Study design, setting, and participants
comorbidity, cognitive impairment, dementia, pain, breathlessness, Dementia, DSM-5
DEMENTIA WITH LEWY BODIES, SECONDARY, HOLIDAY, NEUROLOGICAL DISORDER
We performed a multicentre, individually randomised (1:1), stratified, pragmatic, parallel group, randomised controlled trial.Trained researchers from five sites in England recruited participants through secondary care memory clinics (dementia diagnostic services), general practice registers, dementia support groups, and the National Institute for Health and Care Research Join Dementia Research register. The intervention was delivered in participants’ homes and in local communities.Patient participants were older than 65 years, had a diagnosis of early dementia or mild cognitive impairment, were willing to undertake an exercise programme, and had a family member or carer who knew the participant and who provided a minimum of one hour of weekly contact in person or by telephone or internet and was willing to act as informant. The diagnosis of dementia or mild cognitive impairment was based on Diagnostic and Statistical Manual DSM-5 criteria, including brain imaging, in memory clinics. The neuropsychological tests that we report were done for the purposes of the trial and were not used in diagnosis. We operationalised mild severity as a Montreal cognitive assessment score of 13-25. Participants had to be able to walk without human help; be able to communicate in English; have adequate sight, hearing, and dexterity to complete neuropsychological tests; have mental capacity to give consent, as assessed by a study researcher; and consented to participate. Carers participated in their own right, and their consent was obtained separately.Exclusion criteria included a diagnosis of dementia with Lewy bodies, a comorbidity preventing participation (such as severe breathlessness, pain, or severe neurological disorder), anticipated unavailability over the next year (eg, relocation, prolonged holiday), or life expectancy less than a year.