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The Effects of Exercise on Some Biochemical Parameters in Patients With Rheumatoid Arthritis

Primary Purpose

Rheumatoid Arthritis

Status
Unknown status
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Aerobic exercise
Sponsored by
Gazi University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Rheumatoid Arthritis focused on measuring Rheumatoid Arthritis, Biochemical Parameters, exercise

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Songul Baglan YenturRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Study group

Control group

Arm Description

Aerobic exercise will be performed for a single session

Aerobic exercise will be performed to healthy population for a single session

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

BDNF, VEGF, TNF- α, IL-6, IL-1β and α- 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.

Full Information

First Posted
June 17, 2020
Last Updated
June 17, 2020
Sponsor
Gazi University
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1. Study Identification

Unique Protocol Identification Number
NCT04439682
Brief Title
The Effects of Exercise on Some Biochemical Parameters in Patients With Rheumatoid Arthritis
Official Title
The Effects of Exercise on Some Biochemical Parameters in Patients With Rheumatoid Arthritis
Study Type
Interventional

2. Study Status

Record Verification Date
June 2020
Overall Recruitment Status
Unknown status
Study Start Date
July 17, 2020 (Anticipated)
Primary Completion Date
September 17, 2020 (Anticipated)
Study Completion Date
June 17, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Gazi University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rheumatoid Arthritis
Keywords
Rheumatoid Arthritis, Biochemical Parameters, exercise

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Non-Randomized
Enrollment
90 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Study group
Arm Type
Experimental
Arm Description
Aerobic exercise will be performed for a single session
Arm Title
Control group
Arm Type
Active Comparator
Arm Description
Aerobic exercise will be performed to healthy population for a single session
Intervention Type
Other
Intervention Name(s)
Aerobic exercise
Intervention Description
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.
Primary Outcome Measure Information:
Title
Irisin
Description
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.
Time Frame
1 minute
Secondary Outcome Measure Information:
Title
BDNF, VEGF, TNF- α, IL-6, IL-1β and α- Klotho
Description
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.
Time Frame
1 minute

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Songul B Yentur
Phone
0424 237 8282
Email
songulbaglan23@hotmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Süleyman S Koca, Prof. Dr.
Phone
0424 2370000
Ext
0000
Email
kocassk@gmail.com
Facility Information:
Facility Name
Songul Baglan Yentur
City
Elazığ
ZIP/Postal Code
23000
Country
Turkey
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Songul B Yentur
Phone
+90 506 272 6511
Email
songulbaglan23@hotmail.com

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
18484150
Citation
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.
Results Reference
background
PubMed Identifier
25455510
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.
Results Reference
background
PubMed Identifier
35296975
Citation
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. 2023 Feb;192(1):491-497. doi: 10.1007/s11845-022-02970-7. Epub 2022 Mar 16.
Results Reference
derived

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The Effects of Exercise on Some Biochemical Parameters in Patients With Rheumatoid Arthritis

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