Exercise-related Irisin on Inflammation and Pain

May 20, 2022 updated by: Furkan BİLEK, Firat University

Effects of Exercise-related Irisin on Inflammation and Pain in Individuals With Osteoarthritis

Osteoarthritis (OA) is a chronic disease that usually starts with cartilage damage in weight-bearing joints and then causes pain and loss of function secondary to damage in surrounding tissues. Osteoarthritis, which is seen with a frequency of approximately 10% in men over the age of 60 and approximately 18% in women, ranks first among the diseases related to the joint. Many factors such as age, gender, obesity, physical activity, trauma, and genetic factors are involved in the etiology of the disease. In osteoarthritis, intra-articular production and destruction events can occur simultaneously, so it is a dynamic process. Among the joints in the lower and upper extremities, osteoarthritis is most common in the knee joint. Various approaches are used in the treatment, including drug therapy, hyaluronic acid injection, use of glucosamine and chondritis sulfate, exercises, physiotherapy applications, and diet applications for weight loss to reduce pain and increase physical function.

Physiotherapy and rehabilitation are important treatment options in OA. Generally, range of motion exercises, strengthening exercises, and endurance exercises are applied to patients. An exercise program can be as effective as an NSAID in reducing pain. Decreased quadriceps muscle strength is a finding seen in patients with symptomatic knee OA. In addition, aerobic exercise has the potential to improve cardiovascular fitness, many of the comorbidities often associated with OA, such as diabetes, hypertension, and obesity.

Because OA is a major public health problem, a less costly population-based approach is desirable. Therefore, the aim of this study was to investigate the effects of exercise-related irisin on inflammation and pain in patients with OA who underwent exercise.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

Osteoarthritis, which is seen with a frequency of approximately 10% in men over the age of 60 and approximately 18% in women, ranks first among the diseases related to the joint. Many factors such as age, gender, obesity, physical activity, trauma, and genetic factors are involved in the etiology of the disease. In osteoarthritis, intra-articular production and destruction events can occur simultaneously, so it is a dynamic process. Among the joints in the lower and upper extremities, osteoarthritis is most common in the knee joint. Various approaches are used in the treatment, including drug therapy, hyaluronic acid injection, use of glucosamine and chondritis sulfate, exercises, physiotherapy applications, and diet applications for weight loss to reduce pain and increase physical function.

The most important indicator of osteoarthritis is cartilage destruction. In general, the main factor that initiates cartilage damage is the abnormal mechanical forces that the joint is exposed to. It is thought that the most important factors in the pathogenesis of cartilage damage are chondrocytes, which are sensitive to mechanical loading. Chondrocytes additionally have the ability to produce and respond to inflammatory mediators. Chondrocytes secrete catabolic enzymes such as nitric oxide synthetase and cyclooxygenase, matrix metalloproteinases (MMP), disintegrin-metalloproteinase containing thrombospondin 1 domain (ADAMTS 4 and 5) and proinflammatory cytokines. is considered. In addition, prostaglandin E 2 (PGE 2) and nitric oxide (NO) have been described as effective mediators of inflammation and cartilage destruction. Proinflammatory cytokines [for example, interleukin-1 (IL-1), interleukin-6 (IL-6) and tumor necrosis factor-a (TNFα)] cyclooxygenase-2 (COX-2) and nitric oxide synthase (NOS), particularly NOS induces the expression of the inducible isoform (iNOS). COX-2 and iNOS are responsible for the increase in PGE 2 and NO levels, which play an important role in inflammation and pain. Therefore, it can be predicted that the severity of OA will be related to local prostanoid levels and/or other proinflammatory messengers.

Physiotherapy and rehabilitation is one of the important treatment options in OA. Generally, range of motion exercises, strengthening exercises and endurance exercises are applied to patients. An exercise program can be as effective as an NSAID in reducing pain. Decreased quadriceps muscle strength is a finding seen in patients with symptomatic knee OA. In addition, aerobic exercise has the potential to improve cardiovascular fitness, many of the comorbidities often associated with OA, such as diabetes, hypertension, and obesity.

In humans, increased levels of physical activity are generally associated with reduced concentrations of circulating proinflammatory mediators such as C-reactive protein and tumor necrosis factor a (TNFα). Interleukin-6 (IL-6), which is proinflammatory under certain conditions, is released at high levels from exercising muscles and has been shown to exert anti-inflammatory effects on TNFα and endotoxin-induced inflammation.

Irisin is an exercise-induced myokine that has attracted the attention of the scientific community for its potential thermogenic effect. It has been found that the release of irisin is stimulated by exercise in people who exercise for a certain period of time. However, studies on the effect of irisin on inflammatory and pain in individuals with OA have not been found in the literature. Because OA is a major public health problem, a less costly population-based approach is desirable. Therefore, the aim of this study was to investigate the effects of exercise-related irisin on inflammation and pain in patients with OA who underwent exercise.

In this study, patients who will be diagnosed with osteoarthritis by the Fırat University Training and Research Hospital, and orthopedic specialist will be evaluated prospectively. Patients; Before and after exercise, irisin value and C-Reactive Protein, Substance p, Interleukin-6, TNFalpha, Cyclooxygenase 2, Neuropeptide y, cartilage oligomeric matrix protein (COMP) and Matrix metalloproteinase 3 factors will be measured. In addition, as demographic characteristics of the patients; age, gender, body weight, height, occupation and education level of the patients, and the history of the disease will be taken. Orthopedic evaluation form; muscle strength, range of motion, gait analysis, pain status, contracture status, obesity status, the status of intracapsular structures, etc. information will be received.

With these data, it will be investigated whether the pain and inflammation values of the patients change with irisin before and after exercise, and which factors depend on it.

diagnosis of osteoarthritis

Study Type

Interventional

Enrollment (Anticipated)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Turkey
      • Elazığ, Turkey, 23100
        • Furkan Bilek

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Diagnosed with osteoarthritis
  • No knee joint contracture

Exclusion Criteria:

  • Those with cardiopulmonary disease
  • Individuals who exercise regularly
  • Those who received intra-articular injection therapy in the last 3 months

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Exercise
The initial implementation for the 8-week combined exercise program consisted of a progressive aerobic exercise program with a lower extremity bike (Ergoline Ergoselect 200; Ergoline GMBH, Bitz, Germany). All sessions are individually supervised and conducted. Training intensity was started at 70% of maximum aerobic capacity and training intensity was increased by 5% of VO2peak every two weeks. Pedal speed was fixed at 50 rpm throughout 8 weeks of training. Exercise sessions; It started with a 5 minute warm-up period (30% of VO2peak), followed by a total of 40 minutes with a 30-minute load period and a 5-minute cool-down period (without resistance).
Other: Exercise
The initial implementation for the 8-week combined exercise program consisted of a progressive aerobic exercise program with a lower extremity bike (Ergoline Ergoselect 200; Ergoline GMBH, Bitz, Germany). All sessions are individually supervised and conducted. Training intensity was started at 70% of maximum aerobic capacity and training intensity was increased by 5% of VO2peak every two weeks. Pedal speed was fixed at 50 rpm throughout 8 weeks of training. Exercise sessions; It started with a 5 minute warm-up period (30% of VO2peak), followed by a total of 40 minutes with a 30-minute load period and a 5-minute cool-down period (without resistance).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Kellgren-Lawrence Scale
Time Frame: 8 weeks

Radiologic examinations are the most important examination that gives us information in the diagnosis of gonarthrosis. AP and lateral radiographs taken by standing up give us precise information about the severity of the disease and the treatment to be planned. . In cases where the disease is more advanced, intra-knee joint mouse, subluxation and severe deformities can be seen. The Kellgren-Lawrence Scale, which was described in 1957, is used in radiological staging. Classification is made as 5 items. Stage 0: There is no sign of osteoarthritis.

Stage 1: Suspected joint space narrowing and possible osteophyte formation. Stage 2: Definite osteophyte and possible joint space narrowing. Stage 3: Numerous osteophytes, definite narrowing of the joint space, sclerosis, and deformity of the bone boundaries may be present.

Stage 4: Large osteophytes, severe narrowing of the joint space, severe sclerosis, and overt deformities of the bone margins.
8 weeks
Lequesne knee osteoarthritis severity index
Time Frame: 8 weeks
he Lequesne knee osteoarthritis index (LDOI), which was defined in 1989, aims to measure the severity of osteoarthritis involvement in the knee joint. It questions pain and discomfort (5 questions), walking (2 questions), and activities in daily life (4 questions). The weight of the questions is different and the result is a score between 0 and 24.
8 weeks
WOMAC scale
Time Frame: 8 weeks
The WOMAC scale is a measure of health status specific to osteoarthritis. It consists of three parts and 24 questions that assess clinically significant pain, stiffness, and physical function status in patients with knee or hip osteoarthritis. It can be completed in 5 minutes. Each question was scored on a Likert scale as 0=absent, 1=mild, 2=moderate, 3=severe, 4=very severe. The score of each section is calculated on its own and the total score ranges from 0 to 100. High scores indicate increased pain and stiffness, impaired physical function.
8 weeks
Irisin Hormone Analiz
Time Frame: 8 weeks
Samples of venous blood were collected after overnight (12 h) fasting in the morning before and after the study from all patients. Venous blood was drawn using venipuncture and clotted for serum and centrifuged at 4000g for 5 minutes at 4°C. Serum samples then were aliquoted, and stored at -80°C until were assayed with enzyme-linked immunosorbent assay (ELISA) analysis.
8 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Firat University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

May 18, 2022

Primary Completion (Anticipated)

July 18, 2022

Study Completion (Anticipated)

August 18, 2022

Study Registration Dates

First Submitted

May 17, 2022

First Submitted That Met QC Criteria

May 20, 2022

First Posted (Actual)

May 24, 2022

Study Record Updates

Last Update Posted (Actual)

May 24, 2022

Last Update Submitted That Met QC Criteria

May 20, 2022

Last Verified

May 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FiratUnive.

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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