AbstractBackgroundThe effectiveness of exercise interventions to improve activities of daily living function in people with dementia is inconclusive. This study aimed to assess the long-term cost-effectiveness of the PrAISED intervention from a National Health Service (NHS) perspective.MethodThis novel robust economic analysis used a Markov model to evaluate the incremental cost-effectiveness ratio (ICER) over a lifetime horizon of 15 years for a cohort of patients. Sensitivity analyses were conducted to investigate the uncertainty and robustness of high-impacting parameters and results.ResultsThis study included 365 adults, aged 65 years and above with 183 and 182 randomised to the PrAISED and standard care groups respectively. The PrAISED intervention had mean per-patient cost of £60,465 for the PrAISED arm and £54,604 for standard care. The Praised intervention gained an incremental QALYs of 0.05 resulting in an ICER of £129,614 per QALY. The sensitivity analysis of the intervention cost varied the ICER value between £68,173 and £191,054/QALY. To achieve the recommended NICE willingness to pay threshold value of less than £30,000/QALYs would require the intervention cost to be reduced from £1,236 (current cost) to £263 to break even and be cost-effective. The sensitivity analyses revealed that there was a 40% probability of standard care dominating the PrAISED treatment.ConclusionsAlthough the PrAISED intervention was a low-cost intervention, it did not produce a cost-effective intervention in this analysis. The flexibility of the PrAISED program to adapt to government policy during the COVID-19 pandemic was positive.Trial registrationISRCTN15320670

BACKGROUND:Interventions promoting social activity may reduce behavioural psychological symptoms and improve quality of life in people living with dementia. This study aimed to identify social benefits for participants living with dementia in the context of Promoting Activity, Independence and Stability in Early Dementia (PrAISED), an exercise intervention programme promoting physical activity and independence in participants living with dementia in England. METHODS:This was a multi-method realist evaluation undertaking secondary analysis of data collected during the PrAISED process evaluation, including qualitative interviews with participants with dementia, caregivers and therapists, personal notes of researchers, and video recordings of therapy sessions. The study consisted of four phases: (1) Setting operational definition of social outcomes in PrAISED; (2) Developing Context, Mechanisms, Outcome (CMO) configurations; (3) Testing and refining CMOs; and (4) Synthesising definitive CMOs into a middle range theory. RESULTS:Two CMOs were identified. (1) When therapists were able to make therapy sessions engaging and had the caregivers' support, the participants experienced therapy sessions as an opportunity to achieve goals in areas they were interested in. They also found the sessions enjoyable. This all led to the participants being highly engaged in their social interactions with the therapists. (2) When the participants realised that they were gaining benefits and progress through the PrAISED intervention, such as increased balance, this boosted their confidence in physical ability. It might also reduce caregivers' risk-aversion/gatekeeping attitude, which in turn would lead to participants' increased participation in social activities. CONCLUSION:The PrAISED intervention supported social participation in participants living with dementia. Under certain circumstances, home-based therapy interventions can be beneficial for social health (regardless of physical health gains). Given the limitations of currently available outcome measures to assess social participation, qualitative methods should be used to explore social health outcomes.

Background. The 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. Objective. To explore participant responses to PrAISED and explain the mechanisms behind a complex intervention that did not lead to expected health gains. Methods. A process evaluation using qualitative methods, comprising interviews and researcher notes Setting. Data were collected in the homes of participants or remotely by telephone or videoconferencing. Sample. Eighty-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. Results. Participants 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, therapist 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. Conclusions. Interventions 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.

Pain is common in people with dementia, and pain can exacerbate the behavioural and psychological symptoms of dementia. Effective pain management is challenging, not least in people with dementia. Impairments of cognition, communication and abstract thought can make communicating pain unreliable or impossible. It is unclear which biopsychosocial interventions for pain management are effective in people with dementia, and which interventions for behavioural and psychological symptoms of dementia are effective in people with pain. The result is that drugs, physical therapies and psychological therapies might be either underused or overused. People with dementia and pain could be helped by assessment processes that characterise an individual’s pain experience and dementia behaviours in a mechanistic manner, phenotyping. Chronic pain management has moved from a ‘one size fits all’ approach, towards personalised medicine, where interventions recommended for an individual depend upon the key mechanisms underlying their pain, and the relative values they place on benefits and adverse effects. Mechanistic phenotyping through careful personalised evaluation would define the mechanisms driving pain and dementia behaviours in an individual, enabling the formulation of a personalised intervention strategy. Central pain processing mechanisms are particularly likely to be important in people with pain and dementia, and interventions to accommodate and address these may be particularly helpful, not only to relieve pain but also the symptoms of dementia.

Abstract Objective To determine the effectiveness of an exercise and functional activity therapy intervention in adults with early dementia or mild cognitive impairment compared with usual care. Design Randomised controlled trial. Setting Participants’ homes and communities at five sites in the United Kingdom. Participants 365 adults with early dementia or mild cognitive impairment who were living at home, and family members or carers. Intervention The intervention, Promoting activity, Independence, and Stability in Early Dementia and mild cognitive impairment (PrAISED), was a specially designed, dementia specific, rehabilitation programme focusing on strength, balance, physical activity, and performance of activities of daily living, which was tailored and progressive and addressed risk and the psychological needs of people with dementia. Up to 50 therapy sessions were provided over 12 months. The control group received usual care plus a falls risk assessment. Procedures were adapted during the covid-19 pandemic. Main outcome measures The primary outcome was score on the carer (informant) reported disability assessment for dementia scale 12 months after randomisation. Secondary outcomes were self-reported activities of daily living, physical activity, quality of life, balance, functional mobility, fear of falling, frailty, cognition, mood, carer strain, service use at 12 months, and falls between months 4 and 15. Results 365 patient participants were randomised, 183 to intervention and 182 to control. The median age of participants was 80 years (range 65-95), median Montreal cognitive assessment score was 20 out of 30 (range 13-26), and 58% (n=210) were men. Intervention participants received a median of 31 therapy sessions (interquartile range 22-40) and reported completing a mean 121 minutes of PrAISED exercise each week. Primary outcome data were available for 149 intervention and 141 control participants. Scores on the disability assessment for dementia scale did not differ between groups: adjusted mean difference −1.3, 95% confidence interval −5.2 to 2.6; Cohen’s d effect size −0.06, 95% confidence interval −0.26 to 0.15; P=0.51). Upper 95% confidence intervals excluded small to moderate effects on any of the range of outcome measures. Between months 4 and 15 the intervention group experienced 79 falls and the control group 200 falls (adjusted incidence rate ratio 0.78, 95% confidence interval 0.5 to 1.3; P=0.3). Conclusion The intensive PrAISED programme of exercise and functional activity training did not improve activities of daily living, physical activity, or quality of life; reduce falls; or improve any other secondary health status outcomes, despite good uptake. Future research should consider alternative approaches to maintaining ability and wellbeing in people with dementia. Trial registration ISRCTN Registry ISRCTN15320670 .

Introduction Dementia is becoming increasingly prevalent in the UK. Older adults from black and south Asian communities have a higher risk for dementia due to an increased prevalence of dementia specific risk factors such as hypertension, diabetes, and heart disease. Deprivation has also been linked to an increased risk of dementia. Ethnic minority and lower socioeconomic groups are underrepresented in dementia research. The aim of this study was to explore factors influencing diversity in dementia and rehabilitation research within the context of the Promoting Activity, Independence, and Stability in Early Dementia (PrAISED) randomised controlled trial (RCT). Methods We conducted an exploratory sequential mixed methods study to explore disparities in socioeconomic and ethnic diversity between the PrAISED RCT population and recruitment pathways used in one study site (Nottinghamshire) and compared these with regional and national data. We aimed to collate and summarise data available on ethnicity and deprivation for recruitment/referral pathways (Nottinghamshire site) and the PrAISED cohort (all sites). Additionally, we interviewed healthcare professionals (n=2), researchers (n=2) and members of black and south Asian communities (n=4) to explore barriers to participating in research for people with dementia. Results Under 2% of the overall PrAISED RCT sample (across all sites) were from a non-white ethnic minority background and a third of participants lived in areas with the least deprivation. Referrals to memory assessment services in Nottinghamshire included people from diverse socioeconomic backgrounds, with 7.3% being from non-white ethnic minority communities. Through interviews, several barriers to healthcare, research and rehabilitation were identified. Healthcare barriers included lack of awareness of dementia, mistrust, stigma, fear, and lack of culturally appropriate services. Research barriers included recruitment routes, awareness of research, language, and recruiter beliefs. Barriers to rehabilitation research included a lack of use of culturally appropriate language, more culturally specific barriers, and lack of representation. Conclusion Participants recruited to the PrAISED RCT were mainly white and socioeconomically privileged. Data recording and access around ethnicity is still inconsistent, making it difficult to ascertain at which point services and research become inaccessible for people from underserved communities. Future research needs to work with these communities to develop innovative solutions to overcome the barriers identified in this study and to put recommendations made into practice.

Therapeutic exercise is commonly used by healthcare professionals to support people recovering from injury or illness. There is little guidance on how to personalise these standardised programmes for people living with dementia (PLWD). The Movement with Dementia resource was co-designed by PLWD, exercise instructors and healthcare professionals to address this knowledge gap. The aim of this study was to explore the feasibility and usability of implementing the Movement with Dementia shared decision-making resource to assist prescribers and deliverers of therapeutic exercise interventions for PLWD. A single site, non-blinded feasibility study was conducted with an NHS community therapy team and their patients living with dementia. Eligibility criteria were people with a diagnosis of dementia, prescribed and undertaking an exercise programme as part of their care by the therapy team, able to provide consent and participate in the shared decision-making process. Therapist participants undertook training (2-hr session) on the Movement with Dementia resource and asked to use it during prescription and delivery of exercise with the patient participants, as part of their care episode. Questionnaires recorded demographic and usability information from all participants. Between January and March 2023 we recruited 9 therapist and 6 patient participants. Four physiotherapists (100% female; mean age = 39yrs) and six patient participants (50% female; mean age = 81yrs) completed the questionnaires. Patient participants had various dementia diagnoses (n = 1 AD, n = 3 VD, n = 1 LBD, n = 1 unsure), all were white-British, and most lived with others (n = 4). None of the patient participants could recall using the resource, but 83% (n = 5) were still undergoing active care. All therapist participants were ‘likely’ or ‘very likely’ to recommend it but found the current material too ‘wordy’, both for themselves and PWLD. Whilst it reinforced knowledge and provided supportive ‘prompts’ for their approach, it was recommended for those with less experience treating PLWD. The co-designed Movement with Dementia resource was successfully implemented into a clinical setting to support therapists prescribing and delivering exercise programmes for PLWD. Further refinement is required before wider evaluation and implementation. A focus on supporting therapists with less experience treating PLWD will direct future study.

BACKGROUND:The Promoting Activity, Independence and Stability in Early Dementia (PrAISED) intervention is a programme of physical activity and exercise designed to maintain participation in activities of daily living, mobility, and quality of life for people living with dementia. During the COVID-19 pandemic first national lockdown in England, the PrAISED physiotherapists, occupational therapists, and rehabilitation support workers adapted to delivering the intervention remotely via telephone or video conferencing. OBJECTIVE:The aim of this study was to explore therapists' experience of delivering the PrAISED intervention during the COVID-19 pandemic and derive implications for clinical practice. METHODS:Qualitative semi-structured interviews were conducted with 16 therapists using purposive sampling. Thematic analysis was used to analyze the transcripts. RESULTS:Therapists reported a change in the relationship between themselves, the person with dementia and the caregiver, with an increased reliance on the caregiver and a loss of autonomy for the person living with dementia. There was concern that this would increase the burden on the caregiver. The therapists reported using creativity to adapt to different modes of delivery. They felt their sessions were mostly focused on providing social and emotional support, and that assessing, progressing, and tailoring the intervention was difficult. CONCLUSION:It is possible to deliver some elements of a physical intervention using remote delivery, but a dual modal approach including remote and face-to-face delivery would optimize treatment efficacy. Educational support would be required to enable people living with dementia and their caregivers to overcome barriers relating to digital literacy.

Background Dementia is associated with frailty leading to increased risks of falls and hospitalisations. Interventions are required to maintain functional ability, strength and balance. Design Multi-centre parallel group randomised controlled trial, with embedded process evaluation. Procedures were adapted during the COVID-19 pandemic. Participants People with mild dementia or mild cognitive impairment (MCI), living at home, and a family member or carer. Objectives To determine the effectiveness of an exercise and functional activity therapy intervention compared to usual care. Intervention A 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 measure The 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). Results 365 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. Conclusion The 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 registration ISRCTN15320670. Funding National Institute for Health and Care Research What is already known What this study tells us ### Competing Interest Statement The authors have declared no competing interest. ### Clinical Trial ISRCTN15320670 ### Clinical Protocols ### Funding Statement This study was funded by the NIHR Programme Grants for Applied Health Research, award number RP-PG-0614-20007. The views expressed are those of the authors and not necessarily those of the NIHR or the Department of Health and Social Care. ### Author Declarations I confirm all relevant ethical guidelines have been followed, and any necessary IRB and/or ethics committee approvals have been obtained. Yes The details of the IRB/oversight body that provided approval or exemption for the research described are given below: This study was approved by the Bradford-Leeds Research Ethics Committee (REC number 18/YH/0059, IRAS project identification 236099) and research governance departments in each participating organisation. I confirm that all necessary patient/participant consent has been obtained and the appropriate institutional forms have been archived, and that any patient/participant/sample identifiers included were not known to anyone (e.g., hospital staff, patients or participants themselves) outside the research group so cannot be used to identify individuals. Yes I understand that all clinical trials and any other prospective interventional studies must be registered with an ICMJE-approved registry, such as ClinicalTrials.gov. I confirm that any such study reported in the manuscript has been registered and the trial registration ID is provided (note: if posting a prospective study registered retrospectively, please provide a statement in the trial ID field explaining why the study was not registered in advance). Yes I have followed all appropriate research reporting guidelines and uploaded the relevant EQUATOR Network research reporting checklist(s) and other pertinent material as supplementary files, if applicable. Yes All data produced in the present study are available upon reasonable request to the authors

OBJECTIVES:Digital health interventions enable services to support people living with dementia and Mild Cognitive Impairment (MCI) remotely. This literature review gathers evidence on the effectiveness of digital health interventions on physical, cognitive, behavioural and psychological outcomes, and Activities of Daily Living in people living with dementia and MCI. METHODS/DESIGN:Searches, using nine databases, were run in November 2021. Two authors carried out study selection/appraisal using the Critical Appraisal Skills Programme checklist. Study characteristics were extracted through the Cochrane handbook for systematic reviews of interventions data extraction form. Data on digital health interventions were extracted through the template for intervention description and replication (TIDieR) checklist and guide. Intervention effectiveness was determined through effect sizes. Meta-analyses were performed to pool data on intervention effectiveness. RESULTS:Twenty studies were included in the review, with a diverse range of interventions, modes of delivery, activities, duration, length, frequency, and intensity. Compared to controls, the interventions produced a moderate effect on cognitive abilities (SMD = 0.36; 95% CI = -0.03 to 0.76; I2 = 61%), and a negative moderate effect on basic ADLs (SMD = -0.40; 95% CI = -0.86 to 0.05; I2 = 69%). Stepping exergames generated the largest effect sizes on physical and cognitive abilities. Supervised training produced larger effect sizes than unsupervised interventions. CONCLUSION:Supervised intervention delivery is linked to greatest benefits. A mix of remote and face-to-face delivery could maximise benefits and optimise costs. Accessibility, acceptability and sustainability of digital interventions for end-users must be pre-requisites for the development of future successful services.

To explore the longitudinal associations between pain characteristics at baseline and subsequent falls risks, at 2-year follow-up, in community-dwelling adults aged ≥ 50 years, in the Survey of Health, Ageing and Retirement in Europe (SHARE). Higher intensity of pain and number of pain sites at baseline were associated with an increased risk of subsequent falls in community-dwelling adults, in a dose–response way, independent of socio-demographic and clinical characteristics. The strength of the association between pain intensity and falls risk varied by age, being greater in middle-aged adults. The association between pain intensity and falls risk is of greater clinical significance in middle-aged adults versus older adults. To investigate the longitudinal associations between pain and falls risks in adults. Prospective cohort study on data from 40,636 community-dwelling adults ≥ 50 years assessed in Wave 5 and 6 in the Survey of Health, Ageing and Retirement in Europe (SHARE). Socio-demographic and clinical information was collected at baseline (Wave 5). At 2-year follow-up (Wave 6), falls in the previous 6 months were recorded. The longitudinal associations between pain intensity, number of pain sites and pain in specific anatomic sites, respectively, and falls risk were analysed by binary logistic regression models; odds ratios (95

Introduction: The Promoting Activity, Independence and Stability in Early Dementia (PrAISED) is delivering an exercise programme for people with dementia. The Lincolnshire partnership National Health Service (NHS) foundation Trust successfully delivered PrAISED through a video-calling platform during the Coronavirus Disease 2019 (COVID-19) pandemic. Methods: This qualitative case-study aimed to identify participants that video delivery worked for, to highlight its benefits and its challenges. Interviews were conducted between May and August 2020 with five participants with dementia and their caregivers (n = 10), as well as five therapists from the Lincolnshire partnership NHS foundation Trust. The interviews were analysed through thematic analysis. Results: Video delivery worked best when participants had a supporting caregiver and when therapists showed enthusiasm and had an established rapport with the client. Benefits included time efficiency of sessions, enhancing participants’ motivation, caregivers’ dementia awareness, and therapists’ creativity. Limitations included users’ poor IT skills and resources. Discussion: The COVID-19 pandemic required innovative ways of delivering rehabilitation. This study supports that people with dementia can use tele-rehabilitation, but success is reliant on having a caregiver and an enthusiastic and known therapist.

Exercise has multiple benefits for people living with dementia. A programme of group exercise classes for people with dementia and their family carers has been established in a University sports centre. This study aims to explore the impact of this programme on participants with dementia and their carers. A mixed-methods design including a prospective, repeated measures cohort study followed by focus groups was employed. Physiological and cognitive outcome measures were repeated at baseline and three months in a cohort of people with dementia attending a group exercise class. Focus groups on the participants’ experiences and their perceptions of the impact of the exercise class on their lives were then conducted. The results were analysed and mapped on a model, to illustrate the components that most likely promote participation. Sixteen participants (n = 8 with dementia, and n = 8 carers) were recruited, and completed both baseline and follow up assessments. Positive mean differences were found in physical activity (4.44), loneliness (1.75), mood (1.33) and cognition (1.13). Ten participants were included in the focus groups, which found that accessibility of the exercise venue, opportunities for socialisation and staff who were experienced working with people living with dementia were key to participants reporting benefits. The four key themes from the focus group data were synthesised to produce a model outlining the components that might generate a positive impact of the exercise classes and promote participation. Exercise classes for people with dementia can be delivered with success in novel environments such as University sports centres. There is some indication of improvement over a short period of time. The model derived from this study will inform strategies to promote attendance at dementia-friendly exercise classes.

Introduction The Promoting Activity, Independence and Stability in Early Dementia (PrAISED) randomised controlled trial (RCT) is evaluating a home-based, face-to-face, individually tailored, activity and exercise programme for people living with dementia. Social distancing requirements following the COVID-19 pandemic necessitated rapid changes to intervention delivery. Methods and analysis A mixed-methods process evaluation will investigate how the changes were implemented and the impact that these have on participants’ experience. An implementation study will investigate how the intervention was delivered during the pandemic. A study on the mechanisms of impact and context will investigate how these changes were experienced by the PrAISED participants, their carers and the therapists delivering the intervention. The study will commence in May 2020. Ethics and dissemination The PrAISED RCT and process evaluation have received ethical approval number 18/YH/0059. The PrAISED process evaluation will enable us to understand how distancing and isolation affected participants, their activity and exercise routines and whether the therapy programme could be continued with remote support. This will be valuable both in explaining trial results and also contribute to understanding and designing new ways of delivering home-based services and rehabilitation interventions for people with dementia and their carers. Trial registration number ISRCTN15320670; Pre-results .