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Exercise on microRNA in Rheumatoid Arthritis

Primary Purpose

Rheumatoid Arthritis

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
exercise
gene expressions of miRNA
Sponsored by
Saglik Bilimleri Universitesi
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Rheumatoid Arthritis focused on measuring Rheumatoid arthritis, exercise, microRNA

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Sakarya Training and Research Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Rheumatoid Arthritis Group

Arm Description

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.

Outcomes

Primary Outcome Measures

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.
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.
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.
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.
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.

Secondary Outcome Measures

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.
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.
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.

Full Information

First Posted
April 17, 2023
Last Updated
June 13, 2023
Sponsor
Saglik Bilimleri Universitesi
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1. Study Identification

Unique Protocol Identification Number
NCT05914337
Brief Title
Exercise on microRNA in Rheumatoid Arthritis
Official Title
Investigation Into the Effects of Exercise on microRNA Expressions in Patients With Rheumatoid Arthritis
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Completed
Study Start Date
August 1, 2018 (Actual)
Primary Completion Date
September 11, 2019 (Actual)
Study Completion Date
June 17, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Saglik Bilimleri Universitesi

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rheumatoid Arthritis
Keywords
Rheumatoid arthritis, exercise, microRNA

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Rheumatoid Arthritis Group
Arm Type
Experimental
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
exercise
Intervention Description
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.
Intervention Type
Biological
Intervention Name(s)
gene expressions of miRNA
Intervention Description
In the samples taken, gene expressions of miRNA-146a, miRNA-155, miRNA-16, miRNA-145 were determined by real-time polymerase chain reaction method.
Primary Outcome Measure Information:
Title
Pre-Treatment DAS28 for Treatment Group
Description
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.
Time Frame
Baseline
Title
Post-Treatment DAS28 for Treatment Group
Description
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.
Time Frame
Through study completion, an average of 2 months
Title
Pre-Treatment Gene Expressions of microRNA for Treatment Group
Description
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.
Time Frame
Baseline
Title
Post-Treatment Gene Expressions of microRNA for Treatment Group
Description
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.
Time Frame
Through study completion, an average of 2 months
Title
Gene Expressions of microRNA for Healthy Control Group
Description
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.
Time Frame
Baseline
Secondary Outcome Measure Information:
Title
NRS
Description
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.
Time Frame
at the beginning of the intervention and through study completion, an average of 2 month
Title
HAQ
Description
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.
Time Frame
at the beginning of the intervention and through study completion, an average of 2 month
Title
SF-36
Description
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.
Time Frame
at the beginning of the intervention and through study completion, an average of 2 month

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Zeynep Betül ÖZCAN, M. Sc.
Organizational Affiliation
Saglik Bilimleri Universitesi
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Fulya Senem KARAAHMETOĞLU, M. Sc.
Organizational Affiliation
Saglik Bilimleri Universitesi
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Bekir ERDOĞAN, M. Sc.
Organizational Affiliation
Saglik Bilimleri Universitesi
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Sibel KURAŞ, M. Sc.
Organizational Affiliation
Saglik Bilimleri Universitesi
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Mehmet Zahid ÇIRACI, MD
Organizational Affiliation
Sakarya Training and Research Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Halime Hanım PENÇE, Assoc. Pr
Organizational Affiliation
Saglik Bilimleri Universitesi
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Meltem VURAL, Prof. Dr.
Organizational Affiliation
Istanbul Bakırköy Dr.Sadi Konuk Training and Research Hospital
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Alev KURAL, Assoc. Pr.
Organizational Affiliation
Istanbul Bakırköy Dr.Sadi Konuk Training and Research Hospital
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Işıl ÜSTÜN, MD
Organizational Affiliation
Istanbul Bakırköy Dr.Sadi Konuk Training and Research Hospital
Official's Role
Study Chair
Facility Information:
Facility Name
Sakarya Training and Research Hospital
City
Sakarya
Country
Turkey

12. IPD Sharing Statement

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Exercise on microRNA in Rheumatoid Arthritis

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