Effects of a long-term exercise programme on functional ability in people with dementia living in nursing homes: Research protocol of the LEDEN study, a cluster randomised controlled trial.

Summary Abstract Background 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. Results 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. Discussion LEDEN will provide the preliminary evidence needed to inform the development of larger and more complex interventions using exercise or non-exercise social interventions.