ifestyle intervention trial in early stage knee osteoarthritis
- Conditions
- Knee osteoarthritis
- Registration Number
- NL-OMON24915
- Lead Sponsor
- Erasmus MC University Medical Center Rotterdam, Department of General Practice
- Brief Summary
/A
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 234
Patients aged between 45 and 70 years, a BMI of 25 kg/m2 or higher, diagnosis of clinical knee OA (according to NICE guidelines), and a first presentation at their general practitioner with knee complaints within the previous 24 months will be included.
-Other pathological conditions that could explain the joint complaints like traumatic onset knee complaints or presence of other forms of arthritis (rheumatoid arthritis, psoriatic arthritis), pre-patellar bursitis or patellar tendinitis;
- Any lower extremity condition other than KOA resulting in physical impairment that will limit GLI participation.
-Previously participated in a combined lifestyle intervention (GLI);
-Contraindications for MRI;
-Not being able to speak, read or write Dutch.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The primary outcomes include a 5 kg or 5% weight reduction at 24 months follow-up, clinical progression (mean pain intensity during the last month (11-point NRS) over 24 months of follow-up), structural progression on MRI at 24 months follow-up (MOAKS: change of individual MOAKS features per subregion and summed change per MOAKS features), and health-related quality of life measured with the EQ-5D-5L over 24 months. <br>For the cost-effectiveness analysis, societal costs over 24 months using the medical consumption and productivity cost questionnaire (iMCQ and iPCQ) will be evaluated.
- Secondary Outcome Measures
Name Time Method Patients’ reported severity of knee pain and activity limitations evaluated over 24 months with the Knee injury and Osteoarthritis Outcome Score (KOOS); the severity of intermittent and constant osteoarthritis pain (ICOAP); the global rating of change (GRoC); Patient Acceptable Symptom State (PASS); and mean pain intensity during the last month (11-point NRS) over the last 12 months of follow-up. Moreover, general health outcomes including blood pressure, HbA1c levels, and cholesterol are evaluated at 24 month follow-up.