[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Marius Henriksen\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":68},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,42],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":28,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":31,"lastUpdatePostDateStruct":32,"startDateStruct":35,"completionDateStruct":37,"leadSponsor":39,"locationsCount":4},"100609159","self-managed-vs-supervised-exercise-for-knee-oa-100609159",false,"NCT07210931","Self-managed vs Supervised Exercise for Knee OA","A Cluster Randomized Trial in Patients With Knee Osteoarthritis Comparing Self-Managed Exercise in Fitness Centers With Physiotherapist-Supervised Exercise in Primary Care","SELFIT","Inclusion criteria\n\n• Diagnosis of knee OA according to the NICE criteria: Adults aged 45 or over with activity-related joint pain and either no morning joint-related stiffness or morning stiffness that lasts no longer than 30 minutes.\n\nExclusion criteria\n\n* Completion of a supervised therapeutic exercise program for knee OA within 3 months\n* Contraindication to exercise (e.g., resting systolic blood pressure \\> 200 or diastolic blood pressure \\>110 mmHg, acute or reoccurring chest pain, unstable angina. uncontrolled cardiac arrhythmias, decompensated heart failure. suspected or known dissecting aortic aneurysm)\n* Lack of independent mobility that requires aid for transportation to\u002Ffrom exercise facilities.\n* Any condition or impairment that, in the opinion of the recruiting GP, makes a potential participant unsuitable for participation or which may obstruct participation (e.g. psychiatric or cognitive disorders, language barriers, or opiate dependency).","ALL","45 Years",{"count":20,"type":21},300,"ESTIMATED","INTERVENTIONAL",[24],"NA","Knee osteoarthritis (OA) is a common painful condition associated with pain and disability. OA healthcare costs the Danish society 4.6 billion DKK more per year than the non-OA population and we lack evidence on how best to organize and deliver care to reduce costs. Recommended first line treatment for knee OA is exercise with proven effects on symptoms. The current paradigm assumes that exercise needs to be delivered and supervised by a physiotherapist which require patients to attend a clinic at specific times and geographical locations. This is an expensive model of care and creates barriers for people that are active on the labor market or lives in remote areas with long distances to the nearest clinic. In fact, the productivity loss in Denmark associated with OA is estimated to be 12.4 billion DKK per year.\n\nWhile effective on symptoms, the current model with supervised physiotherapy associates with significant shortcomings, and barriers related to patient heterogeneity, costs, accessibility, and work absenteeism.\n\nAs an alternative, a local fitness center is far more accessible as these are widely dispersed across the country, are accessible daily (including weekends) at all hours, is cheap and offers a wide variety of exercise types, classes, and equipment to accommodate individual preferences. The cost of a fitness center membership is approximately 300 DKK per month and includes exercise ad libitum. In contrast, a typical physiotherapist-supervised exercise program costs 3-4,000 DKK for a 2-month treatment with 2 weekly sessions.\n\nConsequently, there is a need to investigate if self-managed exercise in a fitness center is cost-effective as first-line management of knee OA. To answer this question, the present trial aims to compare self-managed exercise in a fitness center to the current standard - supervised exercise. This has the potential to improve quality of care for people with knee OA by adding a cost-effective option for first line management of people with knee OA.",[27],"Knee Osteoarthritis",[29],"Exercise","NOT_YET_RECRUITING","2026-06-15",{"date":33,"type":34},"2026-06-16","ACTUAL",{"date":36,"type":21},"2026-07-01",{"date":38,"type":21},"2027-12-31",{"name":40,"class":41},"Marius Henriksen","OTHER",{"id":43,"slug":44,"hasResults":11,"nctId":45,"briefTitle":46,"officialTitle":47,"acronym":48,"eligibilityCriteria":49,"healthyVolunteers":11,"sex":17,"minAge":50,"maxAge":4,"enrollmentInfo":51,"targetDuration":4,"studyType":22,"phases":53,"briefSummary":55,"conditions":56,"keywords":4,"overallStatus":58,"whyStopped":4,"lastUpdateSubmitDate":59,"lastUpdatePostDateStruct":60,"startDateStruct":62,"completionDateStruct":64,"leadSponsor":66,"locationsCount":67},"100544315","phase-3-metformin-treatment-of-patients-with-hand-osteoarthritis-100544315","NCT06367283","Metformin Treatment of Patients with Hand Osteoarthritis","Metformin Treatment of Patients with Hand Osteoarthritis: a Randomised, Placebo-controlled Trial","METRO","Inclusion Criteria:\n\n1. Age ≥18 years\n2. Hand OA according to the ACR criteria\n3. Average finger (2 to 5) pain ≥4 on a 0-10 numeric rating scale (NRS where 10 is worst pain) over the past 30 days\n4. Metformin naive\n\nExclusion Criteria:\n\nComorbidities\n\n1. History of, or current signs of medical disease that may affect joints, e.g. rheumatoid arthritis, gout, psoriatic arthritis\n2. Psoriasis\n3. Known malignancy (except successfully treated squamous or basal cell skin carcinoma)\n4. Drug or alcohol abuse in the last year\n5. Existing nerve entrapment syndromes (e.g. carpal tunnel syndrome)\n6. Known diabetes\n7. Generalised pain syndromes such as fibromyalgia\n8. Known peripheral neuropathies\n9. Known allergies towards the interventions\n10. Gastric bypass or other malabsorption syndrome\n11. In case of pharmacological weight loss medication (e.g. glucagon like peptide-1 (GLP-1) analogues) or pharmacological osteoporosis medication, dosage must have been stable for 3 months without any plan of up-titration during the study period\n12. Any other condition or impairment that, in the opinion of the investigator, makes a potential participant unsuitable for participation or obstructs participation e.g. psychiatric disorders.\n\n    Surgical history\n13. History of hand surgery in the target hand within 12 months prior to enrolment\n14. History of arthroplasty, arthrodesis or surgical treatment of thumb base osteoarthritis in the target hand\n\n    Management strategies\n15. Use of systemic corticosteroids equivalent of ≥ 7.5 mg prednisolone daily within 3 months\n16. Treatment with denosumab (Prolia\u002FXgeva)\n17. Participation in experimental device or experimental drug study 3 months prior to enrolment\n18. Intra-articular treatments of any kind of any joint of the target hand 3 months before inclusion\n19. Current use of synthetic or non-synthetic opioids\n20. Planning to start other treatment for hand OA in the study participation period\n21. Planned CT scan with iodine contrast\n22. Scheduled surgery on upper extremity of the target hand during study participation\n23. Scheduled surgery requiring pause of metformin, e.g. surgery in general anaesthesia, during study participation\n\n    Reproductive system\n24. Pregnancy\n25. Planned pregnancy within the study period, 3 months after end of study treatment for female fertile participant and 6 months after end of study treatment for male participant\n26. Insufficient anti-conception therapy for female fertile participants within the study period and 3 months after end of study treatment\n\n    * Sufficient anti-conception therapy consists of intra-uterine device (coil), hormonal anti-conception (birth control pills, implant, intra-uterine system, dermal patch, vaginal ring, or injections) or sexual abstinence\n    * Female participants are considered infertile if they are postmenopausal or if they have undergone surgical sterilisation (bilateral salpingectomy, hysterectomy or bilateral oophorectomy)\n    * Postmenopausal state is defined as no menses for 12 months without alternative medical cause before inclusion in the study\n27. Insufficient anti-conception therapy for male participants within the study period and 6 months after end of study treatment\n\n    * Sufficient anti-conception therapy consists of condom or sexual abstinence\n    * Male participants are considered sterile if they have undergone surgical sterilisation (vasectomy)\n28. Breast-feeding\n\n    Blood analysis\n29. Positive anti-cyclic citrullinated peptide (\\>10 kU\u002FL)\n30. eGFR \\\u003C60 ml\u002Fmin\u002F1.73 m2\n31. Vitamin B12 deficiency \\\u003C 200 pmol\u002FL\n32. Hba1c ≥ 48 mmol\u002Fmol","18 Years",{"count":52,"type":21},150,[54],"PHASE3","To compare metformin (2 g daily), or maximum tolerated dose, for 16 weeks with placebo as a treatment of hand osteoarthritis symptoms.",[57],"Hand Osteoarthritis","RECRUITING","2025-02-25",{"date":61,"type":34},"2025-02-27",{"date":63,"type":34},"2024-06-03",{"date":65,"type":21},"2026-04",{"name":40,"class":41},1,""]