Exercise-induced Irisin in Individuals With Knee Osteoarthritis.

NCT ID: NCT06758388

Last Updated: 2025-08-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 46 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-03-13
• Study Completion Date: 2025-08-04

Brief Summary

The goal of this prospective randomised controled study is to investigate the effect of 8-weeks brisk walking exercise on irisin levels, physical and psychosocial parameters in individuals with knee osteoarthritis, and the relationship between irisin levels and physical and psychosocial parameters. The main question it aims to answer is: does 8-weeks brisk walking exercise increase irisin levels and imoroves physical and psychosocial parameters and is the irisin level in relation with the physical and psychosocial parameters.

Detailed Description

Irisin is a myokine secreted by skeletal muscle after physical activity. It improves subchondral bone density and quality by increasing osteoblast differentiation and proliferation and improves the mechanical support of cartilage. In addition, irisin promotes chondrocyte proliferation, inhibits chondrocyte apoptosis, and reduces the secretion of inflammatory factors and matrix metalloproteinases. As a result of all these, improvements in joint function may be achieved.

Besides, irisin can improve depressive mood in patients with depression, and irisin level is found to be positively correlated with sleep quality and negatively correlated with disease duration and disease activity in patients with rheumatoid arthritis.

This study aims to investigate the effect of an 8-week moderate-intensity brisk walking exercise program on irisin serum levels and physical and psychosocial parameters in individuals with knee osteoarthritis and the relationship between irisin levels and physical and psychosocial parameters.

Conditions

Knee Osteoarthritis (Knee OA)

Study Design

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

Study Groups

Control group

The control group will perform a home exercise program that includes progressive strengthening exercises.

Group Type: OTHER

home exercise program

Intervention Type: OTHER

The prepared home exercise program is a program that includes gradual strengthening exercises that participants will do once a day, 5 days a week, for 8 weeks. The exercises will be performed as 1 set for the first 2 weeks, 2 sets in the 3rd and 4th weeks, and 3 sets in the last 4 weeks.

Intervention group

The intervention group will perform a home exercise program that includes progressive strengthening exercises and brisk walking exercise.

Group Type: ACTIVE_COMPARATOR

home exercise program + brisk walking exercise

Intervention Type: BEHAVIORAL

In addition to the home exercise program applied by the control group, a brisk walk will be performed. The brisk walking exercise will be done for 30 minutes, 5 days a week for 8 weeks. The intensity of the exercise will be adjusted according to the Borg CR-10 scale and the Speech test. Moderate intensity exercise is recommended for participants. The participant will walk rhythmically for 30 minutes at a speed where he/she will give 4-6 points on the Borg CR-10 Scale, and can speak a few sentences without getting out of breath according to the Speech test, but cannot sing. Before and after the brisk walk, he/she will be asked to walk at a slow speed for 5 minutes (warm-up-cool down).

Interventions

home exercise program

The prepared home exercise program is a program that includes gradual strengthening exercises that participants will do once a day, 5 days a week, for 8 weeks. The exercises will be performed as 1 set for the first 2 weeks, 2 sets in the 3rd and 4th weeks, and 3 sets in the last 4 weeks.

Intervention Type: OTHER

home exercise program + brisk walking exercise

In addition to the home exercise program applied by the control group, a brisk walk will be performed. The brisk walking exercise will be done for 30 minutes, 5 days a week for 8 weeks. The intensity of the exercise will be adjusted according to the Borg CR-10 scale and the Speech test. Moderate intensity exercise is recommended for participants. The participant will walk rhythmically for 30 minutes at a speed where he/she will give 4-6 points on the Borg CR-10 Scale, and can speak a few sentences without getting out of breath according to the Speech test, but cannot sing. Before and after the brisk walk, he/she will be asked to walk at a slow speed for 5 minutes (warm-up-cool down).

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• Patients with idiopathic knee OA
• Stage 1-3 knee OA according to the Kellgren-Lawrence classification
• Patients aged 40-65
• Patients agreeing to participate in the study
• Patients having physical and cognitive ability to participate in the exercise program

Exclusion Criteria

• History of depression and/or anxiety etc. psychiatric disease
• Uncontrolled hypertension, uncontrolled heart rhythm disorders, history of hospitalization for cardiovascular reasons in the last 6 months
• History of symptomatic pulmonary disease
• Use of medication due to dyslipidemia and/or diabetes
• Presence of acute inflammation or effusion in the knee joint
• Presence of central or peripheral neurological disease that will cause loss of lower extremity muscle strength, sensation, and balance
• Presence of a prosthetic joint in the knee and previous lower extremity surgery
• Having received a physical therapy program in the last 6 months
• Patients with severe visual or hearing impairment
• Patients with severe peripheral vascular disorders
• Presence of severe knee joint instability, ligament and meniscal damage
• Being illiterate

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ümmahani Kuş

OTHER

Sponsor Role: lead

Responsible Party

Ümmahani Kuş

Investigator

Responsibility Role: SPONSOR_INVESTIGATOR

Locations

Karaman Training and Research Hospital

Karaman, , Turkey (Türkiye)

Countries

Turkey (Türkiye)

Other Identifiers

E-11095095-050.04-225853

Identifier Type: -

Identifier Source: org_study_id