Exercise-related Irisin on Inflammation and Pain

NCT05388994 | Unknown

• 1 other identifier: FiratUnive.
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Osteo Arthritis Knee; Pain; Inflammation

Keywords

Osteoarthritis; pain; irisin; inflammation; exercise

Outcome Measures

Primary Outcomes (4)

• Kellgren-Lawrence Scale

  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

  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

  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

  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

Study Arms (1)

Exercise

EXPERIMENTAL

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

Interventions

Exercise OTHER

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).

Exercise

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnosed with osteoarthritis
• No knee joint contracture

You may not qualify if:

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

Sponsors & Collaborators

• Firat University: lead

Study Sites (1)

Furkan Bilek

Elâzığ, 23100, Turkey (Türkiye)

Location

Related Publications (18)

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MeSH Terms

Conditions

Pain; Inflammation; Osteoarthritis; Motor Activity

Interventions

Exercise

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Pathologic Processes; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Behavior

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Central Study Contacts

Furkan Bilek

CONTACT

+905442772249; fzt.furkanbilek@gmail.com

Ömer Esmez, MD

CONTACT

04242370000; dresmezomer@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: prospective

Study Record Dates

• First Submitted: May 17, 2022
• First Posted: May 24, 2022
• Study Start: May 18, 2022
• Primary Completion: July 18, 2022
• Study Completion: August 18, 2022
• Last Updated: May 24, 2022

Record last verified: 2022-05

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)