Rheumatoid ArthritisNCT05914337
Exercise on microRNA in Rheumatoid Arthritis
A study testing exercise and gene expressions of miRNA in people with Rheumatoid Arthritis, run by Saglik Bilimleri Universitesi at 1 site in Turkey (Türkiye).
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?… Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Rheumatoid Arthritis
- What is being tested?
- exercise and gene expressions of miRNA
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Aug 2018to 17 Jun 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Individuals with not having any deformity in the last six months, not having a diagnosed cardiovascular disease
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Sakarya Training and Research Hospital
Sakarya
About this study
Official title: 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:
Read more
- 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.
Read the 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.
- Conditions
- Rheumatoid Arthritis
- Being tested
- exercise, gene expressions of miRNA
- Keywords
- Rheumatoid arthritis, exercise, microRNA
- Medical subject headings
- Arthritis, Rheumatoid, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
exerciseBehavioural
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.
gene expressions of miRNABiological
In the samples taken, gene expressions of miRNA-146a, miRNA-155, miRNA-16, miRNA-145 were determined by real-time polymerase chain reaction method.
| Study group | Role | What they receive |
|---|---|---|
| Rheumatoid Arthritis Group | Experimental | 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. Receives: Behavioral: exercise; Biological: gene expressions of miRNA |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Through study completion, an average of 2 months
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.
Measured: Baseline
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.
Measured: Through study completion, an average of 2 months
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.
Measured: Baseline
Secondary outcomes (3)
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.
Measured: 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.
Measured: 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.
Measured: at the beginning of the intervention and through study completion, an average of 2 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jun 2023
- Study start1 Aug 2018
- Primary completion11 Sep 2019
- Study completion17 Jun 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rheumatoid ArthritisStudies of the same condition, open and under way.
- More trials run by Saglik Bilimleri UniversitesiThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Saglik Bilimleri Universitesi
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Zeynep Betül ÖZCAN, M. Sc., Study chair, Saglik Bilimleri UniversitesiFulya Senem KARAAHMETOĞLU, M. Sc., Study chair, Saglik Bilimleri UniversitesiBekir ERDOĞAN, M. Sc., Study chair, Saglik Bilimleri UniversitesiSibel KURAŞ, M. Sc., Study chair, Saglik Bilimleri UniversitesiMehmet Zahid ÇIRACI, MD, Principal investigator, Sakarya Training and Research HospitalHalime Hanım PENÇE, Assoc. Pr, Study chair, Saglik Bilimleri UniversitesiMeltem VURAL, Prof. Dr., Study chair, Istanbul Bakırköy Dr.Sadi Konuk Training and Research HospitalAlev KURAL, Assoc. Pr., Study chair, Istanbul Bakırköy Dr.Sadi Konuk Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05914337
- Sponsor's protocol ID
- RA_miRNA
- Status last verified
- Mar 2023
- First submitted
- 17 Apr 2023
- Last updated
- 22 Jun 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation Into the Effects of Exercise on microRNA Expressions in Patients With Rheumatoid Arthritis
- ClinicalTrials.gov ID
- NCT05914337
- Acronym / sponsor ID
- RA_miRNA
- Conditions
- Rheumatoid Arthritis
- Keywords
- Rheumatoid arthritis, exercise, microRNA
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Saglik Bilimleri UniversitesiUniversity, hospital or other
- Study start
- 1 Aug 2018 (actual)
- Primary completion
- 11 Sep 2019 (actual)
- Study completion
- 17 Jun 2020 (actual)
- First posted
- 22 Jun 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Rheumatoid Arthritis Group | Experimental | Behavioral: exercise, Biological: gene expressions of miRNA30 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. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Individuals with not having any deformity in the last six months, not having a diagnosed cardiovascular disease
Key exclusion criteria (1 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| exerciseA 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. | Behavioural | Rheumatoid Arthritis Group |
| gene expressions of miRNAIn the samples taken, gene expressions of miRNA-146a, miRNA-155, miRNA-16, miRNA-145 were determined by real-time polymerase chain reaction method. | Biological | Rheumatoid Arthritis Group |
Primary outcome
Pre-Treatment DAS28 for Treatment Group
Time frame: 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.
Post-Treatment DAS28 for Treatment Group
Time frame: 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.
Pre-Treatment Gene Expressions of microRNA for Treatment Group
Time frame: 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.
Post-Treatment Gene Expressions of microRNA for Treatment Group
Time frame: 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.
Gene Expressions of microRNA for Healthy Control Group
Time frame: 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.
3 secondary outcomes
NRS
Time frame: at the beginning of the intervention and through study completion, an average of 2 month
HAQ
Time frame: at the beginning of the intervention and through study completion, an average of 2 month
SF-36
Time frame: at the beginning of the intervention and through study completion, an average of 2 month
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jun 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Zeynep Betül ÖZCAN, M. Sc. study chair
Saglik Bilimleri Universitesi
Fulya Senem KARAAHMETOĞLU, M. Sc. study chair
Saglik Bilimleri Universitesi
Bekir ERDOĞAN, M. Sc. study chair
Saglik Bilimleri Universitesi
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing exercise and gene expressions of miRNA in people with Rheumatoid Arthritis, run by Saglik Bilimleri Universitesi at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pre-Treatment DAS28 for Treatment Group (time frame: Baseline). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jun 2023.