Trials
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The benefit of physical exercise in ageing and particularly in frailty has been the aim of recent research. Moreover, physical activity in the elderly is associated with a decreased risk of mortality, of common chronic illnesses (i.e. cardiovascular disease or osteoarthritis) and of institutionalization as well as with a delay in functional decline. Additionally, very recent research has shown that, despite its limitations, physical exercise is associated with a reduced risk of dementia, Alzheimer disease or mild cognitive decline. Nevertheless, the effect of physical exercise as a systematic, structured and repetitive type of physical activity, in the reduction of risk of cognitive decline in the elderly, is not very clear. The purpose of this study aims to examine whether an innovative multicomponent exercise programme called VIVIFRAIL has benefits for functional and cognitive status among pre-frail/frail patients with mild cognitive impairment or dementia. ⋯ Frailty and cognitive impairment are two very common geriatric syndromes in elderly patients and are frequently related and overlapped. Functional decline and disability are major adverse outcomes of these conditions. Exercise is a potential intervention for both syndromes. If our hypothesis is correct, the relevance of this project is that the results can contribute to understanding that an individualized multicomponent exercise programme (VIVIFRAIL) for frail elderly patients with cognitive impairment is more effective in reducing functional and cognitive impairment than conventional care. Moreover, our study may be able to show that an innovative individualized multicomponent exercise prescription for these high-risk populations is plausible, having at least similar therapeutic effects to other pharmacological and medical prescriptions.
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Nursing home residents are frequently affected by joint contractures, which impacts their participation and daily activities. A complex intervention, the Participation Enabling Care in Nursing (PECAN), was previously developed and pilot tested to address their needs. Its effectiveness and safety will be evaluated in the present study. ⋯ We expect a clinically relevant improvement of participation and activities in residents with joint contractures. Our findings will provide important insights regarding participation in the situation of the affected individuals.
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Multicenter Study
Remote ischemic conditioning in septic shock (RECO-Sepsis): study protocol for a randomized controlled trial.
Septic shock is a major public health problem that is associated with up to 50% mortality. Unfavorable outcomes are mainly attributed to multiple organ failure (MOF) resulting from an uncontrolled inflammatory response and ischemia-reperfusion processes. REmote ischemic COnditioning (RECO) is a promising intervention to prevent ischemia-reperfusion injury. We hypothesize that RECO would reduce the severity of septic shock-induced MOF. ⋯ Results of this proof-of-concept trial should provide information on the efficacy of RECO in patients with septic shock.
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Multicenter Study Pragmatic Clinical Trial
Targeted interventions to prevent transitioning from acute to chronic low back pain in high-risk patients: development and delivery of a pragmatic training course of psychologically informed physical therapy for the TARGET trial.
Low back pain (LBP) is a public health concern because it is highly prevalent and the leading cause of disability worldwide. Psychologically informed physical therapy (PIPT) is a secondary prevention approach that first aims to identify individuals at high risk for transitioning to chronicity and then provides tailored treatment to reduce that risk. Training models that are feasible to implement with acceptable training quality are needed to improve scalability for widespread implementation of PIPT. This manuscript describes the PIPT training program that was developed for training physical therapists providing PIPT in the TARGET trial. ⋯ PIPT training for provider participation in the TARGET trial was feasible to deliver. Course content was acceptable to physical therapists and resulted in improved beliefs and confidence in applying PIPT skills during clinical practice. Ongoing consultation and site-based continuing education were methods by which specific TARGET sites maintained or augmented PIPT skill training; however, implementing ongoing training was challenging in general. Due to the pragmatic nature of the TARGET trial, it was not possible to directly measure the effect of PIPT training on treatment fidelity, which was a limitation of our approach.
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Multicenter Study Comparative Study Pragmatic Clinical Trial
Comparative effectiveness of Chuna manual therapy versus conventional usual care for non-acute low back pain: a pilot randomized controlled trial.
Low back pain (LBP) is common, with a lifetime prevalence of 80%, and as such it places substantial social and economic burden on individuals and society. Chuna manual therapy (CMT) combines aspects of physiology, biodynamics of spine and joint motion, and basic theory of movement dynamics. This study aimed to test the comparative effectiveness and safety of CMT for non-acute LBP. ⋯ Our results suggest that CMT has comparative efficacy for non-acute LBP and is generally safe. As this was a preliminary study, a well-powered (over 192 participants) two-arm (CMT versus UC) verification trial will be performed to assess the generalizability of these results.