Effects of a Multicomponent Exercise Regimen on Subchondral Bone, Cartilage, and Inflammation Markers in Postmenopausal Women With Knee Osteoarthritis: A Randomized Controlled Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 103
- 试验地点
- 2
- 主要终点
- Tibiofemoral articular cartilage volume (mm^3)
研究概览
简要总结
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:
- Intervention group, which conducts multicomponent exercise regimen including alternating step-aerobic and resistance training.
- 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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 55 Years 至 75 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •body-mass index over 35 kg/m
- •knee instability or trauma that would jeopardize the training.
- •inflammatory joint disease.
- •intra-articular steroid injections in the preceding 12 months in the knee.
研究组 & 干预措施
multicomponent exercise group
8 months of multicomponent exercise (3 sessions/week).
干预措施: Multicomponent exercise regimen (Behavioral)
Reference group
8 months of standard rehabilitative care based home exercises.
干预措施: Standard rehabilitative management (Behavioral)
结局指标
主要结局
Tibiofemoral articular cartilage volume (mm^3)
时间窗: Baseline, 8 months, 20 months
Assessed by 3D-texture analysis.
Tibiofemoral articular cartilage thickness (mm)
时间窗: Baseline, 8 months, 20 months
Assessed by 3D-texture analysis.
Tibiofemoral subchondral bone mineral density (g/cm^3)
时间窗: Baseline, 8 months, 20 months
Assessed by high-resolution cone beam computed tomography (CBCT).
Tibiofemoral articular cartilage's glycosaminoglycan content
时间窗: 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 subchondral bone mineral content (g)
时间窗: Baseline, 8 months, 20 months
Assessed by high-resolution CBCT.
Tibiofemoral joint space narrowing (mm)
时间窗: Baseline, 8 months, 20 months
Assessed by high-resolution CBCT.
Tibiofemoral articular cartilage's collagen content and orientation
时间窗: 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.
次要结局
- 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)
- Total body fat percentage (%)(Baseline, 8 months, 20 months)
- Timed up and go (TUG) (seconds)(Baseline, 8 months, 20 months)
- Knee extension and flexion maximal isometric muscle strength(Baseline, 8 months, 20 months)
- Areal bone mineral density (aBMD, g/cm^2) of the femoral neck(Baseline, 8 months, 20 months)
- Cross-sectional area (cm^2) of the femoral neck(Baseline, 8 months, 20 months)
- Section modulus (cm^3) of the femoral neck(Baseline, 8 months, 20 months)
- Bone mineral content (BMC, g) of the femoral neck(Baseline, 8 months, 20 months)
- Cortical thickness (mm) of the femoral neck(Baseline, 8 months, 20 months)
- Fat Free Mass Index (FFMI, kg/m^2)(Baseline, 8 months, 20 months)
- Health-related quality of life(Baseline, 8 months, 20 months)
- Walking biomechanics(Baseline, 8 months, 20 months)
- Femoral neck width (mm)(Baseline, 8 months, 20 months)
- Clinically important OA-symptoms and physical function(Baseline, 8 months, 20 months)
- Objective daily physical activity(See above)
- Cardiorespiratory fitness(Baseline, 8 months, 20 months)
- Stair climb test (seconds)(Baseline, 8 months, 20 months)
- Work disablement(Baseline, 8 months, 20 months)
- Self-rated physical activity(IPAQ: Baseline, 8 months, 20 months. Physical activity diary: through the 8-month study intervention in the control group)
- Quantity of painkillers consumed(Through the 8-month study intervention)
- Systemic inflammation markers(Baseline, 8 months, 20 months)
- Metabolic profile(Baseline, 8 months, 20 months)
- Static balance(Baseline, 8 months, 20 months)
- 40m Fast-paced walk test (seconds)(Baseline, 8 months, 20 months)