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Exercise-related Irisin on Inflammation and Pain

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ClinicalTrials.gov Identifier: NCT05388994
Recruitment Status : Not yet recruiting
First Posted : May 24, 2022
Last Update Posted : May 24, 2022
Sponsor:
Information provided by (Responsible Party):
Furkan BİLEK, Firat University

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.


Condition or disease Intervention/treatment Phase
Osteo Arthritis Knee Pain Inflammation Other: Exercise Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description: prospective
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Effects of Exercise-related Irisin on Inflammation and Pain in Individuals With Osteoarthritis
Estimated Study Start Date : May 18, 2022
Estimated Primary Completion Date : July 18, 2022
Estimated Study Completion Date : August 18, 2022

Resource links provided by the National Library of Medicine


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).




Primary Outcome Measures :
  1. 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.


  2. 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.

  3. 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.

  4. 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.



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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05388994


Contacts
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Contact: Furkan Bilek +905442772249 fzt.furkanbilek@gmail.com
Contact: Ömer Esmez, MD 04242370000 ext 4592 dresmezomer@gmail.com

Locations
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Turkey
Furkan Bilek
Elazığ, Turkey, 23100
Sponsors and Collaborators
Firat University
Publications:

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Responsible Party: Furkan BİLEK, Principal Investigator, Firat University
ClinicalTrials.gov Identifier: NCT05388994    
Other Study ID Numbers: FiratUnive.
First Posted: May 24, 2022    Key Record Dates
Last Update Posted: May 24, 2022
Last Verified: May 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Furkan BİLEK, Firat University:
Osteoarthritis
pain
irisin
inflammation
exercise
Additional relevant MeSH terms:
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Osteoarthritis
Osteoarthritis, Knee
Inflammation
Arthritis
Joint Diseases
Musculoskeletal Diseases
Pathologic Processes
Rheumatic Diseases