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NCT Number: NCT06173193

Effects of Multicomponent Exercise on Subchondral Bone and Cartilage in Postmenopausal Women With Knee Osteoarthritis

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.

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Key information

Conditions

Osteoarthritis, Knee Arthritis Behavior Joint Diseases Motor Activity Musculoskeletal Diseases Osteoarthritis Rheumatic Diseases

Age range

55 year–75 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

University of Jyväskylä

Jyväskylä, 40014, Finland

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

Multicomponent exercise regimen

Behavioral

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.

Standard rehabilitative management

Behavioral

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.

Primary outcomes

  1. Tibiofemoral articular cartilage's glycosaminoglycan content

    Time frame: 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.

  2. Tibiofemoral articular cartilage's collagen content and orientation

    Time frame: 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.

  3. Tibiofemoral articular cartilage thickness (mm)

    Time frame: Baseline, 8 months, 20 months

    Assessed by 3D-texture analysis.

  4. Tibiofemoral articular cartilage volume (mm^3)

    Time frame: Baseline, 8 months, 20 months

    Assessed by 3D-texture analysis.

  5. Tibiofemoral subchondral bone mineral density (g/cm^3)

    Time frame: Baseline, 8 months, 20 months

    Assessed by high-resolution cone beam computed tomography (CBCT).

  6. Tibiofemoral subchondral bone mineral content (g)

    Time frame: Baseline, 8 months, 20 months

    Assessed by high-resolution CBCT.

  7. Tibiofemoral joint space narrowing (mm)

    Time frame: Baseline, 8 months, 20 months

    Assessed by high-resolution CBCT.

Secondary outcomes

  1. Bone mineral content (BMC, g) of the femoral neck

    Time frame: Baseline, 8 months, 20 months

    Assessed by Dual-energy X-ray absorptiometry (DXA).

  2. Areal bone mineral density (aBMD, g/cm^2) of the femoral neck

    Time frame: Baseline, 8 months, 20 months

    Assessed by DXA.

  3. Cortical thickness (mm) of the femoral neck

    Time frame: Baseline, 8 months, 20 months

    Assessed by Advanced Hip Analysis software.

  4. Femoral neck width (mm)

    Time frame: Baseline, 8 months, 20 months

    Assessed by Advanced Hip Analysis software.

  5. Cross-sectional area (cm^2) of the femoral neck

    Time frame: Baseline, 8 months, 20 months

    Assessed by Advanced Hip Analysis software.

  6. Cross-sectional moment of inertia (cm^4) of the femoral neck

    Time frame: Baseline, 8 months, 20 months

    Assessed by Advanced Hip Analysis software.

  7. Section modulus (cm^3) of the femoral neck

    Time frame: Baseline, 8 months, 20 months

    Assessed by Advanced Hip Analysis software.

  8. Total body fat percentage (%)

    Time frame: Baseline, 8 months, 20 months

    Assessed by DXA.

  9. Fat Free Mass Index (FFMI, kg/m^2)

    Time frame: Baseline, 8 months, 20 months

    Assessed by DXA.

  10. Clinically important OA-symptoms and physical function

    Time frame: Baseline, 8 months, 20 months

    Assessed by Knee Injury and Osteoarthritis Outcome Score (KOOS) questionnaire (Score 0-100). Higher scores represent better outcomes.

  11. Health-related quality of life

    Time frame: 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.

  12. Work disablement

    Time frame: 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.

  13. Self-rated physical activity

    Time frame: 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.

  14. Objective daily physical activity

    Time frame: 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.

  15. Quantity of painkillers consumed

    Time frame: Through the 8-month study intervention

    Assessed by diary.

  16. Systemic inflammation markers

    Time frame: 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.

  17. Metabolic profile

    Time frame: Baseline, 8 months, 20 months

    Circulating metabolomes including resistin, leptin, adiponectin, lipids, lipoproteins, and metabolites will be assessed from blood.

  18. Cardiorespiratory fitness

    Time frame: Baseline, 8 months, 20 months

    Assessed by UKK 2km walk test (minutes and seconds).

  19. Knee extension and flexion maximal isometric muscle strength

    Time frame: Baseline, 8 months, 20 months

    Assessed by an adjustable dynamometer chair (Newtons).

  20. Static balance

    Time frame: Baseline, 8 months, 20 months

    Assessed by a single leg stance test (seconds).

  21. 30 second chair-stand test (seconds)

    Time frame: Baseline, 8 months, 20 months

  22. Timed up and go (TUG) (seconds)

    Time frame: Baseline, 8 months, 20 months

  23. 40m Fast-paced walk test (seconds)

    Time frame: Baseline, 8 months, 20 months

  24. Stair climb test (seconds)

    Time frame: Baseline, 8 months, 20 months

  25. Walking biomechanics

    Time frame: 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).

Sponsors and collaborators

Lead sponsor

University of Jyvaskyla

Other

Collaborators

  • Research Council of Finland
  • UKK Institute
  • University of Oulu
  • Wellbeing Services County of Central Finland

Registry information

Official study title

Effects of a Multicomponent Exercise Regimen on Subchondral Bone, Cartilage, and Inflammation Markers in Postmenopausal Women With Knee Osteoarthritis: A Randomized Controlled Study

Acronym: LuRu2

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Dec 15, 2023
Registry last updated
May 11, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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