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

NCT06173193 | Active Not Recruiting

• 2 other identifiers: 21000057531351483
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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. 1.Intervention group, which conducts multicomponent exercise regimen including alternating step-aerobic and resistance training.
2. 2.Reference group, which represents the standard rehabilitative management for knee OA patients with home exercises.

Conditions

Osteoarthritis, Knee

Keywords

Exercise; Subchondral bone; Cartilage; Randomized controlled trial; Postmenopausal women; Osteoarthritis; Physiotherapy; Joint Diseases; Musculoskeletal Diseases; Physical functioning

Outcome Measures

Primary Outcomes (7)

• 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.

  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.

  Baseline, 8 months, 20 months

• Tibiofemoral articular cartilage thickness (mm)

  Assessed by 3D-texture analysis.

  Baseline, 8 months, 20 months

• Tibiofemoral articular cartilage volume (mm^3)

  Assessed by 3D-texture analysis.

  Baseline, 8 months, 20 months

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

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

  Baseline, 8 months, 20 months

• Tibiofemoral subchondral bone mineral content (g)

  Assessed by high-resolution CBCT.

  Baseline, 8 months, 20 months

• Tibiofemoral joint space narrowing (mm)

  Assessed by high-resolution CBCT.

  Baseline, 8 months, 20 months

Secondary Outcomes (25)

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

  Baseline, 8 months, 20 months

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

  Baseline, 8 months, 20 months

• Cortical thickness (mm) of the femoral neck

  Baseline, 8 months, 20 months

• Femoral neck width (mm)

  Baseline, 8 months, 20 months

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

  Baseline, 8 months, 20 months

Study Arms (2)

multicomponent exercise group

EXPERIMENTAL

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

Behavioral: Multicomponent exercise regimen

Reference group

ACTIVE COMPARATOR

8 months of standard rehabilitative care based home exercises.

Behavioral: Standard rehabilitative management

Interventions

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.

multicomponent exercise group

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.

Reference group

Eligibility Criteria

• Age: 55 Years - 75 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Jyvaskyla: lead
• University of Oulu: collaborator
• Wellbeing Services County of Central Finland: collaborator
• UKK Institute: collaborator
• Research Council of Finland: collaborator

Study Sites (1)

University of Jyväskylä

Jyväskylä, 40014, Finland

Location

Related Publications (2)

• 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.

  PMID: 23680877 BACKGROUND

• 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.

  PMID: 40551179 DERIVED

MeSH Terms

Conditions

Osteoarthritis, Knee; Motor Activity; Osteoarthritis; Joint Diseases; Musculoskeletal Diseases

Condition Hierarchy (Ancestors)

Arthritis; Rheumatic Diseases; Behavior

Study Officials

• Ari Heinonen, Prof., emeritus

  University of Jyvaskyla

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 31, 2023
• First Posted: December 15, 2023
• Study Start: June 1, 2023
• Primary Completion: March 1, 2026
• Study Completion: March 1, 2026
• Last Updated: March 30, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

FI (1)