de Souto Barreto Philipe, Denormandie Philippe, Lepage Benoit, Armaingaud Didier, Rapp Thomas, Chauvin Pauline, Vellas Bruno, Rolland Yves
Gérontopôle de Toulouse, Institut du Vieillissement, Centre Hospitalo-Universitaire de Toulouse (CHU Toulouse), Toulouse, France; UMR INSERM 1027, University of Toulouse III, Toulouse, France.
Institut du Bien Vieillir Korian, Paris, France.
Contemp Clin Trials. 2016 Mar;47:289-95. doi: 10.1016/j.cct.2016.02.004. Epub 2016 Feb 13.
Exercise may lead to improvements on functional ability, physical function, and neuropsychiatric symptoms (particularly depression) in people with dementia (PWD). However, high-quality randomised controlled trial (RCT), controlling for the socialisation aspect of group-based exercise interventions, and designed to delay the declines on the functional ability of PWD in the nursing home (NH) setting is almost inexistent. This article describes the protocol of the LEDEN study, an exercise RCT for PWD living in NHs.
METHODS/DESIGN: LEDEN is a cluster-randomised controlled pilot trial composed of two research arms: exercise training (experimental group) and social/recreational activity (control group). Both interventions will be provided twice a week, for 60 min, during the 6-month intervention. The total duration of the study is 12 months, being six months of intervention plus six months of observational follow-up. Eight French NHs volunteered to participate in LEDEN; they have been randomised to either exercise intervention or social/recreational intervention in a 1:1 ratio.
The primary objective is to investigate the effects of exercise, compared to a social/recreational intervention, on the ability of PWD living in NHs to perform activities of daily living (ADL). Secondary objectives are related with the cost-effectiveness of the interventions, and the effects of the interventions on patients' physical function, neuropsychiatric symptoms, pain, nutritional status, and the incidence of falls and fractures.
LEDEN will provide the preliminary evidence needed to inform the development of larger and more complex interventions using exercise or non-exercise social interventions.
运动可能会改善痴呆症患者（PWD）的功能能力、身体机能和神经精神症状（尤其是抑郁症）。然而，高质量的随机对照试验（RCT）几乎不存在，这类试验要控制基于团体的运动干预的社交化方面，并旨在延缓养老院（NH）环境中PWD功能能力的下降。本文描述了LEDEN研究的方案，这是一项针对居住在养老院的PWD的运动RCT。
方法/设计：LEDEN是一项整群随机对照试验性研究，由两个研究组组成：运动训练（实验组）和社交/娱乐活动（对照组）。在为期6个月的干预期间，两种干预措施均每周进行两次，每次60分钟。研究总时长为12个月，包括6个月的干预期和6个月的观察随访期。八家法国养老院自愿参与LEDEN研究；它们已按1:1的比例随机分为运动干预组或社交/娱乐干预组。
主要目的是研究与社交/娱乐干预相比，运动对居住在养老院的PWD进行日常生活活动（ADL）能力的影响。次要目的与干预措施的成本效益有关，以及干预措施对患者身体机能、神经精神症状、疼痛、营养状况以及跌倒和骨折发生率的影响。
LEDEN将提供初步证据，为使用运动或非运动社交干预措施开展更大规模、更复杂的干预措施提供依据。
