Trials
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Randomized Controlled Trial
Early rehabilitation using a passive cycle ergometer on muscle morphology in mechanically ventilated critically ill patients in the Intensive Care Unit (MoVe-ICU study): study protocol for a randomized controlled trial.
Patients in Intensive Care Units (ICU) are often exposed to prolonged immobilization which, in turn, plays an important role in neuromuscular complications. Exercise with a cycle ergometer is a treatment option that can be used to improve the rehabilitation of patients on mechanical ventilation (MV) in order to minimize the harmful effects of immobility. ⋯ The MoVe-ICU study will be the first randomized controlled trial to test the hypothesis that early rehabilitation with a passive cycle ergometer can preserve the morphology of knee extensors and diaphragm in critical patients on MV in ICUs.
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Randomized Controlled Trial Multicenter Study
Effect of a patient-centered drug review on polypharmacy in primary care patients: study protocol for a cluster-randomized controlled trial.
Managing patients with polypharmacy is a challenging issue in primary care. The aim of this study is to determine whether a patient-centered systematic review leads to more appropriate medication use in patients without negatively affecting quality of life and the course of the disease. ⋯ Answering the four questions of the algorithm requires a weighing-up of risks and benefits and contains a shared-decision-making approach: a prioritization of the treatment goals is necessary. This can only be done in collaboration with the patient. The majority of patients with multimorbidity are treated in the primary care setting. This underlines the significance of our study carried out in this setting: given the high prevalence of adverse drug events in patients with multimorbidity an intervention like ours has a large potential to reduce drug-related morbidity.
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Randomized Controlled Trial Multicenter Study
Mindfulness-based cognitive therapy for inflammatory bowel disease patients: findings from an exploratory pilot randomised controlled trial.
Inflammatory bowel disease (IBD) is a chronic gastrointestinal condition with a relapsing disease course. Managing the relapsing nature of the disease causes daily stress for IBD patients; thus, IBD patients report higher rates of depression and anxiety than the general population. Mindfulness-based Cognitive Therapy (MBCT) is an evidence-based psychological program designed to help manage depressive and stress symptoms. There has been no randomized controlled trial (RCT) testing the use of MBCT in IBD patients. The purpose of this pilot study is to test the trial methodology and assess the feasibility of conducting a large RCT testing the effectiveness of MBCT in IBD. ⋯ This pilot study suggests that a multicentre randomized clinical trial testing the effectiveness of MBCT for IBD patients is feasible with some changes to the protocol. Improvement in depression, trait anxiety and dispositional mindfulness scores are promising when coupled with patients reporting a perceived improvement of their quality of life.
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Randomized Controlled Trial
Effects of electroacupuncture therapy for Bell's palsy from acute stage: study protocol for a randomized controlled trial.
Although many patients with facial paralysis have obtained benefits or completely recovered after acupuncture or electroacupuncture therapy, it is still difficult to list intuitive evidence besides evaluation using neurological function scales and a few electrophysiologic data. Hence, the aim of this study is to use more intuitive and reliable detection techniques such as facial nerve magnetic resonance imaging (MRI), nerve electromyography, and F waves to observe changes in the anatomic morphology of facial nerves and nerve conduction before and after applying acupuncture or electroacupuncture, and to verify their effectiveness by combining neurological function scales. ⋯ A total of 132 patients with Bell's palsy (grades III and IV in the House-Brackmann [HB] Facial Nerve Grading System) will be randomly divided into electroacupuncture, manual acupuncture, non-acupuncture, and medicine control groups. All the patients will be given electroacupuncture treatment after the acute period, except for patients in the medicine control group. The acupuncture or electroacupuncture treatments will be performed every 2 days until the patients recover or withdraw from the study. The primary outcome is analysis based on facial nerve functional scales (HB scale and Sunnybrook facial grading system), and the secondary outcome is analysis based on MRI, nerve electromyography and F-wave detection. All the patients will undergo MRI within 3 days after Bell's palsy onset for observation of the signal intensity and facial nerve swelling of the unaffected and affected sides. They will also undergo facial nerve electromyography and F-wave detection within 1 week after onset of Bell's palsy. Nerve function will be evaluated using the HB scale and Sunnybrook facial grading system at each hospital visit for treatment until the end of the study. The MRI, nerve electromyography, and F-wave detection will be performed again at 1 month after the onset of Bell's palsy.
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Randomized Controlled Trial
Remote ischaemic preconditioning versus sham procedure for abdominal aortic aneurysm repair: an external feasibility randomized controlled trial.
Despite advances in perioperative care, elective abdominal aorta aneurysm (AAA) repair carries significant morbidity and mortality. Remote ischaemic preconditioning (RIC) is a physiological phenomenon whereby a brief episode of ischaemia-reperfusion protects against a subsequent longer ischaemic insult. Trials in cardiovascular surgery have shown that RIC can protect patients' organs during surgery. The aim of this study was to investigate whether RIC could be successfully introduced in elective AAA repair and to obtain the information needed to design a multi-centre RCT. ⋯ This study provided essential information for the planning and design of a multi-centre RCT to assess effectiveness of RIC for improving clinical outcomes in elective AAA repair. Patient consent was high, and the RIC intervention was carried out with minimal disruption to clinical care. The allocation scheme for a definite trial should take into account both the surgical procedure and its complexity to avoid confounding the effect of the RIC, as was observed in this study.