Effects of Multicomponent Exercise on Subchondral Bone and Cartilage in Postmenopausal Women With Knee Osteoarthritis — LuRu2  

Osteoarthritis, Knee Clinical Trial

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

Status Recruiting

Clinical 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 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.

Clinical Trial 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. ;

Related Conditions & MeSH terms

• Osteoarthritis
• Osteoarthritis, Knee

• NCT number: NCT06173193
• Study type: Interventional
• Source: University of Jyvaskyla
• Contact: Ari Heinonen, Prof., emeritus
• Phone: +358408053551
• Email: ari.o.heinonen@jyu.fi
• Status: Recruiting
• Phase: N/A
• Start date: June 1, 2023
• Completion date: March 2026