Effects of Multicomponent Exercise on Subchondral Bone and Cartilage in Postmenopausal Women with Knee Osteoarthritis (LuRu2)

University of Jyväskylä

Status: Active, not recruiting

Conditions: Osteoarthritis, Knee

Treatments: Behavioral: Standard rehabilitative management; Behavioral: Multicomponent exercise regimen

Study type: Interventional

Funder types: Other

Identifiers

NCT06173193

21000057531

351483 (Other Grant/Funding Number)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 100 estimated patients

Sex: Female

Ages: 55 to 75 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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100 participants in 2 patient groups

multicomponent exercise group

Experimental group

Description:

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

Treatment:

Behavioral: Multicomponent exercise regimen

Reference group

Active Comparator group

Description:

8 months of standard rehabilitative care based home exercises.

Treatment:

Behavioral: Standard rehabilitative management