Pre- and post-operative voice therapy for benign vocal fold lesions: protocol for a non-randomised, multicentre feasibility trial with embedded process evaluation.

BACKGROUND: Management of benign vocal fold lesions (BVFLs) is variable with individuals 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 (RTSS) 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: Forty 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 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 .

Cognitive Functional Therapy compared with usual physiotherapy care in people with persistent low back pain: a mixed methods feasibility randomised controlled trial in the United Kingdom National Health Service.

OBJECTIVES: To determine the feasibility of completing a definitive randomised controlled trial (RCT), evaluating the clinical and cost-effectiveness of Cognitive Functional Therapy (CFT) in comparison to usual physiotherapy care (UPC), for people with persistent low back pain (LBP). DESIGN AND SETTING: A two-arm parallel feasibility RCT completed in a United Kingdom (UK) Secondary Care National Health Service (NHS) physiotherapy service. PARTICIPANTS: Sixty adult participants who reported LBP lasting for more than three months, that was not attributable to a serious (e.g. cancer) or specific (e.g. radiculopathy) underlying cause, were invited to participate. Participants were allocated at random to receive CFT or UPC. INTERVENTIONS: Cognitive Functional Therapy and Usual Physiotherapy Care for persistent LBP. MAIN OUTCOME MEASURES: The primary outcome was the feasibility of completing a definitive RCT, defined by recruitment of at least 5 participants per month, delivery of CFT per protocol and securing relevant and acceptable outcome measures. Data concerning study processes, resources, management and participant reported outcome measures were collected at baseline, 3, 6 and 12-month follow-up. RESULTS: Sixty participants (n = 30 CFT and n = 30 UPC) were recruited with 80% (n = 48), 72% (n = 43) and 53% (n = 32) retained at 3, 6 and 12-month follow-up respectively. NHS physiotherapists were trained to competence and delivered CFT with fidelity. CFT was tolerated by participants with no adverse events. Relevant and clinically important outcome data were collected at all time points (0.4%, 3%, 1% and 0.8% of data was missing from the returned outcome measure booklets at baseline and 3, 6 and 12-month follow-up respectively). The Roland-Morris disability questionnaire was considered the most suitable primary outcome measure with a proposed sample size of 540 participants for a definitive cluster RCT. CONCLUSION: It is feasible to conduct a randomised study of CFT in comparison to UPC for NHS patients. A future study should incorporate an internal pilot to address aspects of feasibility further, including participant retention strategies. CLINICAL TRIAL REGISTRATION NUMBER: ISRCTN12965286 CONTRIBUTION OF THE PAPER.

The effect of early mobilisation (< 14 days) on pathophysiological and functional outcomes in animals with induced spinal cord injury: a systematic review with meta-analysis.

INTRODUCTION: The optimum time to mobilise (standing, walking) following spinal cord injury (SCI) is unknown but may have implications for patient outcomes. There are no high-quality experimental studies that examine this issue, with a paucity of guidance for clinicians. Pre-clinical studies lead research in this field and can contribute to knowledge and support future clinical practice. OBJECTIVE: to evaluate the effect of early compared to no mobilisation on pathophysiological and functional outcomes in animals with induced SCI. METHODS: A systematic review with meta-analysis was conducted by searching pre-clinical literature in MEDLINE (PubMed), Embase (Ovid), Web of Science, OpenGrey, and EThOS (June 2023). Studies were included of any research method giving numerical results comparing pathophysiological and functional outcomes in rats and mice mobilised within 14-days of induced SCI to those that did not mobilise. Data were synthesised using random-effects meta-analyses. The quality of the evidence was assessed using the CAMARADES checklist. The certainty of findings was reported using the GRADE approach. This study is registered on PROSPERO (CRD42023437494). RESULTS: Seventeen studies met the inclusion criteria. Outcomes found that Brain Derived Neurotrophic Factor levels were greater in those that initiated mobilisation within 14-days of SCI compared to the groups that did not. Mobilisation initiated within 14-days of SCI was also associated with statistically significant functional gains: (Basso, Beattie and Bresnahan locomotor rating score (BBB) = 2.13(0-21), CI 1.43, 2.84, Ladder Rung Walking Task = - 12.38(0-100), CI 20.01, - 4.76). Meta-analysis identified the greatest functional gains when mobilisation was initiated within 3 days of SCI (BBB = 3.00, CI 2.31-3.69, p < 0.001), or when delivered at low intensity (BBB = 2.88, CI 2.03-3.70, p < 0.001). Confidence in the findings from this review was low to moderate due to the risk of bias and mixed methodological quality. CONCLUSION: Mobilisation instigated within 14-days of injury, may be an effective way of improving functional outcomes in animal models following SCI, with delays potentially detrimental to recovery. Outcomes from this study support further research in this field to guide future clinical practice.

Understanding how therapeutic exercise prescription changes outcomes important to patients with persistent non-specific low back pain: a realist review protocol.

INTRODUCTION: Persistent low back pain (LBP) is the leading cause of disability worldwide, and therapeutic exercise is recommended as a first-line treatment in international guidelines. The effects of exercise on clinical outcomes of pain and physical function are small to moderate, despite broader impacts on cardiovascular systems, biological health, mood, and emotional well-being. Therapeutic exercise prescription is defined as exercise that is prescribed by a clinician for a health-related treatment. It is unknown how therapeutic exercise prescription creates effects on outcomes of importance. Realist reviews explore how underlying mechanisms (M) may be active in the context (C) of certain situations, settings, or populations to create an intended or unintended outcome (O). Our objective is to explore and understand the mechanisms by which therapeutic exercise prescription changes outcomes for people with persistent LBP. METHODS: We will develop initial programme theories based on preliminary data from a previous systematic review and consensus workshop. These theories will be modified with input from a steering group (experts), a stakeholder group (people with lived experience of exercise for persistent LBP and clinicians), and a scoping search of the published literature. An information specialist will design and undertake an iterative search strategy. These will be used to create CMO configurations, which will be refined and tested using the literature. The realist review will be reported following RAMESES guidance. DISCUSSION: Realist reviews are uncommon in LBP research to date, yet those offer an opportunity to contrast with traditional methods of randomised controlled trials and systematic reviews and provide additional information regarding the contexts and mechanisms that may trigger certain outcomes. This can aid our understanding of the contextual features that may influence exercise prescription, such as for whom they are most effective, in what setting, how they are implemented and why. This realist synthesis will enhance our understanding of therapeutic exercise prescription to improve adherence and engagement and ultimately will provide clinically relevant recommendations regarding exercise prescription for those with persistent LBP. SYSTEMATIC REVIEW REGISTRATION: The review has been registered with PROSPERO (CRD42017072023).

Contexts, behavioural mechanisms and outcomes to optimise therapeutic exercise prescription for persistent low back pain: a realist review.

OBJECTIVE: Therapeutic exercises are a core treatment for low back pain (LBP), but it is uncertain how rehabilitative exercise facilitates change in outcomes. Realist reviews explore how the context (C) of certain settings or populations and underlying mechanisms (M) create intended or unintended outcomes (O). Our objective was to explore and understand the behavioural mechanisms by which therapeutic exercise creates change in outcomes of adherence, engagement and clinical outcomes for patients with LBP. METHODS: This was a realist review reported following the Realist and Meta-narrative Evidence Syntheses: Evolving Standards guidance. We developed initial programme theories, modified with input from a steering group (experts, n=5), stakeholder group (patients and clinicians, n=10) and a scoping search of the published literature (n=37). Subsequently, an information specialist designed and undertook an iterative search strategy, and we refined and tested CMO configurations. RESULTS: Of 522 initial papers identified, 75 papers were included to modify and test CMO configurations. We found that the patient-clinician therapeutic consultation builds a foundation of trust and was associated with improved adherence, engagement and clinical outcomes, and that individualised exercise prescription increases motivation to adhere to exercise and thus also impacts clinical outcomes. Provision of support such as timely follow-up and supervision can further facilitate motivation and confidence to improve adherence to therapeutic exercises for LBP. CONCLUSIONS: Engagement in and adherence to therapeutic exercises for LBP, as well as clinical outcomes, may be optimised using mechanisms of trust, motivation and confidence. These CMO configurations provide a deeper understanding of ways to optimise exercise prescription for patients with LBP.

Effectiveness of the "Evidence-Based Scientific Exercise Guidelines" in Increasing Cardiorespiratory Fitness, Cardiometabolic Health, and Muscle Strength in Acute Spinal Cord Injury Rehabilitation: A Systematic Review.

Objective: To determine the effect of exercise and physical activity interventions that meet current guideline recommendations on cardiorespiratory fitness, cardiometabolic health, and muscle strength in adults in the acute stage (<1 year post onset) of spinal cord injury (SCI) rehabilitation. Data Sources: Six electronic databases (PubMed, CINAHL, SPORTDiscus, Google Scholar, National Institute Clinical Excellence, World Health Organization) were searched (January 2016-March 2022) to extend a previously published review. Study Selection: Included studies implemented exercise interventions in the acute stage of SCI rehabilitation participants which met the exercise guidelines and measured cardiorespiratory fitness, cardiometabolic health, and strength outcomes. Data Extraction: Titles and abstracts were screened against eligibility criteria and duplicates removed using EndNote X8. Full texts were independently assessed and results presented in a Preferred Reporting Items for Systematic Reviews and Meta-Analyses flowchart. Data extraction was completed on included studies by 2 reviewers (L.R. and V.B.) using a modified Cochrane Group form. Data Synthesis: Data were synthesized, appraised using the Modified Downs & Black checklist and presented in narrative and tabular format. This review was registered on PROSPERO (Register ID:CRD42021249441). Of the 1255 studies, 4 were included, featuring 108 total participants <1-year post-SCI. Functional electrical stimulation cycle ergometry reduced muscle atrophy after 3 months training and increased lean body mass after 6 months. Resistance training increased muscle peak torque, perceived muscle strength and function. Aerobic exercise interventions did not increase cardiorespiratory fitness. Conclusions: Interventions meeting the exercise guidelines did not increase cardiorespiratory fitness but were shown to improve cardiometabolic health and perceived muscle strength and function in adults in the acute stage of SCI rehabilitation. Further empirical research using standardized outcome measures are required to explore the effectiveness of aerobic exercise and strengthening interventions in acute stage of SCI rehabilitation to support the development of exercise guidelines.

The facilitators and barriers to improving functional activity and wellbeing in people with dementia: a qualitative study from the process evaluation of Promoting Activity, Independence and Stability in Early Dementia (PrAISED).

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 showed no measurable benefits in activities of daily living, physical activity or quality of life. OBJECTIVE: To explore participants' responses to PrAISED and explain why an intervention that might be expected to have produced measurable health gains did not do so. METHODS: A process evaluation using qualitative methods, comprising interviews and researcher notes. SETTING: Data were collected in participants' homes or remotely by telephone or videoconferencing. SAMPLE: A total of 88 interviews were conducted with 44 participants living with dementia (n = 32 intervention group; n = 12 control group) and 39 caregivers. A total of 69 interviews were conducted with 26 therapists. RESULTS: Participants valued the intervention as proactively addressing health issues that were of concern to them, and as a source of social contact, interaction, information and advice. Facilitators to achieving positive outcomes included perceiving progress towards desired goals, positive expectations, therapists' skills and rapport with participants, and caregiver support. Barriers included: cognitive impairment, which prevented independent engagement and carry-over 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: Self-directed interventions may not be appropriate in the context of dementia, even in the mild stages of the condition. Dementia-specific 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.

Promoting Activity, Independence, and Stability in Early Dementia and mild cognitive impairment (PrAISED): randomised controlled trial.

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.

Association between pain intensity and depressive symptoms in community-dwelling adults: longitudinal findings from the Survey of Health, Ageing and Retirement in Europe (SHARE).

PURPOSE: To investigate the longitudinal associations between pain and depressive symptoms in adults. METHODS: Prospective cohort study on data from 28,515 community-dwelling adults ≥ 50 years, free from depression at baseline (Wave 5), with follow-up in Wave 6 of the Survey of Health, Ageing and Retirement in Europe (SHARE). Significant depressive symptoms were defined by a EURO-D score ≥ 4. The longitudinal association between baseline pain intensity and significant depressive symptoms at follow-up was analysed using logistic regression models; odds ratios (ORs) and confidence intervals (CI) were calculated, adjusting for socio-demographic and clinical factors, physical inactivity, loneliness, mobility and functional impairments. RESULTS: Mean age was 65.4 years (standard deviation 9.0, range 50-99); 14,360 (50.4%) participants were women. Mean follow-up was 23.4 (standard deviation 3.4) months. At baseline, 2803 (9.8%) participants reported mild pain, 5253 (18.4%) moderate pain and 1431 (5.0%) severe pain. At follow-up, 3868 (13.6%) participants-1451 (10.3%) men and 2417 (16.8%) women-reported significant depressive symptoms. After adjustment, mild, moderate and severe baseline pain, versus no pain, were associated with an increased likelihood of significant depressive symptoms at follow-up: ORs (95% CI) were 1.20 (1.06-1.35), 1.32 (1.20-1.46) and 1.39 (1.19-1.63), respectively. These associations were more pronounced in men compared to women, and consistent in participants aged 50-64 years, those without mobility or functional impairment, and those without loneliness at baseline. CONCLUSION: Higher baseline pain intensity was longitudinally associated with a greater risk of significant depressive symptoms at 2-year follow-up, in community-dwelling adults without baseline depression.

"We Just Don't Know Where They Are": The Geographical Distribution of Exercise Classes for Older People, Including Those Living with Dementia in the East Midlands.

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.

Pre- and Postoperative Voice Therapy for Benign Vocal Fold Lesions: An International Electronic Delphi Consensus Study.

INTRODUCTION: Voice therapy management of benign vocal fold lesions (BVFLs) is variable and there are currently no clinical guidelines. Poor descriptions of voice therapy interventions lead to unwarranted variation in treatment. Triangulation of the current evidence identifies a number of potential best practice elements, but also a number of outstanding questions to be explored. The aim of this study was to refine and gain global consensus on "best practice" for a pre- and postoperative voice therapy intervention for adults with BVFLs. METHODS: An international sample of expert voice therapists (n = 42) were recruited to take part in this three-round electronic modified Delphi study. Participants were presented with statements concerning a pre- and postoperative voice therapy intervention. Statements were developed from previous research and based on the TIDieR checklist (eg, why, when, what, how?) Participants rated the extent to which they agreed or disagreed with a statement and gave comments to support their response. Consensus was defined as >75% of participants agreeing or strongly agreeing with a given statement. If consensus was not reached, participant comments were used to generate new statements and were rated in the next round. Stability of consensus between rounds was assessed. RESULTS: The 42 international experts achieved consensus on 33 statements relating to components of a best practice pre- and postoperative voice therapy intervention for patients with BVFLs. Consensus on statements ranged from 81% to 100%. These statements were explicitly mapped to the TIDieR checklist to ensure that all aspects of the intervention were considered and the questions of "why, what, how, when and individual tailoring" were addressed. CONCLUSIONS: This study has significantly enhanced our understanding of what should be in a best practice pre- and postoperative voice therapy intervention. It is important to now test these findings for acceptability and feasibility, prior to considering effectiveness research.

A Qualitative Study on the Experiences of Therapists Delivering the Promoting Activity, Independence and Stability in Early Dementia (PrAISED) Intervention During the COVID-19 Pandemic.

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.

Pre- and post-operative voice therapy (PaPOV): Development of an intervention for patients with benign vocal fold lesions.

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).

Association of pain and risk of falls in community-dwelling adults: a prospective study in the Survey of Health, Ageing and Retirement in Europe (SHARE).

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 < 0.001); mild pain was not associated with falls risk. Associations between pain intensity and falls risk were greater at younger age (p for interaction < 0.001). Among participants with pain, pain in ≥ 2 sites or all over (multisite pain) was associated with an increased falls risk of 1.29 (1.14-1.45) compared to pain in one site (p < 0.001). CONCLUSIONS: Moderate, severe and multisite pain were associated with an increased risk of subsequent falls in adults.

A systematic literature review and meta-analysis on digital health interventions for people living with dementia and Mild Cognitive Impairment.

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.

Optimal management of older people with frailty non-weight bearing after lower limb fracture: a scoping review.

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.

Tele-Rehabilitation for People with Dementia during the COVID-19 Pandemic: A Case-Study from England.

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.

Protocol for the process evaluation of the Promoting Activity, Independence and Stability in Early Dementia (PrAISED), following changes required by the COVID-19 pandemic.

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.

Adherence to exercise interventions in older people with mild cognitive impairment and dementia: A systematic review and meta-analysis.

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.

The Impact of a Dementia-Friendly Exercise Class on People Living with Dementia: A Mixed-Methods Study.

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.