Progressive Resistance Training or Neuromuscular Exercise for Hip Osteoarthritis : A Multicenter Cluster Randomized Controlled Trial.

BACKGROUND: Exercise is recommended as first-line treatment for patients with hip osteoarthritis (OA). However, randomized controlled trials providing evidence for the optimal exercise type are lacking. OBJECTIVE: To investigate whether progressive resistance training (PRT) is superior to neuromuscular exercise (NEMEX) for improving functional performance in patients with hip OA. DESIGN: Multicenter, cluster-randomized, controlled, parallel-group, assessor-blinded, superiority trial. (ClinicalTrials.gov: NCT04714047). SETTING: Hospitals and physiotherapy clinics. PARTICIPANTS: 160 participants with clinically diagnosed hip OA were enrolled from 18 January 2021 to 28 April 2023 and randomly assigned to PRT (n = 82) or NEMEX (n = 78). INTERVENTION: Twelve weeks of PRT or NEMEX with 2 supervised 60-minute group sessions each week. The PRT intervention consisted of 5 high-intensity resistance training exercises targeting muscles at the hip and knee joints. The NEMEX intervention included 10 exercises and emphasized sensorimotor control and functional stability. MEASUREMENTS: The primary outcome was change in the 30-second chair stand test (30s-CST). Key secondary outcomes were changes in scores on the pain and hip-related quality of life (QoL) subscales of the Hip Disability and Osteoarthritis Outcome Score (HOOS). RESULTS: The mean changes from baseline to 12-week follow-up in the 30s-CST were 1.5 (95% CI, 0.9 to 2.1) chair stands with PRT and 1.5 (CI, 0.9 to 2.1) chair stands with NEMEX (difference, 0.0 [CI, -0.8 to 0.8] chair stands). For the HOOS pain subscale, mean changes were 8.6 (CI, 5.3 to 11.8) points with PRT and 9.3 (CI, 5.9 to 12.6) points with NEMEX (difference, -0.7 [CI, -5.3 to 4.0] points). For the HOOS QoL subscale, mean changes were 8.0 (CI, 4.3 to 11.7) points with PRT and 5.7 (CI, 1.9 to 9.5) points with NEMEX (difference, 2.3 [CI, -3.0 to 7.6] points). LIMITATION: Participants and physiotherapists were not blinded. CONCLUSION: In patients with hip OA, PRT is not superior to NEMEX for improving functional performance, hip pain, or hip-related QoL. PRIMARY FUNDING SOURCE: Independent Research Fund Denmark.

Collaborative model of care between orthopaedics and allied healthcare professionals (CONNACT) in knee osteoarthritis: Effectiveness-implementation hybrid randomized controlled trial of a community-based, multidisciplinary, stratified intervention.

OBJECTIVE: To compare the clinical and cost effectiveness of the Collaborative Model of Care between Orthopaedics and Allied Healthcare Professionals (CONNACT), a community-based, stratified, multidisciplinary intervention consisting of exercise, education, psychological and nutrition delivered through a chronic care model to usual hospital care in adults with knee osteoarthritis (OA). METHODS: Pragmatic, parallel-arm, single-blinded superiority RCT trial. Community-dwelling, ambulant adults with knee OA (Kellgren-Lawrence grade > 1; Knee Injury and OA Outcome Score (KOOS4) ≤75) were enrolled. Primary outcome was KOOS4 at 12-months; secondary outcomes included: quality of life, physical performance measures, symptom satisfaction, psychological outcomes, dietary habits, and global perceived effect. Intention-to-treat analysis using generalized linear model (GLM) and regression modeling were conducted. Economic evaluation through a societal approach was embedded. RESULTS: 110 participants (55 control, 55 intervention) were randomized. No between-group difference found for the primary outcome (MD [95%CI]: -1.86 [-9.11. 5.38]), although both groups demonstrated within-group improvement over 12-months. Among the secondary outcomes, the CONNACT group demonstrated superior dietary change (12 months) and physical performance measures (3 months), and global perceived effect (6 months). While there was no between-group difference in total cost, significant productivity gains (reduced indirect cost) were seen in the CONNACT group. CONCLUSION: CONNACT was not superior to usual care at 1 year. Further efforts are needed to understand the underlying contextual and implementation factors in order to further improve and refine such community-based, stratified care models moving forward. TRIAL REGISTRATION: Clinicaltrials.gov Identifier: NCT03809975. Registered January 18, 2019. https://clinicaltrials.gov/ct2/show/NCT03809975.

GLA:D to Be Walking Better: Change in Self-Reported Difficulty Walking After Exercise Therapy and Education in Persons With Knee Osteoarthritis.

OBJECTIVE: Difficulty walking is a primary reason that individuals with knee osteoarthritis (OA) seek care. We examined the change in self-reported difficulty walking after participating in the Good Life With Osteoarthritis in Denmark (GLA:D) 8-week education and exercise program and assessed patient factors associated with improvement in difficulty walking. METHODS: This was a registry-based cohort study of individuals in Denmark with knee OA who enrolled in GLA:D. Assessments were administered at baseline, program completion (~3 months), and 12 months. Our prespecified primary outcome was change in self-reported difficulty walking assessed using the EuroQol 5-dimension 5-level walking item. Exposures included sociodemographic factors, measures of OA illness severity, comorbidities, and psychological factors. In those with baseline moderate/severe difficulty walking, using multivariable regression analysis, we assessed the relationship between exposures of interest and improvement to no/slight difficulty walking. RESULTS: We included 5262 participants. Of 2178 (41.4%) individuals with baseline moderate/severe difficulty walking, 51.4% and 58.3% reported no/slight difficulty walking at 3 and 12 months, respectively. Greater self-efficacy, younger age, female sex, lower BMI, less intense knee pain, and better function at baseline were associated with greater likelihood of improvement in difficulty walking, whereas severe difficulty walking at baseline and back pain intensity were associated with decreased likelihood of improvement. CONCLUSION: More than half of those with baseline difficulty walking experienced substantial improvement after completing GLA:D and this improvement was maintained at 12 months. Several patient factors were associated with the outcome, suggesting that some individuals may require additional support and extended treatment.

Benefits and harms of structured outdoor physical activity for people with somatic or mental diseases: A systematic review and meta-analysis.

OBJECTIVE: To examine the benefits and harms of structured outdoor physical activity (PA) for people living with one or more somatic or mental diseases. METHODS: We identified articles from inception until Marts 2023 in MEDLINE, EMBASE, CINAHL and CENTRAL and citation tracking in Web of Science. We included randomized controlled trials (RCTs) and observational studies examining structured outdoor PA reporting physical function, health-related quality of life (HRQOL), pain or mental outcomes. We used random-effect meta-analyses and investigated heterogeneity in subgroups, sensitivity and meta-regression analyses. Observational studies and studies with insufficient data were summarized narratively. Certainty of evidence was assessed with GRADE. RESULTS: From 4098 hits, 20 studies (19 RCTs and 1 cohort) were included (n: 1759 participants). Studies varied in type of disease and intervention. End of intervention results suggested a small effect on HRQOL (k = 10, SMD = 0.45, 95%CI: 0.19 to 0.71) and physical function (k = 14, SMD = 0.39, 95%CI: 0.13 to 0.64), while effects were moderate on mental outcomes (k = 13, SMD = -0.52, 95%CI: -0.82 to -0.23) favoring the outdoor intervention over comparators (no intervention, usual care, indoor PA or outdoor intervention without exercise). We were not able to conclude on outdoor interventions' effect on pain. Four studies reported adverse events including non-serious (pain, falls, fatigue) and serious (hospitalization, pneumonia). Certainty of evidence was overall very low. CONCLUSION: Structured outdoor PA may improve HRQOL and physical function, as well as mental health outcomes. The very low certainty of evidence calls for high quality RCTs to determine benefits and harms of structured outdoor PA.

Use of prescribed analgesics before and after exercise therapy and patient education in patients with knee or hip osteoarthritis.

The aim of this study was to investigate utilisation patterns of prescribed analgesics before, during, and after an exercise therapy and patient education program among patients with knee or hip osteoarthritis. This cohort study is based on data from the nationwide Good Life with osteoarthritis in Denmark (GLA:D®) patient-register linked with national health registries including data on prescribed analgesics. GLA:D® consists of 8-12 weeks of exercise and patient education. We included 35,549 knee/hip osteoarthritis patients starting the intervention between January 2013 and November 2018. Utilisation patterns the year before, 3 months during, and the year after the intervention were investigated using total dispensed defined daily doses (DDDs) per month per 1000 population as outcome. During the year before the intervention, use of prescribed paracetamol, non-steroidal anti-inflammatory drugs (NSAIDs), and opioids increased with 85%, 79% and 22%, respectively. During the intervention, use of paracetamol decreased with 16% with a stable use the following year. Use of NSAIDs and opioids decreased with 38% and 8%, respectively, throughout the intervention and the year after. Sensitivity analyses indicated that the prescription of most analgesics changed over time. For paracetamol, NSAIDs, and opioids, 10% of analgesic users accounted for 45%, 50%, and 70%, respectively, of the total DDDs dispensed during the study period. In general, analgesic use increased the year before the intervention followed by a decrease during the intervention and the year after. A small proportion of analgesic users accounted for half or more of all paracetamol, NSAIDs, and opioids dispensed during the study period.

One-year effectiveness of high-load compared with low-load strengthening exercise on self-reported function in patients with hypermobile shoulders: a secondary analysis from a randomised controlled trial.

OBJECTIVES: To investigate the long-term effectiveness of high-load versus low-load strengthening exercise on self-reported function in patients with hypermobility spectrum disorder (HSD) and shoulder symptoms. METHODS: A secondary analysis of a superiority, parallel-group, randomised trial (balanced block randomisation 1:1, electronic concealment) including adult patients (n=100) from primary care with HSD and shoulder pain and/or instability ≥3 months. Patients received 16 weeks of shoulder exercises (three sessions/week): HEAVY (n=50, full-range, high-load, supervised twice/week) or LIGHT (n=50, neutral/mid-range, low-load, supervised three times in total). The 1-year between-group difference in change in self-reported function was measured using the Western Ontario Shoulder Instability Index (WOSI, scale 0-2100, 0=best). Secondary outcomes were self-reported measures including changes in shoulder-related symptoms, function, emotions and lifestyle, quality of life, patient-perceived effect, treatment utility and adverse events. A blinded analyst conducted the analyses using linear mixed model repeated measurements analysis. RESULTS: One-year data were available in 86 out of 100 participants (79% women, mean age 37.8 years) (LIGHT 84%, HEAVY 88%). The mean WOSI score between-group difference favoured HEAVY (-92.9, 95% CI -257.4 to 71.5, p=0.268) but was not statistically significant. The secondary outcomes were mostly inconclusive, but patients in HEAVY had larger improvement in the WOSI emotions subdomain (-36.3; 95% CI -65.4 to -7.3, p=0.014). Patient-perceived effect favoured HEAVY anchored in WOSI-emotions (55% vs 31%, p=0.027) and WOSI-lifestyle (50% vs 29%, p=0.042). CONCLUSION: High-load shoulder strengthening exercise was not superior to low-load strengthening exercise in improving self-reported function at 1 year. High-load strengthening exercise may be more effective in improving patient emotions about shoulder pain and function, but more robust data are needed to support these findings. TRIAL REGISTRATION NUMBER: NCT03869307.

Total Hip Arthroplasty Versus Education and Exercise: A Propensity-Matched Analysis of 266 Patients Who Have Hip Osteoarthritis.

BACKGROUND: Total hip arthroplasty (THA) for osteoarthritis (OA) is a major health system cost. Education and exercise (Edu + Ex) programs may reduce the number of THAs needed, but supporting data are limited. This study aimed to estimate the treatment effect of THA versus Edu + Ex on pain, function, and quality of life outcomes 3 and 12 months after treatment initiation for hip OA. METHODS: Patients who had hip OA who underwent THA or an Edu + Ex program were included in this propensity-matched study. In 778 patients (Edu + Ex, n = 303; THA, n = 475), propensity scores were based on pretreatment characteristics, and patients were matched on a 1:1 ratio. Between-group treatment effects (pain, function, and quality of life) were estimated as the mean difference (MD) in change from pretreatment to 3-month and 12-month follow-up using linear mixed models. RESULTS: The matched sample consisted of 266 patients (Edu + Ex, n = 133; THA, n = 133) who were balanced on all pretreatment characteristics except opioid use. At 12-month follow-up, THA resulted in significantly greater improvements in pain (MD 35.4; 95% confidence interval [CI] 31.4 to 39.4), function (MD 30.5; 95% CI 26.3 to 34.7), and quality of life (MD 33.6; 95% CI 28.8 to 38.4). Between 17% and 30% of patients receiving Edu + Ex experienced a surgical threshold for clinically meaningful improvement in outcomes, compared to 84% and 90% of THA patients. CONCLUSIONS: A THA provides greater improvements in pain, function, and quality of life. A notable proportion of Edu + Ex patients had clinically meaningful improvements, suggesting Edu + Ex may result in THA deferral in some patients, but confirmatory trials are needed.

Patients' behaviour after referral to a wound care clinic for diabetic foot ulcer care: a grounded theory study.

OBJECTIVE: The aim of this study was to construct a grounded theory regarding patients' activity behaviour over time after referral to an outpatient clinic for diabetic foot ulcer (DFU) care. METHOD: A constructivist grounded theory approach was used. Data from observations of and interviews with participants were collected and analysed using the constant comparative method. Based on this, the grounded theory 'Just a bump in the road' was constructed. RESULTS: The cohort included five participants who considered their ulcers as 'Just a bump in the road' in their lives, and four subcategories were embedded in this core category: 'Restricting my freedom'; 'Trusting or doubting the system'; 'Feeling no pain or illness'; and 'Receiving insufficient information'. Together, these categories describe the participants' behaviour and underlying concerns related to daily activities after referral to an outpatient clinic for the care of their DFU. CONCLUSION: The grounded theory 'Just a bump in the road' describes how participants with a DFU viewed their condition as merely a passing phase that would end with them regaining what they considered a normal life. Integrating these results into clinical practice could lead to improved care and a focus shift among health professionals from viewing patients as being defined by their wounds to seeing them as people who live with a wound.

Nature-Based Group Exercises for People With Arthritis: A Qualitative Along-Side Interview Study of Lived Experiences.

Arthritis affects many individuals and can cause pain and limit physical functioning. Exercise is an important treatment option for individuals with arthritis; however, adherence to exercise programs can be challenging. A new initiative in Denmark has introduced nature-based exercises for patients with arthritis. This qualitative study aimed to explore the experiences of the individuals who participated in those exercises. The study used a hermeneutic-phenomenological approach and conducted along-side interviews with 12 women and three men who participated in nature-based exercise programs for arthritis. Analysis of the data revealed two main themes. The first theme highlighted the positive effects of being in nature, such as increased vitality, reduced pain, and a sense of well-being. The second theme emphasized the social benefits of participating in these exercises, including a sense of connection and community with others. Overall, this study suggests that incorporating nature-based exercises in treatment programs for arthritis could have significant benefits for individuals with this condition.

Searching for a brighter future-Lived experiences of ongoing recovery processes following COVID-19 infection.

BACKGROUND: Research in Denmark indicates that approximately 30% of people with confirmed COVID-19 infection experience at least one physical symptom 6-12 months after the acute infection. The lived experiences of undergoing prolonged recovery processes and how these processes unfold need further attention. AIM: To contribute in-depth knowledge about recovery, as experienced over time by people living with the post COVID-19 condition. METHODS: Within a qualitative research design, nine women and six men were interviewed. Ten of them gave a follow-up interview. Prompt cards and participant-generated photographs were included. A phenomenological-hermeneutic approach inspired by Ricoeur's theory of interpretation guided the data analysis. FINDINGS: Living with long-term health problems associated with the post COVID-19 condition involved recovery processes where participants struggled with reduced capacity, new unpredictability and uncertainty in everyday life. Participants continuously searched for improvement and aimed for regaining former health and well-being. Lack of knowledge, acknowledgement and support made it difficult to find clear directions for improvement. Participants created a protective shield and struggled, often jointly with family and friends, to cope with bodily, cognitive, emotional, existential and social challenges. Over time, some participants realised that they might not be able to fully return to their earlier habitus. However, some of them gained a new foothold and sense of hope for the future. CONCLUSION: This study provides in-depth insight into the experience of changing and open-ended recovery processes while living with the post COVID-19 condition. Over time, some participants learned to rebuild their lives, adapting to their reduced capacities. Future care and rehabilitation models for these patients must address the complex and challenging nature of recovery processes associated with living with post-COVID-19 condition.

Neo-train: study protocol and feasibility results for a two-arm randomized controlled trial investigating the effect of supervised exercise during neoadjuvant chemotherapy on tumour response in patients with breast cancer.

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.

Value of gym-based group exercise versus usual care for young adults receiving antipsychotic medication: study protocol for the multicenter randomized controlled Vega trial.

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.

Effect of In-Person Delivered Behavioural Interventions in People with Multimorbidity: Systematic Review and Meta-analysis.

BACKGROUND: To investigate the effect of in-person delivered behavioural interventions in people with multimorbidity and which behaviour change techniques (BCTs), targeting lifestyle behaviours, are associated with better outcomes. METHODS: Systematic review of randomised controlled trials. We searched MEDLINE, EMBASE, CENTRAL, and CINAHL and screened reference list of reviews including people with multimorbidity, registries, and citation tracking of included studies. Meta-analyses using random-effects model to assess the effect of behavioural interventions and meta-regression analyses and effectiveness ratios to investigate the impact of mediators on effect estimates. Cochrane 'Risk of Bias Tool' 2.0 and the GRADE assessment to evaluate the overall quality of evidence. RESULTS: Fourteen studies involving 1,378 people. Behavioural interventions had little to no effect on physical activity (standardised mean difference 0.38, 95% CI -0.12-0.87) and the effect on weight loss was uncertain (BMI mean difference -0.17, 95% CI -1.1-0.83) at the end-treatment follow-up. Small improvements were seen in health-related quality of life (SMD 0.29, 95% CI 0.17-0.42) and physical function (SMD 0.42, 95% CI 0.12-0.73), and moderate improvements were seen for depression symptoms (SMD -0.70, 95% CI -0.97-0.42). Studies using the BCTs 'action planning' and 'social support (practical)' reported greater physical activity and weight loss. CONCLUSIONS: Behavioural interventions targeting lifestyle behaviours may improve health-related quality of life and physical function, and reduce depression, whereas little to no effect was achieved on physical activity and weight loss in people with multimorbidity. However, the evidence for physical activity and weight loss were of low quality and the end-treatment benefits diminished over time.

Prevalence and consequences of spinal pain among people with type 1 and type 2 diabetes mellitus in Denmark.

PURPOSE: To describe 1-week and 1-year prevalence of spinal pain and its consequences in relation to leisure activity, work-life, and care-seeking in people with type 1 and 2 diabetes mellitus (DM). METHODS: A cross-sectional survey including adults diagnosed with DM from two Danish secondary care centres. Using the Standardised Nordic Questionnaire, spinal pain prevalence (cervical, thoracic, lumbar) and its consequences were evaluated (proportions, 95% confidence intervals) and compared to the general population. RESULTS: Among 3767 people, 1-week and 1-year spinal pain prevalence were 11.6-32.4 and 18.5-49.6%, respectively, highest for lumbar pain (24.6-49.6%). The prevalence was similar between DM types for cervical and thoracic pain, but higher in type 2 for lumbar spine. Women had higher pain prevalence across spinal regions and DM types, while cervical and thoracic pain estimates were higher for age < 60 vs. ≥ 60. Within the past year, > 50% reported pain > 30 days, high proportions had reduced their activities (leisure time, 43.7-63.9%; work, 20.7-33.3%), 13.3-28.1% reported sick-leave > 30 days, and 44.3-48.5% had sought care due to spinal pain. CONCLUSION: Spinal pain is common in people with type 1 and 2 DM, resulting in considerable consequences for work/leisure activities, sick-leave, and healthcare utilisation as compared to the general population.

Characteristics associated with comorbid lumbar spinal stenosis symptoms in people with knee or hip osteoarthritis: an analysis of 9,136 good life with osteoArthritis in Denmark (GLA:D®) participants.

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.

Singapore KneE osTeoarthritis CoHort (SKETCH): protocol for a multi-centre prospective cohort study.

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).

Effect of exercise therapy versus surgery on mechanical symptoms in young patients with a meniscal tear: a secondary analysis of the DREAM trial.

OBJECTIVE: To compare the effect of early surgery versus exercise and education on mechanical symptoms and other patient-reported outcomes in patients aged 18-40 years with a meniscal tear and self-reported mechanical knee symptoms. METHODS: In a randomised controlled trial, 121 patients aged 18-40 years with a MRI-verified meniscal tear were randomised to surgery or 12-week supervised exercise and education. For this study, 63 patients (33 and 30 patients in the surgery and in the exercise group, respectively) reporting baseline mechanical symptoms were included. The main outcome was self-reported mechanical symptoms (yes/no) at 3, 6 and 12 months assessed using a single item from the Knee Injury and Osteoarthritis Outcome Score (KOOS). Secondary outcomes were KOOS4 and the 5 KOOS-subscales and the Western Ontario Meniscal Evaluation Tool (WOMET). RESULTS: In total, 55/63 patients completed the 12-month follow-up. At 12 months, 9/26 (35%) in the surgery group and 20/29 (69%) in the exercise group reported mechanical symptoms. The risk difference and relative risk at any time point was 28.7% (95% CI 8.6% to 48.8%) and 1.83 (95% CI 0.98 to 2.70) of reporting mechanical symptoms in the exercise group compared with the surgery group. We did not detect any between-group differences in the secondary outcomes. CONCLUSION: The results from this secondary analysis suggest that early surgery is more effective than exercise and education for relieving self-reported mechanical knee symptoms, but not for improving pain, function and quality of life in young patients with a meniscal tear and mechanical symptoms. TRIAL REGISTRATION NUMBER: NCT02995551.

Benefits and Harms of Digital Health Interventions Promoting Physical Activity in People With Chronic Conditions: Systematic Review and Meta-Analysis.

BACKGROUND: Digital health interventions for managing chronic conditions have great potential. However, the benefits and harms are still unclear. OBJECTIVE: This systematic review and meta-analysis aimed to investigate the benefits and harms of digital health interventions in promoting physical activity in people with chronic conditions. METHODS: We searched the MEDLINE, Embase, CINAHL, and Cochrane Central Register of Controlled Trials databases from inception to October 2022. Eligible randomized controlled trials were included if they used a digital component in physical activity promotion in adults with ≥1 of the following conditions: depression or anxiety, ischemic heart disease or heart failure, chronic obstructive pulmonary disease, knee or hip osteoarthritis, hypertension, or type 2 diabetes. The primary outcomes were objectively measured physical activity and physical function (eg, walk or step tests). We used a random effects model (restricted maximum likelihood) for meta-analyses and meta-regression analyses to assess the impact of study-level covariates. The risk of bias was assessed using the Cochrane Risk of Bias 2 tool, and the certainty of the evidence was assessed using the Grading of Recommendations Assessment, Development, and Evaluation. RESULTS: Of 14,078 hits, 130 randomized controlled trials were included. Compared with usual care or minimal intervention, digital health interventions increased objectively measured physical activity (end of intervention: standardized mean difference [SMD] 0.29, 95% CI 0.21-0.37; follow-up: SMD 0.17, 95% CI 0.04-0.31) and physical function (end of intervention: SMD 0.36, 95% CI 0.12-0.59; follow-up: SMD 0.29, 95% CI 0.01-0.57). The secondary outcomes also favored the digital health interventions for subjectively measured physical activity and physical function, depression, anxiety, and health-related quality of life at the end of the intervention but only subjectively measured physical activity at follow-up. The risk of nonserious adverse events, but not serious adverse events, was higher in the digital health interventions at the end of the intervention, but no difference was seen at follow-up. CONCLUSIONS: Digital health interventions improved physical activity and physical function across various chronic conditions. Effects on depression, anxiety, and health-related quality of life were only observed at the end of the intervention. The risk of nonserious adverse events is present during the intervention, which should be addressed. Future studies should focus on better reporting, comparing the effects of different digital health solutions, and investigating how intervention effects are sustained beyond the end of the intervention. TRIAL REGISTRATION: PROSPERO CRD42020189028; https://www.crd.york.ac.uk/prospero/display_record.php?RecordID=189028.

Two-year MRI-defined structural damage and patient-reported outcomes following surgery or exercise for meniscal tears in young adults.

OBJECTIVE: To investigate potential differences in structural knee joint damage assessed by MRI and patient-reported outcomes (PROMs) at 2-year follow-up between young adults randomised to early surgery or exercise and education with optional delayed surgery for a meniscal tear. METHODS: A secondary analysis of a multicentre randomised controlled trial including 121 patients (18-40 years) with an MRI-verified meniscal tear. For this study, only patients with 2-year follow-up were included. The main outcomes were the difference in worsening of structural knee damage, assessed by MRI using the Anterior Cruciate Ligament OsteoArthrits Score, and the difference in change in the mean score of four Knee Injury and Osteoarthritis Outcome Score (KOOS4) subscales covering pain, symptoms, function in sport and recreation, and quality of life, from baseline to 2 years. RESULTS: In total, 82/121 (68%) patients completed the 2-year follow-up (39 from the surgical group and 43 from the exercise group). MRI-defined cartilage damage had developed or progressed in seven (9.1%) patients and osteophytes developed in two (2.6%) patients. The worsening of structural damage from baseline to 2-year follow-up was similar between groups. The mean (95% CI) adjusted differences in change in KOOS4 between intervention groups from baseline to 2 years was -1.4 (-9.1, 6.2) points. The mean improvement in KOOS4 was 16.4 (10.4, 22.4) in the surgical group and 21.5 (15.0, 28.0) in the exercise group. No between group differences in improvement were found in the KOOS subscales. CONCLUSIONS: The 2-year worsening of MRI-defined structural damage was limited and similar in young adult patients with a meniscal tear treated with surgery or exercise with optional delayed surgery. Both groups had similar clinically relevant improvements in KOOS4, suggesting the choice of treatment strategy does not impact 2-year structural knee damage or PROMs. TRIAL REGISTRATION NUMBER: NCT02995551.

Chronic Pain and Functional Outcome 3 years After Total Knee Arthroplasty and Perioperative Dexamethasone: A Follow-Up of the Randomized, Clinical DEX-2-TKA Trial.

BACKGROUND: Perioperative dexamethasone as an adjunct to multimodal analgesia, has an opioid-sparing and pain alleviating effect after total knee arthroplasty (TKA), however, the 3-year effects are unknown. We aimed to investigate the 3-year effect of 1 (DX1) or 2 (DX2) intravenous doses of 24 mg dexamethasone or placebo on pain, physical function, and health-related quality of life after TKA. METHODS: Patients who participated in the Dexamethasone Twice for Pain Treatment after TKA (DEX-2-TKA) were invited to physical tests and questionnaires (self-reported characteristics, Oxford Knee Score, EuroQol-5Dimensions-5Levels (EQ5D5L), and PainDetect). The tests were 40-meter Fast Paced Walk (40FPW) test, Timed Up and Go (TUG), 30 Second Chair Stand test (30CST), Stair Climb Test (SCT), bilateral knee Range of Motion, and knee extension torque. For each test the peak pain intensity was registered on a 0 to 100 mm Visual Analogue Scale. Primary outcome was average peak pain intensity during the 40FPW, TUG, 30CST and SCT. Secondary outcomes were the tests and questionnaires. Out of 252 eligible patients, 133 (52.8%) underwent the tests and 160 (63.5%) answered the questionnaires. Mean follow-up time was 33 months (range, 23 to 40). RESULTS: Median (interquartile range) peak pain intensity was 0 (0 to 65) for the DX2 group, 0 (0 to 51) for DX1 group and 0 (0 to 70) for the placebo group (P = .72). No differences in secondary outcomes were identified. CONCLUSION: One or 2 intravenous doses of 24 mg dexamethasone did not impact chronic pain development or physical function 3 years after TKA.