Trials
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Randomized Controlled Trial Comparative Study
A novel comparative effectiveness study of Tai Chi versus aerobic exercise for fibromyalgia: study protocol for a randomized controlled trial.
Fibromyalgia is a chronic musculoskeletal pain syndrome that causes substantial physical and psychological impairment and costs the US healthcare system over $25 billion annually. Current pharmacological therapies may cause serious adverse effects, are expensive, and fail to effectively improve pain and function. Finding new and effective non-pharmacological treatments for fibromyalgia patients is urgently needed. We are currently conducting the first comparative effectiveness randomized trial of Tai Chi versus aerobic exercise (a recommended component of the current standard of care) in a large fibromyalgia population. This article describes the design and conduct of this trial. ⋯ This study is the first comparative effectiveness randomized trial of Tai Chi versus aerobic exercise in a large fibromyalgia population with long-term follow up. We present here a robust and well-designed trial to determine the optimal frequency and duration of a supervised Tai Chi intervention with regard to short- and long-term effectiveness. The trial also explores multiple outcomes to elucidate the potential mechanisms of Tai Chi and aerobic exercise and the generalizability of these interventions across instructors. Results of this study are expected to have important public health implications for patients with a major disabling disease that incurs substantial health burdens and economic costs.
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Randomized Controlled Trial
Effectiveness of dual-task functional power training for preventing falls in older people: study protocol for a cluster randomised controlled trial.
Falls are a major public health concern with at least one third of people aged 65 years and over falling at least once per year, and half of these will fall repeatedly, which can lead to injury, pain, loss of function and independence, reduced quality of life and even death. Although the causes of falls are varied and complex, the age-related loss in muscle power has emerged as a useful predictor of disability and falls in older people. In this population, the requirements to produce explosive and rapid movements often occurs whilst simultaneously performing other attention-demanding cognitive or motor tasks, such as walking while talking or carrying an object. The primary aim of this study is to determine whether dual-task functional power training (DT-FPT) can reduce the rate of falls in community-dwelling older people. ⋯ The study offers a novel approach that may guide the development and implementation of future community-based falls prevention programmes that specifically focus on optimising muscle power and dual-task performance to reduce falls risk under 'real life' conditions in older adults. In addition, the 'step down' programme will provide new information about the efficacy of a less intensive maintenance programme for reducing the risk of falls over an extended period.
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Knowledge translation (KT) involves implementation of evidence-based strategies and guidelines into practice to improve the process of care and health outcomes for patients. Findings from pragmatic trials may be used in KT to provide patients, healthcare providers and policymakers with information to optimize healthcare decisions based on how a given strategy or intervention performs under the real world conditions. However, pragmatic trials have been criticized for having the following problems: i) high rates of loss to follow-up; ii) nonadherence to study intervention; iii) unblinded treatment and patient self-assessment, which can potentially create bias; iv) being less perfect experiments than efficacy trials; v) sacrificing internal validity to achieve generalizability; and vi) often requiring large sample sizes to detect small treatment effects in heterogeneous populations. In this paper, we discuss whether these criticisms hold merit, or if they are simply driven by confusion about the purpose of pragmatic trials. We use the Cardiovascular Health Awareness Program (CHAP) trial--a community randomized pragmatic trial designed to assess whether offering a highly organized, community-based CHAP intervention compared to usual care can reduce cardiovascular disease-related outcomes--to address these specific criticisms and illustrate how to reduce this confusion.
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Randomized Controlled Trial Comparative Study
Short-term study on risk-benefit outcomes of two spinal manipulative therapies in the treatment of acute radiculopathy caused by lumbar disc herniation: study protocol for a randomized controlled trial.
That patients with acute radiculopathy caused by lumbar disc herniation (LDH) will benefit from spinal manipulation (SM) treatment has been taken for granted, despite no solid evidence to support that claim. There is a demand for a win-win SM treatment that is both effective and less risky, and we attempt to use this trial to demonstrate such a treatment. In this study, Feng's Spinal Manipulative Therapy (FSM) is selected as the observational SM. FSM can be performed with either manipulation or mobilization, and also can be easily mimicked as a sham SM. ⋯ Two hundred and sixteen qualified hospitalized participants will be randomly allocated to one of the three following groups: sham SM, mobilization, or manipulation, according to a ratio of 1:1:1. Participants in each group will receive specific FSM treatments four times, along with basic therapies over a course of 2 weeks. Two days after each SM appointment, risk outcomes will be assessed using a questionnaire developed to identify accompanying unpleasant reactions (AUR). The pain pressure threshold (PPT) will be measured paraspinally on the tender spot beside the involved joint before and immediately after each SM treatment. Relative risk (RR) of AUR, number needed to harm (NNH) and the 95% confidence intervals of each group will be calculated and compared. Benefit outcomes will be assessed by analyzing the following data recordings: the Numerical Rating Scale (NRS), Oswestry Disability Index (ODI), and Global Perceived Effect (GPE) before enrollment and at the 7th, and 15th day after the treatment. Analyses will include comparisons of NRS, ODI and changes at the different visit times among the three groups by Repeated Measures Data ANOVA, an evaluation of reduced scores of NRS and ODI after the therapy to determine if they meet the minimum acceptable outcome (MAO), and the determination of the minimal clinically important difference (MCID) by the average improvement in NRS and ODI scores of all participants who have been allocated to the category 'improved' on the GPE assessment.
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Ventilator-associated pneumonia (VAP) is the most common infection in intubated critically ill patients. Microaspiration of the contaminated gastric and oropharyngeal secretions is the main mechanism involved in the pathophysiology of VAP. Tracheal cuff plays an important role in stopping the progression of contaminated secretions into the lower respiratory tract. Previous in vitro studies suggested that conical cuff shape might be helpful in improving tracheal sealing. However, clinical studies found conflicting results. The aim of this study is to determine the impact of conical tracheal cuff shape on the microaspiration of gastric contents in critically ill patients. ⋯ BEST Cuff is the first randomized controlled study evaluating the impact of PVC tracheal-cuff shape on gastric microaspirations in patients receiving invasive mechanical ventilation. Enrollment began in June 2014 and is expected to end in October 2015.