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Background: Pre- and post-operative voice therapy may improve voice and quality-of-life outcomes for patients undergoing phonosurgery to remove benign vocal fold lesions (BVFLs). However, what constitutes voice therapy in this population is poorly described, resulting in a poor evidence base, lack of clinical guidelines and unwarranted variation in management. In order to develop the evidence base, a robust, iterative process of intervention development work should precede feasibility testing and effectiveness studies. Methods & Procedures: Guidance for developing complex interventions, drawing on evidence, theory and modelling, was used to inform the development of a pre- and post-operative voice therapy intervention entitled ‘PaPOV’. Data from four sources of evidence were synthesized using a published triangulation protocol. Data from a systematic review, national survey of current practice, expert interview study, and patient and public involvement conversations were used to populate a triangulation matrix, outlining components of a PaPOV. Data were coded to reflect areas of agreement, dissonance and silence with each component of the intervention. Based on this evidence, an assessment of convergence for each intervention component could be made. Outcomes & Results: In total, 61 components of the PaPOV intervention were explored. Of these, 27 were categorized as having stability of consensus according to a priori criteria. A total of 34 failed to meet the criteria. This was more frequently due to silence (27) rather than dissonance (seven) in the data. By evidencing areas of agreement and stability of consensus across data sources, the validity of individual findings has been enhanced. Furthermore, the study has exposed specific areas of the intervention that lack consensus and require exploration through further intervention development studies. Conclusions & Implications: This systematic triangulation process has contributed to the development of a PaPOV intervention for patients with BVFLs. Exploration of specific components relating to the intervention will allow outstanding questions to be answered in preparation for feasibility testing. WHAT THIS PAPER ADDS: What is already known on the subject BVFLs cause dysphonia by preventing vocal fold closure, impacting on vibratory characteristics and increasing compensatory muscle tension. Management for these patients is variable with them being offered phonosurgery, voice therapy, pharmacological management or a combined approach. Pre- and post-operative voice therapy may improve both voice and quality-of-life outcomes. This patient group has unique complexities when considering voice therapy, including surgical preparation, wound healing and epithelial mobilization. What this paper adds to existing knowledge This study uses a robust triangulation process to synthesize current evidence and patient experiences in order to inform the development of a PaPOV. It outlines some of the key components and considerations when delivering pre- and post-operative voice therapy to adults with BVFLs. Furthermore, it serves as a methodological example for intervention development in complex interventions, highlighting key guidance and recommended processes for developing and evaluating complex interventions. What are the potential or actual clinical implications of this work? The 61 components discussed as potential ‘ingredients’ for a PaPOV enable clinicians to reflect on key considerations when planning and delivering voice therapy to adults with BVFLs. This study highlights the pitfalls both clinically and in research of failing to describe interventions adequately and the benefits of using accurate, specific and agreed terminology in clinical practice, such as that outlined in the Rehabilitation Treatment Specification System (TRSS).

Background: Management of benign vocal fold lesions (BVFLs) is variable with some receiving surgery, voice therapy or a combination of these approaches. Some evidence suggests that the best outcomes may be achieved when patients are offered pre and post-operative voice therapy in addition to phonosurgery, but what constitutes pre and post-operative voice therapy is poorly described. The pre and post-operative voice therapy (PaPOV) intervention has been developed and described according to the TiDIER checklist and Rehabilitation Treatment Specification System for voice. The PaPOV intervention is delivered by specialist speech and language therapists trained in the intervention and comprises 7 essential and 4 additional components, delivered in voice therapy sessions with patients who are having surgery on their vocal folds for removal of BVFLs. Study Design: Non-randomised, multicentre feasibility trial with embedded process evaluation Method: 40 patients from two sites who are due to undergo phonosurgery will be recruited to receive the PaPOV intervention. Measures of feasibility, including recruitment, retention, and adherence will be assessed. The feasibility of gathering clinical and cost effectiveness data will be measured pre treatment, then at 3 and 6 months post-operatively. An embedded process evaluation will be undertaken to explain feasibility findings. Discussion: This study will assess the feasibility of delivering a described voice therapy intervention protocol to patients who are undergoing surgery for removal of benign vocal fold lesions (BVFLs). Findings will be used to inform the development and implementation of a subsequent effectiveness trial, should this be feasible. TRIAL REGISTRATION This trial has been prospectively registered on ISRCTN, (date 4th January 2023), registration number 17438192 and can be viewed here: https://www.isrctn.com/ISRCTN17438192

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.

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: Combined physical and psychological programmes (CPPP) are recommended for people with disabling low back pain (LBP). Cognitive Functional Therapy (CFT) is a physiotherapist-led low intensity CPPP with positive effects in previous studies. The clinical and cost effectiveness of CFT has not previously been evaluated in a randomised controlled trial (RCT) in the United Kingdom (UK) National Health Service (NHS). Before a definitive RCT can be completed it is necessary to determine if completing such a study is possible. PURPOSE: To determine the feasibility of completing a definitive RCT, that will evaluate the clinical and cost-effectiveness of CFT in comparison to usual physiotherapy care for people with persistent LBP in the UK NHS. METHODS: A pragmatic two-arm parallel feasibility RCT comparing CFT with usual physiotherapy care for people with persistent LBP will be completed. Sixty participants will be randomly allocated to receive CFT or usual physiotherapy care. The primary outcome will be feasibility of completing a definitive RCT. Participant reported outcome measures will be recorded at baseline, three, six and twelve-month follow-up, including disability, pain intensity, quality of life and psychosocial function. Data will be analysed descriptively. A qualitative process evaluation will explore the acceptability of the research processes and interventions. DISCUSSION: The rationale and methodological design of a mixed methods feasibility RCT is presented. This study aims to inform the planning, design and completion of a future definitive RCT in the UK NHS. The results will be disseminated through peer reviewed open access journal publication.

Purpose To investigate the longitudinal associations between pain and falls risks in adults. Methods 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% confidence intervals) were calculated. All analyses were adjusted for socio-demographic and clinical factors and stratified by sex. Results Mean age was 65.8 years (standard deviation 9.3; range 50–103); 22,486 (55.3%) participants were women. At follow-up, 2805 (6.9%) participants reported fall(s) in the previous 6 months. After adjustment, participants with moderate and severe pain at baseline had an increased falls risk at follow-up of 1.35 (1.21–1.51) and 1.52 (1.31–1.75), respectively, compared to those without pain (both p p for interaction p Conclusions Moderate, severe and multisite pain were associated with an increased risk of subsequent falls in adults.

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; I 2 = 61%), and a negative moderate effect on basic ADLs (SMD = −0.40; 95% CI = −0.86 to 0.05; I 2 = 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.

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.

Background People with dementia progressively lose cognitive and functional abilities. Interventions promoting exercise and activity may slow decline. We developed a novel intervention to promote activity and independence and prevent falls in people with mild cognitive impairment (MCI) or early dementia. We successfully undertook a feasibility randomised controlled trial (RCT) to refine the intervention and research delivery. We are now delivering a multi-centred RCT to evaluate its clinical and cost-effectiveness. Methods We will recruit 368 people with MCI or early dementia (Montreal Cognitive Assessment score 13–25) and a family member or carer from memory assessment clinics, other community health or social care venues or an online register (the National Institute for Health Research Join Dementia Research). Participants will be randomised to an individually tailored activity and exercise programme delivered using motivational theory to promote adherence and continued engagement, with up to 50 supervised sessions over one year, or a brief falls prevention assessment (control). The intervention will be delivered in participants’ homes by trained physiotherapists, occupational therapists and therapy assistants. We will measure disabilities in activities of daily living, physical activity, balance, cognition, mood, quality of life, falls, carer strain and healthcare and social care use. We will use a mixed methods approach to conduct a process evaluation to assess staff training and delivery of the intervention, and to identify individual- and context-level mechanisms affecting intervention engagement and activity maintenance. We will undertake a health economic evaluation to determine if the intervention is cost-effective. Discussion We describe the protocol for a multi-centre RCT that will evaluate the clinical and cost-effectiveness of a therapy programme designed to promote activity and independence amongst people living with dementia. Trial registration ISRCTN, ISRCTN15320670. Registered on 4 September 2018.

Introduction The 'Promoting Activity, Independence and Stability in early dementia and cognitive impairment' (PrAISED 2) is a randomised controlled trial testing the effectiveness of an exercise and physical activity programme for people with mild cognitive impairment and early dementia. Parallel to the trial, our team is conducting a process evaluation, whose aims are to: 1. Determine the extent to which the programme is being delivered according to plan; 2. Gather feedback from the primary stakeholders on the quality of programme implementation. Here we present preliminary results from the PrAISED 2 process evaluation. Methods The process evaluation comprises two studies: 1. An implementation study, examining the extent to which the programme is being delivered according to plan, which investigates Fidelity (i.e. the consistency of what is implemented with the planned intervention), Adaptations (i.e. alterations made to achieve better contextual fit), Dose (i.e. how much intervention is delivered) and Reach (i.e. the extent to which agents come into contact with the intervention). 2. A study on the mechanisms of impact and context, gathering feedback on the quality of implementation thorugh qualitative interviews with participants with dementia and their carers (as dyads) and therapists delivering the intervention. Results The process evaluation is ongoing and results will be available in Autumn 2019. Conclusion Results from the PrAISED 2 process evaluation will: enable the identification of the active ingredients within the intervention and explain how they are exerting their effect; explain discrepancies between expected and observed outcomes; help to understand how context influences outcomes; provide crucial insights to aid implementation. Findings from this study will represent transferable knowledge for researchers interested in the mechanisms that affect the success of physical interventions for people with frailty.

Background Patients with lower limb fractures who are non-weight bearing are at risk of the complications of the associated immobility and disability, particularly people with frailty, but there is lack of clarity about what constitutes optimal care for such patients. A scoping literature review was conducted to explore what evidence is available for the management of this patient group. Methods MEDLINE (PubMed) CINAHL, EMBASE and the Cochrane databases of published literature and the HMIC and SIGLE sites for grey literature were searched for primary research studies and expert reports, using an iterative approach initially including the key term ‘non-weight bearing’. All study types were included. Analysis was by narrative synthesis. Results No papers were identified from a search using the key phrase ‘non-weight bearing’. With this term removed, 11 indirectly relevant articles on lower limb fractures were retrieved from the searches of the electronic databases comprising three observational studies, five non-systematic review articles, a systematic review, an opinion piece and a survey of expert opinion that had relevance to restricted weight bearing patients. The observational studies indicated depression, cognition and nutrition affect outcome and hence have indirect relevance to management. The non-systematic reviews articles emphasised the importance of maintaining strength and range of movement during immobilisation and advised an orthogeriatric model of care. Fourteen UK and 97 non-UK guidelines relevant to fragility fractures, falls and osteoporosis management were found in the grey literature, but none made specific recommendations regarding the management of any period of non-weight bearing. Discussion These findings provide a summary of the evidence base that can be used in the development of a clinical guideline for these patients but is not sufficient. We propose that, a guideline should be developed for these patients using an expert consensus process.

Background Older people who are non-weight-bearing after a lower limb fracture are at risk of poor outcomes but there are no clinical guidelines for this group of patients. Given the paucity of the research evidence base, we conducted a consensus exercise to ascertain expert opinion about the management of this group. Methods A three-round e-Delphi technique was planned to use the online JISC survey tool with a multidisciplinary panel of health professionals. Panellists were invited by email via professional organisations and UK NHS Trusts. The initial statements for this study were prepared by the authors based upon the findings of their scoping review. Consensus required >/= 70% agreement with statements. Results Only 2 survey rounds were required. Ninety panellists, representing seven clinical disciplines, reached consensus for 24 statements about general issues (osteoporosis detection and management, falls risk reduction and nutrition) and specific non-weight bearing issues (such as the need for activity to be promoted during this period). Conclusions These findings can be used in the generation of a clinical guideline for this group of patients.

1. Introduction: In partnership between Children’s Health Queensland Hospital and Health Service (CHQ) and the Queensland Department of Education’s Autism Hub (DoE), a Project ECHO-enabled community of practice has been developed to support education professionals working with students diagnosed with Autism Spectrum Disorder (ASD) across Queensland and is an Australasian first. The community of practice is known as Autism Edu-ECHO and will be delivered from a hub site in Brisbane. 2. Short description of practice change implemented: Project ECHO is a guided practice model that exponentially increases access to best-practice care and reduces health disparities, through hub-and-spoke knowledge sharing networks. Online, interactive case discussions provide a platform for collaborative learning by primary care clinicians, educators, and social care providers, to empower providers to practice at the top of their scope. 3. Aim and theory of change: By creating a knowledge network to support educators across Queensland, students diagnosed with ASD can have their learning and developmental needs better supported by fostering integrated partnership between health and education experts. 4. Targeted population and stakeholders: • Students diagnosed with ASD • Families • Educators 5. Timeline: The pilot will run for twelve months, with the view for extension. 6. Highlights: • Australasian first; • Rapid roll-out across Queensland state schools; • Customised curricula to meet the objectives of education professionals; • Engaged, sustainable partnership between CHQ and DoE’s Autism Hub. 7. Comments on sustainability and transferability: Project ECHO is a highly sustainable way to disseminate knowledge and support enhanced practice for improved health and educational outcomes for this target population. In comparison to traditional models of learning, ECHO presents a cost-effective and immediately scalable alternative that eliminates geography as a rate-limiting factor to address the needs of this vulnerable population, and the professional workforce seeking to support them. CHQ has scaled the ECHO model since 2016 to address seven vulnerable populations or health priorities. The Autism Edu-ECHO demonstrates transferability of the model and how strategic inter-agency partnerships can co-fund scalable, sustainable solutions to address unmet needs. 8. Conclusions: Autism Edu-ECHO seeks to demonstrate positive improvement across: • Increased school attendance rates; • Reduced exclusion rates (suspension, expulsion); • Increased staff job satisfaction, knowledge and confidence; • Increased parent/carer satisfaction; • Increased student satisfaction; and • Increased education outcomes for students. 9. Discussions: Autism Edu-ECHO’s benefits to children, young people and education professionals cover a myriad of metrics linked to education outcomes. By facilitating a community of practice made up of health and education professionals it is anticipated that more collaborative, practical and customised interventions can be designed and implemented to support approximately 20,000 students with ASD statewide. Improving students’ health and education outcomes is expected to reduce challenges faced in adulthood, including isolation, education drop-out, unemployment and poor health and wellbeing. 10. Lessons learned: This co-designed pilot shifted culture and practice through a partnership model between government agencies. Successes relied on collaborative cross-agency leadership, joint funding and evaluation to capture the pilot’s maturity over time.

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.

IntroductionThe 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 analysisA 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 disseminationThe 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 numberISRCTN15320670; Pre-results.

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&rsquo, 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.

Physical activity is beneficial for people with dementia. We previously developed a theoretical model to explain behaviour change in physical activity in dementia (PHYT-in-dementia). This study aimed to externally validate the model. Validation occurred through the process evaluation of a programme promoting activity in people with dementia (PrAISED 2). Twenty participants with dementia and their carers were interviewed to investigate their experience of the programme. The data were analysed through content analysis. The original constructs of the model were used as initial codes and new codes were generated, if elicited from the data. The constructs were also ranked, based on their frequency in the interviews. All of the original model constructs were validated and two novel constructs created: &lsquo, personal history&rsquo, and &lsquo, information/knowledge&rsquo, Certain constructs (e.g., support) were more frequently mentioned than others (e.g., personal beliefs). We suggested modifications and integrated them into a revised model. The PHYT-in-dementia recognised that dementia has an impact on motivation to initiate and maintain behaviour change over time. The model advocates that interventions adopt a more holistic approach than traditional behaviour change strategies. The suggested revisions require further validation to accurately predict behaviour change in physical activity in people with dementia.

People with dementia progressively lose abilities and are prone to falling. Exercise- and activity-based interventions hold the prospect of increasing abilities, reducing falls, and slowing decline in cognition. Current falls prevention approaches are poorly suited to people with dementia, however, and are of uncertain effectiveness. We used multiple sources, and a co-production approach, to develop a new intervention, which we will evaluate in a feasibility randomised controlled trial (RCT), with embedded adherence, process and economic analyses. We will recruit people with mild cognitive impairment or mild dementia from memory assessment clinics, and a family member or carer. We will randomise participants between a therapy programme with high intensity supervision over 12 months, a therapy programme with moderate intensity supervision over 3 months, and brief falls assessment and advice as a control intervention. The therapy programmes will be delivered at home by mental health specialist therapists and therapy assistants. We will measure activities of daily living, falls and a battery of intermediate and distal health status outcomes, including activity, balance, cognition, mood and quality of life. The main aim is to test recruitment and retention, intervention delivery, data collection and other trial processes in advance of a planned definitive RCT. We will also study motivation and adherence, and conduct a process evaluation to help understand why results occurred using mixed methods, including a qualitative interview study and scales measuring psychological, motivation and communication variables. We will undertake an economic study, including modelling of future impact and cost to end-of-life, and a social return on investment analysis. In this study, we aim to better understand the practicalities of both intervention and research delivery, and to generate substantial new knowledge on motivation, adherence and the approach to economic analysis. This will enable us to refine a novel intervention to promote activity and safety after a diagnosis of dementia, which will be evaluated in a definitive randomised controlled trial. ClinicalTrials.gov: NCT02874300 ; ISRCTN 10550694 .

Introduction Research has established that exercise and physical activity can improve executive functioning, independence and quality of life in people with dementia. A dedicated theory explaining behaviour change in relation to physical activity in people with dementia does not exist. We aimed to develop a theoretical model which can be used to inform effective interventions to promote physical activity in people with dementia. Methods There were five phases: 1. A search of the literature to identify theories which have been used to explain behaviour change in relation to physical activity in adult populations without a diagnosis of dementia; 2. Description of the theories (and sub-theories) and their main constructs; 3. Synthesis of the constructs; 4. Adaptation of the constructs to dementia; 5. Development and explanation of a model for physical activity in people with dementia (the ‘PHYT in dementia’). Results We identified nine theories used to explain behaviour change in relation to physical activity in adult populations without a diagnosis of dementia. Through our synthesis, we identified nine umbrella constructs. We integrated three more dementia-relevant constructs and developed the ‘PHYT in dementia’. The model was explained by providing a practical example of its application. Discussion Based on a scoping review of behaviour change theories in adults without dementia and following adaptation of the constructs from these theories to dementia, we derived a new theoretical model, the ‘PHYT in dementia’, which includes both individual-level and environment-level constructs. The model needs to be tested empirically, which our research team will do in the process evaluation of the Promoting Activity, Independence and Stability in Early Dementia and Mild Cognitive Impairment (PrAISED 2) study. Results from field-testing will inform refinement of the model.

Highlights • This literature review is on adherence to exercise interventions. • It focuses on people with dementia and mild cognitive impairment (MCI) • Forty-one studies are included in the review. • Mean adherence is 70%. It does not differ between participants with dementia and MCI. • Interventions with endurance/resistance elements yield higher adherence., Adherence to physical exercise is associated with multiple benefits in people with mild cognitive impairment (MCI) and dementia. Given the gap in research, this systematic literature review aimed to determine in the context of exercise intervention studies for people with MCI and dementia: 1. How adherence is defined, monitored and recorded; 2. Adherence rates; 3. Attrition, compliance and adverse events and 4. Intervention characteristics associated with adherence. Embase, Medline, PsychInfo, SPORTDiscus, AMED, CINAHL and the International Bibliography of Social Sciences were searched in November 2018. The data were analyzed through descriptive and correlation/inferential statistics. Forty-one studies were included, 34 involving participants with dementia (n = 2149) and seven participants with MCI (n = 970). Half of the studies operationally defined adherence. Mean adherence rate was 70% [CI, 69–73%]. Adherence was significantly associated with endurance/resistance training, and interventions not including walking. The review found a lack of consistency around reporting of adherence and of key variables mediating adherence, including compliance, attrition and adverse events. Further research using more reliable measures is needed to confirm whether a correlation exists between length of interventions and adherence in participants with MCI and dementia and to identify the factors or strategies that mediate adherence in this population. Relevant implications for practice include a consideration in the development of new interventions of elements associated with higher adherence in this review, such as endurance/resistance training, and the provision of exercise in group formats.

Introduction We are conducting a randomised controlled trial (Promoting Activity, Independence and Stability in Early Dementia and Mild Cognitive Impairment - PrAISED 2) to test the effectiveness of an intervention to promote activity and independence amongst people with mild cognitive impairment and early dementia. A process evaluation is needed to determine how the intervention works. This protocol outlines the rationale, aims, objectives and methods of the process evaluation. Methods The process evaluation will use a mixed-methods design and comprise two studies: An implementation study, examining the process through which PrAISED 2 is delivered, and a study on the mechanisms of impact and context, focussing on the mediating mechanisms that contribute to study outcomes. Integration of separate analyses of quantitative and qualitative data will provide a holistic view of how the PrAISED 2 intervention works. Conclusion Results from this process evaluation will further the understanding of the factors that can impinge on the success of complex interventions. This will represent invaluable information for researchers undertaking further research around behaviour change among people with cognitive impairment and dementia.

ObjectivesThis review aimed to identify mechanisms underlying participation in falls prevention interventions, in older adults with cognitive impairment. In particular we studied the role of motivation.DesignA realist review of the literature.Data sourcesEMBASE, MEDLINE, CINAHL, the Cochrane Library, PsycINFO and PEDRO.Eligibility criteriaPublications reporting exercise-based interventions for people with cognitive impairment, including dementia, living in the community.Data extraction and synthesisA ‘rough programme theory’ (a preliminary model of how an intervention works) was developed, tested against findings from the published literature and refined. Data were collected according to elements of the programme theory and not isolated to outcomes. Motivation emerged as a key element, and was prioritised for further study.ResultsAn individual will access mechanisms to support participation when they think that exercise will be beneficial to them. Supportive mechanisms include having a ‘gate-keeper’, such as a carer or therapist, who shares responsibility for the perception of exercise as beneficial. Lack of access to support decreases adherence and participation in exercise. Motivational mechanisms were particularly relevant for older adults with mild-to-moderate dementia, where the exercise intervention was multicomponent, in a preferred setting, at the correct intensity and level of progression, correctly supported and considered, and flexibly delivered.ConclusionMotivation is a key element enabling participation in exercise-based interventions for people with cognitive impairment. Many of the mechanisms identified in this review have parallels in motivational theory. Clinically relevant recommendations were derived and will be used to further develop and test a motivationally considered exercise-based falls intervention for people with mild dementia.PROSPERO registration numberCRD42015030169.

ObjectivesRehabilitation interventions for older adults are complex as they involve a number of interacting components, have multiple outcomes of interest and are influenced by a number of contextual factors. The importance of rigorous intervention development prior to formal evaluation has been acknowledged and a number of frameworks have been developed. This review explored which frameworks have been used to guide the development of rehabilitation interventions for older adults.DesignSystematic scoping review.SettingStudies were not limited for inclusion based on setting.ParticipantsStudies were included that featured older adults (>65 years of age).InterventionsStudies were included that reported the development of a rehabilitation intervention.Primary and secondary outcome measuresData were extracted on study population, setting, type of intervention developed and frameworks used. The primary outcome of interest was the type of intervention development framework.ResultsThirty-five studies were included. There was a range of underlying medical conditions including mild cognitive impairment and dementia (n=5), cardiac (n=4), stroke (n=3), falls (n=3), hip fracture (n=2), diabetes (n=2), breast cancer (n=1), Parkinson’s disease (n=1), depression (n=1), chronic health problems (n=1), osteoarthritis (n=1), leg ulcer (n=1), neck pain (n=1) and foot problems (n=1). The intervention types being developed included multicomponent, support based, cognitive, physical activities, nursing led, falls prevention and occupational therapy led. Twelve studies (34%) did not report using a framework. Five frameworks were reported with the Medical Research Council (MRC) framework for developing and evaluating complex interventions being the most frequently cited (77%, n=17).ConclusionAt present, the MRC framework is the most popular for developing rehabilitation interventions for older adults. Many studies do not report using a framework. Further, specific guidance to assist this complex field of rehabilitation research is required.

Objective: To evaluate whether virtual reality interventions, including interactive gaming systems, are effective at improving balance in adults with impaired balance. Design: Systematic review and meta-analysis of randomized control trials. Methods: Studies were identified from electronic databases (CENTRAL, MEDLINE, EMBASE, AMED, CINAHL, PyschINFO, PyschBITE, OTseeker, Ei Compendex, and Inspec) searched to November 2011, and repeated in November 2012. Two reviewers selected studies meeting inclusion criteria and quality of included studies assessed using a Joanna Briggs Institute appraisal tool. Data was pooled and a meta-analysis completed. The systematic review was reported following guidance of the PRISMA statement. Results: A total of 251 articles were screened. Eight randomized control trials were included. These studies presented the results of 239 participants, with various aetiologies, and used a variety of virtual reality systems. The number of falls was documented in only one included study. Meta-analysis was completed on data from the Berg Balance Scale, walking speed, 30 second sit-to-stand test, and Timed Up and Go Test, and favoured standard therapy when compared with standard plus virtual reality interventions. Conclusions: There was a notable inconsistency in the outcome measures, experimental, and control interventions used within the included studies. The pooled results of the studies showed no significant difference. Therefore this review cannot support nor refute the use of virtual reality interventions, rather than conventional physiotherapy, to improve balance in adults with impaired balance.

Cognitive impairment is a risk factor for falls. Older adults with cognitive impairment (such as dementia) have an increased risk of falling compared with age-matched individuals without a cognitive impairment. To reduce falls in this population, interventions could theoretically target and train both physical and cognitive abilities. Combining and addressing cognitive components in falls rehabilitation is a novel and emerging area of healthcare.The objective of this review was to identify the effectiveness of combined cognitive and physical interventions on the risk of falls in cognitively impaired older adults.Older persons who were 65 years or older and identified as having a cognitive impairment either through diagnosis or assessment of global cognition.Multifactorial or multiple interventions where physical and cognitive elements were combined was compared against standard care or a single element intervention.Randomized controlled trials (RCTs), controlled clinical trials and experimental studies in which randomization was used.Outcomes related to falls, including falls rate, specific falls risk measures (i.e. Physiological Profile Assessment) or related clinical outcome measures (i.e. Timed Up and Go test, Tinetti and gait speed).A three-step search strategy was utilized in this review, including search of electronic databases: CENTRAL, JBISRIR, MEDLINE, EMBASE, AMED, CINAHL and PsychINFO. Initial keywords used were dementia, cognitive impairment, memory loss, exercise, rehabilitation and accidental falls. Grey literature (Google Scholar) and trials registers (Current Controlled Trials) searches were also completed.The methodological quality of included studies was assessed using Joanna Briggs Institute Meta-Analysis of Statistics Assessment and Review Instrument (JBI-MAStARI) software.Data was extracted from articles included in the review using the standardized data extraction tool from JBI-MAStARI.A quantitative meta-analysis was performed where possible. Otherwise, data synthesis was in the form of narrative review. Sub-group analysis according to level of cognitive impairment was completed where possible.Eight RCTs were included in this review; they evaluated the effectiveness of multicomponent exercise programs, including physical and cognitive activities, music-based group exercise and mind-body tai chi on falls related outcomes. Most of the studies were of good quality with an average quality score of 7.5. Four studies reported effectiveness based on the number of falls, half of which reported a significant difference between the groups, but pooling of results into meta-analysis was not possible because of differences in reporting of the outcome. Falls related outcomes that were combined in meta-analysis included balance (Berg balance scale), functional mobility (Timed Up and Go) and gait speed (m/s). There was a statistically significant improvement in balance and gait speed following the intervention; however, the studies were too heterogeneous to be included in the analysis from the functional mobility results.Overall, multicomponent interventions incorporating both physical and cognitive components demonstrated positive effects on balance, functional mobility and gait speed when compared with a control and had significantly better effect on balance and gait speed within mild cognitive impairment populations.

Balance impairment can result in falls and reduced activities of daily living and function. Virtual reality and interactive gaming systems provide a novel and potentially environmentally flexible treatment option to improve postural stability and reduce falls in balance impaired populations. There are no existing systematic reviews in this topic area.To search, critically appraise and synthesise the best available evidence on whether virtual reality interventions, including interactive gaming systems, are effective at improving balance in adults with impaired balance.Adults with impaired, altered or reduced balance identified either through reduced balance outcome measure score or increased risk or incidence of falls.Types of interventions:Any virtual reality or interactive gaming systems used within a rehabilitative setting.The primary outcome was an objective measure of balance (i.e. balance outcome measure such as Berg Balance Score) or number and/or incidence of falls. Secondary outcome measures of interest included any adverse effects experienced, an outcome measure indicating functional balance (i.e. walking speed), quality of life (through use of an objective measure i.e. EuroQOL), and number of days in hospital due to falls.Types of studies:Randomised controlled trials (RCT).A three-stage strategy searched the following electronic databases: The Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, EMBASE, AMED, CINAHL, PsycINFO, PsycBITE, OTseeker, Ei Compendex, Inspec, Current Controlled Trials, and the National Institute of Health Clinical Trials Database.The methodological quality of each included study was independently assessed using the Joanna Briggs Institute Meta Analysis of Statistics Assessment and Review Instrument (JBI-MAStARI) to systematically comment on influence of bias.Data was individually extracted from the included studies using the standardised JBI data extraction tool from JBI-MAStARI.Data was analysed using Review Manager 5 software. Results were expressed as mean difference (MD) with 95% confidence intervals for continuous outcomes. Meta-analysis was not possible due to the variation of the interventions given and small number of included trials; hence, a description of the results was given.Four studies were included in the systematic review. All the included studies used different types of virtual reality or interactive gaming interventions. Two of the included studies used the same balance outcome measure. There was a notable inconsistency of balance outcome measurement between all the included studies. No data was given regarding falls in any of the studies. A secondary outcome, the 10m walk test, was recorded in two of the studies.The four included studies had small sample sizes and poor methodological quality. Despite the presentation of statistically significant results, the clinical significance is questionable.The review can not recommend the inclusion of virtual reality or interactive gaming systems into the rehabilitation of balance impairment based on the results of the four included studies.Further investigation in this topic area is required.