Osteoarthritis (OA) and osteoporosis (OP) Musculoskeletal Diseases Gonarthrosis [arthrosis of knee]
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1. Voluntary, 52-65 years old postmenopausal women 2. Regular intensive exercise (such as strength or aerobic, impact type of training) no more than two times a week 3. No history of any illness for which exercise is contraindicated or that would limit their participation in the exercise programme 4. Subjects with mild to moderate knee pain during the last 12 months 5. Willingness, and voluntarily signed informed consent to undergo testing and intervention procedures with all of its aspects 6. Weight-bearing knee x-rays show grade 1-2 OA according to Kellgren-Lawrence grade I or II
Exclusion criteria
Exclusion criteria: 1. Body-mass index over 34 2. Knee instability or trauma 3. Inflammatory joint disease 4. Intra-articular steroid injections in the preceding 12 months in the knee 5. Osteoporosis and medications
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The following will be assessed at baseline and 12 months: Cartilage measurements Structural changes of the tibiofemoral cartilage will be revealed by magnetic resonance imaging (MRI) at 1.5T magnetic field strength. The combination of two techniques, T2 relaxation time, indexing the collagen component of cartilage, and dGEMRIC, reflective of glycosaminoglycan concentration, and volumetric MRI assessment of cartilage thickness will be used to provide a comprehensive assessment of the cartilage status. T2 mapping and structural analysis of bone will provide MRI parameters sensitive to the properties of bone according our previous studies. Bone measurements Peripheral quantitative computed tomography (pQCT) (XCT 2000, Stratec Medizintechnik GmbH) will be performed to measure tibial shaft and distal tibia geometry, bone mass distribution and bone strength. Dual energy X-ray absorptiometry (DXA) will be performed to assess bone mineral content (BMC) (in grams) and areal bone mineral density (aBMD) (in g/cm^2) at the proximal femur, distal femur and proximal tibia. In addition, a structural analysis of the narrowest section of the femoral neck will be carried out using a customised bone strength analysis software. Based on our previous study, the quality of subchondral bone will be evaluated with MRI using the T2 relaxation time measurements. | — |
Secondary
| Measure | Time frame |
|---|---|
| The following will be assessed at baseline, 6 and 12 months: 1. Knee pain will be evaluated by a 100 mm visual analogue scale (VAS) with 0 mm and 100 mm indicating no pain and the worst possible pain, respectively. Pain will be measured before, during and after every training session. 2. Physical function and clinically-important symptoms will be evaluated by the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) and the Knee Injury and Osteoarthritis Outcome Score (KOOS). Physical function and symptoms will be correlated with structural changes of cartilage assessed with MRI. This will brings up clinically important information in terms of cartilage alterations association with clinical findings. 3. X-ray (weight-bearing anteroposterior and mediolateral radiographs) will be taken for both knees. The radiographs will be evaluated by two physicians without knowledge in which study arm the subject belongs to, using the criteria for the classification of osteoarthritis of the knee (blinded assessment). 4. Quality of life will be evaluated by the RAND 36-Item Health Survey questionnaire. 5. Muscle strength (leg extension and flexion) will be measured using the David-200 and 210 dynamometers. 6. Dynamic balance and agility will be evaluated with a timed figure-of-eight running test. 7. Physical activity monitoring: Physical activity will be monitored using an accelerometer-based body movement monitor (Newtest Ltd), analysing the activity data at different acceleration levels to evaluate the intensity of exercise according to our procedures. | — |
Countries
Finland