Exercise on microRNA in Rheumatoid Arthritis

Sponsor
Saglik Bilimleri Universitesi (Other)
Overall Status
Completed
CT.gov ID
NCT05914337
Collaborator
(none)
60
1
1
22.5
2.7

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: exercise
  • Biological: gene expressions of miRNA
N/A

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 Design

Study Type:
Interventional
Actual Enrollment :
60 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Investigation Into the Effects of Exercise on microRNA Expressions in Patients With Rheumatoid Arthritis
Actual Study Start Date :
Aug 1, 2018
Actual Primary Completion Date :
Sep 11, 2019
Actual Study Completion Date :
Jun 17, 2020

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

  1. Pre-Treatment DAS28 for Treatment Group [Baseline]

    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.

  2. Post-Treatment DAS28 for Treatment Group [Through study completion, an average of 2 months]

    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.

  3. Pre-Treatment Gene Expressions of microRNA for Treatment Group [Baseline]

    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.

  4. Post-Treatment Gene Expressions of microRNA for Treatment Group [Through study completion, an average of 2 months]

    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.

  5. Gene Expressions of microRNA for Healthy Control Group [Baseline]

    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.

Secondary Outcome Measures

  1. NRS [at the beginning of the intervention and through study completion, an average of 2 month]

    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.

  2. HAQ [at the beginning of the intervention and through study completion, an average of 2 month]

    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.

  3. SF-36 [at the beginning of the intervention and through study completion, an average of 2 month]

    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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 60 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Sakarya Training and Research Hospital Sakarya Turkey

Sponsors and Collaborators

  • Saglik Bilimleri Universitesi

Investigators

  • Study Chair: Zeynep Betül ÖZCAN, M. Sc., Saglik Bilimleri Universitesi
  • Study Chair: Fulya Senem KARAAHMETOĞLU, M. Sc., Saglik Bilimleri Universitesi
  • Study Chair: Bekir ERDOĞAN, M. Sc., Saglik Bilimleri Universitesi
  • Study Chair: Sibel KURAŞ, 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 Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Saglik Bilimleri Universitesi
ClinicalTrials.gov Identifier:
NCT05914337
Other Study ID Numbers:
  • RA_miRNA
First Posted:
Jun 22, 2023
Last Update Posted:
Jun 22, 2023
Last Verified:
Mar 1, 2023
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Saglik Bilimleri Universitesi
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jun 22, 2023