Promoting Activity, Independence and Stability in early dementia and mild cognitive impairment (PrAISED): A randomised controlled trial

BackgroundDementia is associated with frailty leading to increased risks of falls and hospitalisations. Interventions are required to maintain functional ability, strength and balance. DesignMulti-centre parallel group randomised controlled trial, with embedded process evaluation. Procedures were adapted during the COVID-19 pandemic. ParticipantsPeople with mild dementia or mild cognitive impairment (MCI), living at home, and a family member or carer. ObjectivesTo determine the effectiveness of an exercise and functional activity therapy intervention compared to usual care. InterventionA specially-designed dementia-specific rehabilitation programme focussing on strength, balance, physical activity and performance of ADL, which was tailored, progressive, addressed risk and the psychological and learning needs of people with dementia, providing up to 50 therapy sessions over 12 months. The control group received usual care plus a falls risk assessment. Main outcome measureThe primary outcome was the informant-reported Disability Assessment for Dementia (DAD) 12 months after randomisation. Secondary outcomes were: self-reported ADL, cognition, physical activity, quality of life, frailty, balance, functional mobility, fear of falling, mood, carer strain and service use (at 12 months) and falls (between months 4 and 15). Results365 people were randomised, 183 to intervention and 182 to control. Median age of participants was 80 years (range 65-95), median Montreal Cognitive Assessment score 20/30 (range 13-26), 58% were men. Participants received a median of 31 (IQR = 22-40) therapy sessions out of a possible maximum of 50. Participants reported completing a mean 121 minutes/week of PrAISED activity outside of supervised sessions. Primary outcome data were available for 149 (intervention) and 141 (control) participants. There was no difference in DAD scores between groups: adjusted mean difference -1.3/100, 95% Confidence Interval (-5.2 to +2.6); Cohens d effect size -0.06 (-0.26 to +0.15); p=0.5. Upper 95% confidence intervals excluded small to moderate effects on any of the range of secondary outcome measures. Between months 4 and 15 there were 79 falls in the intervention group and 200 falls in the control group, adjusted incidence rate ratio 0.78 (0.5 to 1.3); p= 0.3. ConclusionThe intensive PrAISED programme of exercise and functional activity training did not improve ADLs, physical activity, quality of life, reduce falls or improve any other secondary health status outcomes even though uptake was good. Future research should consider alternative approaches to risk reduction and ability maintenance. Trial registrationISRCTN15320670. FundingNational Institute for Health and Care Research What is already knownO_LIDementia is associated with progressive loss of functional ability, including activities of daily living and mobility, and a high risk of falls C_LIO_LIExercise programmes and rehabilitation therapies may improve ability, or slow the rate of decline, but evidence from trials and systematic reviews is equivocal C_LI What this study tells usO_LIWe developed an intensive dementia-specific exercise and functional activity rehabilitation programme, lasting 12 months, taking account of motivation, learning needs and context, in particular the need to engage carers, and evaluated it in a randomised controlled trial C_LIO_LIThe programme was very well received by participants and therapists, but had no effect on activities of daily living, physical activity, quality of life, falls, cognition or any other health status outcome C_LIO_LIWe are unlikely to be able to change rate of loss of ability in dementia through exercise or functionally orientated rehabilitation therapy. C_LIO_LIWe need different ways of defining wellbeing after a dementia diagnosis. C_LI