Clinical trial NCT06758388: Exercise-induced Irisin in Individuals With Knee Osteoarthritis.
Official title: The Relationship Between Physical and Psychosocial Status and Irisin Level in Individuals With Knee Osteoarthritis Performing Brisk Walking Exercise
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Knee Osteoarthritis (Knee OA)
Keywords: Knee osteoarthritis
İrisin
FNDC5
Pain
Functional capacity
Depression
Fatigue
Sleep quality
Quality of life
Muscle strength
Lead sponsor: Alanya Alaaddin Keykubat University
Sponsor class: OTHER
First posted: 2025-01-03
Enrollment: 46
Sex: ALL
Minimum age (years): 40
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Pain intensity
timeFrame: 8 weeks
measure: Range of Motion of the Joint
timeFrame: 8 weeks
measure: Muscle Strength
timeFrame: 8 weeks
measure: Functional Level
timeFrame: 8 weeks
measure: Knee Injury and Osteoarthritis Outcome Score (KOOS)
timeFrame: 8 weeks
measure: Assessment of quality of life
timeFrame: 8 weeks
measure: Depression
timeFrame: 8 weeks
measure: Fatigue
timeFrame: 8 weeks
measure: Sleep Quality
timeFrame: 8 weeks
measure: İrisin level
timeFrame: 8 weeks
measure: Body mass index
timeFrame: 8 weeks
Secondary outcomes:
measure: Correlation between irisin level (ng/mL) and primary outcome measures
timeFrame: 8 weeks
Other outcomes:
Locations:
city: Karaman
country: Turkey
facility: Karaman Training and Research Hospital
Study officials:
References: