To evaluate the feasibility of using wearable inertial measurement units (IMUs; small body-worn sensors that capture linear acceleration and angular velocity) combined with machine learning (ML) to identify anterior cruciate ligament (ACL) injuries during clinical knee joint laxity assessments.
Prospective exploratory feasibility study using a case–control design. A feed-forward neural network classifier was trained on time-normalised IMU signals recorded during Lachman and Anterior Drawer tests to distinguish ACL-injured from healthy knees. Model performance was assessed using 10-fold participant-level cross-validation and reported at repetition-wise and subject-wise levels.
Biomechanics laboratory within a secondary care setting in London, UK. Recruitment occurred through an acute soft-tissue injury management clinic.
50 participants were recruited: 26 healthy controls and 24 individuals with an MRI-confirmed ACL injury (partial or complete) sustained within the current injury episode. Healthy controls contributed 52 uninjured legs and ACL-injured participants contributed 25 injured and 23 contralateral uninjured legs (including 1 bilateral injury). Inclusion criteria for the injured group were acute knee injury, MRI-confirmed ACL tear and ability to bear weight. Controls were ≥18 years with no history of knee ligament injury. Exclusion criteria included age 45, chronic joint conditions, non-weightbearing status, pregnancy, allergy to adhesives or inability to provide informed consent. All participants completed the study.
Not applicable. Participants underwent standardised clinical Lachman and Anterior Drawer tests performed by a specialist physiotherapist while IMUs were mounted on the femur and tibia using a custom three-dimensional-printed rig.
The primary outcome was diagnostic accuracy of an ML model classifying ACL injury status (injured vs healthy) based on IMU-derived linear acceleration and angular velocity (three axes per sensor). Secondary outcomes included sensitivity, specificity, positive predictive value (PPV), negative predictive value (NPV), area under the receiver operating characteristic curve (AUROC) and F1 score. Planned model assessments (repetition-wise and subject-wise) were completed as intended. Hyperparameter adjustments were made post hoc to address overfitting when expanding to the full dataset.
Across the full dataset (n=50), the comparative leg model (method 2) achieved a subject-wise diagnostic accuracy of 81%, sensitivity 83%, specificity 79%, PPV 80% and NPV 83% using 10-fold participant-level cross-validation. Repetition-wise accuracy was 71%. Discriminative performance was moderate (AUROC 0.773), with an F1 score of 0.889. The individual leg model (method 1) showed lower performance (subject-wise accuracy 70%; sensitivity 43%; specificity 81%).
This study supports the feasibility of wearable sensors to be used in the clinical assessment of ACL injury to assist in capturing movement features associated with joint laxity. More work should be done to increase generalisability and validate findings further.
This study aimed to investigate the effects of different types of exercise on body composition in women with overweight or obesity and to compare the relative effectiveness of these interventions using a systematic review and network meta-analysis.
Systematic review and network meta-analysis using the CINeMA (Confidence in Network Meta-Analysis) approach.
PubMed, Embase, CINAHL, SportsDiscus, the Cochrane Library, Web of Science and Scopus were searched through September 2025.
We included randomised controlled trials enrolling adult women with overweight or obesity that evaluated structured exercise interventions, including aerobic exercise, resistance training, aerobic exercise with resistance training, high-intensity interval training or whole-body vibration training. Eligible studies compared these interventions with control conditions or other exercise modalities and reported at least one body composition outcome, including body fat percentage, body mass index, fat mass, lean body mass or waist circumference.
Two independent reviewers used standardised methods to search, screen and code included studies. Risk of bias was assessed using the Cochrane Collaboration and Evidence Project tools. Network meta-analysis was conducted using random effects models. Confidence in the estimates was assessed using the CINeMA approach.
43 randomised controlled trials involving 2315 women were included. For body fat percentage, aerobic exercise with resistance training, high-intensity interval training and aerobic exercise across varying intensities were associated with greater reductions relative to control conditions, with vigorous aerobic exercise showing the highest probability of benefit. A similar pattern was observed for other adiposity-related outcomes: vigorous aerobic exercise appeared most favourable for body mass index, high-intensity interval training for fat mass and moderate to vigorous intensity aerobic exercise for waist circumference. No intervention was associated with statistically significant improvements in lean body mass compared with control; however, resistance training demonstrated a comparatively favourable ranking profile.
Structured exercise confers meaningful improvements in adiposity among women, particularly with aerobic-based modalities, whereas effects on lean mass remain limited. These results underscore the importance of tailored exercise strategies for optimising body composition in female populations.
CRD420251161064.
Asthma, chronic obstructive pulmonary disease (COPD) and obstructive sleep apnoea (OSA) are prevalent chronic respiratory diseases associated with increased comorbidity, mortality and healthcare costs. Physical activity and exercise are widely recommended as part of treatment for these conditions, yet the specific effects of Nordic walking (NW) remain underexplored. The aims of this randomised controlled trial (RCT) are to improve physical fitness, functional capacity and respiratory health and increase regular physical activity and quality of life of older adults with asthma and/or COPD and/or OSA through a supervised 3-month group-based NW intervention combined with resistance, balance and mobility training.
This single-blinded, parallel-group RCT will recruit 100 adults aged 55–80 years diagnosed with asthma and/or COPD and/or OSA in the Northern Savo region of Finland. Participants will be randomly allocated to either an intervention group or a control group.
The intervention group will participate in a 12-week supervised exercise programme consisting of progressive NW sessions twice per week and resistance, balance and mobility training once per week. The primary outcome is a change in cardiorespiratory endurance. Secondary outcomes include functional capacity, physical activity level, spirometry parameters and quality of life. The control group will continue their usual physical activity and receive physical activity guidance after 12 weeks. Measurements were conducted at baseline, three and 9 months. Data will be analysed according to the intention-to-treat principle. Group differences over time will be examined using appropriate parametric or non-parametric methods depending on data distribution.
Ethical approval was obtained from the Regional Medical Research Ethics Committee of Eastern Finland Collaborative Area (892/13.00/2023). Findings will be disseminated through publications in peer-reviewed journals and presentations at scientific conferences.
The trial is registered at ISRCTN12097135, registration date: 7 June 2024.
Sports-related concussion (SRC) is an established research topic in the context of sport professionals suffering from mild traumatic brain injury (mTBI), but there is scant investigation of SRC arising in school-aged athletes. Effective management of SRC in adolescents is especially dependent on obtaining an understanding of its pathophysiology and the multifaceted nature of recovery. In this planned observational study, we shall investigate the associations among multimodal data comprising blood-based and saliva-based biomarkers, diffusion tensor imaging (DTI), quantified susceptibility imaging (QSM), resting state functional connectivity MRI (rsfMRI) and cognitive testing in school rugby players with a conventional diagnosis of concussion. Our objective is to map out a natural history of the post-concussion injury and recovery process as measured by diverse biomarkers.
This prospective cohort study will enrol 450 male adolescents who participate in sports (including rugby, basketball and swimming). We shall quantify blood biomarker levels (total tau, neurofilament light, glial fibrillar acidic protein and ubiquitin C-terminal hydrolase-L1), white matter integrity on DTI, cerebral venous oxygen saturation on QSM, connectivity metrics on rsfMRI and cognitive performance after SRC. We conduct measurements at pre-injury baseline measure and post-SRC at four to five pivotal times: day 1 (day of injury), 3, 6, 13 and 21 (if symptoms persist) post-concussion. Using mixed-effects and trajectory modelling, we shall assess biomarker trajectories.
We have secured ethical approval for this study from The University of Queensland’s Human Research Ethics Committee, Queensland. We shall inform participants and/or their guardians verbally and in writing of the study’s scope and procedures as a condition for informed consent. The dissemination of findings shall entail peer-reviewed publications and presentations at national and international conferences and via research and clinical networks. Completion of this study should provide a clearer understanding of anatomic and functional outcomes in adolescents with sports-related concussion.
The multimodal investigation of a cohort of adolescents suffering from concussion in the context of community sports should offer broad insight into the effects of mTBI on the developing brain.
The purpose of this study is to evaluate the relationship between psychosocial factors, muscle performance and treatment response in individuals undergoing an exercise-based physical therapy (EBPT) programme for chronic low back pain (CLBP).
A secondary analysis of a prospectively collected clinical registry involving participants with CLBP enrolled in an 8–10-week EBPT programme. Participants completed psychosocial questionnaires before starting EBPT for CLBP. Lumbar extensor muscle performance was assessed using an isokinetic dynamometer, which recorded absolute and age and sex adjusted torque. Differences in muscle performance (absolute and adjusted) were calculated and regressed against psychosocial factors and clinical outcomes.
Absolute and adjusted torque increased with treatment (33.33% and 82.84% respectively, p0.20).
Individuals with CLBP demonstrated improved muscle performance and clinical outcomes after EBPT, though these improvements were independent of each other. Better absolute lumbar extensor muscle performance correlated with higher pain self-efficacy, and greater treatment response corresponded with lower fear-avoidance. These data suggest that pain coping strategies and addressing fear avoidance through educational and exposure-based interventions may be a target for modifying muscle performance in CLBP.
Research has yielded contradictory results regarding differences in physical fitness and cardiometabolic risk between children and adolescents living in rural and urban areas.
The present study aimed to analyse the moderating role of area of residence on the association of physical fitness and anthropometric parameters in Chilean adolescents.
Cross-sectional analysis of a nationally representative school-based sample from Chile.
A total of 7,833 adolescents with an average age of 15.8±0.7 years participated in both rural (n=759) and urban (n=7,074) settings. Physical fitness tests were evaluated using the Assessing Levels of Physical Activity and Fitness (ALPHA-Fitness) battery and anthropometric variables such as body mass index (BMI), waist circumference (WC) and waist-to-height ratio (WHtR). Generalised linear models with Gaussian distributions were constructed to estimate moderation models, with anthropometric-related variables as dependent variables, physical fitness variables as independent variables and area of residence as a moderator. Moderation analyses were conducted to examine whether the area of residence influences the association between physical fitness and anthropometric indicators (WC, WHtR and BMI).
In all models, place of residence did not moderate the potential associations between physical fitness and anthropometric indicators; for example, cardiorespiratory fitness with WC (B=0.13, 95% CI 0.05 to 0.31; 0=0.160), WHtR (B=0.08, 95% CI –0.03 to 0.20; p=0.143) or BMI (B=0.08, 95% CI –0.03 to 0.20; p=0.207).
These findings suggest the associations between physical fitness and anthropometric outcomes do not differ significantly between rural and urban adolescents.
While exercise adherence is known to vary during cancer treatment, little is known about what predicts these changes during chemotherapy or within individual treatment cycles for breast cancer. We examined changes in adherence and its predictors (1) across chemotherapy treatment and (2) within treatment cycles in women undergoing (neo-)adjuvant chemotherapy for breast cancer.
This study is based on data from the Phys-Can multicentre parallel randomised trial.
The exercise intervention was conducted at public gyms in three Swedish university cities.
178 women undergoing (neo-)adjuvant chemotherapy without any chemotherapy treatment delays and had any adherence data were included in the analysis.
Participants in the Phys-Can trial were randomised to either high or low-to-moderate intensity combined endurance and resistance training.
The primary outcome variable for this secondary analysis of Phys-Can trial data was adherence to endurance and resistance training. Bayesian multilevel growth curve models were used to examine adherence to resistance and endurance training throughout the chemotherapy treatment period and within chemotherapy cycles. Potential predictors of adherence included exercise intensity, chemotherapy dose, muscle strength, body mass index, cardiorespiratory fitness, fatigue and age. Results are reported with 95% credibility intervals (CrIs).
Adherence to endurance and resistance training declined on average across the chemotherapy treatment by 1% (95% CrI –1.5, –0.5) and 5.2% (95% CrI –6.8, –3.6), respectively, per week. Adherence decreased within the chemotherapy treatment cycle by 2.4% for endurance (95% CrI –4.2, –0.7) and 6.1% (95% CrI –8.2, –4.1) for resistance training, respectively. Higher baseline fitness predicted better adherence to endurance exercise (β=1.2, 95% CrI 0.1, 2.3), while high-intensity training predicted a steeper decline (β=–1.2, 95% CrI –2.2, 0.2). No significant predictors were found for adherence to resistance training over time.
Women with breast cancer may require additional support to maintain exercise adherence during the later stages of chemotherapy and during the second and third weeks of their chemotherapy cycles. Those with lower pretreatment fitness levels may benefit from more intensive support to sustain engagement in exercise.
The Phys-Can trial was registered in Clinical trials: ClinicalTrials.gov NCT02473003,
Overweight and obesity are major global public health challenges and increase the risk of type 2 diabetes, dyslipidaemia, hypertension and cardiovascular disease. Exercise is a safe and cost-effective non-pharmacological strategy to improve cardiometabolic health, yet the optimal combinations of exercise modality and dose for key cardiometabolic outcomes remain uncertain. This protocol aims to synthesise evidence on the joint effects of exercise modality and dose in adults with overweight or obesity and to identify modality–dose combinations associated with the most favourable cardiometabolic profiles.
We will search PubMed, Embase, Web of Science, the Cochrane Library, Scopus, SPORTDiscus and China National Knowledge Infrastructure (CNKI) from inception to June 2026 for randomised controlled trials of exercise interventions in adults (≥18 years) with overweight or obesity. Risk of bias will be assessed using the Cochrane Risk of Bias 2 tool. We will conduct a Bayesian model-based dose–response network meta-analysis to estimate modality-specific dose–response relationships across cardiometabolic outcomes, with exercise dose standardised as metabolic equivalent of task minutes per week. Non-linear dose–response curves will be fitted to estimate minimum effective doses and optimal dose ranges. Meta-classification and regression tree analyses will be used to explore potential effect modifiers.
Ethical approval is not required because no primary data will be collected. Findings will be submitted to a peer-reviewed journal.
CRD420251229131.
People with longstanding hip and groin pain (LHGP) are often referred to orthopaedic care. Physical therapist-led interventions are recommended in consensus statements as the first line of treatment, but it is unknown if structured interventions are more effective than usual care. The aim of this trial is to evaluate the effectiveness of a structured physical therapist-led treatment model (HIPSTER) compared with usual care on hip-related quality of life at 4 months for people with LHGP referred to orthopaedic care.
This is a preregistered (clinicaltrials.gov, NCT05853640) study protocol for a double-blinded two-armed pragmatic randomised controlled trial. Patients with LHGP (n=122), referred to the Department of Orthopaedics at a university hospital in Sweden, will be randomised into the HIPSTER model or usual care. The HIPSTER model is a 16-week structured, individualised progressive treatment using exercise therapy and patient education. Usual care consists of a recommendation to contact a physical therapist in primary care. Both groups will undergo standard examinations and a surgical consultation at the Department of Orthopaedics. The primary outcome will be the mean group change in the International Hip Outcome Tool from baseline to 4 months, according to intention-to-treat principles. Secondary outcomes include patient-reported outcomes (such as perceived improvement, psychological factors and physical activity), physical impairment tests and radiographic measures. Additional time points will be 1, 2 and 5 years after baseline. Subgroups of patients will complete semistructured interviews and report additional data on psychosocial variables to provide more information on patient experience as well as determinants of adherence.
The Swedish Ethical Review Authority approved this study (Dnr 202205023–01). The results of this study will be published, regardless of results, in scientific journals and as plain language summaries for participants.
This study aimed to address the lack of a holistic understanding of the total knee arthroplasty (TKA) journey in China by systematically mapping patient experiences to identify interconnected needs, emotional transitions and critical pain points across the entire care continuum.
A longitudinal descriptive qualitative study using patient journey mapping methodology. Data from three sequential one-on-one semistructured interviews (preoperative, in-hospital postoperative and home rehabilitation phases) were chronologically coded into journey stages.
A tertiary hospital in Shanghai, China.
Twelve patients scheduled for elective TKA, aged 61–80 years (mean 70.25±5.86).
Five categories with 17 subcategories were identified: (1) declining quality of life drives the need for change, (2) trust compensates for information gaps in decision-making, (3) hospital adaptation challenges heighten anxiety, (4) strong support needs emerge post-surgery and (5) navigating complex home recovery needs with insecurity. The patient journey was mapped across four stages: intention to change, consultation and decision-making, hospitalisation and surgery and rehabilitation and recovery. Analysis revealed several cross-stage issues: (1) the influence of disease status and treatment decision quality on postoperative outcomes, (2) inadequate preadmission preparation hindering hospital adaptation and comorbidity management and (3) insufficient predischarge planning leading to negative post-hospital rehabilitation experiences.
Quality deficits in early-stage interactions can trigger a cascading effect on subsequent patient experience and clinical outcomes. During the two critical phases of selecting a healthcare provider and deciding on surgery, patients undergo a transition from ‘insufficient information support’ to ‘reliance on trust’. However, irrational decision-making and unrealistic expectations collectively form a potential risk for postoperative decisional regret and dissatisfaction. Underused preoperative preparation leads to difficulties during hospitalisation, while inadequate discharge support hinders home recovery. Identifying these cross-stage pain points highlights timely intervention opportunities. Future improvements can be achieved through process redesign and technology integration, such as intelligent decision aids and remote rehabilitation systems, to enhance overall patient experience and outcomes.
To examine the association between spinal mobility, disease activity, frailty and cardiorespiratory fitness (maximal oxygen uptake (VO2max)) in patients with ankylosing spondylitis (AS).
A cross-sectional comparative study was conducted at the University of Lahore and seven government hospitals (March–August 2025) including 74 patients with AS (40–55 years, modified New York criteria) and 77 age-matched and sex-matched healthy controls. Assessments included disease activity (Bath Ankylosing Spondylitis Disease Activity Index), functional limitation (Bath Ankylosing Spondylitis Functional Index), spinal mobility (Bath Ankylosing Spondylitis Metrology Index (BASMI)), chest expansion, frailty (Fatigue, Resistance, Ambulation, Illnesses, Loss of weight scale), pulmonary function and cardiorespiratory fitness (VO2max) via symptom-limited cardiopulmonary exercise testing. Functional performance was measured with the 6 min walk test (6MWT), and physical activity with the International Physical Activity Questionnaire (IPAQ). Data were analysed using t-tests, 2 tests, correlations and regression models to examine associations between clinical measures and cardiorespiratory fitness.
Among 151 participants (74 AS, 77 controls), AS patients showed significantly reduced pulmonary function (forced expiratory volume in one second 83.5% vs 91.2%, forced vital capacity 85.1% vs 93.0%), lower VO2max (27.8 vs 33.4 mL/kg/min), impaired spinal mobility (BASMI 5.1 vs 1.2) and decreased chest expansion (2.8 vs 5.6 cm; all p2max was inversely correlated with disease activity, spinal stiffness, frailty and structural damage and positively correlated with chest expansion, 6MWT and activity levels. AS status, higher disease activity, greater spinal stiffness and reduced chest expansion independently predicted low physical activity.
AS is associated with impaired pulmonary function, reduced spinal mobility and lower cardiorespiratory fitness, with disease activity, stiffness and restricted chest expansion potentially influencing physical activity and overall functional capacity.
The use of bone-anchored prostheses (BAPs) has greatly increased quality of life for lower limb amputees. However, the long-term frequency of skeletal fractures and the need for arthroplasty surgery in the lower extremities following BAP use is scarce.
The current study aimed to investigate the frequency of fractures and arthroplasties in the lower limb after BAP surgery with the Osseointegrated Prosthesis for the Rehabilitation of Amputees (OPRA) system.
Retrospective cohort study using the OPRA database and medical record review for data collection.
A single-centre study at a tertiary hospital.
All patients with a transfemoral BAP (OPRA system) who underwent surgery between 1999 and 2019, and had completed at least 2 years of follow-up were included in the study. Patients with bilateral transfemoral amputations were excluded. A total of 100 patients were included.
The primary outcome measure was to identify patients who had a fracture or had undergone arthroplasty surgery in the lower extremities after BAP surgery.
Of the 100 patients included, 16 patients (16%) had an event in their lower limb. 11 patients (11%) had a fracture, all of the femur, and six patients (6%) underwent arthroplasty surgery due to osteoarthritis. Long-term prosthetic use was not affected by the occurrence of an event.
Patients with BAP may be at a higher risk for femur fractures and arthroplasty surgery than the general population. Although encouraging that prosthetic usage is not affected after a fracture or arthroplasty surgery, prospective studies on larger cohorts and control groups need to be conducted.
Childhood and adolescence are critical developmental periods marked by increasing physical inactivity, stress and mental health problems. TABATA training, a supramaximal form of high-intensity interval training, has been increasingly promoted as a time-efficient approach to improving health. However, evidence on its specific effects in children and adolescents remains limited, fragmented and not systematically synthesised. The objective of this review is to determine whether TABATA training improves physical fitness and mental health outcomes in children and adolescents aged 6–18 years.
We will perform a systematic review of experimental studies in the following databases: PubMed, Scopus, Cochrane Library and Web of Science. The initial literature search was conducted in May 2025, and the systematic review is expected to be completed by March 2026. Eligible studies will include multisession Tabata interventions defined as repeated 20 s high-intensity bouts with 10 s rest intervals, typically performed for 7–8 cycles per set, with or without multiple sets. Outcomes will include physical fitness indicators and mental health indicators. Study selection and data extraction will follow the Population, Intervention, Comparison, Outcomes, Study design framework and Preferred Reporting Items for Systematic Review and Meta-Analysis Protocols guidelines. The risk of bias will be assessed using the Cochrane Risk of Bias 2 tool for randomised trials and Risk Of Bias In Non-randomised Studies - of Interventions for non-randomised studies. When sufficient data are available, quantitative synthesis will be conducted using a three-level random-effects meta-analytic model to account for dependency among effect sizes and anticipated clinical and methodological heterogeneity across studies. Effect sizes for continuous outcomes will be calculated as standardised mean differences. Sensitivity analyses will be performed, and publication bias will be assessed using funnel plots when an adequate number of studies is available. Statistical analyses will be performed using R and Review Manager (RevMan) V.5.4, where appropriate.
The results of the systematic review will be disseminated via publication in a peer-reviewed journal and presented at a relevant conference. As we will not use individual patient data, ethical approval is not required.
CRD42025632986.
Low physical functioning and frailty are prevalent in non-geriatric vulnerable populations such as people experiencing homelessness, addiction and mental health challenges. The objective of this study was to explore the feasibility and impact of a targeted exercise intervention with protein supplementation for women experiencing homelessness, addiction and mental health challenges.
Mixed-methods feasibility study.
A women’s-only day service for people with homelessness and addiction issues, in Dublin, Ireland.
Women experiencing homelessness, addiction and mental health challenges.
The intervention was a 10-week low-threshold exercise and protein supplementation pre-post programme (LEAP-W). Qualitative interviews were conducted following the intervention with programme participants and key stakeholders.
The primary outcome was feasibility measured by recruitment, retention, adherence, safety and acceptability, and secondary outcomes measured pre-post intervention change in physical function, pain, nutritional and frailty status, and overall health status.
Overall, 33 participants were recruited. Data generated demonstrated that LEAP-W was feasible by its safety, acceptability and high retention in certain subgroups, and high adherence to the exercise and protein supplement; its impact was demonstrated by pre-post intervention improvement in multiple domains (strength (chair stand test), balance (the single leg stance test), pain and quality of life/mental health (mental component summary of the Short Form-12; 95% CI, p
Targeted exercise interventions with trauma-sensitive, flexible design can be successfully delivered and yield impact in women with complex needs who experience homelessness, addiction and mental health challenges. Service design should be considered when delivering interventions to this population. Further higher-powered longitudinal studies are warranted.
The management of active patients with symptomatic knee osteoarthritis (KnOA) who are too young for total knee arthroplasty poses a specific challenge to clinicians. Research studies show that improving quadriceps muscle strength improves pain and function; however, aspects of the disease render it difficult for patients to achieve and maintain improvements. Recombinant human growth hormone (rHGH) is shown to increase the magnitude and duration of muscle growth when combined with exercise treatment in adult populations. Hence, rHGH combined with physical therapy may provide meaningful benefits in the treatment of KnOA.
This is a single-centre, double-blind, randomised trial to pilot a future Phase III trial from 2025 to 2028. Participants are aged 18–60 with clinical and radiographic evidence of isolated degenerative arthritis of the knee (patellofemoral or tibiofemoral). The investigational product is rHGH (Saizen (somatropin of rDNA origin, EMD Serono)) and a saline placebo. Participants will deliver the solution via subcutaneous injection area once per day at a dose of 0.5 mg HGH per body surface area (0.5 mg/m2) for 6 weeks, alongside participation in a lower limb strengthening programme developed by rehabilitation specialists. 17 participants will be recruited into each study arm.
The primary outcomes are feasibility (compliance with the study drug regimen for the 6-week administration period and enrolment rate) and safety (the proportion of minor and major adverse events between groups). The primary endpoint for these outcomes will be at 6 weeks. The secondary outcomes are knee extension strength, knee flexion strength, radiographic arthritis progression, thigh muscle circumference, MRI-measured quadriceps muscle volume and patient-reported outcome measures (Knee Osteoarthritis Outcome Score (KOOS), SF-20 and Tegner). The primary endpoint for these outcomes will be at 12 weeks, and the final endpoint will be 24 months, where final radiographic (X-ray) assessment will take place.
The primary outcome of compliance will be a calculation of mean compliance between groups, which can be analysed as a t-test after the treatment period. A two-sample, two-sided t-test will compare the clinical (secondary) outcome of greatest interest: knee extension strength at baseline versus week 6 compared between treatment groups. Other secondary outcomes will be compared using a simple linear mixed-effects model. The 2 test will be used to determine whether the number of participants who made meaningful changes was different between groups. The null hypotheses are that the rHGH and placebo groups will have no difference in compliance rates, safety events, knee extension strength at 12 weeks and arthritis grade progression at 24 months.
This study has been approved by the Sunnybrook Research Institute Research and Ethics Board (#6427) and received a no-objection letter from Health Canada Clinical Trials. The primary sponsor is the Sunnybrook Centre for Clinical Trial Studies (CCTS). The findings of this study will be published in a peer-reviewed journal and presented at orthopaedic conferences.
To evaluate the criterion validity and test–retest reliability of the Chinese version International Physical Activity Questionnaire-Short Form (cIPAQ-SF) for assessing sedentary behaviour and physical activity (PA) in overweight and obese Chinese adults, using activPAL as the reference.
A cross-sectional study was conducted at a Clinical Nutrition Clinic in China. Participants completed the cIPAQ-SF before and after wearing an activPAL for 7 consecutive days. Criterion validity was assessed using Pearson’s/Spearman’s correlation coefficients and Bland-Altman plots for sitting time (hours/day), moderate, vigorous and moderate-to-vigorous PA (MVPA) (min/week). Sensitivity and specificity evaluated the IPAQ-SF’s accuracy in identifying those not engaging in any PA and those not meeting the PA recommendation (MVPA ≥150 min/week). Test–retest reliability was assessed using intraclass correlation (ICC).
Among 80 participants (age 33.9±7.3 years; body mass index 29.1±4.5 kg/m²), the IPAQ-SF demonstrated moderate criterion validity for sitting time (r=0.577 on weekdays, r=0.444 on weekends) and MVPA (=0.451) compared with activPAL. It underestimated sitting time by 3.5 hours/day on weekdays and 2.9 hours/day on weekends. The cIPAQ-SF showed moderate-to-high sensitivity for correctly identifying individuals who were not engaging in any PA (53.6%–85.7%) or not meeting PA recommendations (93.8%), but its specificity was low to moderate (47.8%–73.7%) for PA engagement and meeting guidelines (55.2%). Test–retest reliability was moderate for sitting time (ICC=0.549–0.614) and poor to moderate for PA levels (ICC=0.453–0.592).
The IPAQ-SF demonstrates moderate validity and reliability in assessing sedentary behaviour and insufficient PA among overweight and obese Chinese adults. It can be used to identify physically inactive individuals for targeted interventions and monitor changes in sedentary behaviour.
The Latarjet procedure is the mainstay treatment in high-demand patients with substantial glenoid bone loss or after failed capsulolabral repairs. Patients typically return to sport (RTS) within 6 months postoperatively, requiring intensive rehabilitation. Current rehabilitation protocols focus on mobility, strength and stability. Yet, psychological factors, such as fear of reinjury, are the main reason not to RTS. Therefore, this study aims to determine whether integrating psychological interventions into postoperative rehabilitation improves patient-reported shoulder function compared with physical therapy alone.
This monocentric randomised controlled trial will enrol 52 patients undergoing a Latarjet procedure for anterior shoulder instability. Participants will be equally and randomly assigned to either postoperative physical therapy combined with cognitive behavioural therapy or physical therapy alone. Eligibility criteria include patients aged 18–67 years undergoing an open or arthroscopic Latarjet procedure at our institution. Exclusion criteria include posterior or multidirectional instability, rotator cuff tear, prior shoulder surgery, anxiety disorder, using anxiolytics, neurological disorder, systemic disease, previous hospitalisation for shoulder pain and proximal humerus fractures.
The primary outcome is the Western Ontario Shoulder Index at 6 months postoperatively. Secondary outcomes include incidence of recurrent dislocations, RTS and return-to-work rates, Tampa Scale of Kinesiophobia for Shoulder Instability, subjective shoulder value and visual analogue score for pain at 6 months postoperatively as well as the Shoulder Instability Return to Sport after Injury scale at 4.5 months postoperatively.
This study was approved by the French Committee of Person Protection West I. The national registration number is 2023-A02057-38. The study has been registered at Clinicaltrials.gov with trial registration number NCT06154889. Patients are not financially compensated for participation and are allowed to withdraw from the study at any time without any preconditions. The final results of the study will be submitted for publication in a peer-reviewed journal and an abstract of the study will be submitted to international scientific meetings by the end of 2026. Data will be made available by the corresponding author on reasonable request.
The study has been registered at Clinicaltrials.gov with trial registration number NCT06154889. The trial sponsor is Vivalto Santé.
The Shoulder Instability Registry (SIR) was established in 2019 to systematically capture and monitor outcomes following surgical treatment of shoulder instability (SI). The aim of this cohort profile is to describe the purpose, design, data structure and baseline characteristics of the SIR, and to outline how the registry supports longitudinal assessment of safety, functional recovery, quality of life and patient-reported outcomes after surgical treatment of SI.
The registry includes all patients treated surgically for SI. Data collection includes medical history of instability, surgical techniques and intraoperative findings. Clinical assessments include range of motion, instability-specific tests, hyperlaxity signs, Constant Score, subjective shoulder value and SI-specific scores such as the ROWE Score and the Western Ontario Shoulder Instability Index. Radiological evaluations included initial and follow-up imaging via X-rays and CT to assess bony lesions and SI-related arthropathy, as well as MRI for soft tissue injuries. Data are documented preoperatively, at 6 months and at 24 months postoperatively. Although the SIR is an observational cohort rather than a randomised clinical trial, treatment effectiveness is evaluated through longitudinal changes in validated patient-reported outcomes, clinical performance measures and imaging findings.
Between January 2019 and December 2024, 668 patients have been registered (mean age 31 years, 82% men, mean body mass index of 25). According to the American Association of Anesthesiology (ASA) Classification, 66% of patients were classified as ASA I, 33% as ASA II and only 1% as ASA III. 69% of admissions were due to accidents and 31% due to illness. Mean surgery duration was 75 min, and the median hospital stay was 2 days. 38% of patients were insured privately and had general insurance in 62%. 85% of cases were treated arthroscopically, and 15% were treated openly. Baseline clinical scores showed a mean Constant Score of 77 points, mean subjective shoulder value of 49%, mean ROWE Score of 46 points and mean Western Ontario Shoulder Instability Index of 53. Based on Gerber’s classification, 68% of cases were type B2, 29% B3, 2% B5 and fewer than 2% were classified as B4 or B1. 85% of cases suffered from anterior instability, while only 13% experienced posterior instability, the remaining 2% showed multidirectional instability. Among posterior cases, Moroder’s classification identified 58% as type B2, 19% as A2, 7% as A1, 6% as B1, 6% as C1 and 4% as C2. Regarding osteochondral lesions, 20% showed none, 31% showed a glenoid defect, 54% showed a Hill-Sachs lesion and 13% showed a cartilage defect. Scheibel’s classification identified glenoid defects as type 3a in 38% of cases, type 2 in 24%, type 1a in 13% of cases, type 3b in 11%, type 1b in 8% and type 1c in 5% of cases. Positive Gagey and Walch signs were observed in 29% and 27% of cases, respectively. Dislocations presented as primary events in 24% of cases, while 76% were recurrent. Surgical interventions included 459 (70%) Bankart repairs, 6 Bankart plus repairs (
We will continue prospectively enrolling and monitoring patients that receive surgical treatment of SI. There are no current plans to halt the data collection in the near future, thereby consistently increasing the number of patients in the registry. A larger availability of data will additionally allow us to apply machine learning modelling and develop risk-prediction tools with the goal of aiding surgical decision making.
To investigate the efficacy of two volumes of acute isometric wall squat exercise on pain sensitivity (primary outcome: pressure pain threshold (PPT)) and intensity (secondary outcome) in adults with knee osteoarthritis.
A parallel-group randomised controlled trial.
Outpatient physiotherapy clinics at hospitals in Saudi Arabia.
Participants (n = 90; mean (SD) age 49.0 (13.0) years) with chronic knee osteoarthritis, diagnosed by a specialist orthopaedic physician using radiographic evidence and clinical judgement, were recruited via two tertiary hospitals in Saudi Arabia.
Participants were stratified by sex and randomly allocated to one of three groups: isometric single-repetition wall-squat (ISO-SR; one repetition of a 3-min wall squat or to volitional fatigue at a 100° knee joint angle), isometric multiple-repetition wall-squat (ISO-MR; three repetitions of the same intervention) and control (quiet sitting for 7 min).
PPT was measured at the calf (primary site of interest), lumbar spine and forearm using a pressure algometer. Pain intensity was assessed using a visual analogue scale. Primary analyses compared changes between intervention and control groups. All participants were included in the ITT analysis.
The ISO-MR group had higher mean PPT ratings immediately postintervention in the calf (mean difference=9.4 (95% CI 5.6 to 13.2), p
Both the ISO-SR and ISO-MR exercises to volitional fatigue reduced pain sensitivity in patients with knee osteoarthritis. Neither exercise volume changed clinical pain intensity.
ClinicalTrials.gov registry (ID: NCT05605444).
Research investigating the efficacy of spinal muscular atrophy type II rehabilitation has yielded conflicting conclusions, underscoring the need for high-quality research to validate the role of physical therapy. Furthermore, exercise training should be considered as a potential non-pharmacological strategy to enhance motor function in SMA type III patients. Hence, this study is designed to explore the effectiveness of physical therapy for improving motor function in individuals with SMA type III.
This study is an open-label, randomised controlled trial. We will first stratify patients by disease severity (mild=independent walking, severe=non-ambulatory) and then randomly assign 428 participants to either the treatment group or the control group for a period of 12 weeks using a computer-generated randomisation schedule with a 1:1 allocation ratio. The intervention group will undergo a combination of cycling, resistance training, balance exercises, postural control training and locomotion exercises, while the control group will receive education sessions and a standard home exercise programme consisting of stretching and relaxation exercises. Outcome measurements will be assessed at baseline, immediately postintervention and at 3-month and 6-month follow-up assessments. The primary outcome will be assessed using the Hammersmith Functional Motor Scale Expanded, while secondary outcomes will include: Manual Muscle Test, Six-Minute Walk Test, 10 Metre Walk/Run Test, adverse events monitoring, Paediatric Quality of Life Inventory Multidimensional Fatigue Score and active and passive range of motion measurements.
The study protocol and consent form have been approved by the Ethics Committee on Biomedical Research of West China Hospital of Sichuan University (#2025-56) on 19 February 2025. Results will be published in peer-reviewed journals, presented at national and/or international conferences and disseminated to Chinese rare disease support groups.
ChiCTR2500101177.