Exercise on microRNA in Rheumatoid Arthritis

Investigation Into the Effects of Exercise on microRNA Expressions in Patients With Rheumatoid Arthritis

The goal of this prospective cohort study is to learn about whether exercise alters microRNA expression levels in 30 rheumatoid arthritis patients and 30 healthy controls.

The main questions it aims to answer are:

• Does exercise affect microRNA expression levels related to the pathophysiology of rheumatoid arthritis?
• Are microRNA levels correlated with disease activity? Participants was applied program consisting of strengthening and stretching exercises 2 days a week for 8 weeks. One day a week, 30 minutes of mild moderate walking was requested.

Researchers will compare rheumatoid arthritis patients and healthy controls to see if that the microRNA expression levels of patients with rheumatoid arthritis as a result of exercise training would not make a significant difference with healthy controls.

Study Overview

• Status: Completed
• Conditions: Rheumatoid Arthritis
• Intervention / Treatment: Behavioral: exercise; Biological: gene expressions of miRNA

Detailed Description

Rheumatoid arthritis can be a systemic, inflammatory, autoimmune breathing that can cause heavy, joint destruction with vibrations in the synovial vessels of the joints. Although great strides have been made in understanding the disease, the pathogenesis of Rheumatoid arthritis.A has not yet been fully elucidated. Early treatment can prevent serious disability.

The goal of treatment for patients with rheumatoid arthritis is to achieve remission or at least a state of low disease activity.Combinations with disease-modifying antirheumatic drugs (DMARDs) and biologic agents are recommended for patients who fail to respond to treatment, based on patient prognosis and response to treatment.

In addition to drug therapy, exercise training is recommended in patients with Rheumatoid arthritis. Decreased joint health, including joint pain and inflammation, fatigue, increased incidence of cardiovascular disease in patients with rheumatoid arthritis; it causes functional limitation, disability, comorbidities and a decrease in quality of life.Therefore, it is recommended that aerobic and resistance exercise training should be encouraged as part of the routine treatment of all Rheumatoid arthritis patients.

microRNAs (miRNAs) are small, non-coding RNAs that mediate messenger RNA (mRNA) cleavage, translational repression. As regulators of gene expression, miRNAs participate in critical cellular processes and show varying levels of expression in many cell types in different diseases.It became clear that there were changes in miRNA expression in Rheumatoid arthritis patients.In many studies, it has been shown that miRNAs contribute to the disruption of joint destruction, inflammation and apoptosis in peripheral blood mononuclear cells, isolated T lymphocytes, synovial tissue and synovial fibroblasts. Thus, miRNAs are known to constitute the pathophysiological process specific to Rheumatoid arthritis.

miRNA-146a is one of the miRNAs that has been extensively studied in Rheumatoid arthritis. It was found that the expression of miRNA-146a in the synovial fluid and synovial tissue of Rheumatoid arthritis A patients was significantly higher than in healthy individuals, and miRNA-16 and miRNA-155 together with miRNA-146a may be related to disease pathology. In addition, high levels of miRNA-16 expression are known to correlate with active disease and low expression levels with remission. It has been reported that the expression level of miRNA-145 is increased in peripheral blood mononuclear cells and synovium of Rheumatoid arthritis patients, which supports osteoclastogenesis.

In this study, it was aimed to determine whether miRNAs, which play a role in determining the effectiveness of the treatment and the severity of the disease, change with exercise training, to know the effect of exercise training on the person, to accept it as an auxiliary practice in controlling the disease and to prove it with scientific facts.

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • Sakarya, Turkey
    • Sakarya Training and Research Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Individuals with not having any deformity in the last six months, not having a diagnosed cardiovascular disease

Exclusion Criteria:

• Exclusion criteria were not giving written consent, severe hypertension that would prevent physical activity, orthopedic problems that would prevent participation in the study, uncontrolled chronic systemic disease, central and peripheral nervous system diseases, recent neurological, orthopedic or other

Study Plan

How is the study designed?

Design Details

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

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Rheumatoid Arthritis Group; 30 patients aged 18-60 years who met the 2010 American College of Rheumatology / European League Against Rheumatism Rheumatoid arthritis criteria were included in the study. A program consisting of strengthening and stretching exercises 2 days a week was applied to the study group for 8 weeks. One day a week, 30 minutes of mild moderate walking was requested. 30 healthy controls aged 18-60 years who included in the study. Of the cases at the beginning and at the end of the treatment; 5-10 cc peripheral blood samples were taken into one Ethylenediaminetetraacetic acid tube. Then Numeric Rating Scale (NRS) was used for pain, 28-joint Disease Activity Score (DAS28) was used to calculate disease activity, Health Assessment Questionnaire (HAQ) was used to assess general health and Short Form-36 (SF-36) was used to evaluate quality of life. In the samples taken, gene expressions of miRNA-146a, miRNA-155, miRNA-16, miRNA-145 were determined by real-time polymerase chain reaction method.

Behavioral: exercise; A program consisting of strengthening and stretching exercises 2 days a week was applied to the study group for 8 weeks. One day a week, 30 minutes of mild moderate walking was requested.; Biological: gene expressions of miRNA; In the samples taken, gene expressions of miRNA-146a, miRNA-155, miRNA-16, miRNA-145 were determined by real-time polymerase chain reaction method.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Gene Expressions of microRNA for Healthy Control Group	By examining the expression level of RNA, U6 small nuclear 1 (human) as a control gene, it is decided whether the expression levels of microRNAs are expressed up or down.	Baseline
Pre-Treatment Gene Expressions of microRNA for Treatment Group	By examining the expression level of RNA, U6 small nuclear 1 (human) as a control gene, it is decided whether the expression levels of microRNAs are expressed up or down.	Baseline
Pre-Treatment DAS28 for Treatment Group	28-joint Disease Activity Score (DAS28), which is widely used in clinics, is used to find disease findings in patients with rheumatoid arthritis. Calculation is made with the C-Reactive Protein value. DAS28> 5.1 is considered high disease activity, 3.2<DAS28≤5.1 is considered moderate disease activity, DAS28≤3.2 is low disease activity, and DAS28<2.6 is considered disease remission.	Baseline
Post-Treatment DAS28 for Treatment Group	28-joint Disease Activity Score (DAS28), which is widely used in clinics, is used to find disease findings in patients with rheumatoid arthritis. Calculation is made with the C-Reactive Protein value. DAS28> 5.1 is considered high disease activity, 3.2<DAS28≤5.1 is considered moderate disease activity, DAS28≤3.2 is low disease activity, and DAS28<2.6 is considered disease remission.	Through study completion, an average of 2 months
Post-Treatment Gene Expressions of microRNA for Treatment Group	By examining the expression level of RNA, U6 small nuclear 1 (human) as a control gene, it is decided whether the expression levels of microRNAs are expressed up or down.	Through study completion, an average of 2 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
NRS	Then Numeric Rating Scale (NRS) was used for pain. In this scale, pain intensity is measured with an 11-point scale. Here 0: No pain and 10: the most severe pain level.	at the beginning of the intervention and through study completion, an average of 2 month
HAQ	Health Assessment Questionnaire was used to assess general health. It consists of 20 questions in total, including 8 subsections. Subjects score between 0-3 according to their level of difficulty in activities. The total score is obtained by calculating the arithmetic mean of the sums of the highest scores in the subsections. Higher scores indicate higher functional disability and pain.	at the beginning of the intervention and through study completion, an average of 2 month
SF-36	Short Form-36 (SF-36) was used to evaluate quality of life. This Questionnaire consists of eight subsections. Scoring is made between 0-100 for each of the subsections. Higher scores indicate better function and well-being.	at the beginning of the intervention and through study completion, an average of 2 month

Collaborators and Investigators

• Sponsor: Saglik Bilimleri Universitesi
• Investigators: Study Chair: Fulya Senem KARAAHMETOĞLU, M. Sc., Saglik Bilimleri Universitesi; Study Chair: Zeynep Betül ÖZCAN, M. Sc., Saglik Bilimleri Universitesi; Study Chair: Sibel KURAŞ, M. Sc., Saglik Bilimleri Universitesi; Study Chair: Bekir ERDOĞAN, M. Sc., Saglik Bilimleri Universitesi; Principal Investigator: Mehmet Zahid ÇIRACI, MD, Sakarya Training and Research Hospital; Study Chair: Halime Hanım PENÇE, Assoc. Pr, Saglik Bilimleri Universitesi; Study Chair: Meltem VURAL, Prof. Dr., Istanbul Bakırköy Dr.Sadi Konuk Training and Research Hospital; Study Chair: Alev KURAL, Assoc. Pr., Istanbul Bakırköy Dr.Sadi Konuk Training and Research Hospital; Study Chair: Işıl ÜSTÜN, MD, Istanbul Bakırköy Dr.Sadi Konuk Training and Research Hospital

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2018
• Primary Completion (Actual): September 11, 2019
• Study Completion (Actual): June 17, 2020

Study Registration Dates

• First Submitted: April 17, 2023
• First Submitted That Met QC Criteria: June 13, 2023
• First Posted (Actual): June 22, 2023

Study Record Updates

• Last Update Posted (Actual): June 22, 2023
• Last Update Submitted That Met QC Criteria: June 13, 2023
• Last Verified: March 1, 2023

More Information

Terms related to this study

• Keywords: exercise; microRNA; Rheumatoid arthritis
• Additional Relevant MeSH Terms: Immune System Diseases; Autoimmune Diseases; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Arthritis; Arthritis, Rheumatoid
• Other Study ID Numbers: RA_miRNA

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No