Clinical trial NCT05914337: 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
Overall status: COMPLETED
Phase: NA
Conditions: Rheumatoid Arthritis
Keywords: Rheumatoid arthritis
exercise
microRNA
Lead sponsor: Saglik Bilimleri Universitesi
Sponsor class: OTHER
First posted: 2023-06-22
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Pre-Treatment DAS28 for Treatment Group
timeFrame: Baseline
measure: Post-Treatment DAS28 for Treatment Group
timeFrame: Through study completion, an average of 2 months
measure: Pre-Treatment Gene Expressions of microRNA for Treatment Group
timeFrame: Baseline
measure: Post-Treatment Gene Expressions of microRNA for Treatment Group
timeFrame: Through study completion, an average of 2 months
measure: Gene Expressions of microRNA for Healthy Control Group
timeFrame: Baseline
Secondary outcomes:
measure: NRS
timeFrame: at the beginning of the intervention and through study completion, an average of 2 month
measure: HAQ
timeFrame: at the beginning of the intervention and through study completion, an average of 2 month
measure: SF-36
timeFrame: at the beginning of the intervention and through study completion, an average of 2 month
Other outcomes:
Locations:
city: Sakarya
country: Turkey
facility: Sakarya Training and Research Hospital
Study officials:
affiliation: Saglik Bilimleri Universitesi
name: Zeynep Betül ÖZCAN, M. Sc.
role: STUDY_CHAIR
affiliation: Saglik Bilimleri Universitesi
name: Fulya Senem KARAAHMETOĞLU, M. Sc.
role: STUDY_CHAIR
affiliation: Saglik Bilimleri Universitesi
name: Bekir ERDOĞAN, M. Sc.
role: STUDY_CHAIR
affiliation: Saglik Bilimleri Universitesi
name: Sibel KURAŞ, M. Sc.
role: STUDY_CHAIR
affiliation: Sakarya Training and Research Hospital
name: Mehmet Zahid ÇIRACI, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Saglik Bilimleri Universitesi
name: Halime Hanım PENÇE, Assoc. Pr
role: STUDY_CHAIR
affiliation: Istanbul Bakırköy Dr.Sadi Konuk Training and Research Hospital
name: Meltem VURAL, Prof. Dr.
role: STUDY_CHAIR
affiliation: Istanbul Bakırköy Dr.Sadi Konuk Training and Research Hospital
name: Alev KURAL, Assoc. Pr.
role: STUDY_CHAIR
affiliation: Istanbul Bakırköy Dr.Sadi Konuk Training and Research Hospital
name: Işıl ÜSTÜN, MD
role: STUDY_CHAIR
References: