Abstract

Background: Caregiving for people with dementia is highly demanding. It is unclear which patient factors should be targeted to relieve caregiver burden. We aimed to identify potential mechanisms that could alleviate caregiver burden. Methods: We conducted a causal mediation analysis of the Dementia And Physical Activity (DAPA) randomised controlled trial. DAPA was a pragmatic, investigator masked, randomised controlled trial conducted in 15 regions across England. DAPA recruited a sample of 494 people with mild to moderate dementia (DSM-IV) and their caregivers and compared a moderate to high intensity exercise programme (n=329) versus usual care (n=165). We estimated mediating effects of the intervention on caregiver burden at 12 months through the following mediators measured at six months, participants' social quality of life (Quality of Life in Alzheimer's Disease scale), physical function (Bristol Activities of Daily Living scale), behavioural symptoms (Neuropsychiatric Inventory), and cognitive function (Alzheimer disease assessment scale cognitive subscale). Findings: The exercise programme had no effect on behavioural, cognitive, physical and social mediators. All mediators were significantly associated with less caregiver burden. Physical function had the strongest association with carer burden (0.20, 95%CI = 0.11 to 0.30), followed by behavioural symptoms (0.19, CI = 0.08 to 0.30). Interpretation: Interventions that can improve physical function and reduce behavioural symptoms of people with dementia can reduce caregiver burden. Funding Statement: National Institute of Health Research (NIHR) Health Technology Assessment Programme, NIHR Collaboration for Leadership in Applied Health Research and Care Oxford at Oxford Health NHS Foundation Trust, and the NIHR Oxford Musculoskeletal Biomedical Research Unit. Declaration of Interests: All authors declare no conflicts of interests. Ethics Approval Statement: The national ethics review committees (REC No 11/SW/0232) and research governance departments in each organisation approved the original DAPA trial.

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