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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04439682
Other study ID # 97132852/050.01.04/
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date July 17, 2020
Est. completion date June 17, 2021

Study information

Verified date June 2020
Source Gazi University
Contact Songul B Yentur
Phone 0424 237 8282
Email songulbaglan23@hotmail.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


Recruitment information / eligibility

Status Recruiting
Enrollment 90
Est. completion date June 17, 2021
Est. primary completion date September 17, 2020
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 65 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Other:
Aerobic exercise
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.

Locations

Country Name City State
Turkey Songul Baglan Yentur Elazig

Sponsors (1)

Lead Sponsor Collaborator
Gazi University

Country where clinical trial is conducted

Turkey, 

References & Publications (2)

Grimsholm O, Rantapää-Dahlqvist S, Dalén 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. — View Citation

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. Review. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Irisin 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 BDNF, VEGF, TNF- a, IL-6, IL-1ß and a- Klotho 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
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