"Exercise to Me, It's Freedom": Motivation, Support, and Self-Management to Keep Physically Active with Parkinson's Disease: A Qualitative Study.

The benefits of exercise have been widely explored among people with Parkinson's (PwP). Exercise can improve non-motor (fatigue, pain, sleep, etc.) and motor features (balance, muscle strength, gait speed, etc.), maintain function, as well as prevent disease progression. Although the benefits are well known, PwP continue to show difficulty adhering to physical activity and exercise. This study aims to explore motivation to exercise, support, and self-management needs among people with Parkinson's, their family members, and physiotherapists. Purposeful and maximum-variation sampling methods (age, sex, geographical setting, and disease severity) were employed. PwP and family members were recruited through physiotherapy services and local support groups. Twelve semi-structured interviews with PwP and two group interviews, one with family members (n = 4) and one with physiotherapists (n = 5), were conducted. Interview guides were informed by patient-public input and a recent systematic review. Interviews were recorded, transcribed, and analysed using thematic analysis informed by the Grounded Theory methodology. Four common themes emerged: (1) The value of an intrinsic connection with exercise, for which there are challenges. A greater connection to exercise led to long-term adherence. (2) Adapting exercise to the needs and preferences of a person is essential. Preferred exercises and environments were mixed, with differences emerging between sexes. (3) Physiotherapists' aim to only maintain physical function led to frustration. Limited self-management opportunities, stigma, and dehumanisation were discussed. (4) Non-motor symptoms, stigma, fear, and determination as well as apathy, pain, and low mood were discussed. Exercise provided physical, emotional, and social rewards. Supports are necessary; however, challenges arise when PwP's motivations are mismatched to family members' and physiotherapists' goals. Co-created goals, tailored to their preferences, and exercise plans with supported self-management are recommended.

Comparison of surgical or non-surgical management for non-acute anterior cruciate ligament injury: the ACL SNNAP RCT.

Background: Anterior cruciate ligament injury of the knee is common and leads to decreased activity and risk of secondary osteoarthritis of the knee. Management of patients with a non-acute anterior cruciate ligament injury can be non-surgical (rehabilitation) or surgical (reconstruction). However, insufficient evidence exists to guide treatment. Objective(s): To determine in patients with non-acute anterior cruciate ligament injury and symptoms of instability whether a strategy of surgical management (reconstruction) without prior rehabilitation was more clinically and cost-effective than non-surgical management (rehabilitation). Design: A pragmatic, multicentre, superiority, randomised controlled trial with two-arm parallel groups and 1:1 allocation. Due to the nature of the interventions, no blinding could be carried out. Setting: Twenty-nine NHS orthopaedic units in the United Kingdom. Participants: Participants with a symptomatic (instability) non-acute anterior cruciate ligament-injured knee. Interventions: Patients in the surgical management arm underwent surgical anterior cruciate ligament reconstruction as soon as possible and without any further rehabilitation. Patients in the rehabilitation arm attended physiotherapy sessions and only were listed for reconstructive surgery on continued instability following rehabilitation. Surgery following initial rehabilitation was an expected outcome for many patients and within protocol. Main outcome measures: The primary outcome was the Knee Injury and Osteoarthritis Outcome Score 4 at 18 months post randomisation. Secondary outcomes included return to sport/activity, intervention-related complications, patient satisfaction, expectations of activity, generic health quality of life, knee-specific quality of life and resource usage. Results: Three hundred and sixteen participants were recruited between February 2017 and April 2020 with 156 randomised to surgical management and 160 to rehabilitation. Forty-one per cent (n = 65) of those allocated to rehabilitation underwent subsequent reconstruction within 18 months with 38% (n = 61) completing rehabilitation and not undergoing surgery. Seventy-two per cent (n = 113) of those allocated to surgery underwent reconstruction within 18 months. Follow-up at the primary outcome time point was 78% (n = 248; surgical, n = 128; rehabilitation, n = 120). Both groups improved over time. Adjusted mean Knee Injury and Osteoarthritis Outcome Score 4 scores at 18 months had increased to 73.0 in the surgical arm and to 64.6 in the rehabilitation arm. The adjusted mean difference was 7.9 (95% confidence interval 2.5 to 13.2; p = 0.005) in favour of surgical management. The per-protocol analyses supported the intention-to-treat results, with all treatment effects favouring surgical management at a level reaching statistical significance. There was a significant difference in Tegner Activity Score at 18 months. Sixty-eight per cent (n = 65) of surgery patients did not reach their expected activity level compared to 73% (n = 63) in the rehabilitation arm. There were no differences between groups in surgical complications (n = 1 surgery, n = 2 rehab) or clinical events (n = 11 surgery, n = 12 rehab). Of surgery patients, 82.9% were satisfied compared to 68.1% of rehabilitation patients. Health economic analysis found that surgical management led to improved health-related quality of life compared to non-surgical management (0.052 quality-adjusted life-years, p = 0.177), but with higher NHS healthcare costs (£1107, p < 0.001). The incremental cost-effectiveness ratio for the surgical management programme versus rehabilitation was £19,346 per quality-adjusted life-year gained. Using £20,000-30,000 per quality-adjusted life-year thresholds, surgical management is cost-effective in the UK setting with a probability of being the most cost-effective option at 51% and 72%, respectively. Limitations: Not all surgical patients underwent reconstruction, but this did not affect trial interpretation. The adherence to physiotherapy was patchy, but the trial was designed as pragmatic. Conclusions: Surgical management (reconstruction) for non-acute anterior cruciate ligament-injured patients was superior to non-surgical management (rehabilitation). Although physiotherapy can still provide benefit, later-presenting non-acute anterior cruciate ligament-injured patients benefit more from surgical reconstruction without delaying for a prior period of rehabilitation. Future work: Confirmatory studies and those to explore the influence of fidelity and compliance will be useful. Trial registration: This trial is registered as Current Controlled Trials ISRCTN10110685; ClinicalTrials.gov Identifier: NCT02980367. Funding: This award was funded by the National Institute of Health and Care Research (NIHR) Health Technology Assessment programme (NIHR award ref: 14/140/63) and is published in full in Health Technology Assessment; Vol. 28, No. 27. See the NIHR Funding and Awards website for further award information.

The study aimed to find out whether it is better to offer surgical reconstruction or rehabilitation first to patients with a more long-standing injury of their anterior cruciate ligament in their knee. This injury causes physical giving way of the knee and/or sensations of it being wobbly (instability). The instability can affect daily activities, work, sport and can lead to arthritis. There are two main treatment options for this problem: non-surgical rehabilitation (prescribed exercises and advice from physiotherapists) or an operation by a surgeon to replace the damaged ligament (anterior cruciate ligament reconstruction). Although studies have highlighted the best option for a recently injured knee, the best management was not known for patients with a long-standing injury, perhaps occurring several months previously. Because the surgery is expensive to the NHS (around £100 million per year), it was also important to look at the costs involved. We carried out a study recruiting 316 non-acute anterior cruciate ligament-injured patients from 29 different hospitals and allocated each patient to either surgery or rehabilitation as their treatment option. We measured how well they did with special function and activity scores, patient satisfaction and costs of treatment. Patients in both groups improved substantially. It was expected that some patients in the rehabilitation group would want surgery if non-surgical management was unsuccessful. Forty-one per cent of patients who initially underwent rehabilitation subsequently elected to have reconstructive surgery. Overall, the patients allocated to the surgical reconstruction group had better results in terms of knee function and stability, activity level and satisfaction with treatment than patients allocated to the non-operative rehabilitation group. There were few problems or complications with either treatment option. Although the surgery was a more expensive treatment option, it was found to be cost-effective in the UK setting. The evidence can be discussed in shared decision-making with anterior cruciate ligament-injured patients. Both strategies of management led to improvement. Although a rehabilitation strategy can be beneficial, especially for recently injured patients, it is advised that later-presenting non-acute and more long-standing anterior cruciate ligament-injured patients undergo surgical reconstruction without necessarily delaying for a period of rehabilitation.

Effectiveness of supervised versus self-directed rehabilitation for adults aged 50 years and over with ankle fractures: protocol for the AFTER trial.

Aims: Ankle fractures are common, mainly affecting adults aged 50 years and over. To aid recovery, some patients are referred to physiotherapy, but referral patterns vary, likely due to uncertainty about the effectiveness of this supervised rehabilitation approach. To inform clinical practice, this study will evaluate the effectiveness of supervised versus self-directed rehabilitation in improving ankle function for older adults with ankle fractures. Methods: This will be a multicentre, parallel-group, individually randomized controlled superiority trial. We aim to recruit 344 participants aged 50 years and older with an ankle fracture treated surgically or non-surgically from at least 20 NHS hospitals. Participants will be randomized 1:1 using a web-based service to supervised rehabilitation (four to six one-to-one physiotherapy sessions of tailored advice and prescribed home exercise over three months), or self-directed rehabilitation (provision of advice and exercise materials that participants will use to manage their recovery independently). The primary outcome is participant-reported ankle-related symptoms and function six months after randomization, measured by the Olerud and Molander Ankle Score. Secondary outcomes at two, four, and six months measure health-related quality of life, pain, physical function, self-efficacy, exercise adherence, complications, and resource use. Due to the nature of the interventions, participants and intervention providers will be unblinded to treatment allocation. Conclusion: This study will assess whether supervised rehabilitation is more effective than self-directed rehabilitation for adults aged 50 years and older after ankle fracture. The results will provide evidence to guide clinical practice. At the time of submission, the trial is currently completing recruitment, and follow-up will be completed in 2024.

Patients' perspectives on planned interventions tested in the Otago MASTER feasibility trial: an implementation-based process evaluation study.

BACKGROUND: Patients are key stakeholders of clinical research, and their perspectives are relevant for researchers when planning and conducting clinical trials. Numerous aspects of trial process can influence participants' experiences. Their experiences within a trial can impact retention rates. Poor treatment adherence may bias treatment effect estimates. One way to improve recruitment and adherence is to design trials that are aligned with patients' needs and preferences. This study reports a process evaluation of the Otago MASTER feasibility trial. OBJECTIVES: Our aims were to investigate the patients' perceptions of the trial interventions through individual interviews. METHODS: Twenty-five participants were recruited for the feasibility trial and were allocated to two groups: tailored or standardised exercise. Sixteen participants agreed to take part in individual semi-structured interviews. Interviews were transcribed verbatim, and all interviews were analysed thematically using an iterative approach. RESULTS: Our key findings suggest participants: (1) took part in the study to access healthcare services and contribute to research; (2) valued interventions received; (3) reported certain barriers and facilitators to participate in the trial; and (4) highlighted areas for improvement when designing the full trial. CONCLUSION: Participants volunteered to access healthcare and to contribute to research. Participants valued the personalised care, perceived that their engagement within the trial improved their self-management and self-efficacy behaviour, valued the time spent with clinicians, and the empathetic environment and education received. Facilitators and barriers will require careful consideration in the future as the barriers may impact reliability and validity of future trial results.

Behavioural change for Parkinson's Disease: A randomised controlled feasibility study to promote physical activity and exercise adherence among people with Parkinson's: study protocol.

Background: Parkinson's is a common progressive neurological condition characterized by motor and non-motor deficits. Physical activity and exercise can improve health, but many people with Parkinson's (PwP) have trouble reaching the recommended dosage. Our recent literature review found improvements in exercise adherence with behavioural change interventions, but it remains unclear which are most effective. Further qualitative research and patient and public involvement has informed a novel behavioural change intervention to be tested alongside an existing exercise program. Objective: To examine the feasibility of behavioural change techniques delivered alongside an exercise programme to improve physical activity, function, and self-efficacy in PwP (and study procedures) to inform a future pilot RCT trial. Methods: A parallel-arm single blinded randomised feasibility study. Twenty participants with Parkinson's (Hoehn and Yahr stage 1-3) will be recruited from a physiotherapy primary-care waiting list. Following written consent, and baseline assessment, the participants will be randomly allocated to the intervention (n=10) or the control group (n=10). Both groups will receive usual care, which includes a weekly program of a multidisciplinary education, a supervised exercise class and a prescribed home exercise program. The intervention group will receive additional behavioural change techniques, targeting behaviour regulation, belief about capabilities and social influences. Class and home exercise adherence, behavioural component uptake and adherence, and negative events will be recorded. Outcomes will include enrolment and maintenance rates, physical function, falls, physical activity, and exercise self-efficacy measured pre- and post- the 12-week program (in-person). Surveys will be used to compare experiences and satisfaction between groups. Exit interviews will be completed with the intervention group only, exploring their experience of the behavioural change techniques. Discussion: The results will help inform a future pilot RCT, based on the intervention acceptability, consent rate, maintenance, and protocol integrity. Trial Registration: ClincialTrials.gov NCT06192628.

Developing an international consensus Reporting guideline for intervention Fidelity in Non-Drug, non-surgical trials: The ReFiND protocol.

BACKGROUND: Inadequate reporting of fidelity to interventions in trials limits the transparency and interpretation of trial findings. Despite this, most trials of non-drug, non-surgical interventions lack comprehensive reporting of fidelity. If fidelity is poorly reported, it is unclear which intervention components were tested or implemented within the trial, which also hinders research reproducibility. This protocol describes the development process of a reporting guideline for fidelity of non-drug, non-surgical interventions (ReFiND) in the context of trials. METHODS: The ReFiND guideline will be developed in six stages. Stage one: a guideline development group has been formed to oversee the guideline methodology. Stage two: a scoping review will be conducted to identify and summarize existing guidance documents on the fidelity of non-drug, non-surgical interventions. Stage three: a Delphi study will be conducted to reach consensus on reporting items. Stage four: a consensus meeting will be held to consolidate the reporting items and discuss the wording and structure of the guideline. Stage five: a guidance statement, an elaboration and explanation document, and a reporting checklist will be developed. Stage six: different strategies will be used to disseminate and implement the ReFiND guideline. DISCUSSION: The ReFiND guideline will provide a set of items developed through international consensus to improve the reporting of intervention fidelity in trials of non-drug, non-surgical interventions. This reporting guideline will enhance transparency and reproducibility in future non-drug, non-surgical intervention research.

How can we improve Comprehensive Geriatric Assessment for older people living with frailty in primary care and community settings? A qualitative study.

OBJECTIVE: With advancing age comes the increasing prevalence of frailty and increased risk of adverse outcomes (eg, hospitalisation). Evidence for comprehensive geriatric assessment (CGA), a multidimensional holistic model of care, is mixed in community settings. Uncertainties remain, such as the key components of CGA, who delivers it, and the use of technology. This study aimed to understand the perspectives, beliefs and experiences, of both older people and health professionals, to improve the current CGA and explore factors that may impact on CGA delivery in community settings. DESIGN: A qualitative interview study was conducted with older people and healthcare professionals (HCPs) identified using a maximum variation strategy. Data were analysed using an abductive analysis approach. The non-adoption, abandonment, scale-up, spread and sustainability framework and the theoretical framework of acceptability guided the categorisation of the codes and identified categories were mapped to the two frameworks. SETTING: England, UK. RESULTS: 27 people were interviewed, constituting 14 older people and 13 HCPs. We identified limitations in the current CGA: a lack of information sharing between different HCPs who deliver CGA; poor communication between older people and their HCPs and a lack of follow-up as part of CGA. When we discussed the potential for CGA to use technology, HCPs and older people varied in their readiness to engage with it. CONCLUSIONS: Viable solutions to address gaps in the current delivery of CGA include the provision of training and support to use digital technology and a designated comprehensive care coordinator. The next stage of this research will use these findings, existing evidence and stakeholder engagement, to develop and refine a model of community-based CGA that can be assessed for feasibility and acceptability.

A systematic review of Behaviour Change Interventions to improve exercise self-efficacy and adherence in people with Parkinson's disease using the Theoretical Domains Framework.

Physical activity and exercise can limit the development of sarcopenia in Parkinson's Disease. This review aims to evaluate the potential effects of behavioural change (BC) interventions on exercise self-efficacy and adherence in people with Parkinson's. We searched nine databases and included randomised and non-randomised studies reporting exercise self-efficacy, quality of life (QoL), physical function and/or exercise adherence. Two reviewers independently screened, data extracted, and assessed risk of bias and certainty of evidence. The interventions were mapped to the Theoretical Domains Framework. Eleven studies (n=901) were included. Four were randomised trials and risk of bias was mixed. Most interventions were multi-component, including education, behavioural techniques, and support groups. The most effective domains appear to be Behavioural regulation, Belief about Capabilities, Social influences, Reinforcement and Goals. Future research should examine multi-component BC interventions encompassing the five most effective TDF domains.

Mediators of the effects of exercise and manual therapy for people with knee and hip osteoarthritis: A secondary, exploratory analysis of the MOA trial.

Objective: To explore whether pain beliefs and functional strength mediate the treatment effect of manual therapy (MT) and exercise therapy (ET) on the Western Ontario and McMaster Osteoarthritis Index (WOMAC) composite scores and its subscales in individuals with hip and/or knee osteoarthritis in the MOA trial. Design: Secondary analysis of a randomised controlled trial that compared the incremental effects of supervised MT and ET in addition to usual care in patients with osteoarthritis of the hip or knee. 206 participants enrolled in the MOA trial were analysed. The primary outcome measure was the WOMAC composite score after 1 year. Results: Pain belief mediated the effect of MT (b: -10.7, 95 â€‹% CI: -22.3, -0.9), ET (b: -14.5 95%CI: -26.0, -4.4). Functional strength did not mediate the effect of MT, ET, or MT â€‹+ â€‹ET. Mediation sensitivity analyses suggest findings are likely to change if small confounding between those mediators and WOMAC composite score is present. Conclusions: We identified possible mediators of MT and ET. Future confirmatory studies could be designed to assess the mechanisms through which manual therapy and exercise cause improvements in pain and function scores in patients with hip or knee osteoarthritis.

Exercise treatments for lumbar spinal stenosis: A systematic review and intervention component analysis of randomised controlled trials.

OBJECTIVE: To analyse the components used in exercise interventions for people with symptoms of neurogenic claudication due to lumbar spinal stenosis and identify components associated with successful interventions. DATA SOURCES: Eligible papers published up to April 2023 from MEDLINE, EMBASE, CINAHL, PEDro, CENTRAL, Web of Science, and trial registry websites. REVIEW METHODS: Literature searches were performed by an Information Specialist. We searched for randomised trials evaluating exercise interventions for people with neurogenic claudication symptoms (the primary symptom of lumbar spinal stenosis). Two authors independently performed study selection, data extraction, and quality assessments using the Cochrane Risk of Bias tool Version 2 and the TIDieR checklist for intervention reporting. Details of intervention components were extracted, tabulated, and synthesised using an intervention component analysis approach. RESULTS: We found thirteen trials reporting 23 exercise interventions delivered to 1440 participants. These featured 60 different components. Most exercise interventions included supervision and flexion-based exercises. Balance exercises were rarely included. Exercise components featured more frequently in successful interventions included stretches, strength or trunk muscle exercises, fitness exercises, especially cycling, and psychologically informed approaches. Interpretation is limited by low study numbers and heterogeneity. No conclusions could be drawn about exercise supervision or dose. DISCUSSION: Exercise interventions for people with neurogenic claudication typically feature multiple components. Common features such as supervision, lumbar flexion, and aerobic fitness exercises and also less common features such as stretches, strengthening exercises, and psychologically informed approaches warrant consideration for inclusion when designing and optimising exercise interventions for people with lumbar spinal stenosis.

Comparison of different statistical models for the analysis of fracture events: findings from the Prevention of Falls Injury Trial (PreFIT).

BACKGROUND: Fractures are rare events and can occur because of a fall. Fracture counts are distinct from other count data in that these data are positively skewed, inflated by excess zero counts, and events can recur over time. Analytical methods used to assess fracture data and account for these characteristics are limited in the literature. METHODS: Commonly used models for count data include Poisson regression, negative binomial regression, hurdle regression, and zero-inflated regression models. In this paper, we compare four alternative statistical models to fit fracture counts using data from a large UK based clinical trial evaluating the clinical and cost-effectiveness of alternative falls prevention interventions in older people (Prevention of Falls Injury Trial; PreFIT). RESULTS: The values of Akaike information criterion and Bayesian information criterion, the goodness-of-fit statistics, were the lowest for negative binomial model. The likelihood ratio test of no dispersion in the data showed strong evidence of dispersion (chi-square = 225.68, p-value < 0.001). This indicates that the negative binomial model fits the data better compared to the Poisson regression model. We also compared the standard negative binomial regression and mixed effects negative binomial models. The LR test showed no gain in fitting the data using mixed effects negative binomial model (chi-square = 1.67, p-value = 0.098) compared to standard negative binomial model. CONCLUSIONS: The negative binomial regression model was the most appropriate and optimal fit model for fracture count analyses. TRIAL REGISTRATION: The PreFIT trial was registered as ISRCTN71002650.

Lower limb muscle strength and balance in older adults with a distal radius fracture: a systematic review.

BACKGROUND: Distal radius fractures are common fractures in older adults and associated with increased risk of future functional decline and hip fracture. Whether lower limb muscle strength and balance are impaired in this patient population is uncertain. To help inform rehabilitation requirements, this systematic review aimed to compare lower limb muscle strength and balance between older adults with a distal radius fracture with matched controls, and to synthesise lower limb muscle strength and balance outcomes in older adults with a distal radius fracture. METHODS: We searched Embase, MEDLINE, and CINAHL (1990 to 25 May 2022) for randomised and non-randomised controlled clinical trials and observational studies that measured lower limb muscle strength and/or balance using instrumented measurements or validated tests, in adults aged ≥ 50 years enrolled within one year after distal radius fracture. We appraised included observational studies using a modified Newcastle-Ottawa Scale and included randomised controlled trials using the Cochrane risk-of-bias tool. Due to the clinical and methodological heterogeneity in included studies, we synthesised results narratively in tables and text. RESULTS: Nineteen studies (10 case-control studies, five case series, and four randomised controlled trials) of variable methodological quality and including 1835 participants (96% women, mean age 55-73 years, median sample size 82) were included. Twelve included studies (63%) assessed strength using 10 different methods with knee extension strength most commonly assessed (6/12 (50%) studies). Five included case-control studies (50%) assessed lower limb strength. Cases demonstrated impaired strength during functional tests (two studies), but knee extension strength assessment findings were conflicting (three studies). Eighteen included studies (95%) assessed balance using 14 different methods. Single leg balance was most commonly assessed (6/18 (33%) studies). All case-control studies assessed balance with inconsistent findings. CONCLUSION: Compared to controls, there is some evidence that older adults with a distal radius fracture have impaired lower limb muscle strength and balance. A cautious interpretation is required due to inconsistent findings across studies and/or outcome measures. Heterogeneity in control participants' characteristics, study design, study quality, and assessment methods limited synthesis of results. Robust case-control and/or prospective observational studies are needed. REGISTRATION: International prospective register of systematic reviews (date of registration: 02 July 2020, registration identifier: CRD42020196274).

Experience of patients and physiotherapists within the AFTER pilot randomised trial of two rehabilitation interventions for people aged 50 years and over post ankle fracture: a qualitative study.

OBJECTIVES: To explore patient and staff experience of best-practice rehabilitation advice (one session of face-to-face self-management advice with up to two additional optional sessions) compared with progressive functional exercise (up to six sessions of face-to-face physiotherapy) after ankle fracture. DESIGN: The study drew on phenomenology using interviews and a focus group. SETTING: Participants were from three NHS Trusts in England, UK. PARTICIPANTS: A purposive sample of 20 patients with ankle (malleolar) fractures from the Ankle Fracture Treatment: Enhancing Rehabilitation-pilot trial (now completed) were interviewed (median 50 min) from May 2019 to January 2020. They were 6 months post injury, over 50 years of age, (median 66, 12 females) and had received surgical or non-surgical treatment (seven internal fixation surgery, seven close contact casting, six walking boot). A focus group of five physiotherapists who had provided the study interventions (2.5 hours) was undertaken. RESULTS: The findings show the acceptability of both interventions through the themes, 'being helped' (for patients) and 'developing expertise' (for staff) with subthemes of choosing and progressing. Progressive exercise added value with a perceived increase in strength, motion, ability to undertake activities and continued use of the workbook. Both staff and patients valued physiotherapy expertise demonstrated through interpersonal skills, advice, individualised exercise plans and active monitoring of progression. Best practice advice was particularly helpful in the early stages of recovery and with the use of mobility aids. CONCLUSION: Both interventions were acceptable but progressive exercise was highly valued by patients. Developing expertise through experiential learning enabled staff to facilitate progression. Adjustments to the workbook and the addition of exercises for continued recovery in the best practice advice would enhance a future study. Research during treatment provision may provide further insights into the challenges of facilitating progression of exercise. TRIAL REGISTRATION: ISRCTN16612336; AFTER-pilot trial).

Tailored exercise management (TEMPO) versus usual care for people aged 80 years or older with hip/knee osteoarthritis: study protocol for a feasibility randomised controlled trial.

BACKGROUND: Exercise is recommended for all people with osteoarthritis. However, these recommendations are based on randomised clinical trials including people with an average age between 60 and 70 years, and these findings cannot reliably be generalised to people aged 80 years or older. Rapid loss of muscle occurs after 70 years of age, and older people are more likely to also have other health conditions that contribute to difficulties with daily activities and impact on their response to exercise. To improve care for people aged 80 or older with osteoarthritis, it is thought that a tailored exercise intervention targeting both osteoarthritis and any other health conditions they have, may be needed. The aim of this study will be to test if it is possible to conduct a randomised controlled trial (RCT) for people over 80 years of age with hip/knee osteoarthritis of a tailored exercise intervention. METHODS: A multicentre, parallel, 2-group, feasibility RCT with embedded qualitative study, conducted in ≥ 3 UK NHS physiotherapy outpatient services. Participants (n ≥ 50) with clinical knee and/or hip osteoarthritis and ≥ 1 comorbidity will be recruited by screening referrals to participating NHS physiotherapy outpatient services, via screening of general practice records and via identification of eligible individuals from a cohort study run by our research group. Participants will be randomised (computer-generated: 1:1) to receive either: a 12-week education and tailored exercise intervention (TEMPO); or usual care and written information. The primary feasibility objectives are to estimate: (1) ability to screen and recruit eligible participants; (2) retention of participants, measured by the proportion of participants who provide outcome data at 14-week follow-up. Secondary quantitative objectives are to estimate: (1) participant engagement assessed by physiotherapy session attendance and home exercise adherence; (2) sample size calculation for a definitive RCT. One-to-one semi-structured interviews will explore the experiences of trial participants and physiotherapists delivering the TEMPO programme. DISCUSSION: Progression criteria will be used to determine whether a definitive trial to evaluate the clinical and cost-effectiveness of the TEMPO programme is considered feasible with or without modifications to the intervention or trial design. TRIAL REGISTRATION: ISRCTN75983430. Registered 3/12/2021. https://www.isrctn.com/ISRCTN75983430.

Clinicians' perspectives on planned interventions tested in the Otago MASTER feasibility trial: an implementation-based process evaluation study.

OBJECTIVES: This study reports a process evaluation of the Otago MASTER (MAnagement of Subacromial disorders of The shouldER) feasibility trial. This mixed-methods, process evaluation study was conducted parallel to the Otago MASTER feasibility trial. Our aims were to investigate: (1) supervised treatment fidelity of the interventions and (2) clinicians' perceptions of the trial interventions through a focus group. DESIGN: Nested process evaluation study using a mixed-methods approach. SETTING: Outpatient clinic. PARTICIPANTS: Five clinicians (two men, three women) aged 47-67 years, with clinical experience of 18-43 years and a minimum of postgraduate certificate training, were involved with the delivery of interventions within the feasibility trial. We assessed treatment fidelity for supervised exercises through audit of clinicians' records and compared those with the planned protocol. Clinicians took part in a focus group that lasted for approximately 1 hour. The focus group was transcribed verbatim and focus group discussion was analysed thematically using an iterative approach. RESULTS: The fidelity score for the tailored exercise and manual therapy intervention was 80.3% (SD: 7.7%) and for the standardised exercise intervention, 82.9% (SD: 5.9%). Clinicians' perspectives about the trial and planned intervention were summarised by one main theme 'conflict experienced between individual clinical practice and the intervention protocol', which was supported by three subthemes: (1) programme strengths and weaknesses; (2) design-related and administrative barriers; and (3) training-related barriers. CONCLUSION: This mixed-methods study assessed supervised treatment fidelity of interventions and clinicians' perceptions on planned interventions tested in the Otago MASTER feasibility trial. Overall, treatment fidelity was acceptable for both intervention arms; however, we observed low fidelity for certain domains within the tailored exercise and manual therapy intervention. Our focus group identified several barriers clinicians faced while delivering the planned interventions. Those findings are of relevance for planning the definite trial and for researchers conducting feasibility trials. TRIAL REGISTRATION NUMBER: ANZCTR: 12617001405303.

Getting Recovery Right After Neck Dissection (GRRAND-F): Mixed-methods feasibility study to design a pragmatic randomised controlled trial.

Objective: To determine the feasibility of a randomised controlled trial to estimate the effectiveness and cost-effectiveness of a rehabilitation intervention following neck dissection (ND) after head and neck cancer (HNC). Design: Two-arm, open, pragmatic, parallel, multicentre, randomised controlled feasibility trial. Setting: Two UK NHS hospitals. Participants: People who had HNC in whom a ND was part of their care. We excluded those with a life expectancy of six months or less, pre-existing, long-term neurological disease affecting the shoulder and cognitive impairment. Intervention: Usual care (standard care supplemented with a booklet on postoperative self-management) was received by all participants. The GRRAND intervention programme consisted of usual care plus up to six individual physiotherapy sessions including neck and shoulder range of motion and progressive resistance exercises, advice and education. Between sessions, participants were advised to complete a home exercise programme. Randomisation: 1:1 randomisation. Allocation was based on minimisation, stratified by hospital site and spinal accessory nerve sacrifice. It was not possible to mask treatment received. Main outcome measures: Primary: Participant recruitment, retention and fidelity to the study protocol and interventions from study participants and staff at six months post-randomisation (and 12 months for those reaching that time-point). Secondary: clinical measures of pain, function, physical performance, health-related quality of life, health utilisation and adverse events. Results: 36 participants were recruited and enrolled. The study achieved five of its six feasibility targets. These included consent - 70% of eligible participants were consented; intervention fidelity - 78% participants discharged completed the intervention sessions; contamination - none - no participants in the control arm received the GRRAND-F intervention and retention - 8% of participants were lost to follow-up. The only feasibility target that was not achieved was the recruitment target where only 36 of the planned 60 participants were recruited over 18 months. This was principally due to the COVID-19 pandemic which caused all research activity to be paused or reduced, with a subsequent reduction in. Conclusions: Based on the findings a full-trial can now be designed to better understand whether this proposed intervention is effective. Clinical Trial Registration: https://www.isrctn.com/ISRCTN1197999, identifier ISRCTN11979997.

Environmental interventions for preventing falls in older people living in the community.

BACKGROUND: Falls and fall-related injuries are common. A third of community-dwelling people aged over 65 years fall each year. Falls can have serious consequences including restricting activity or institutionalisation. This review updates the previous evidence for environmental interventions in fall prevention. OBJECTIVES: To assess the effects (benefits and harms) of environmental interventions (such as fall-hazard reduction, assistive technology, home modifications, and education) for preventing falls in older people living in the community. SEARCH METHODS: We searched CENTRAL, MEDLINE, Embase, other databases, trial registers, and reference lists of systematic reviews to January 2021. We contacted researchers in the field to identify additional studies. SELECTION CRITERIA: We included randomised controlled trials evaluating the effects of environmental interventions (such as reduction of fall hazards in the home, assistive devices) on falls in community-residing people aged 60 years and over.   DATA COLLECTION AND ANALYSIS: We used standard methodological procedures expected by Cochrane. Our primary outcome was rate of falls. MAIN RESULTS: We included 22 studies from 10 countries involving 8463 community-residing older people. Participants were on average 78 years old, and 65% were women. For fall outcomes, five studies had high risk of bias and most studies had unclear risk of bias for one or more risk of bias domains. For other outcomes (e.g. fractures), most studies were at high risk of detection bias. We downgraded the certainty of the evidence for high risk of bias, imprecision, and/or inconsistency.  Home fall-hazard reduction (14 studies, 5830 participants) These interventions aim to reduce falls by assessing fall hazards and making environmental safety adaptations (e.g. non-slip strips on steps) or behavioural strategies (e.g. avoiding clutter).  Home fall-hazard interventions probably reduce the overall rate of falls by 26% (rate ratio (RaR) 0.74, 95% confidence interval (CI) 0.61 to 0.91; 12 studies, 5293 participants; moderate-certainty evidence); based on a control group risk of 1319 falls per 1000 people a year, this is 343 (95% CI 118 to 514) fewer falls. However, these interventions were more effective in people who are selected for higher risk of falling, with a reduction of 38% (RaR 0.62, 95% CI 0.56 to 0.70; 9 studies, 1513 participants; 702 (95% CI 554 to 812) fewer falls based on a control risk of 1847 falls per 1000 people; high-certainty evidence). We found no evidence of a reduction in rate of falls when people were not selected for fall risk (RaR 1.05, 95% CI 0.96 to 1.16; 6 studies, 3780 participants; high-certainty evidence). Findings were similar for the number of people experiencing one or more falls. These interventions probably reduce the overall risk by 11% (risk ratio (RR) 0.89, 95% CI 0.82 to 0.97; 12 studies, 5253 participants; moderate-certainty evidence); based on a risk of 519 per 1000 people per year, this is 57 (95% CI 15 to 93) fewer fallers. However, for people at higher risk of falling, we found a 26% decrease in risk (RR 0.74, 95% CI 0.65 to 0.85; 9 studies, 1473 participants), but no decrease for unselected populations (RR 0.99, 95% CI 0.92 to 1.07; 6 studies, 3780 participants) (high-certainty evidence). These interventions probably make little or no important difference to health-related quality of life (HRQoL) (standardised mean difference 0.09, 95% CI -0.10 to 0.27; 5 studies, 1848 participants; moderate-certainty evidence). They may make little or no difference to the risk of fall-related fractures (RR 1.00, 95% 0.98 to 1.02; 2 studies, 1668 participants), fall-related hospitalisations (RR 0.96, 95% CI 0.87 to 1.06; 3 studies, 325 participants), or in the rate of falls requiring medical attention (RaR 0.91, 95% CI 0.58 to 1.43; 3 studies, 946 participants) (low-certainty evidence). The evidence for number of fallers requiring medical attention was unclear (2 studies, 216 participants; very low-certainty evidence). Two studies reported no adverse events. Assistive technology Vision improvement interventions may make little or no difference to the rate of falls (RaR 1.12, 95% CI 0.84 to 1.50; 3 studies, 1489 participants) or people experiencing one or more falls (RR 1.09, 95% CI 0.79 to 1.50) (low-certainty evidence). We are unsure of the evidence for fall-related fractures (2 studies, 976 participants) and falls requiring medical attention (1 study, 276 participants) because the certainty of the evidence is very low. There may be little or no difference in HRQoL (mean difference 0.40, 95% CI -1.12 to 1.92) or adverse events (falls while switching glasses; RR 1.00, 95% CI 0.98 to 1.02) (1 study, 597 participants; low-certainty evidence). Results for other assistive technology - footwear and foot devices, and self-care and assistive devices (5 studies, 651 participants) - were not pooled due to the diversity of interventions and contexts.  Education  We are uncertain whether an education intervention to reduce home fall hazards reduces the rate of falls or the number of people experiencing one or more falls (1 study; very low-certainty evidence). These interventions may make little or no difference to the risk of fall-related fractures (RR 1.02, 95% CI 0.96 to 1.08; 1 study, 110 participants; low-certainty evidence).  Home modifications We found no trials of home modifications that measured falls as an outcome for task enablement and functional independence. AUTHORS' CONCLUSIONS: We found high-certainty evidence that home fall-hazard interventions are effective in reducing the rate of falls and the number of fallers when targeted to people at higher risk of falling, such as having had a fall in the past year and recently hospitalised or needing support with daily activities. There was evidence of no effect when interventions were targeted to people not selected for risk of falling. Further research is needed to examine the impact of intervention components, the effect of awareness raising, and participant-interventionist engagement on decision-making and adherence.  Vision improvement interventions may or may not impact the rate of falls. Further research is needed to answer clinical questions such as whether people should be given advice or take additional precautions when changing eye prescriptions, or whether the intervention is more effective when targeting people at higher risk of falls. There was insufficient evidence to determine whether education interventions impact falls.

'It Makes Me Feel Old': Understanding the Experience of Recovery From Ankle Fracture at 6 Months in People Aged 50 Years and Over.

Ankle fracture is a common injury, and depending on injury severity, treatment may be a support boot, cast or surgery. Older people, particularly those with severe injuries who are asked to restrict weight bearing, struggle with early recovery. To elicit older peoples' experience of recovery 6 months after injury, we drew on a phenomenological approach using interviews. Findings revealed that getting on with life was a way of accepting what it feels like to 'be vulnerable', needing to 'be safe' while determinedly working hard to 'be myself'. Being vulnerable identified endurance of inactivity, loneliness and dependency in the non-weight bearing period of recovery, followed by a struggle to weight bear while lacking confidence and being fearful of falling and causing further damage. Being safe conveyed fragility where sensations, pain and stiffness acted as bodily reminders of injury. Lack of function and awareness of danger led to carefulness where planning or curtailing of activities ensured their safety. Being myself showed a determination to push away from a disrupted self-identify of being older or disabled while being challenged by the continuous process of learning to be more mobile. A lack of readiness for old age created a drive to age well. Despite loss of ability, participants hoped to regain their pre-injury way of living. This study challenges practice that disregards the hard work required to recover from ankle fracture. As comorbidity increases with age, failure to consider this aspect may contribute to frailty in this group of older people.