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Aim To provide detailed descriptions of the amount of daily physical activity (PA) performed by people with multimorbidity and investigate the association between the number of conditions, multimorbidity profiles, and PA. Methods All adults (≥18 years) from The Lolland-Falster Health Study, conducted from 2016 to 2020, who had PA measured with accelerometers and reported medical conditions were included (n=2,158). Sedentary behavior and daily PA at light, moderate, vigorous, and moderate to vigorous intensity and number of steps were measured with two accelerometers. Associations were investigated using multivariable and quantile regression analyses. Results Adults with multimorbidity spent nearly half their day sedentary, and the majority did not adhere to the World Health Organization’s (WHO) PA recommendations (two conditions: 63%, three conditions: 74%, ≥four conditions: 81%). Number of conditions was inversely associated with both PA for all intensity levels except sedentary time and daily number of steps. Participants with multimorbidity and presence of mental disorders (somatic/mental multimorbidity) had significantly lower levels of PA at all intensity levels, except sedentary time, and number of daily steps, compared to participants with multimorbidity combinations of exclusively somatic conditions. Conclusion Levels of sedentary behavior and non-adherence to PA recommendations in adults with multimorbidity were high. Inverse associations between PA and the number of conditions and mental multimorbidity profiles suggest that physical inactivity increases as multimorbidity becomes more complex.

Objective: To investigate associations between changes in leg extensor muscle power of the affected limb (ΔLEP) and changes in physical function after 12 weeks of progressive resistance training (PRT) or neuromuscular exercise (NEMEX) in patients with hip osteoarthritis. Design: Secondary analyses of a randomized controlled trial. From 160 participants enrolled in the clinical trial and cluster randomized to PRT (n ​= ​82) or NEMEX (n ​= ​78), a total of 147 (92%) had complete follow-up data and were included in the analyses. Simple linear and multivariate linear regression models estimated the crude and adjusted associations between ΔLEP normalized to body weight (watt/kg) and changes in performance-based and patient-reported measures of physical function. Results: Adjusted estimates [95% confidence intervals] showed associations between ΔLEP (watt/kg) and changes in 30-s chair stand test (β: 2.34 [1.33; 3.35], R2: 0.13), 9-step timed stair climb test (β: −1.47 [-2.09; −0.85], R2: 0.38), 40-m fast paced walking test (β: −2.20 [-3.30; −1.11], R2: 0.09), Activities of Daily Life function (β: 8.63 [3.16; 14.10], R2: 0.23) and Sport and Recreation function (β: 10.57 [2.32; 18.82], R2: 0.21) subscales from the Hip disability and Osteoarthritis Outcomes Score. Group allocation to PRT did not lead to greater regression coefficients than in NEMEX. Conclusions: Changes in leg extensor muscle power after supervised exercise are consistently associated with changes in physical function across performance-based and patient-reported measures in patients with hip osteoarthritis. These associations seem to be independent of allocation to PRT or NEMEX.

BackgroundBoth adherence rates to pulmonary rehabilitation (PR) programmes and long-term attendance in exercise training after PR remain a challenge. In our previous randomised controlled trial (RCT), effects were positively associated with a dose-response pattern, regardless of whether PR contained conventional physical exercise training (PExT) or Singing for Lung Health (SLH) as a training modality within a 10 weeks’ PR programme for chronic obstructive pulmonary disease (COPD). However, long-term status of this RCT cohort remains unknown. In this study, we investigated whether current status (=attendance in supervised exercise training or a lung choir and scoring in quality of life (QoL)) was related to initial PR completion, randomisation, or adherence.MethodsWe collected data via telephone, using a researcher-developed questionnaire on current self-reported attendance in supervised exercise training or a lung choir and on perceived benefits of the initial RCT intervention. Additionally, we used COPD-validated questionnaires (primarily: QoL (measure: St George's Respiratory Questionnaire; SGRQ).ResultsIn 2023 (i.e., mean/median 4.7 years after initial PR), surviving participants were contacted (n = 196; 73% of 270), and 160 (82% of 196) were included. Out of the included participants, 30 (19%) had not completed initial PR. Compared to the initial PR-completers, non-completers reported less current attendance in exercise training or lung choir (24% vs. 46%, p = 0.03) but SGRQ scores were comparable. Yet, those who attended exercise training or lung choir at present (n = 66/160; 41% out of 160) reported better QoL score than those with no current attendance (SGRQ; Attending: 39.9 ± 15.4; Not attending: 43.1 ± 16.7; p = 0.02). Neither having had SLH instead of PExT, nor adherence level during initial PR, was related to current attendance or to QoL scores.ConclusionThis study indicates that long-term self-reported attendance and current QoL scores are positively related to initial completion of a PR programme. Surprisingly, neither initial PR content (PExT or SLH) nor initial PR adherence was related to long-term outcomes. We suggest that future PR programmes include special attention to those who do not complete PR to support long-term attendance and QoL status.

Abstract We developed the Navigate intervention to improve survival among vulnerable lung cancer patients. In this intervention-only study, we examined feasibility in terms of recruitment, retention, attendance, adherence, and acceptability to specify adjustments to study procedures and intervention components prior to a randomized trial. The Navigate intervention includes nurse navigation, patient-reported outcomes, and physical exercise. Patients ≥ 18 years old, diagnosed with non-small cell lung cancer at any stage, with performance status ≤ 2, eligible for cancer treatment and vulnerable according to a screening instrument were included. The recruitment goal of eligible patients was 40% while the retention goal was 85%. The predefined cut-offs for sufficient attendance and adherence were ≥ 75%. Acceptability was evaluated by semi-structured interviews with participants, nurse navigators, and physiotherapists. Seventeen (56%) out of 30 screened patients were considered vulnerable and eligible for the study, 14 (82%) accepted participation, and 3 (21%) were subsequently excluded due to ineligibility, leaving 11 patients. Four patients dropped out (36%) and four patients died (36%) during follow-up and 3 (27%) were retained. All 11 patients participated in nurse sessions (mean 16, range 1–36) with 88% attendance and dialogue tools being applied in 68% of sessions. Ninety-one percent of patients responded to PROs (mean of 9 PROs, range 1–24) with 76% of the PRO questionnaires used (attendance) and 100% adherence (completion of all questions in PRO questionnaires), and 55% participated in exercise sessions with 58% attendance and 85% adherence. We identified important barriers primarily related to transportation, but overall acceptability was high. The Navigate intervention was feasible with high participation, acceptability and satisfactory adherence. Retention and exercise attendance were low, which resulted in adjustments. Trial registration: The feasibility study was initiated prior to the multicenter randomized controlled trial registered by ClinicalTrials.gov (number: NCT05053997; date 23/09/2021).

Abstract Background Prehabilitation with exercise interventions during neoadjuvant chemotherapy (NACT) is effective in reducing physical and psychosocial chemotherapy-related adverse events in patients with cancer. In preclinical studies, data also support a growth inhibitory effect of aerobic exercise on the tumour microenvironment with possible improved chemotherapy delivery but evidence in human patients is limited. The aim of the study here described is to investigate if supervised exercise with high-intensity aerobic and resistance training during NACT can improve tumour reduction in patients with breast cancer. Methods This parallel two-armed randomized controlled trial is planned to include 120 women aged ≥ 18 years with newly diagnosed breast cancer starting standard NACT at a university hospital in Denmark (a total of 90 participants needed according to the power calculation and allowing 25% (n = 30) dropout). The participants will be randomized to usual care or supervised exercise consisting of high-intensity interval training on a stationary exercise bike and machine-based progressive resistance training offered three times a week for 24 weeks during NACT, and screening-based advice to seek counselling in case of moderate-severe psychological distress (Neo-Train program). The primary outcome is tumour size change (maximum diameter of the largest lesion in millimetre) measured by magnetic resonance imaging prior to surgery. Secondary outcomes include clinical/pathological, physical and patient-reported measures such as relative dose intensity of NACT, hospital admissions, body composition, physical fitness, muscle strength, health-related quality of life, general anxiety, depression, and biological measures such as intratumoural vascularity, tumour infiltrating lymphocytes, circulating tumour DNA and blood chemistry. Outcomes will be measured at baseline (one week before to 1–2 weeks after starting NACT), during NACT (approximately week 7, 13 and 19), pre-surgery (approximately week 21–29), at surgery (approximately week 21–30) and 3 months post-surgery (approximately 33–42 weeks from baseline). Discussion This study will provide novel and important data on the potential benefits of supervised aerobic and resistance exercise concomitant to NACT on tumour response and the tumour microenvironment in patients with breast cancer, with potential importance for survival and risk of recurrence. If effective, our study may help increase focus of exercise as an active part of the neoadjuvant treatment strategy. Trial registration The trial was registered at ClinicalTrials.gov (NCT04623554) on November 10, 2020.

Abstract Background Exercise is recommended to protect physical health among people with severe mental illness and holds the potential to facilitate long-term recovery. An inclusive exercise community provides an opportunity for life skill training and social connectedness and may reduce the experience of loneliness and internalized stigmatization which together may improve personal recovery. Using a pragmatic randomized design, we aim to examine the effectiveness of a gym-based exercise intervention tailored to young adults in antipsychotic treatment (i.e., Vega Exercise Community) compared to usual care. It is hypothesized that the Vega Exercise Community will be superior to usual care for personal recovery at four months. Methods The trial will be conducted at four sites in Denmark from which 400 participants, aged 18 to 35 years, who are in current treatment with antipsychotic medications for the management of schizophrenia spectrum or affective disorders, will be recruited. Participants will be randomized (2:1) to Vega Exercise Community or usual care. Vega Exercise Community includes three weekly group-based exercise sessions hosted in commercial functional training centers delivered by certified Vega instructors. After four months, participants in Vega Exercise Community will be randomized (1:1) to minimal versus extended support with regards to sustained physical activity. Data will be collected at baseline, four, six and 12 months. The primary outcome is personal recovery assessed by Questionnaire about the Process of Recovery at four months. Behavioral symptoms, health-related quality of life, metabolic health, and program costs will be evaluated to further determine the effectiveness and cost-effectiveness of the Vega Exercise Community. Finally, the quality of life and physical and mental health of the participants’ primary relative will be evaluated. Discussion The results of this trial may have important implications for health, sustained physical activity, and recovery for individuals in treatment with antipsychotics. Given the pragmatic design, positive results may readily be implemented by mental health care professionals to promote exercise as an integrated part of treatment of severe mental illness. Trial registration Clinical Trials.gov (NCT05461885, initial registration June 29th, 2022). WHO Universal Trial Number (UTN): U1111-1271–9928.

Objectives This study explored associations between digital health literacy and physical activity levels and assessed potential interactions of long-term health conditions. Methods A cross-sectional survey was sent to 34,000 inhabitants in Region Zealand, Denmark. The survey included items on physical activity levels and three electronic Health Literacy Questionnaire (eHLQ) scales (1, 4, and 5). Associations were assessed by logistic regression and adjusted for confounders. Results A total of 19,231 participated in the survey. Positive associations were found between higher digital health literacy and being active >30 min./week at moderate-to-vigorous intensity (eHLQ 1: OR 1.24, p

Abstract ESCAPE Evaluation of a patient‐centred biopsychosocial blended collaborative care pathway for the treatment of multimorbid elderly patients. Therapeutic Area Healthcare interventions for the management of older patients with multiple morbidities. Aims Multi‐morbidity treatment is an increasing challenge for healthcare systems in ageing societies. This comprehensive cohort study with embedded randomized controlled trial tests an integrated biopsychosocial care model for multimorbid elderly patients. Hypothesis A holistic, patient‐centred pro‐active 9‐month intervention based on the blended collaborative care (BCC) approach and enhanced by information and communication technologies can improve health‐related quality of life (HRQoL) and disease outcomes as compared with usual care at 9 months. Methods Across six European countries, ESCAPE is recruiting patients with heart failure, mental distress/disorder plus ≥2 medical co‐morbidities into an observational cohort study. Within the cohort study, 300 patients will be included in a randomized controlled assessor‐blinded two‐arm parallel group interventional clinical trial (RCT). In the intervention, trained care managers (CMs) regularly support patients and informal carers in managing their multiple health problems. Supervised by a clinical specialist team, CMs remotely support patients in implementing the treatment plan—customized to the patients' individual needs and preferences—into their daily lives and liaise with patients' healthcare providers. An eHealth platform with an integrated patient registry guides the intervention and helps to empower patients and informal carers. HRQoL measured with the EQ‐5D‐5L as primary endpoint, and secondary outcomes, that is, medical and patient‐reported outcomes, healthcare costs, cost‐effectiveness, and informal carer burden, will be assessed at 9 and ≥18 months. Conclusions If proven effective, the ESCAPE BCC intervention can be implemented in routine care for older patients with multiple morbidities across the participating countries and beyond.

Objective: To describe 1) the proportion of patients with knee osteoarthritis (OA) undergoing guideline-adherent core treatments until six months after primary referral to an orthopaedic surgeon, 2) which specific treatment pathways these patients undertake and 3) the characteristics of patients choosing different treatment pathways. Design: This prospective cohort study consecutively invited patients referred to an orthopaedic surgeon due to knee OA at two Danish hospitals from October 2018 to December 2020. Before and six months after consulting the surgeon, patients answered a questionnaire reporting which treatments they had received for knee OA. The proportion receiving the combination of guideline-adherent treatments (i.e., exercise, education, and dietary weight management if needed) was determined. We evaluated the specific treatment usage before and until six months after the consultation and investigated characteristics of patients undertaking different pathways. Results: Out of 5251 eligible patients, 2574 (49%) had complete data and were included in analyses. 23% received guideline-adherent treatments, 10% had no treatment. Patients underwent 1143 unique treatment pathways, 62% including treatments not recommended/recommended against. Those who underwent guideline-adherent pathways had similar characteristics to those who did not but tended to be females, retired, had longer-lasting knee problems, have comorbidities, and higher education levels. Conclusions: Only one in four patients with knee OA received treatment adhering to clinical guidelines before and six months after consulting the surgeon. Patients used many different treatment pathways. There is a need for a structured effort to increase the use of guideline-adherent core treatments. Trial Identifiers: Registration: NCT03746184, Protocol: PMID: 34233992.

AbstractIntroduction Exercise is an effective component in rehabilitation of a range of chronic conditions. There is a growing interest in the use of exercise-based nature interacted rehabilitation (EBNIR), but an overview of current evidence is missing. The objective of this scoping review was to map existing exercise-based rehabilitation interventions conducted with incidental or intentional nature interaction focusing on its populations, types of outcomes, and theoretical rationale for people with physical and mental disabilities.Methods This scoping review identified peer-reviewed publications, registered upcoming trials and grey literature. To map all available knowledge, a comprehensive search of selected databases (MEDLINE; EMBASE; CINAHL; Cochrane; Web of Science; Pedro) from inception to October 2022. Data were synthesized in a thematic presentation guided by TIDieR, supplemented by a checklist developed for this study accounting nature incidental or intentional interaction.Results Twelve studies including 856 participants met the inclusion criteria. Eleven were completed trials and one was registered in clinicaltrials.gov to be run in 2023. A total of 856 patients were enrolled in the 12 studies (range 18–262, median 50). The included studies had great variation. The incidental or intentional interacted exercise-based interventions consisted of outdoor walks, neck exercises and surfing interventions in patients with physical or mental health conditions.Conclusions This scoping review presents an overview of limited and diverse evidence within the field of EBNIR, in patients with physical or mental health conditions. Our review provides an overview that will be helpful in the design of future EBNIR trials.

Abstract Background Previous studies have found that lumbar spinal stenosis (LSS) often co-occurs with knee or hip OA and can impact treatment response. However, it is unclear what participant characteristics may be helpful in identifying individuals with these co-occurring conditions. The aim of this cross-sectional study was to explore characteristics associated with comorbid symptoms of lumbar spinal stenosis (LSS) in people with knee or hip osteoarthritis (OA) enrolled in a primary care education and exercise program. Methods Sociodemographic, clinical characteristics, health status measures, and a self-report questionnaire on the presence of LSS symptoms was collected at baseline from the Good Life with osteoArthritis in Denmark primary care program for knee and hip OA. Cross-sectional associations between characteristics and the presence of comorbid LSS symptoms were assessed separately in participants with primary complaint of knee and hip OA, using domain-specific logistic models and a logistic model including all characteristics. Results A total of 6,541 participants with a primary complaint of knee OA and 2,595 participants with a primary complaint of hip OA were included, of which 40% and 50% reported comorbid LSS symptoms, respectively. LSS symptoms were associated with similar characteristics in knee and hip OA. Sick leave was the only sociodemographic variable consistently associated with LSS symptoms. For clinical characteristics, back pain, longer symptom duration and bilateral or comorbid knee or hip symptoms were also consistently associated. Health status measures were not consistently related to LSS symptoms. Conclusion Comorbid LSS symptoms in people with knee or hip OA undergoing a primary care treatment program of group-based education and exercise were common and associated with a similar set of characteristics. These characteristics may help to identify people with co-occurring LSS and knee or hip OA, which can be used to help guide clinical decision-making.

Abstract Background Exercise therapy is safe and effective in people with single conditions, but the feasibility in people with two or more conditions is unclear. Therefore, the aim was to evaluate the feasibility of exercise therapy and self-management in people with multimorbidity prior to a randomised, controlled trial (RCT). Methods This was a mixed-methods feasibility study performed in two general hospitals and one psychiatric hospital. 20 adult patients (8 females; mean age (SD) 67 (6.9)) with at least two long-term conditions and a score of ≥ 3 on Disease Burden Impact Scale for at least one condition (at least moderate limitations of daily activities) and of ≥ 2 for at least one other condition. Patients with unstable health conditions, at risk of serious adverse events (SAE) or with terminal conditions were excluded. Participants received 12 weeks of exercise (18 60-min group-based and 6 home-based sessions) and self-management support (6 90-min group-based sessions) supervised by physiotherapists. Pre-defined progression to RCT criteria were the primary outcomes and included recruitment rate (acceptable 20 participants in 3 months), retention through follow-up (75% retention), compliance (75% complete > 9 of exercise and > 3 self-management sessions), outcome burden (80% do not find outcomes too burdensome), improvement in quality of life (EQ-5D-5L) and function (6-min walk test; ≥ 50% experience clinically relevant improvements) and intervention-related SAEs (No SAEs). Furthermore, a purposeful sample including eleven participants and two facilitators were interviewed about their experiences of participating/facilitating. Qualitative data was analysed using thematic analysis. Results Recruitment rate (20 in 49 days), retention (85%), outcome burden (95%), and SAEs (0 related to intervention) were acceptable, while compliance (70%) and improvements (35% in quality of life, 46% in function) were not (amendment needed before proceeding to RCT). The intervention was found acceptable by both participants and physiotherapists with some barriers among participants relating to managing multiple chronic conditions while caring for others or maintaining a job. Physiotherapists expressed a need for additional training. Conclusions Exercise therapy and self-management are feasible in people with multimorbidity. The subsequent RCT, amending the intervention according to progression criteria and feedback, will determine whether the intervention is superior to usual care alone. Trial registration ClinicalTrials.gov registration: NCT04645732 Open Science Framework https://osf.io/qk6yg/

Abstract Background To our knowledge, there is no intervention which includes personalised exercise therapy and self-management support for people with multimorbidity, although these interventions may be as effective as for people with single chronic conditions. Therefore, we developed a novel intervention, including personalised exercise therapy and self-management support for people with multimorbidity. Methods We followed the Medical Research Council framework and conducted one scoping review, five systematic reviews, two registry-based studies, one qualitative interview study and a mixed-methods feasibility study. Following an iterative approach, together with feedback from people with multimorbidity and relevant stakeholders, we developed the MOBILIZE intervention. Results The intervention included 24 (60 minutes) sessions of personalised exercise therapy and 24 (30 minutes) sessions of self-management support twice a week for 12 weeks, delivered in small groups by specifically trained physiotherapists. The intervention targets physiological, psychosocial, behavioural, and contextual factors to improve health-related quality of life and physical function in people living with multimorbidity. Conclusions We developed a personalised exercise therapy and self-management support programme for people with multimorbidity. The intervention will be tested for its safety and effectiveness in a randomised controlled trial.

Objective: To explore what it means for patients with knee osteoarthritis (OA) to engage in online delivered exercise and education. Method: We combined participant observations and focus group interviews with knee OA patients who engaged in an 8-week program (12 exercise sessions and 2 education sessions) delivered online. Data underwent a three-level phenomenological-hermeneutic interpretation inspired by Ricoeur's narrative and interpretation theory. Results: We performed 17 participant observations during online group-based exercise sessions with twenty individuals with knee OA (12 females), median age 71 years (range: 48 to 81), and five focus group interviews with fifteen of the individuals. The following three themes emerged from the data analysis: 1. Exercise engagement portrays an experience of ownership of the exercise-based treatment, leading to better function and well-being and raising hope for the future 2. A good start but only halfway supported portrays perceived well-guided in performing knee OA exercise, however also some unmet support needs in the online format, and 3. Beneficial peer companionship with online constraints portrays a socially engaging peer forum that, at times, was limited by the online format. Conclusions: This phenomenological-hermeneutic study reflects that supervised online exercise and education facilitate identity mobility, potentially increasing self-efficacy to adopt weekly exercise habits in patients with knee OA. However, the program may benefit from enabling a more interactive approach between peer participants and combining the online format with physical group classes. Moreover, further individualization and focus on a gradual approach toward self-management are encouraged.

Abstract Background The prevalence of low back pain increases with age and has a profound impact on physical and psychosocial health. With increasing age comes increasing comorbidity, and this also has pronounced health consequences. Whilst exercise is beneficial for a range of health conditions, trials of exercise for low back pain management often exclude older adults. It is currently unknown whether an exercise program for older adults with low back pain, tailored for the presence of comorbidities, is acceptable for participants and primary healthcare providers (PHCPs). Therefore, this mixed-methods study will assess the feasibility of an 8-week comorbidity-adapted exercise program for older people with low back pain and comorbid conditions. Methods The 3-phased feasibility study will be performed in a primary healthcare setting. PHCPs will be trained to deliver a comorbidity-adapted exercise program for older people with low back pain and comorbidities. Healthcare-seeking adults > 65 will be screened for eligibility over telephone, with a recruitment target of 24 participants. Eligible participants will attend an initial appointment (diagnostic phase). During this initial appointment, a research assistant will collect patient demographics, self-reported outcome measurement data, and perform a physical and functional examination to determine contraindications and restrictions to an exercise program. During the development phase, PHCPs will adapt the exercise program to the individual and provide patient education. During the intervention phase, there will be two supervised exercise sessions per week, over 8 weeks (total of 16 exercise sessions). Each exercise session will be approximately 60 min in duration. A qualitative evaluation after the last exercise program session will explore the feasibility of the exercise program for participants and PHCPs. Progression criteria will determine the suitability for a fully powered randomised controlled trial. Discussion This mixed-methods feasibility study will assess an exercise program for older adults with low back pain and comorbidities. Once assessed for feasibility, the exercise program may be tested for effectiveness in a larger, fully powered randomised controlled trial. This information will add to the sparse evidence base on appropriate options for managing back pain in older adults. Trial registration Australian and New Zealand Clinical Trials Registry registration number: ACTRN12621000379819p (06/04/2021; https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?ACTRN=12621000379819p ). Trial sponsor Macquarie University, Department of Chiropractic, Faculty of Medicine, Health and Human Sciences, Macquarie University, NSW 2109, Australia.

Abstract Background One in five patients report chronic pain following total knee arthroplasty (TKA) and are considered non-improvers. Psychological interventions such as cognitive behavioral therapy (CBT), combined with exercise therapy and education may contribute to reduced pain an improved function both for patients with OA or after TKA surgery, but the evidence for the effectiveness of such interventions is scarce. This randomized controlled trial with three arms will compare the clinical effectiveness of patient education and exercise therapy combined with internet-delivered CBT (iCBT), evaluated either as a non-surgical treatment choice or in combination with TKA, in comparison to usual treatment with TKA in patients with knee OA who are considered candidates for TKA surgery. Methods The study, conducted in three orthopaedic centers in Norway will include 282 patients between ages 18 and 80, eligible for TKA. Patients will be randomized to receive the exercise therapy + iCBT, either alone or in combination with TKA, or to a control group who will undergo conventional TKA and usual care physiotherapy following surgery. The exercise therapy will include 24 one hour sessions over 12 weeks led by a physiotherapist. The iCBT program will be delivered in ten modules. The physiotherapists will receive theoretical and practical training to advise and mentor the patients during the iCBT program. The primary outcome will be change from baseline to 12 months on the pain sub-scale from the Knee Injury and Osteoarthritis Outcome Score (KOOS). Secondary outcomes include the remaining 4 sub-scales from the KOOS (symptoms, function in daily living, function in sports and recreation, and knee-related quality of life), EQ-5D-5L, the Pain Catastrophizing Scale, the 30-s sit-to-stand test, 40-m walking test and ActiGraph activity measures. A cost-utility analysis will be performed using QALYs derived from the EQ-5D-5L and registry data. Discussion This is the first randomized controlled trial to investigate the effectiveness of exercise therapy and iCBT with or without TKA, to optimize outcomes for TKA patients. Findings from this trial will contribute to evidence-based personalized treatment recommendations for a large proportion of OA patients who currently lack an effective treatment option. Trial registration Clinicaltrials.gov : NCT03771430 . Registered: Dec 11, 2018.

Abstract Background Osteoarthritis (OA) affecting the knee or hip is highly prevalent in the general population and has associated high disease burden. Early identification of modifiable risk factors that prevent, limit, or resolve disease symptoms is critical. Foot pain may represent a potentially modifiable factor however little is known about the prevalence of foot pain in people with knee or hip OA nor whether foot pain is associated with clinical characteristics. The main aim of this study was therefore to determine the prevalence of foot pain in people with knee or hip OA attending an education and supervised exercise‐based intervention in Denmark (GLA:D®) and determine if baseline demographic or clinical characteristics are associated with foot pain. Methods Analysis was conducted on baseline data of 26,003 people with symptomatic knee or hip OA completing a pain mannequin as part of the Good Life with osteoArthritis in Denmark (GLA:D®) primary care programme. Odds Ratios (OR) and 95% confidence intervals (CI) were calculated to estimate the strength of association between baseline clinical characteristics (including pain severity in worst knee/hip joint, number of painful knee/hip joints, pain medication use and physical activity level) and the presence of baseline foot pain. Results Twelve percent of participants (n = 3,049) reported foot pain. In those people with index knee OA (n = 19,391), knee pain severity (OR 1.01 CI 1.00, 1.01), number of painful knee/hip joints (OR 1.67 CI 1.58, 1.79), and use of pain medication (OR 1.23 CI 1.12, 1.36) were statistically associated with foot pain. Excluding use of pain medication, similar associations were seen in those with index hip OA. Conclusion Twelve percent of people with knee or hip OA participating in GLA:D® had foot pain. Those with worse knee/hip pain, and greater number of painful joints were more likely to report foot pain. This study is the first to demonstrate a significant relationship between clinical characteristics and foot pain in people with knee or hip OA participating in education and supervised exercise. Future investigation should consider the role that foot pain may play on knee and hip related outcomes following therapeutic intervention.

Objective: People with knee or hip osteoarthritis (OA) can experience comorbid lumbar spinal stenosis (LSS), but the impact on treatment outcomes is unknown. The aim of this study was to investigate associations between comorbid LSS symptoms and changes in pain, function, and quality of life following a patient education and exercise therapy program. Design: This was a longitudinal analysis of 6813 participants in the Good Life with osteoArthritis in Denmark (GLA:D®) program; a structured patient education and exercise therapy program for knee and hip OA. Participants were classified as having comorbid LSS symptoms based on self-report symptom items. Linear mixed models were used to assess differences in change in pain, function, and quality of life outcomes (0 worst to 100 best) at 3- and 12-month follow-up. Results: 15% and 23% of knee and hip OA participants had comorbid LSS symptoms, respectively. Knee participants with comorbid LSS symptoms had smaller improvement in pain at 3-months (−1.7, 95% CI -3.3 to −0.1) and hip participants with comorbid LSS symptoms had greater improvement in function at 3- (2.5, 95% CI 0.5 to 5.0) and 12-months (3.8, 95% CI 0.9 to 6.6), when compared to those without LSS symptoms. These differences were not clinically significant and no differences in other outcomes were observed. Conclusion: Knee or hip OA patients with comorbid LSS symptoms should expect similar improvements in knee- or hip-related pain, function, and quality of life outcomes when undergoing a patient education and exercise therapy program compared to those without LSS symptoms.

Abstract Background Approximately 20% of patients experience chronic pain after total knee arthroplasty (TKA). Due to the growing number of TKA procedures, this will affect an increasing number of people worldwide. Catastrophic thinking, dysfunctional illness perception, poor mental health, anxiety and depression characterize these non-improvers, and indicate that these patients may need individualized treatment using a treatment approach based on the bio-psycho-social health model. The present study developed an internet-delivered cognitive behavioral therapy (iCBT) program to be combined with exercise therapy and education for patients with knee osteoarthritis (OA) at increased risk of chronic pain after TKA. Methods The development process followed the first two phases of the UK Medical Research Council framework for complex interventions. In the development phase, the first prototype of the iCBT program was developed based on literature review, established iCBT programs and multidisciplinary workshops. The feasibility phase consisted of testing the program, interviewing users, condensing the program, and tailoring it to the patient group. A physiotherapist manual was developed and adapted to physiotherapists who will serve as mentors. Results The development process resulted in an iCBT program consisting of 10 modules with educational texts, videos and exercises related to relevant topics such as goalsetting, stress and pain, lifestyle, automatic thoughts, mindfulness, selective attention, worry and rumination. A physiotherapist manual was developed to guide the physiotherapists in supporting the patients through the program and to optimize adherence to the program. Conclusions The iCBT program is tailored to patients at risk of chronic pain following TKA, and may be useful as a supplement to surgery and/or exercise therapy. A multicentre RCT will evaluate the iCBT program in combination with an exercise therapy and education program. This novel intervention may be a valuable contribution to the treatment of OA patients at risk of chronic pain after TKA. Trial registration The RCT is pre-registered at ClinicalTrials.gov: NCT03771430 11/12/2018.

Abstract Background Evidence on prognostic factors associated with progression to total hip replacement (THR) in hip osteoarthritis (OA) is for the most patient- and disease-specific characteristics either conflicting or inconclusive. Therefore, the objectives of this study of participants with hip OA enrolled in a structured program of supervised education and exercise therapy were to describe the rate of THR and to identify prognostic factors for receiving THR within the following 2 years. Methods Participants aged ≥ 45 years with hip OA enrolled in Good Life with osteoArthritis in Denmark (GLA:D®) from July 2014 to March 2017 were included. Potential prognostic factors included demographic and disease-specific baseline characteristics and measures of physical activity and quality of life (QoL). Information on THR was retrieved from The Danish National Patient Registry. A multivariable Cox proportional hazards model was developed. Results Of 3657 included participants, 30% received a THR within 2 years. Of the 100 participants already wait-listed for THR, 60% had the procedure. Of 22 candidate prognostic factors, 14 were statistically significant for receiving THR. Factors associated with a faster rate of THR included being “male” (HR 1.43), having “self-reported radiographic hip OA” (HR 2.32), being “wait-listed for THR” (HR 2.17), and having a higher “pain intensity” (HR 1.01). In contrast, faster “walking speed” (HR 0.64), better “hip-related QoL” (HR 0.98), and having “three or more comorbidities” (HR 0.62) were predictive of a slower rate of THR. Conclusion During the 2-year follow-up period, 30% of the cohort received a THR. Notably, 40% of those wait-listed for THR when entering the program did not receive THR within 2 years. A number of baseline prognostic factors for receiving THR were identified.

Abstract Aim To quantify recruitment, retention and differential retention rates and associated trial, participant and intervention characteristics in randomised controlled trials (RCTs) evaluating the effect of exercise therapy in people with multimorbidity. Data sources MEDLINE, EMBASE, CINAHL and CENTRAL from 1990 to April 20, 2020. Study selection RCTs including people with multimorbidity comparing exercise therapy with a non-exposed comparator group reporting at least one of the following outcomes: physical function, health-related quality of life, depression symptoms, or anxiety symptoms. Data extraction and synthesis Recruitment rates (proportion of people randomised/proportion of people eligible), retention rates (proportion of people providing the outcomes of interest/proportion randomised) and differential retention rates (difference in proportion of people providing the outcomes in the intervention group and comparator group) were calculated. Meta-analysis using a random-effects model was used to estimate pooled proportions. Methodological quality was assessed using Cochrane ´Risk of Bias tool 2.0´ for individual studies, and the GRADE approach was used to assess the overall quality of the evidence. Results Twenty-three RCTs with 3363 people were included. The pooled prevalence for recruitment rate was 75% (95%CI 66 to 84%). The pooled prevalence for retention rate was 90% (95%CI 86 to 94%) at the end of the intervention (12 weeks; interquartile range (IQR) (12 to 12)). Meta-regression analyses showed that increasing age and including a higher proportion of people with hypertension was associated with lower retention rates. Retention rates did not differ between the intervention and comparator groups. The overall quality of the evidence was deemed very low. Conclusion Three in four eligible people with multimorbidity were randomised to RCTs using exercise therapy, of which nine out of 10 provided end of treatment outcomes with no difference seen between the intervention and comparison groups. However, the results must be interpreted with caution due to large differences between the included studies. Trial registration ClinicalTrials.gov CRD42020161329 . Registered on 28 April 2020.

Abstract Background Four out of five patients with hypermobility spectrum disorder (HSD) or hypermobile Ehlers-Danlos syndrome (hEDS) experience shoulder complaints including persistent pain and instability. Evidence suggests that patients with HSD/hEDS who experience knee and back complaints improve with exercise-based therapy. However, no study has focused on exercise-based treatment for the shoulder in this patient group. The potential benefits of strengthening the shoulder muscles, such as increased muscle-tendon stiffness, may be effective for patients with HSD/hEDS who often display decreased strength and increased shoulder laxity/instability. The primary aim is to investigate the short-term effectiveness of a 16-week progressive heavy shoulder strengthening programme and general advice (HEAVY) compared with low-load training and general advice (LIGHT), on self-reported shoulder symptoms, function, and quality of life. Methods A superiority, parallel group, randomised controlled trial will be conducted with 100 patients from primary care with HSD/hEDS and shoulder complaints (persistent pain and/or instability) for more than 3 months. Participants will be randomised to receive HEAVY (full range of motion, high load) or LIGHT (neutral to midrange of motion, low load) strengthening programme three times weekly with exercises targeting scapular and rotator cuff muscles. HEAVY will be supervised twice weekly, and LIGHT three times during the 16 weeks. The primary outcome will be between-group difference in change from baseline to 16-week follow-up in the Western Ontario Shoulder Instability Index (WOSI, 0-2100 better to worse). Secondary outcomes will include a range of self-reported outcomes covering symptoms, function, and quality of life, besides clinical tests for shoulder strength, laxity/instability, and proprioception. Outcome assessors will be blinded to group allocation. Participants will be kept blind to treatment allocation through minimal information about the intervention content and hypotheses. Primary analyses will be performed by a blinded epidemiologist. Discussion If effective, the current heavy shoulder strengthening programme will challenge the general understanding of prescribing low-load exercise interventions for patients with HSD/hEDS and provide a new treatment strategy. The study will address an important and severe condition using transparent, detailed, and high-quality methods to potentially support a future implementation. Trial registration ClinicalTrials.gov NCT03869307 . Registered on 11 March 2019.

Abstract Background A comprehensive overview of treatments of common fractures is missing, although it would be important for shared decision-making in clinical practice. The aim was to determine benefits and harms of surgical compared to non-surgical treatments for traumatic skeletal fractures. Methods We searched Medline, Embase, CINAHL, Web of Science, and CENTRAL until November 2018, for randomized trials of surgical treatment in comparison with or in addition to non-surgical treatment of fractures in adults. For harms, only trials with patient enrollment in 2000 or later were included, while no time restriction was applied to benefits. Two reviewers independently assessed studies for inclusion, extracted data from full-text trials, and performed risk of bias assessment. Outcomes were self-reported pain, function, and quality of life, and serious adverse events (SAEs). Random effects model (Hedges’ g) was used. Results Out of 28375 records screened, we included 61 trials and performed meta-analysis on 12 fracture types in 11 sites: calcaneus, clavicula, femur, humerus, malleolus, metacarpus, metatarsus, radius, rib, scaphoideum, and thoraco-lumbar spine. Seven other fracture types only had one trial available. For distal radius fractures, the standardized mean difference (SMD) was 0.31 (95% CI 0.10 to 0.53, n = 378 participants) for function, favoring surgery, however, with greater risk of SAEs (RR = 3.10 (1.42 to 6.77), n = 436). For displaced intra-articular calcaneus fractures, SMD was 0.64 (0.13 to 1.16) for function (n = 244) and 0.19 (0.01 to 0.36) for quality of life (n = 506) favoring surgery. Surgery was associated with a smaller risk of SAE than non-surgical treatment for displaced midshaft clavicular fractures (RR = 0.62 (0.42 to 0.92), n = 1394). None of the other comparisons showed statistical significance differences and insufficient data existed for most of the common fracture types. Conclusions Of 12 fracture types with more than one trial, only two demonstrated a difference in favor of surgery (distal radius fractures and displaced intra-articular calcaneus fractures), one of which demonstrated a greater risk of harms in the surgical group (distal radius fractures). Our results highlight the current paucity of high-quality randomized trials for common fracture types and a considerable heterogeneity and risk of bias in several of the available trials. Systematic review registration PROSPERO CRD42015020805

Abstract Background People with hypermobility spectrum disorder (HSD) are in great risk of experiencing shoulder symptoms, but evidence for treatment is sparse. Therefore, the objective was to evaluate the feasibility of 16-week shoulder strengthening programme for improving shoulder strength and function in people with HSD and shoulder symptoms for more than 3 months to inform a future randomised controlled trial (RCT). Methods Twelve participants (11 females, 39.3 ± 13.9 years) with HSD and shoulder instability and/or pain for more than 3 months underwent a 16-week heavy shoulder strengthening exercise programme three times weekly using exercises targeting scapular and rotator cuff muscles. Primary outcomes were pre-defined research progression criteria including recruitment rate (acceptable, 6 participants/month), assessment duration (acceptable: < 120 min), participant retention (acceptable: > 80% complete intervention), training adherence (acceptable: > 75% adhere to > 36 training sessions) and adverse events (acceptable: minor events with no participants discontinuing the study), besides participant and physiotherapist feedback. Secondary treatment outcomes were assessed using the Western Ontario Shoulder Instability Index (WOSI, 0–2100 better to worse), self-reported pain, kinesiophobia and fatigue, isometric shoulder strength, besides clinical tests for instability, hypermobility, laxity, and proprioception. Results Recruitment rate was 5.6/month, assessment duration (mean ± SD) 105 ± 9 min, retention 100%, adherence 83%, and four participants experienced short-lasting soreness or pain. Participant feedback was positive, and physiotherapists found the intervention relevant and applicable to the population. The WOSI total score showed an improvement by 51% (mean ± SD, points: baseline 1037 ± 215; Follow up 509 ± 365; mean change (95% CI), − 528 (− 738, − 318)), and participants reported reduced pain, kinesiophobia and fatigue. Shoulder strength measurements improved by 28–31% (mean change (95% CI), Nm/kg: scaption 0.51 (0.23, 0.78); internal rotation 1.32 (0.70, 1.95) and external rotation 0.89 (0.37, 1.40)), and clinical tests indicated decreased shoulder laxity/instability. Conclusions The shoulder strengthening exercise programme was feasible and safe for people with HSD and long-lasting shoulder symptoms. A future RCT, with an improved recruitment strategy, will demonstrate whether the exercise programme is also effective in improving symptoms and muscle-tendon function in this population. Trial registration ClinicalTrials.gov : NCT03547570 . Registered on May 3, 2018.

Abstract Background Total knee arthroplasty (TKA) is considered an effective treatment for pain relief and improved physical performances in end-stage knee osteoarthritis. However, several studies have reported less favorable outcomes after TKA with chronic pain rates of approximately 20%. Exercise might be an effective treatment strategy for chronic pain following TKA, but no randomized controlled trials have evaluated its effect. Therefore, the purpose of this randomized controlled trial is to investigate whether a 12-week neuromuscular exercise (NEuroMuscular EXercise training program for patients with knee or hip osteoarthritis assigned for total joint replacement; NEMEX-TJR) program combined with pain neuroscience education (PNE) provides greater pain relief and improvement in physical performances than PNE alone at 12 months follow-up in a population of patients with chronic pain after primary TKA. Methods For this randomized controlled superiority trial, 120 patients with moderate-to-severe chronic pain after TKA are recruited from Aalborg University Hospital, Denmark. Patients are randomly assigned in a 1:1 ratio to one of two interventions: (a) NEMEX-TJR twice weekly for 12 weeks combined with two sessions of PNE or (b) two sessions of PNE given over 6 weeks. Assessment is performed at baseline before intervention and at 3, 6, and 12 months after initiation of the intervention. Outcome assessors are blinded toward group allocation. The primary outcome is the change in the Knee Injury and Osteoarthritis Outcome Score4 (KOOS4), defined as the mean score for the KOOS subscales pain, symptoms, activities of daily living, and quality of life. Secondary outcomes include all KOOS subscale scores and scores for PainDETECT, the Fear-Avoidance Beliefs Questionnaire, Global Perceived Effect, the Pain Catastrophizing Scale, pain intensities, temporal summation, conditioned pain modulation, and pressure pain thresholds. Physical performances are measured with walking, stair climbing, and chair standing tests as well as tests of muscle strength and power. Discussion The findings will be useful in establishing effective treatment strategies for chronic pain after TKA. The randomized controlled trial involves rigorous scientific methods and uses clinically applicable interventions. The study interventions are conducted in clinical settings, thereby enhancing the possibility of future implementation of the treatments in the health care systems. Trial registration ClinicalTrials.gov identifier: NCT03886259. Registered 22 March 2019. Ethics committee registration: N-20180046.

Objective To determine levels of objectively measured physical activity (PA) and the proportion of adults with multimorbidity that adheres to PA guidelines. Methods All studies, where PA was measured at baseline using an activity monitor in an adult (≥18 years) multimorbid (≥80% of the population had ≥2 chronic conditions) population. A systematic literature search was performed in Medline, EMBASE, CINAHL, CENTRAL, ClinicalTrials.gov, opengrey.eu and google.com from inception up until 18th of January 2022. Risk of bias was assessed with a modified version of the Quality Assessment Tool for Quantitative Studies. A random-effects meta-analyses was performed to estimate daily minutes of sedentary behavior (SB), light PA (LPA), moderate PA (MPA), moderate to vigorous PA (MVPA) and steps. Proportions adhering to PA guidelines was narratively synthesized. Certainty of evidence was determined using The Grading of Recommendations Assessment, Development and Evaluation (GRADE) approach. Results Fifteen studies (2,172 participants) were included. The most frequent combination of conditions were type 2 diabetes and hypertension (six studies). Participants spent a daily average of 500.5 (95% CI: 407.1 to 593.9) minutes in SB, 325.6 (95% CI: 246.4 to 404.7 minutes in LPA and 32.7 (95% CI: 20.2 to 45.3) minutes in MVPA. The mean daily number of steps was 5,145 (95% CI: 4264 to 6026) for people in free-living conditions. The proportion adhering to PA guidelines ranged widely (7.4% to 43%). All studies were rated as at high risk of bias and the certainty of evidence was very low. Conclusions PA levels and adherence varied from low to above guideline recommended levels for adults with chronic conditions, depending on PA intensity. The very low certainty of evidence calls for high quality studies focusing on detailed descriptions of PA behavior in people with multimorbidity. PROSPERO registration number CRD42020172456.

Background. Healthy lifestyle is important to decrease health risks in individuals living with chronic pain. From an occupational therapy perspective, human health and lifestyle are linked to occupational engagement in meaningful everyday activities. This study is aimed at investigating the effect of including occupational engagement in chronic pain interventions on lifestyle. Methods. In this systematic review (PROSPERO reg. CRD42020159279), we included randomized controlled trials (RCTs) on interventions involving occupational engagement (i.e., occupational performance based on involvement, choice, positive meaning, and commitment) and assessing modifiable lifestyle factors: physical activity, body anthropometrics, alcohol consumption, smoking, stress, and sleep. We sought the databases Ovid MEDLINE, Embase, PsycINFO, CINAHL, Cochrane, Scopus, Web of Science, OTseeker, ClinicalTrials.gov, OpenGrey, and the web engine Google Scholar and citations and references of relevant publications. We evaluated methodological quality with the Cochrane risk-of-bias tool 2.0, determined the overall evidence certainty using the GRADE methodology, and performed meta-analysis when two or more trials reported on the outcomes. Results. Of the 9526 items identified, 286 were full text screened. We included twelve articles with eleven RCTs comprising 995 adults and assessing physical activity, sleep quality, stress, and Body Mass Index. Sufficient data for meta-analysis was only available for physical activity and sleep quality. The meta-analysis suggested a moderate increase in physical activity after behavioral interventions for fibromyalgia and musculoskeletal pain (SMD=0.69 (0.29; 1.09)) and a small increase in sleep quality up to 6 months after multidisciplinary self-management of fibromyalgia (SMD=0.35 (95% CI 0.08; 0.61)). The overall certainty of the evidence was deemed low. Conclusion. Including occupational engagement in chronic pain interventions may increase short-term physical activity and long-term sleep quality. Due to the few available RCTs including occupational engagement in chronic pain treatment for adults living with chronic pain, further high-quality RCTs are needed and will likely change the conclusion.

Purpose: As part of intervention feasibility evaluation before conducting a clinical trial, this study aimed to investigate perspectives of patients and clinicians involved in the occupational therapy lifestyle-oriented programme REVEAL(OT) [Redesign your EVEveryday Activities and Lifestyle with Occupational Therapy] which was added to multidisciplinary chronic pain treatment. Methods: We conducted three focus group interviews, two with eight voluntarily selected patients and one with four clinicians. Data were analysed using Braun & Clarke’s semantic data-driven analysis. Results: Patients reported satisfaction with the intervention and a greater acceptance of living with chronic pain through increased understanding of pain mechanisms, more effective daily planning and improved social interaction. Patients felt empowered to change lifestyle habits by restarting habitual interests, prioritizing joyful occupations for improved occupational balance, and lifestyle modifications. Contact to occupational therapists and peer support were important empowering factors for working with lifestyle goals. Patients and clinicians expressed their views on further improvement of the REVEAL(OT). Conclusions: Patients and clinicians found the lifestyle-oriented occupational therapy programme relevant as an add-on to the multidisciplinary chronic pain treatment. A need was expressed for a reduced information and treatment load and a higher degree of communication and cooperation among the clinicians involved in the intervention.

Summary: Objective: Differing clinical criteria for hip osteoarthritis (OA) are applied in primary care, but little is known regarding the utility of these criteria. The aim of this study was to evaluate and compare the proportion of patients in a primary care setting with hip OA fulfilling the American College of Rheumatology (ACR), the National Institute for Health and Care Excellence (NICE), and the Danish Health Authority (DHA) criteria. Design: A cross-sectional analysis of baseline data from the Good Life with osteoArthritis in Denmark (GLA:D®) program, a treatment program for patients with symptoms or functional limitations associated with hip OA. The prevalence of hip OA according to the ACR, NICE, and DHA criteria was calculated in all patients and in a subgroup of patients with self-reported radiographic hip OA. Results: 4699 patients were included in the analysis. Mean age (SD) was 66.8 (9.7) years and 71% of the patients were female. 64%, 80%, and 94% fulfilled the ACR, DHA, and NICE criteria, respectively. In those self-reporting radiographic hip OA, the corresponding numbers were 66%, 81%, and 94%. A limited number of patients (4%) did not fulfill any of the criteria. Conclusions: The NICE criteria identified the most patients that were treated because of their symptoms or functional limitations. The DHA and especially the ACR criteria did not identify a significant proportion of these patients. The results suggest the NICE criteria are appropriate to identify individuals treated for hip OA in primary care.

Abstract. The overall quality of care for musculoskeletal pain conditions is suboptimal, partly due to a considerable evidence-practice gap. In osteoarthritis and low back pain, structured models of care exist to help overcome that challenge. In osteoarthritis, focus is on stepped care models, where treatment decisions are guided by response to treatment, and increasingly comprehensive interventions are only offered to people with inadequate response to more simple care. In low back pain, the most widely known approach is based on risk stratification, where patients with higher predicted risk of poor outcome are offered more comprehensive care. For both conditions, the recommended interventions and models of care share many commonalities and there is no evidence that one model of care is more effective than the other. Limitations of existing models of care include a lack of integrated information on social factors, comorbid conditions, and previous treatment experience, and they do not support an interplay between health care, self-management, and community-based activities. Moving forwards, a common model across musculoskeletal conditions seems realistic, which points to an opportunity for reducing the complexity of implementation. We foresee this development will use big data sources and machine-learning methods to combine stepped and risk-stratified care and to integrate self-management support and patient-centred care to a greater extent in future models of care.

Summary: Objective: To model potential cost savings associated with implementing a first-line management program for moderate-severe knee osteoarthritis (OA) at a national level in Australia. Methods: A budget impact analysis was undertaken using published trial data and publically available data. Australian population projections and OA prevalence data were used to forecast likely need for total knee replacement (TKR) surgery for 2019–2029. Published data were sourced on TKR avoidance following a 12-week non-surgical knee OA management program (exercise therapy, education, insoles, dietary advice, analgesia) and cost per TKR in Australia. The cost of providing the first-line program was estimated on a sliding scale ($AUD750-$3000), with a base case of $AUD1,500. These inputs were used to model potential annual savings associated with national implementation of the program. Results: The number of people in Australia with moderate-severe knee OA requiring TKR was estimated to be 56,007 in 2019, rising to 69,038 by 2029. Avoidance of TKR by 34%–68% of people after the first-line management program could translate to savings of $AUD303million-690 million in 2019. Successively lowering the proportion of people who avoided TKR demonstrated that only 1 in 12 program recipients would need to avoid surgery for the program to generate savings. Conclusions: National implementation of a first-line OA management program as an alternative to TKR could produce substantial cost savings for the Australian healthcare system. Longer term data on TKR avoidance is needed to establish whether cost savings are realised or simply shifted to later years.

Abstract Background Clinical guidelines recommend that people with back pain be given information and education about their back pain, advice to remain active and at work, and exercises to improve mobility and physical activity. Guidelines, however, rarely describe how this is best delivered. The aim of this paper is to present the development, theories, and underlying evidence for ‘GLA:D Back’ - a group education and exercise program that translates guideline recommendations into a clinician-delivered program for the promotion of self-management in people with persistent/recurrent back pain. Methods GLA:D Back, which included a rationale and objectives for the program, theory and evidence for the interventions, and program materials, was developed using an iterative process. The content of patient education and exercise programs tested in randomised trials was extracted and a multidisciplinary team of expert researchers and clinicians prioritised common elements hypothesised to improve back pain beliefs and management skills. The program was tested on eight people with persistent back pain in a university clinic and 152 patients from nine primary care physiotherapy and chiropractic clinics. Following feedback from the clinicians and patients involved, the working version of the program was created. Results Educational components included pain mechanisms, pain modulation, active coping strategies, imaging, physical activity, and exercise that emphasised a balance between the sum of demands and the individual’s capacity. These were operationalised in PowerPoint presentations with supporting text to aid clinicians in delivering two one-hour patient education lectures. The exercise program included 16 supervised one-hour sessions over 8 weeks, each comprising a warm-up section and eight types of exercises for general flexibility and strengthening of six different muscle groups at four levels of difficulty. The aims of the exercises were to improve overall back fitness and, at the same time, encourage patients to explore variations in movement by incorporating education content into the exercise sessions. Conclusion From current best evidence about prognostic factors in back pain and effective treatments for back pain, research and clinical experts developed a ready-to-use structured program - GLA:D® Back - to support self-management for people with persistent/recurrent back pain.

Abstract Background Knee osteoarthritis (OA) is a leading cause of global disability. The understanding of the role of psychosocial factors in knee OA outcomes is still evolving particularly in an Asian context. The primary aim of this study is to explore psychosocial factors that prognosticate short and long-term clinical outcomes, productivity, and healthcare utilization in patients with knee OA. Secondary aims are to explore the mediation and directional relationships and the role it plays in predicting the discordance between self-reported measures (SRM), physical-performance measures (PPMs) and objective clinical parameters. Methods A multi-centre prospective cohort study of community ambulant knee OA patients seeking treatment in the tertiary healthcare institutions in Singapore will be conducted. Patients with secondary arthritis, significant cognitive impairment, severe medical comorbidities or previous knee arthroplasty will be excluded. Primary clinical outcome measure is the Knee injury and OA Outcome Score-12 (KOOS-12). Baseline characteristics include sociodemographic status, arthritis status including symptom duration and radiographic severity, comorbidities and functional status through Charlson Comorbidities Index (CCI), Barthel Index (BI) and Parker Mobility Score (PMS). Psychosocial variables include social support, kinesiophobia, negative affect, self-efficacy, injustice, chronic illness shame and the built environment. Clinical outcomes include quality of life, physical performance, global assessment, satisfaction and physical activity levels. Productivity and healthcare utilization will be assessed by a modified OA Cost and Consequences Questionnaire (OCC-Q) and the Work Productivity and Activity Impairment Questionnaire (WPAI). Variables will be collected at baseline, 4, 12 months and yearly thereafter. Regression, mediation and structural equation modelling will be used for analysis. Discussion Results will allow contextualization, identification, and phenotyping of the critical (and potentially modifiable) psychosocial parameters that predict positive clinical outcomes in the OA population to guide optimization and refinement of healthcare and community. This will facilitate: 1. identification of high-risk knee OA subpopulations that will likely experience poor outcomes and 2. formulation of targeted multidisciplinary comprehensive approaches to address these psychosocial factors to optimize non-surgical treatment care, maximize functional outcomes and create more value-based care model for knee OA. Ethics and dissemination The study has been registered under clinicaltrials.gov registry (Identifier: NCT04942236).

Abstract Background The evidence-based interventions of exercise and education have been strongly recommended as part of prominent clinical guidelines for hip and knee osteoarthritis (OA) for more than ten years. Despite the wealth of strong evidence that exists, implementation in practice is sub-optimal. This paper describes the key methodologies used in the co-design, tailoring, and evaluation of the IMPACT project implementation strategies, to confront this problem across multiple levels (micro, meso, macro) in public and private healthcare settings in Ireland. Methods Using a type III hybrid implementation-effectiveness design, a participatory, dynamic and iterative process will be used to tailor and evaluate multi-level implementation strategies using the following stages: 1) Co-design the implementation strategies with key stakeholders using best evidence, a theory-driven implementation framework (Consolidated Framework for Implementation Research), local context and expert consensus; 2) Pilot and evaluate the implementation strategies by training physiotherapists to deliver the evidence-based Good Life with osteoArthritis Denmark (GLA:D®) education and exercise programme using the implementation strategies, and conduct a mixed-methods process evaluation; 3) Adapt the implementation strategies based on implementation process evaluation indicators from stage two. The adapted strategies will be used for scale-up and sustainability in subsequent GLA:D® Ireland training programmes that will be rolled out nationally. Evaluation of effectiveness on patient and cost outcomes will continue up to 12 months post-programme delivery, using an online patient registry and pre-post design. Discussion This implementation science project aims to use participatory health research to address a gap in management of OA across public and private healthcare settings. This research has the potential to change practice and promote a policy of exercise and physical activity referral for chronic musculoskeletal disease that utilises community engagement effectively and enacts change ‘together’, with involvement of researchers, decision-makers, clinicians and patients.

Little is known about the biology of back pain, a leading cause of disability. Here the authors report 30 new back pain loci, implicating genes involved in cartilage/bone biology, as well as neurological and inflammatory processes.

Objective: Evaluate the implementation of Good Life with osteoArthritis from Denmark (GLA:D®) for knee osteoarthritis in Australia using the RE-AIM QuEST (Reach, Effectiveness, Adoption, Implementation, Maintenance Qualitative Evaluation for Systematic Translation) framework. Design: Physiotherapists completed surveys before and after GLA:D® training (2017–2020) to assess practices, and barriers and enablers to implementation. Patients completed online baseline, 3-month (post-treatment) and 12-month patient reported outcomes. Effective implementation was defined as within-participant moderate effect size (ES, ≥0.50) for average pain (100 ​mm VAS) and Knee Injury and Osteoarthritis Outcome Score quality of life scores (KOOS-QoL), and small effect size (≥0.20) for health-related quality of life (EQ-5D-5L). Results: Reach: 1064 physiotherapists and 1945 patients from all states and territories participated. Key barriers included out-of-pocket cost to patients, and program suitability for culturally and linguistically diverse communities. Effectiveness: Following training, more physiotherapists reported discussing treatment goals and weight management, and prescribing supervised, neuromuscular exercise. Patient outcomes at 3- and 12-months (n ​= ​1044 [54%] and 927 [48%]) reflected effective implementation, including reduced pain (ES, 95%CI ​= ​0.72, 0.62–0.84; and 0.65, 0.54–0.77) and improved KOOS-QoL (0.79, 0.69–0.90; and 0.93, 0.81–1.04) and EQ-5D-5L (0.43, 0.31–0.54; and 0.46, 0.35–0.58) scores. Adoption: 297 sites (264 private, 33 public) implemented GLA:D®. Implementation: Most patients completed at least one education (90%), and 10 exercise-therapy (78%) sessions. Adequate staffing to support program delivery was a key enabler. Maintenance: 99% of sites (293/297) continued offering the program in July 2020. Conclusion: Training changed practice and was associated with effective widespread implementation of GLA:D® in Australia.

IntroductionIntermittent claudication is a peripheral artery disease caused by arteriosclerosis. People with intermittent claudication experience leg cramping during walking, with relief of symptoms during rest. Evidence shows that by participating in supervised exercise therapy and smoking cessation programs, people with intermittent claudication can reduce those symptoms and improve health-related quality of life and maximal walking distance while minimizing the need for an operation. However, implementation of such health-promoting initiatives in clinical practice in Denmark and other countries is limited. This is a protocol presenting the implementation process of supervised exercise therapy and smoking cessation in a region of Denmark.Methods and analysisThe implementation process is a collaboration between the municipalities in the Region of Zealand and the Department of Vascular Surgery at University Hospital Zealand. The study uses a convergent mixed-methods prospective clinical cohort design, and the theoretical frame of this implementation process follows the framework for Adapting an existing intervention to a new context (ADAPT). The process involves stakeholder engagement, ongoing evaluation through key performance indicators and relevant outcomes that will inform the implementation process across and within each municipality.DisseminationDissemination will happen throughout the process through continued meetings with stakeholders and dissemination of performance indicators and outcome results obtained through a database. All information about the study and material will be freely available. The project is registred on Clinicalgov (NCT06299956).