Passive exercise to improve quality of life, activities of daily living, care burden and cognitive functioning in institutionalized older adults with dementia - a randomized controlled trial study protocol.

BACKGROUND: Dementia affects cognitive functioning, physical functioning, activities of daily living (ADLs), and quality of life (QOL). Pharmacological treatments to manage, cure or prevent dementia remain controversial. Therefore development of non-pharmacological approaches to prevent, or at least delay the onset and progression of dementia is urgently needed. Passive exercise is proposed to be such a non-pharmacological alternative. This study primarily aims to investigate the effects of three different forms of passive exercise on QOL and ADLs of institutionalized patients with dementia. The secondary aims are to assess the effects of three different forms of passive exercise on cognitive functioning and physical functioning of institutionalized patients with dementia as well as on care burden of both the primary formal and primary informal caregivers of these patients.

METHODS: This is a multicenter randomized controlled trial. Three forms of passive exercise are distinguished; motion simulation (MSim), whole body vibration (WBV), and a combination of both MSim + WBV. Intervention effects are compared to a control group receiving regular care. Institutionalized patients with dementia follow a six-week intervention program consisting of four 4-12 min sessions a week. The primary outcome measures QOL and ADLs and secondary outcome measure care burden are assessed with questionnaires filled in by the primary formal and informal caregivers of the patient. The other secondary outcome measures cognitive and physical functioning are assessed by individual testing. The four groups are compared at baseline, after 6 weeks of intervention, and 2 weeks after the intervention has ended.

DISCUSSION: This study will provide insight in the effects of different forms of passive exercise on QOL, ADLs, cognitive and physical functioning and care burden of institutionalized patients with dementia and their primary formal and informal caregivers. The results of this study might support the idea that passive exercise can be an efficient alternative for physical activity for patients not able to be or stay involved in active physical exercise.

TRIAL REGISTRATION: The Netherlands National Trial Register ( NTR6290 ). Retrospectively registered 29 March 2017.