity-related comorbidities (depression, diabetes, dyslipidemia, and others), nutrient status, physical activity, and eating habits in 144 morbidly-obese adult Hispanic-Americans 6 to 12 months following RYGB. Patients were randomly assigned to either the comprehensive intervention (n=72) or the comparison group (n=72). Participants (mean age 44.5 ± 13.5 years) were mainly Cuban-born females (83.3%). Intervention sessions attendance was 64%. At 12 months, both groups lost weight significantly, but those in the comprehensive intervention experienced greater excess weight loss than those in the comparison group (80% vs. 64% from preoperative excess weight, P<.001). Intervention participants were significantly more involved in physical activity (+ 14 min/week vs. – 4 min/week), had decreased depression, joint illness, and required less medication for comorbidities than comparison participants. Additionally, those in the comprehensive intervention had sustained supplement intake experiencing less folate deficiency (P=.014). The non-comprehensive intervention group significantly decreased their protein and supplement intake compared to the intervention group. Patients in the comprehensive intervention had significantly better eating habits reflected by fewer episodes of dumping syndrome, constipation, and night eating, than those in the comparison group who reported greater eating in response to negative emotions (P=.003). These findings support the importance of a comprehensive educational approach to achieve more effective weight reduction and health-related outcomes to prevent relapse of obesity-related comorbidities and nutritional deficiencies in Hispanic-Americans 6 to 12 months following RYGB.

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Objectivo: este estudo centrava-se na avaliação da eficácia da intervenção de um farmacêutico na Redução do Grau de Complexidade da Medicação num Lar de Idosos. Métodos: tratou-se de um estudo randomizado controlado. A instituição que serviu para a recolha de dados foi o Lar da Santa Casa da Misericórdia das Alcáçovas, localidade que pertence ao concelho de Viana do Alentejo, Distrito de Évora. Foram usados como amostra, os utentes institucionalizados (n=86), que por randomização foram divididos em grupo de intervenção e de controlo respectivamente. Em Março 2007, o Índice Çomplexidade da Medicação (MRCI), foi usado para estabelecer a linha de partida (baseline). Ocorreu uma sessão informativa com o médico acerca da importância e dos efeitos provocados pelo MRCI obtido. A fase de Intervenção teve início em Maio de 2007, e consistiu em reportar ao médico o MRCI para cada utente, o valor médio do MRCI para o Lar e algumas recomendações para o poder reduzir. Noventa dias após a intervenção, o MRCI voltou a ser avaliado para todos os utentes. Resultados: a média de idades para os 86 utentes era de 83,9 anos, com 66,3o/o de mulheres. Na linha de partida, os utentes usavam 7,8 medicamentos e apresentavam um MRCI de 22,9 (95% Cl 20,1: 25,7). Durante a fase de intervenção, 2 utentes do grupo de intervenção e 5 utentes do grupo de controlo faleceram. Após a intervenção, o número de medicamentos reduziu no grupo de intervenção (p = 0,035), mas não no grupo de controlo (p =0,079). O MACI do grupo de intervenção reduziu de 22,2 para 16,8 (p =0,015); enquanto o MRCI do grupo de controlo reduziu apenas de 23,6 para 20,0 (p =0,091). As três secções do MRCI reduziram significativamente no grupo de intervenção, mas nenhum deles reduziu no grupo de controlo. Conclusão: a intervenção de um farmacêutico pode contribuir para reduzir a complexidade da medicação nos idosos, com uma ligeira redução no número de medicamentos a tomar pelos utentes e sem focalizar a intervenção num aspecto específico do regime terapêutico. ABSTRACT; Methods: Randomized controlled study. Patients (n= 86) institutionalized in nursing home to Santa Casa da Misericórdia das Alcáçovas, Viana do Alentejo, Évora. The patients were randomly assigned to intervention and control groups. ln Mars 2007, Medication Regimen Complexity Index (MRCI) was used to establish a baseline... An informative session with the physician about the importance and effects of regime complexity occurred. lntervention started in May 2007, and consisted in reporting to the physician the complexity of each patient medication regime, with references to the average complexity and some recommendations to reduce it. Ninety days after the intervention, MRCI were evaluated in all the patients. Results: average age of the 86 patients was 83,9 years, with 66,3°/o of females. At the baseline, patients were using 7, 8 medicines, and presented a MRCI = 22,9 (95%CI 20,1 : 25,7). During the intervention phase, 2 intervention patients and 5 control patients dead. After the intervention, the number of medicines reduced in intervention group (p=0,035), but not in the control group (p = 0,079).1ntervention MRCI reduced from 22,2 to 16,8 (p =0,015), while control MRCI reduced only from 23,6 to 20,0 (p =0,091). The three section of the MRCI significantly reduced in the intervention, but none of them in the control group. Conclusions: clinical pharmacist interventions can contribute to reducing the medication regime complexity in elderly, with a slight reduction of the number of medicines taken by the patient, and without focusing the intervention in one specific aspect of the medication regime.

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El objetivo de este estudio es establecer si la dexmedetomidina (DEX) es segura y efectiva para el manejo coadyuvante de síndrome de abstinencia a alcohol (SAA) a través de la búsqueda de evidencia científica. Metodología: se realiza una revisión sistemática de literatura publicada y no publicada desde enero de 1989 hasta febrero 2016 en PubMed, Embase, Scopus, Bireme, Cochrane library y en otras bases de datos y portales. Los criterios de inclusión fueron ensayos clínicos aleatorizados y no aleatorizados, estudios cuasi-experimentales, estudios de cohorte, y estudios de casos y controles; que incluyeron pacientes mayores de 18 años hospitalizados con diagnóstico de SAA y donde se usó DEX como terapia coadyuvante. Resultados: 7 estudios, 477 pacientes, se incluyeron en el análisis final. Se encontraron dos ensayos clínicos aleatorizados, tres estudios de casos y controles y dos estudios de cohorte retrospectivo. Solo uno de los estudios fue doble ciego y utilizó placebo como comparador. Análisis y conclusiones: en los estudios experimentales se determinan que el uso de DEX como terapia coadyuvante en el manejo de SAA tiene significancia clínica y estadística para disminuir dosis de BZD en las primeras 24 horas de tratamiento; pero no demostraron tener otros beneficios clínicos. En los estudios no aleatorizados existe consenso que relaciona el uso de DEX con menores dosis de BZD de forma temprana. Recomendaciones: no se recomienda el uso de DEX en SAA de forma rutinaria. Se recomienda usar DEX solo en casos en el que exista evidencia fallo terapéutico a BZD.

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BACKGROUND Major depression will become the second most important cause of disability in 2020. Computerized cognitive-behaviour therapy could be an efficacious and cost-effective option for its treatment. No studies on cost-effectiveness of low intensity vs self-guided psychotherapy has been carried out. The aim of this study is to assess the efficacy of low intensity vs self-guided psychotherapy for major depression in the Spanish health system. METHODS The study is made up of 3 phases: 1.- Development of a computerized cognitive-behaviour therapy for depression tailored to Spanish health system. 2.- Multicenter controlled, randomized study: A sample (N=450 patients) with mild/moderate depression recruited in primary care. They should have internet availability at home, not receive any previous psychological treatment, and not suffer from any other severe somatic or psychological disorder. They will be allocated to one of 3 treatments: a) Low intensity Internet-delivered psychotherapy + improved treatment as usual (ITAU) by GP, b) Self-guided Internet-delivered psychotherapy + ITAU or c) ITAU. Patients will be diagnosed with MINI psychiatric interview. Main outcome variable will be Beck Depression Inventory. It will be also administered EuroQol 5D (quality of life) and Client Service Receipt Inventory (consume of health and social services). Patients will be assessed at baseline, 3 and 12 months. An intention to treat and a per protocol analysis will be performed. DISCUSSION The comparisons between low intensity and self-guided are infrequent, and also a comparative economic evaluation between them and compared with usual treatment in primary. The strength of the study is that it is a multicenter, randomized, controlled trial of low intensity and self-guided Internet-delivered psychotherapy for depression in primary care, being the treatment completely integrated in primary care setting. TRIAL REGISTRATION Clinical Trials NCT01611818.

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BACKGROUND Advanced heart failure (HF) is associated with high morbidity and mortality; it represents a major burden for the health system. Episodes of acute decompensation requiring frequent and prolonged hospitalizations account for most HF-related expenditure. Inotropic drugs are frequently used during hospitalization, but rarely in out-patients. The LAICA clinical trial aims to evaluate the effectiveness and safety of monthly levosimendan infusion in patients with advanced HF to reduce the incidence of hospital admissions for acute HF decompensation. METHODS The LAICA study is a multicenter, prospective, randomized, double-blind, placebo-controlled, parallel group trial. It aims to recruit 213 out-patients, randomized to receive either a 24-h infusion of levosimendan at 0.1 μg/kg/min dose, without a loading dose, every 30 days, or placebo. RESULTS The main objective is to assess the incidence of admission for acute HF worsening during 12 months. Secondarily, the trial will assess the effect of intermittent levosimendan on other variables, including the time in days from randomization to first admission for acute HF worsening, mortality and serious adverse events. CONCLUSIONS The LAICA trial results could allow confirmation of the usefulness of intermittent levosimendan infusion in reducing the rate of hospitalization for HF worsening in advanced HF outpatients.