Effects of Multicomponent Exercise on Subchondral Bone and Cartilage in Postmenopausal Women with Knee Osteoarthritis
- Conditions
- Osteoarthritis, Knee
- Interventions
- Behavioral: Standard rehabilitative managementBehavioral: Multicomponent exercise regimen
- Registration Number
- NCT06173193
- Lead Sponsor
- University of Jyvaskyla
- Brief Summary
Today, osteoarthritis (OA) is considered a whole-organ disease that is amenable to prevention and treatment in the early stages. Information on the articular cartilage and subchondral bone responses to exercise may help to develop safe and feasible exercise programs which can potentially improve cartilage and bone properties. Therefore, the goal of this study is to produce the knowledge needed to understand what effects multicomponent exercise regimen have on subchondral bone and articular cartilage of the knee joint in postmenopausal women with knee OA.
Participants will be randomized into either:
1. Intervention group, which conducts multicomponent exercise regimen including alternating step-aerobic and resistance training.
2. Reference group, which represents the standard rehabilitative management for knee OA patients with home exercises.
Researchers will compare intervention and reference groups to see if subchondral bone morphology and properties and cartilage biochemical alterations differ between the groups at the end of the 8-month intervention and 12-month follow-up period.
- Detailed Description
The study is an 8-month, randomized controlled intervention study with 12-month follow-up in volunteer postmenopausal (55-75-year-old) women with mild radiographic knee OA according to the Kellgren-Lawrence classification (grade 1-2). The participants will be randomly assigned into the subgroups. The study will be conducted in two phases.
8-month multicomponent exercise regimen will be carried out gradually and progressively three times a week by experienced and recently trained exercise instructors. The instructors will keep an attendance and an adverse event record for each of the intervention group's participants. The home exercises carried out three times a week by the reference group represent the standard rehabilitative management for knee OA patients.
In addition to the above-mentioned treatments, all participants will receive instructions to use paracetamol on an as-needed basis. Participants will be called to end-point measurements at 8 months after baseline and follow-up measurements at 20 months after baseline.
The overall goal of this study is to produce the knowledge needed to understand what effects multicomponent exercise regimen have on subchondral bone and articular cartilage of the knee joint in postmenopausal women with knee OA. In addition, the aim is to develop means to improve functional competence as well as to prevent physical disability among women suffering from knee OA. Specifically, the objectives are to investigate the effects of joint loading exercise regimen on knee joint subchondral bone morphology and properties, and cartilage biochemical alterations and their 12 month maintenance in women with knee OA. Also, training effects on molecular biomarkers related to OA and inflammation, bone traits, physical function, performance, body composition, and clinically important symptoms will be examined.
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- Female
- Target Recruitment
- 100
- voluntary women 55-75 years of age.
- no history of any illness for which exercise is contraindicated or that would limit participation in the exercise program.
- knee pain during the last 12 months.
- willingness and voluntarily signed informed consent to undergo testing and intervention procedures with all of its aspects.
- weight-bearing knee x-rays show radiographic Kellgren-Lawrence grade 1-2 OA in one or both tibiofemoral joints.
- body-mass index over 35 kg/m2.
- knee instability or trauma that would jeopardize the training.
- inflammatory joint disease.
- intra-articular steroid injections in the preceding 12 months in the knee.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Reference group Standard rehabilitative management 8 months of standard rehabilitative care based home exercises. multicomponent exercise group Multicomponent exercise regimen 8 months of multicomponent exercise (3 sessions/week).
- Primary Outcome Measures
Name Time Method Tibiofemoral articular cartilage volume (mm^3) Baseline, 8 months, 20 months Assessed by 3D-texture analysis.
Tibiofemoral articular cartilage's glycosaminoglycan content Baseline, 8 months, 20 months Assessed by quantitative Magnetic Resonance Imaging (qMRI) techniques at 3Tesla MR-system. Rotating frame of reference contrast adiabatic T1rho (ms) will be measured.
Tibiofemoral articular cartilage thickness (mm) Baseline, 8 months, 20 months Assessed by 3D-texture analysis.
Tibiofemoral subchondral bone mineral density (g/cm^3) Baseline, 8 months, 20 months Assessed by high-resolution cone beam computed tomography (CBCT).
Tibiofemoral subchondral bone mineral content (g) Baseline, 8 months, 20 months Assessed by high-resolution CBCT.
Tibiofemoral joint space narrowing (mm) Baseline, 8 months, 20 months Assessed by high-resolution CBCT.
Tibiofemoral articular cartilage's collagen content and orientation Baseline, 8 months, 20 months T2 maps (ms) will be assessed by qMRI techniques at 3Tesla MR-system. In addition, some clinical MRI series will be conducted.
- Secondary Outcome Measures
Name Time Method Fat Free Mass Index (FFMI, kg/m^2) Baseline, 8 months, 20 months Assessed by DXA.
Health-related quality of life Baseline, 8 months, 20 months Assessed by RAND 36-Item Health Survey questionnaire (Scores 0-100 on different domains). Higher scores represent a more favorable health state.
Walking biomechanics Baseline, 8 months, 20 months Lower body's segmental acceleration (m/s\^2) in 40m Fast-paced walk test, Stair climb test, and 2-minute walk at the subject's preferred pace will be assessed by Inertial Measurement Unit (IMU).
30 second chair-stand test (seconds) Baseline, 8 months, 20 months Cross-sectional moment of inertia (cm^4) of the femoral neck Baseline, 8 months, 20 months Assessed by Advanced Hip Analysis software.
Total body fat percentage (%) Baseline, 8 months, 20 months Assessed by DXA.
Timed up and go (TUG) (seconds) Baseline, 8 months, 20 months Knee extension and flexion maximal isometric muscle strength Baseline, 8 months, 20 months Assessed by an adjustable dynamometer chair (Newtons).
Areal bone mineral density (aBMD, g/cm^2) of the femoral neck Baseline, 8 months, 20 months Assessed by DXA.
Cross-sectional area (cm^2) of the femoral neck Baseline, 8 months, 20 months Assessed by Advanced Hip Analysis software.
Section modulus (cm^3) of the femoral neck Baseline, 8 months, 20 months Assessed by Advanced Hip Analysis software.
Bone mineral content (BMC, g) of the femoral neck Baseline, 8 months, 20 months Assessed by Dual-energy X-ray absorptiometry (DXA).
Cortical thickness (mm) of the femoral neck Baseline, 8 months, 20 months Assessed by Advanced Hip Analysis software.
Femoral neck width (mm) Baseline, 8 months, 20 months Assessed by Advanced Hip Analysis software.
Clinically important OA-symptoms and physical function Baseline, 8 months, 20 months Assessed by Knee Injury and Osteoarthritis Outcome Score (KOOS) questionnaire (Score 0-100). Higher scores represent better outcomes.
Objective daily physical activity See above Assessed by a tri-axial accelerometer (minutes \& MET-hours), worn 24 hours a day. A tri-axial accelerometer will be used through the 8-month study intervention in the intervention group and periods of 7 consecutive days every two months during the 8-month study intervention in the control group. During the 12-month follow-up, all the participants will be measured every four months for seven consecutive days.
Cardiorespiratory fitness Baseline, 8 months, 20 months Assessed by UKK 2km walk test (minutes and seconds).
Stair climb test (seconds) Baseline, 8 months, 20 months Work disablement Baseline, 8 months, 20 months Assessed by short form of Örebro musculoskeletal pain screening questionnaire (Score 1-100). Higher scores estimate increased risk for future work disability.
Self-rated physical activity IPAQ: Baseline, 8 months, 20 months. Physical activity diary: through the 8-month study intervention in the control group Assessed by International Physical Activity Questionnaire (IPAQ, Metabolic equivalent task (MET) -minutes). Also, physical activity diary (MET-minutes) will be filled by the control group through the 8-month study intervention.
Quantity of painkillers consumed Through the 8-month study intervention Assessed by diary.
Systemic inflammation markers Baseline, 8 months, 20 months High sensitivity C-reactive protein and serum cytokines including interleukin-6 and tumor-necrosis factor alpha will be assessed from blood.
Metabolic profile Baseline, 8 months, 20 months Circulating metabolomes including resistin, leptin, adiponectin, lipids, lipoproteins, and metabolites will be assessed from blood.
Static balance Baseline, 8 months, 20 months Assessed by a single leg stance test (seconds).
40m Fast-paced walk test (seconds) Baseline, 8 months, 20 months
Trial Locations
- Locations (1)
University of Jyväskylä
🇫🇮Jyväskylä, Finland