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BackgroundThe PRomoting Activity, Independence and Stability in Early Dementia (PrAISED) study delivered an exercise and functional activity programme to participants living with dementia. A Randomised Controlled Trial (RCT) showed no measurable benefits in activities of daily living, physical activity or quality of life.ObjectiveTo explore participants’ responses to PrAISED and explain the mechanisms behind a complex intervention that did not lead to expected health gains.MethodsA process evaluation using qualitative methods, comprising interviews and researcher notesSettingData were collected in participants’ homes or remotely by telephone or videoconferencing.SampleEighty-eight interviews were conducted with 44 participants living with dementia (n = 32 intervention group; n = 12 control group) and 39 caregivers. Sixty-nine interviews were conducted with 26 therapists.ResultsParticipants valued the intervention as proactively addressing health issues that were of concern to them, and as sources of social contact, interaction, information, and advice. Facilitators to achieving positive outcomes included perceiving progress toward desired goals, positive expectations, therapists’ skills and rapport with participants, and caregiver support. Barriers included: cognitive impairment, which prevented independent engagement and carryover between sessions; chronic physical health problems and intercurrent acute illness and injury; ‘tapering’ (progressively infrequent supervision intended to help develop habits and independent activity); and the COVID-19 pandemic.ConclusionsInterventions aiming to maintain activity, independence and stability may not be appropriate in the context of dementia even in the mild stages of the condition. Various factors affected outcomes including caregiver support, rapport with therapists, availability of supervision, motivational factors, and the limitations of remote delivery. The effects of cognitive impairment, multimorbidity and frailty overwhelmed any positive impact of the intervention. Maintenance of functional ability is valued, but in the face of inevitable progression of disease, other less tangible outcomes become important, challenging how we frame ‘health gain’ and trial outcomes.

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); Cohen’s 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 ResearchWhat is already knownDementia is associated with progressive loss of functional ability, including activities of daily living and mobility, and a high risk of fallsExercise programmes and rehabilitation therapies may improve ability, or slow the rate of decline, but evidence from trials and systematic reviews is equivocalWhat this study tells usWe 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 trialThe 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 outcomeWe are unlikely to be able to change rate of loss of ability in dementia through exercise or functionally orientated rehabilitation therapy.We need different ways of defining wellbeing after a dementia diagnosis.

Older people living with dementia are advised to exercise to remain independent. Although several exercise classes for older people take place across the UK, there is limited information about the geographical distribution of these classes. This study identified the location and explored the population characteristics of the classes in a UK region, to aid improved access to exercise. Using a geographical information system, data were collected on population characteristics, including size and age, socio-economic status, and rurality of the exercise classes in one area of the UK (East Midlands, population 5 million). The relationship between data sets was explored and a visual representation of these patterns was provided. A systematic internet search identified 520 exercise classes, evenly spread across the region and areas of socio-economic deprivation: 471 (90%) were in urban areas; 428 (80%) were in areas where less than 20% of the population was over 65 years of age; and 13 (2%) stated that they were suitable for people with dementia. People living with dementia are less likely than older people without dementia to have access to exercise classes.

To review the literature on the effectiveness of exercise interventions for people with moderate-to-severe dementia in community settings. The literature was of low quality, but suggested exercise programmes may improve physical function of people with moderate-to-severe dementia. There was no evidence that exercise programmes improve mood. More research is needed to improve the quality of the evidence to better understand the effectiveness of exercise programmes in community-dwelling older people with moderate-to-severe dementia. To conduct a systematic review of the literature to evaluate the effectiveness of exercise interventions for people with moderate-to-severe dementia in community settings. Eight electronic databases (MEDLINE, Embase, CINAHL, AMED, PsycINFO, PEDro, The Cochrane Library and BNI) were searched from inception to July 2018. Snowball searching identified additional articles not identified initially. Articles were included if they: reported randomised or quasi-randomised controlled trials comparing exercise with usual care or no treatment; and involved people over 65 with moderate-to-severe dementia in community settings. Outcome measures of interest were strength, endurance, mobility, mood and quality of life. Titles and abstracts of all studies were screened by one reviewer. Two reviewers independently screened full text articles for all eligible studies, extracted data and assessed quality and risk of bias. Eight studies with 819 participants were included. Interventions were variable in terms of content, duration and frequency. There was some evidence exercise programmes may improve physical function of people with moderate-to-severe dementia, with significant effects seen for gait speed and endurance, and a trend towards improvement in strength. There was little evidence to suggest exercise programmes improve mood. Most studies were of low quality. Exercise was associated with improvements in gait speed and endurance for older people with moderate-to-severe dementia living in the community, but the quality of evidence was low. There was no conclusive evidence regarding effect on strength or mood. Findings are limited by the quality of the available evidence.

To conduct a systematic review of the literature to evaluate the effectiveness of exercise interventions for people with moderate-to-severe dementia in community settings.Eight electronic databases (MEDLINE, Embase, CINAHL, AMED, PsycINFO, PEDro, The Cochrane Library and BNI) were searched from inception to July 2018. Snowball searching identified additional articles not identified initially. Articles were included if they: reported randomised or quasi-randomised controlled trials comparing exercise with usual care or no treatment; and involved people over 65 with moderate-to-severe dementia in community settings. Outcome measures of interest were strength, endurance, mobility, mood and quality of life. Titles and abstracts of all studies were screened by one reviewer. Two reviewers independently screened full text articles for all eligible studies, extracted data and assessed quality and risk of bias.Eight studies with 819 participants were included. Interventions were variable in terms of content, duration and frequency. There was some evidence exercise programmes may improve physical function of people with moderate-to-severe dementia, with significant effects seen for gait speed and endurance, and a trend towards improvement in strength. There was little evidence to suggest exercise programmes improve mood. Most studies were of low quality.Exercise was associated with improvements in gait speed and endurance for older people with moderate-to-severe dementia living in the community, but the quality of evidence was low. There was no conclusive evidence regarding effect on strength or mood. Findings are limited by the quality of the available evidence.

IntroductionThis protocol describes a study of a quality improvement collaborative (QIC) to support implementation and delivery of comprehensive geriatric assessment (CGA) in UK care homes. The QIC will be formed of health and social care professionals working in and with care homes and will be supported by clinical, quality improvement and research specialists. QIC participants will receive quality improvement training using the Model for Improvement. An appreciative approach to working with care homes will be encouraged through facilitated shared learning events, quality improvement coaching and assistance with project evaluation.Methods and analysisThe QIC will be delivered across a range of partnering organisations which plan, deliver and evaluate health services for care home residents in four local areas of one geographical region. A realist evaluation framework will be used to develop a programme theory informing how QICs are thought to work, for whom and in what ways when used to implement and deliver CGA in care homes. Data collection will involve participant observations of the QIC over 18 months, and interviews/focus groups with QIC participants to iteratively define, refine, test or refute the programme theory. Two researchers will analyse field notes, and interview/focus group transcripts, coding data using inductive and deductive analysis. The key findings and linked programme theory will be summarised as context-mechanism-outcome configurations describing what needs to be in place to use QICs to implement service improvements in care homes.Ethics and disseminationThe study protocol was reviewed by the National Health Service Health Research Authority (London Bromley research ethics committee reference: 205840) and the University of Nottingham (reference: LT07092016) ethics committees. Both determined that the Proactive HEAlthcare of Older People in Care Homes study was a service and quality improvement initiative. Findings will be shared nationally and internationally through conference presentations, publication in peer-reviewed journals, a graphical illustration and a dissemination video.