NCT04439682

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.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
90

participants targeted

Target at P50-P75 for not_applicable rheumatoid-arthritis

Timeline
Completed

Started Jul 2020

Shorter than P25 for not_applicable rheumatoid-arthritis

Geographic Reach
1 country

1 active site

Status
unknown

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

First Submitted

Initial submission to the registry

June 17, 2020

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 19, 2020

Completed
28 days until next milestone

Study Start

First participant enrolled

July 17, 2020

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 17, 2020

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 17, 2021

Completed
Last Updated

June 19, 2020

Status Verified

June 1, 2020

Enrollment Period

2 months

First QC Date

June 17, 2020

Last Update Submit

June 17, 2020

Conditions

Rheumatoid Arthritis

Keywords

Rheumatoid ArthritisBiochemical Parametersexercise

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • BDNF, VEGF, TNF- α, IL-6, IL-1β and α- Klotho

    1 minute

Study Arms (2)

Study group

EXPERIMENTAL

Aerobic exercise will be performed for a single session

Other: Aerobic exercise

Control group

ACTIVE COMPARATOR

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

Other: Aerobic exercise

Interventions

Aerobic exerciseOTHER

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.

Control groupStudy group

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Songul Baglan Yentur

Elâzığ, 23000, Turkey (Türkiye)

RECRUITING

Related Publications (3)

  • 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.

    PMID: 18484150BACKGROUND

  • 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.

    PMID: 25455510BACKGROUND

  • 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.

    PMID: 35296975DERIVED

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

Central Study Contacts

Songul B Yentur

CONTACT

0424 237 8282songulbaglan23@hotmail.com

Süleyman S Koca, Prof. Dr.

CONTACT

0424 2370000kocassk@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Research Assistant

Study Record Dates

First Submitted

June 17, 2020

First Posted

June 19, 2020

Study Start

July 17, 2020

Primary Completion

September 17, 2020

Study Completion

June 17, 2021

Last Updated

June 19, 2020

Record last verified: 2020-06

Data Sharing

IPD Sharing
Will not share

Locations

TU(1)