title: 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.
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
  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.
  
  
  CONCLUSIONS
  LEDEN will provide the preliminary evidence needed to inform the development of larger and more complex interventions using exercise or non-exercise social interventions.
authors.affiliation: Gérontopôle de Toulouse, Institut du Vieillissement, Centre Hospitalo-Universitaire de Toulouse (CHU Toulouse), Toulouse, France; UMR INSERM 1027, University of Toulouse III, Toulouse, France. Electronic address: philipebarreto81@yahoo.com.br.
authors.forename: Philipe
authors.initials: P
authors.lastname: de Souto Barreto
authors.affiliation: Institut du Bien Vieillir Korian, Paris, France.
authors.forename: Philippe
authors.initials: P
authors.lastname: Denormandie
authors.affiliation: UMR INSERM 1027, University of Toulouse III, Toulouse, France; Department of Epidemiology, Centre Hospitalo-Universitaire de Toulouse (CHU Toulouse), Toulouse, France.
authors.forename: Benoit
authors.initials: B
authors.lastname: Lepage
authors.affiliation: Institut du Bien Vieillir Korian, Paris, France.
authors.forename: Didier
authors.initials: D
authors.lastname: Armaingaud
authors.affiliation: LIRAES (EA 4470) & Chaire AGEINOMIX, Université Paris Descartes, Sorbonne Paris Cité, France.
authors.forename: Thomas
authors.initials: T
authors.lastname: Rapp
authors.affiliation: LIRAES (EA 4470) & Chaire AGEINOMIX, Université Paris Descartes, Sorbonne Paris Cité, France.
authors.forename: Pauline
authors.initials: P
authors.lastname: Chauvin
authors.affiliation: Gérontopôle de Toulouse, Institut du Vieillissement, Centre Hospitalo-Universitaire de Toulouse (CHU Toulouse), Toulouse, France; UMR INSERM 1027, University of Toulouse III, Toulouse, France.
authors.forename: Bruno
authors.initials: B
authors.lastname: Vellas
authors.affiliation: Gérontopôle de Toulouse, Institut du Vieillissement, Centre Hospitalo-Universitaire de Toulouse (CHU Toulouse), Toulouse, France; UMR INSERM 1027, University of Toulouse III, Toulouse, France.
authors.forename: Yves
authors.initials: Y
authors.lastname: Rolland
mesh_terms: D000368:Aged; D000369:Aged, 80 and over; D002985:Clinical Protocols; D003362:Cost-Benefit Analysis; D003704:Dementia / Q000191:economics / Q000503:physiopathology / Q000628:therapy*; D005081:Exercise Therapy / Q000191:economics / Q000379:methods*; D005260:Female; D005500:Follow-Up Studies; D005602:France; D006707:Homes for the Aged; D006801:Humans; D008297:Male; D009735:Nursing Homes; D010865:Pilot Projects; D012107:Research Design; D016896:Treatment Outcome
keywords: Alzheimer's disease; Dementia; Elderly; Exercise; Long-term care; Nursing home; Physical activity