Exercise on microRNA in Rheumatoid Arthritis

Rheumatoid Arthritis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05914337
• Other study ID #: RA_miRNA
• Status: Completed
• Phase: N/A
• Start date: August 1, 2018
• Est. completion date: June 17, 2020

Study information

• Verified date: March 2023
• Source: Saglik Bilimleri Universitesi
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: June 17, 2020
• Est. primary completion date: September 11, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Rheumatoid
• Rheumatoid Arthritis

Intervention

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.

Locations

Country	Name	City	State
Turkey	Sakarya Training and Research Hospital	Sakarya

Sponsors (1)

Lead Sponsor	Collaborator
Saglik Bilimleri Universitesi

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Baseline
Primary	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	Through study completion, an average of 2 months
Primary	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
Primary	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
Primary	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
Secondary	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
Secondary	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
Secondary	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