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Osteoarthritis, KneeLuRu2NCT06173193

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

A study testing Multicomponent exercise regimen and Standard rehabilitative management in people with Osteoarthritis, Knee, run by University of Jyvaskyla at 1 site in Finland.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 55 to 75 years, women only
Conditions the study is for
Osteoarthritis, Knee
What is being tested?
Multicomponent exercise regimen and Standard rehabilitative management
Could I receive a placebo?
No, everyone receives an active treatment
How many people
103 participants
Where
1 siteFinland
Study dates
1 Jun 2023to 11 Dec 2025
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 55 to 75 years
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

Finland1 site
  • University of Jyväskylä

    Jyväskylä, 40014

Other trials in Finland

About this study

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

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:

Read more
  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.

Read the 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.

Being tested
Multicomponent exercise regimen, Standard rehabilitative management
Keywords
Exercise, Subchondral bone, Cartilage, Randomized controlled trial, Postmenopausal women, Osteoarthritis, Physiotherapy, Joint Diseases, Musculoskeletal Diseases, Physical functioning
Medical subject headings
Osteoarthritis, Knee, Motor Activity, Osteoarthritis, Joint Diseases, Musculoskeletal Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Multicomponent exercise regimenBehavioural

    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 managementBehavioural

    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.

Study groups in NCT06173193
Study groupRoleWhat they receive
multicomponent exercise groupExperimental8 months of multicomponent exercise (3 sessions/week).
Receives: Behavioral: Multicomponent exercise regimen
Reference groupActive comparator8 months of standard rehabilitative care based home exercises.
Receives: Behavioral: Standard rehabilitative management

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: Baseline, 8 months, 20 months

  2. 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.

    Measured: Baseline, 8 months, 20 months

  3. Tibiofemoral articular cartilage thickness (mm)

    Assessed by 3D-texture analysis.

    Measured: Baseline, 8 months, 20 months

  4. Tibiofemoral articular cartilage volume (mm^3)

    Assessed by 3D-texture analysis.

    Measured: Baseline, 8 months, 20 months

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

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

    Measured: Baseline, 8 months, 20 months

  6. Tibiofemoral subchondral bone mineral content (g)

    Assessed by high-resolution CBCT.

    Measured: Baseline, 8 months, 20 months

  7. Tibiofemoral joint space narrowing (mm)

    Assessed by high-resolution CBCT.

    Measured: Baseline, 8 months, 20 months

Secondary outcomes (25)
  1. Bone mineral content (BMC, g) of the femoral neck

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

    Measured: Baseline, 8 months, 20 months

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

    Assessed by DXA.

    Measured: Baseline, 8 months, 20 months

  3. Cortical thickness (mm) of the femoral neck

    Assessed by Advanced Hip Analysis software.

    Measured: Baseline, 8 months, 20 months

  4. Femoral neck width (mm)

    Assessed by Advanced Hip Analysis software.

    Measured: Baseline, 8 months, 20 months

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

    Assessed by Advanced Hip Analysis software.

    Measured: Baseline, 8 months, 20 months

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

    Assessed by Advanced Hip Analysis software.

    Measured: Baseline, 8 months, 20 months

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

    Assessed by Advanced Hip Analysis software.

    Measured: Baseline, 8 months, 20 months

  8. Total body fat percentage (%)

    Assessed by DXA.

    Measured: Baseline, 8 months, 20 months

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

    Assessed by DXA.

    Measured: Baseline, 8 months, 20 months

  10. 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.

    Measured: Baseline, 8 months, 20 months

  11. 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.

    Measured: Baseline, 8 months, 20 months

  12. Work disablement

    Assessed by short form of Örebro musculoskeletal pain screening questionnaire (Score 1-100). Higher scores estimate increased risk for future work disability.

    Measured: Baseline, 8 months, 20 months

  13. 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.

    Measured: IPAQ: Baseline, 8 months, 20 months. Physical activity diary: through the 8-month study intervention in the control group

  14. 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.

    Measured: See above

  15. Quantity of painkillers consumed

    Assessed by diary.

    Measured: Through the 8-month study intervention

  16. Systemic inflammation markers

    High sensitivity C-reactive protein and serum cytokines including interleukin-6 and tumor-necrosis factor alpha will be assessed from blood.

    Measured: Baseline, 8 months, 20 months

  17. Metabolic profile

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

    Measured: Baseline, 8 months, 20 months

  18. Cardiorespiratory fitness

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

    Measured: Baseline, 8 months, 20 months

  19. Knee extension and flexion maximal isometric muscle strength

    Assessed by an adjustable dynamometer chair (Newtons).

    Measured: Baseline, 8 months, 20 months

  20. Static balance

    Assessed by a single leg stance test (seconds).

    Measured: Baseline, 8 months, 20 months

  21. 30 second chair-stand test (seconds)

    Measured: Baseline, 8 months, 20 months

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

    Measured: Baseline, 8 months, 20 months

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

    Measured: Baseline, 8 months, 20 months

  24. Stair climb test (seconds)

    Measured: Baseline, 8 months, 20 months

  25. 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).

    Measured: Baseline, 8 months, 20 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 Dec 2023
  2. Study start1 Jun 2023
  3. Primary completion10 Dec 2025
  4. Study completion11 Dec 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
103 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06173193
Sponsor's protocol ID
21000057531
Other IDs
351483
Acronym
LuRu2
Status last verified
Apr 2026
First submitted
31 Oct 2023
Last updated
11 May 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: IPD cannot be anonymized and will thus remain restricted due to personal data protection. The basic project-level discovery metadata of the dataset(s) will be made openly available in the University's repository with a DOI for permanent findability and accessibility whenever the metadata are sufficiently complete to be published.

Publications

  • Dobson F, Hinman RS, Roos EM, Abbott JH, Stratford P, Davis AM, Buchbinder R, Snyder-Mackler L, Henrotin Y, Thumboo J, Hansen P, Bennell KL. OARSI recommended performance-based tests to assess physical function in people diagnosed with hip or knee osteoarthritis. Osteoarthritis Cartilage. 2013 Aug;21(8):1042-52. doi: 10.1016/j.joca.2013.05.002. Epub 2013 May 13.

    PubMed 23680877
  • Konola VM, Parkkari J, Multanen J, Nikander R, Rantalainen T, Vesanto J, Pekkala S, Kalaja M, Ihalainen JK, Waller B, Munukka M, Sievanen H, Nevalainen M, Kautiainen H, Casula V, Paloneva J, Vasankari T, Peuna A, Saarakkala S, Nieminen MT, Heinonen A. Effects of a multicomponent exercise regimen on subchondral bone and cartilage in postmenopausal women with knee osteoarthritis: protocol for a randomized controlled trial. Trials. 2025 Jun 23;26(1):222. doi: 10.1186/s13063-025-08928-1.

    PubMed 40551179

Questions about this trial

What is this clinical trial studying?

A study testing Multicomponent exercise regimen and Standard rehabilitative management in people with Osteoarthritis, Knee, run by University of Jyvaskyla at 1 site in Finland.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 11 May 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Finland. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Tibiofemoral articular cartilage's glycosaminoglycan content (time frame: Baseline, 8 months, 20 months). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06173193, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 May 2026.

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