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

NCT ID: NCT06173193

Last Updated: 2025-03-30

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-06-01
• Study Completion Date: 2026-03-31

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.

Conditions

Osteoarthritis, Knee

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

multicomponent exercise group

8 months of multicomponent exercise (3 sessions/week).

Group Type: EXPERIMENTAL

Multicomponent exercise regimen

Intervention Type: 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.

Reference group

8 months of standard rehabilitative care based home exercises.

Group Type: ACTIVE_COMPARATOR

Standard rehabilitative management

Intervention Type: 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.

Interventions

Multicomponent exercise regimen

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.

Intervention Type: BEHAVIORAL

Standard rehabilitative management

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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

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.

• Minimum Eligible Age: 55 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

University of Oulu

OTHER

Sponsor Role: collaborator

Wellbeing Services County of Central Finland

UNKNOWN

Sponsor Role: collaborator

UKK Institute

OTHER

Sponsor Role: collaborator

Research Council of Finland

UNKNOWN

Sponsor Role: collaborator

University of Jyvaskyla

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Ari Heinonen, Prof., emeritus

Role: PRINCIPAL_INVESTIGATOR

University of Jyvaskyla

Locations

University of Jyväskylä

Jyväskylä, , Finland

Countries

Finland

References

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.

Reference Type: BACKGROUND

PMID: 23680877 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 40551179 (View on PubMed)

Other Identifiers

351483

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

21000057531

Identifier Type: -

Identifier Source: org_study_id