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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
103
A multicomponent exercise regimen applied is comprised of the step-aerobic and resistance training programs alternating every two weeks. The trainees participate in supervised training sessions 3 times a week for 8 months. Each session will include a 10-minutes warm-up, 30-minutes of effective training part and a 10-minutes period for cooling down. Step-aerobic: The program includes accelerating and decelerating through forwards and sideways movements with stops and turns to music. The degree of difficulty of movements and steps as well as training intensity will be gradually increased by increasing the height of the step benches. Resistance training: The participants will undergo a progressive resistance training program. Resistance training will emphasize training of following muscle groups: Quadriceps and hamstrings, hip abductors, adductors and extensors, and calf muscles. In addition to lower limb exercises, trunk and upper body exercises will be applied at intervals.
The treatments that will be provided to the members of a reference group represent the standard rehabilitative management for knee OA patients. The home exercises focus on functional exercises maintaining lower extremity flexibility and muscle function. The home exercises are instructed to be carried out three times a week, each work-out lasting 30 minutes.
University of Jyväskylä
Jyväskylä, Finland
Tibiofemoral articular cartilage's glycosaminoglycan content
Assessed by quantitative Magnetic Resonance Imaging (qMRI) techniques at 3Tesla MR-system. Rotating frame of reference contrast adiabatic T1rho (ms) will be measured.
Time frame: Baseline, 8 months, 20 months
Tibiofemoral articular cartilage's collagen content and orientation
T2 maps (ms) will be assessed by qMRI techniques at 3Tesla MR-system. In addition, some clinical MRI series will be conducted.
Time frame: Baseline, 8 months, 20 months
Tibiofemoral articular cartilage thickness (mm)
Assessed by 3D-texture analysis.
Time frame: Baseline, 8 months, 20 months
Tibiofemoral articular cartilage volume (mm^3)
Assessed by 3D-texture analysis.
Time frame: Baseline, 8 months, 20 months
Tibiofemoral subchondral bone mineral density (g/cm^3)
Assessed by high-resolution cone beam computed tomography (CBCT).
Time frame: Baseline, 8 months, 20 months
Tibiofemoral subchondral bone mineral content (g)
Assessed by high-resolution CBCT.
Time frame: Baseline, 8 months, 20 months
Tibiofemoral joint space narrowing (mm)
Assessed by high-resolution CBCT.
Time frame: Baseline, 8 months, 20 months
Bone mineral content (BMC, g) of the femoral neck
Assessed by Dual-energy X-ray absorptiometry (DXA).
Time frame: Baseline, 8 months, 20 months
Areal bone mineral density (aBMD, g/cm^2) of the femoral neck
Assessed by DXA.
Time frame: Baseline, 8 months, 20 months
Cortical thickness (mm) of the femoral neck
Assessed by Advanced Hip Analysis software.
Time frame: Baseline, 8 months, 20 months
Femoral neck width (mm)
Assessed by Advanced Hip Analysis software.
Time frame: Baseline, 8 months, 20 months
Cross-sectional area (cm^2) of the femoral neck
Assessed by Advanced Hip Analysis software.
Time frame: Baseline, 8 months, 20 months
Cross-sectional moment of inertia (cm^4) of the femoral neck
Assessed by Advanced Hip Analysis software.
Time frame: Baseline, 8 months, 20 months
Section modulus (cm^3) of the femoral neck
Assessed by Advanced Hip Analysis software.
Time frame: Baseline, 8 months, 20 months
Total body fat percentage (%)
Assessed by DXA.
Time frame: Baseline, 8 months, 20 months
Fat Free Mass Index (FFMI, kg/m^2)
Assessed by DXA.
Time frame: Baseline, 8 months, 20 months
Clinically important OA-symptoms and physical function
Assessed by Knee Injury and Osteoarthritis Outcome Score (KOOS) questionnaire (Score 0-100). Higher scores represent better outcomes.
Time frame: Baseline, 8 months, 20 months
Health-related quality of life
Assessed by RAND 36-Item Health Survey questionnaire (Scores 0-100 on different domains). Higher scores represent a more favorable health state.
Time frame: Baseline, 8 months, 20 months
Work disablement
Assessed by short form of Örebro musculoskeletal pain screening questionnaire (Score 1-100). Higher scores estimate increased risk for future work disability.
Time frame: Baseline, 8 months, 20 months
Self-rated physical activity
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.
Time frame: IPAQ: Baseline, 8 months, 20 months. Physical activity diary: through the 8-month study intervention in the control group
Objective daily physical activity
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.
Time frame: See above
Quantity of painkillers consumed
Assessed by diary.
Time frame: Through the 8-month study intervention
Systemic inflammation markers
High sensitivity C-reactive protein and serum cytokines including interleukin-6 and tumor-necrosis factor alpha will be assessed from blood.
Time frame: Baseline, 8 months, 20 months
Metabolic profile
Circulating metabolomes including resistin, leptin, adiponectin, lipids, lipoproteins, and metabolites will be assessed from blood.
Time frame: Baseline, 8 months, 20 months
Cardiorespiratory fitness
Assessed by UKK 2km walk test (minutes and seconds).
Time frame: Baseline, 8 months, 20 months
Knee extension and flexion maximal isometric muscle strength
Assessed by an adjustable dynamometer chair (Newtons).
Time frame: Baseline, 8 months, 20 months
Static balance
Assessed by a single leg stance test (seconds).
Time frame: Baseline, 8 months, 20 months
30 second chair-stand test (seconds)
Time frame: Baseline, 8 months, 20 months
Timed up and go (TUG) (seconds)
Time frame: Baseline, 8 months, 20 months
40m Fast-paced walk test (seconds)
Time frame: Baseline, 8 months, 20 months
Stair climb test (seconds)
Time frame: Baseline, 8 months, 20 months
Walking biomechanics
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).
Time frame: Baseline, 8 months, 20 months
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