Home-based exercise and support programme for people with dementia and their caregivers: study protocol of a randomised controlled trial

This manuscript describes the design of a Randomised Controlled Trial (RCT) of the effects of a home-based exercise and support programme for people with dementia and their caregivers. The aim is to randomly assign 156 dyads (caregiver and dementia diagnosed person) to an intervention group or a comparison group. The experimental group receives a home programme in which exercise and support for the people with dementia and their caregivers are combined and integrated. The comparison group receives a minimal intervention. Primary outcomes are physical health (people with dementia) and mood (people with dementia and caregivers). In addition, to get more insight in the working components of the intervention and the impact of the intervention on the relationship of the dyads a qualitative sub-study is carried out.This study aims to contribute to an evidence-based treatment to reduce depressive symptoms among people with dementia and their caregivers independently living in the community.The study has been registered at the Netherlands National Trial Register (NTR), which is connected to the International Clinical Trials Registry Platform of the WHO. Trial number: NTR1802.Dementia affects the mood of people with dementia but also of their family caregivers [1,2]. Psychosocial interventions have been demonstrated to reduce caregiver distress and delay nursing home admission [3]. However, benefits of psychological interventions on caregiver's psychological mental health are limited especially with regard to caregivers' depressive symptoms [4-6]. Since the number of people with dementia is increasing worldwide, and most of them will continue to live in the community as long as possible, home-based psychosocial interventions reducing the depressive symptoms of both people with dementia and their caregivers in their own home are highly needed.A review on combined programmes for people with dementia and their caregivers showed the effectiveness of four out of the 22 programmes