title: A home-based exercise intervention for caregivers of persons with dementia: study protocol for a randomised controlled trial.
abstract: BACKGROUND
  Family members, who provide the majority of care for persons with dementia, are especially vulnerable to developing depression. Interventions targeting their depressive symptoms have been proposed but their efficacies vary considerably. It has been suggested that interventions carried out in the home setting and involving both caregivers and care recipients are more efficacious. This study aims to compare the efficacy of a home-based structured exercise programme involving both persons with dementia and their caregivers with nonexercise social contact control in treating depression among caregivers.
  
  
  METHODS
  This is a parallel-group, assessor-blind, randomised controlled trial. A total of 136 caregiver-care-recipient dyads (i.e. 272 participants in total) will be recruited and randomly allocated to either a home-based structured exercise (sitting Tai Chi) group or a social contact control group. The trial comprises a 3-month intervention phase followed by an extended observation phase of another 3 months. All participants will be assessed at baseline, 6th week, 12th week and 24th week. The primary outcome will be the reduction in depression among caregivers as measured by the Hamilton Rating Scale for Depression. The secondary outcomes will be burden, quality of life, cognitive performance and balance ability of the caregivers, as well as the neuropsychiatric symptoms, cognitive function, balance and functional abilities of the persons with dementia. We will also examine whether the brain-derived neurotrophic factor gene modulates mood changes in response to exercise.
  
  
  CONCLUSIONS
  The findings offer a potential avenue of intervention by providing a low-cost, safe and effective treatment for depression among dementia caregivers, which may in turn also benefit the care recipients.
  
  
  BACKGROUND
  ClinicalTrials.gov Identifier: NCT02132039 , registered on 28 April 2014.
authors.affiliation: Department of Psychiatry, The University of Hong Kong, Queen Mary Hospital, Pokfulam, Hong Kong. waicchan@hku.hk.
authors.forename: Wai Chi
authors.identifier: http://orcid.org/0000-0002-7324-0553
authors.initials: WC
authors.lastname: Chan
authors.affiliation: Academic Unit for Psychiatry of Old Age, Department of Psychiatry, University of Melbourne, Melbourne, VIC, Australia.|NorthWestern Aged Mental Health, Royal Park Campus, Parkville, VIC, Australia.|School of Clinical Neurosciences and the Western Australia Centre and Health and Ageing, University of Western Australia, Perth, WA, Australia.
authors.forename: Nicola
authors.initials: N
authors.lastname: Lautenschlager
authors.affiliation: National Ageing Research Institute, The University of Melbourne, Melbourne, VIC, Australia.
authors.forename: Briony
authors.initials: B
authors.lastname: Dow
authors.affiliation: Department of Psychiatry, The Chinese University of Hong Kong, Tai Po Hospital, Tai Po, Hong Kong.
authors.forename: Suk Ling
authors.initials: SL
authors.lastname: Ma
authors.affiliation: Department of Psychiatry, The University of Hong Kong, Queen Mary Hospital, Pokfulam, Hong Kong.
authors.forename: Corine Sau Man
authors.initials: CS
authors.lastname: Wong
authors.affiliation: Department of Psychiatry, The Chinese University of Hong Kong, Tai Po Hospital, Tai Po, Hong Kong.
authors.forename: Linda Chiu Wa
authors.initials: LC
authors.lastname: Lam
keywords: Caregivers; Dementia; Depression; Home-based exercise; Randomised controlled trial; Tai Chi