NCT05914337

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable rheumatoid-arthritis

Timeline
Completed

Started Aug 2018

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2018

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 11, 2019

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 17, 2020

Completed
2.8 years until next milestone

First Submitted

Initial submission to the registry

April 17, 2023

Completed
2 months until next milestone

First Posted

Study publicly available on registry

June 22, 2023

Completed
Last Updated

June 22, 2023

Status Verified

March 1, 2023

Enrollment Period

1.1 years

First QC Date

April 17, 2023

Last Update Submit

June 13, 2023

Conditions

Rheumatoid Arthritis

Keywords

Rheumatoid arthritisexercisemicroRNA

Outcome Measures

Primary Outcomes (5)

  • 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.

    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.

    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.

    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.

    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.

    Baseline

Secondary Outcomes (3)

  • NRS

    at the beginning of the intervention and through study completion, an average of 2 month

  • HAQ

    at the beginning of the intervention and through study completion, an average of 2 month

  • SF-36

    at the beginning of the intervention and through study completion, an average of 2 month

Study Arms (1)

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.

Behavioral: exerciseBiological: gene expressions of miRNA

Interventions

exerciseBEHAVIORAL

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.

Rheumatoid Arthritis Group
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.

Rheumatoid Arthritis Group

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Individuals with not having any deformity in the last six months, not having a diagnosed cardiovascular disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sakarya Training and Research Hospital

Sakarya, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Arthritis, RheumatoidMotor Activity

Interventions

Exercise

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic DiseasesConnective Tissue DiseasesSkin and Connective Tissue DiseasesAutoimmune DiseasesImmune System DiseasesBehavior

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • 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

    STUDY CHAIR

  • Mehmet Zahid ÇIRACI, MD

    Sakarya Training and Research Hospital

    PRINCIPAL INVESTIGATOR

  • 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 CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 17, 2023

First Posted

June 22, 2023

Study Start

August 1, 2018

Primary Completion

September 11, 2019

Study Completion

June 17, 2020

Last Updated

June 22, 2023

Record last verified: 2023-03

Locations

TU(1)