- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04439682
The Effects of Exercise on Some Biochemical Parameters in Patients With Rheumatoid Arthritis
Background: RA may progress with articular and non-articular involvement.Depression prevelance is found to increase for RA patients according to healthy population and to be correlated with pain, decreased quality of life, fatigue and physical disability.BDNF level was found significantly lower in RA patients with depression. Aim of this study is to investigate the variation of BDNF, VEGF, TNF- α, IL-6, IL-1β, irisin and α- Klotho levels following acute exercise.
Methods: This study included 45 RA patients and 45 age and sex matched healthy controls. Blood samples from all subjects were taken and centrifuged before and immediately after the exercise intervention.
Study Overview
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Songul B Yentur
- Phone Number: 0424 237 8282
- Email: songulbaglan23@hotmail.com
Study Contact Backup
- Name: Süleyman S Koca, Prof. Dr.
- Phone Number: 0000 0424 2370000
- Email: kocassk@gmail.com
Study Locations
-
-
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Elazığ, Turkey, 23000
- Recruiting
- Songül Bağlan Yentür
-
Contact:
- Songul B Yentur
- Phone Number: +90 506 272 6511
- Email: songulbaglan23@hotmail.com
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Patients who were aged between 18-65 years,
- Patients who got diagnosed according to American College of Rheumatology criteria
- Patients who were being followed at Firat University Department of Rheumatology
Exclusion Criteria:
- Patients who had regular exercise habits, malignancy, pregnancy, incorporation,
- Patients who took anti-TNF treatment
- Patients who had changes of medical treatment in last 3 months
- Patients who diagnosed with Fibromyalgia Syndrome and Osteoarthritis for lower extremity
- Patients who had cardiac symptoms according to New York Heart Association
- Patients who had dysfunction that can prevent physical activity
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Study group
Aerobic exercise will be performed for a single session
|
Aerobic exercise will be performed to all participants for a single session.
Maximum heart rate was calculated for each subject (220 - age) and a heart rate monitor (Polar FT 100, China) will be used to follow subjects' heart rate during aerobic exercise.
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Active Comparator: Control group
Aerobic exercise will be performed to healthy population for a single session
|
Aerobic exercise will be performed to all participants for a single session.
Maximum heart rate was calculated for each subject (220 - age) and a heart rate monitor (Polar FT 100, China) will be used to follow subjects' heart rate during aerobic exercise.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Irisin
Time Frame: 1 minute
|
Blood samples from all subjects will be taken and centrifuged before and immediately after the exercise intervention.
Obtained serums will be stored at the laboratories of Firat University.
|
1 minute
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
BDNF, VEGF, TNF- α, IL-6, IL-1β and α- Klotho
Time Frame: 1 minute
|
Blood samples from all subjects will be taken and centrifuged before and immediately after the exercise intervention.
Obtained serums will be stored at the laboratories of Firat University.
|
1 minute
|
Collaborators and Investigators
Sponsor
Publications and helpful links
General Publications
- Grimsholm O, Rantapaa-Dahlqvist S, Dalen T, Forsgren S. BDNF in RA: downregulated in plasma following anti-TNF treatment but no correlation with inflammatory parameters. Clin Rheumatol. 2008 Oct;27(10):1289-97. doi: 10.1007/s10067-008-0910-4. Epub 2008 May 17.
- Szuhany KL, Bugatti M, Otto MW. A meta-analytic review of the effects of exercise on brain-derived neurotrophic factor. J Psychiatr Res. 2015 Jan;60:56-64. doi: 10.1016/j.jpsychires.2014.10.003. Epub 2014 Oct 12.
- Ercan Z, Deniz G, Yentur SB, Arikan FB, Karatas A, Alkan G, Koca SS. Effects of acute aerobic exercise on cytokines, klotho, irisin, and vascular endothelial growth factor responses in rheumatoid arthritis patients. Ir J Med Sci. 2022 Mar 16. doi: 10.1007/s11845-022-02970-7. Online ahead of print.
Study record dates
Study Major Dates
Study Start (Anticipated)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 97132852/050.01.04/
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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