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Effects of Acute Exercise on BDNF Levels in Rheumatoid Arthritis Patients

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, Brain Derived Neurotrophic Factor, acute 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

  • Gülnihal DenizRecruiting
  • Songul Baglan YenturRecruiting
  • Süleyman Serdar KocaRecruiting
  • Zübeyde ErcanRecruiting

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

BDNF levels
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

Beck Depression Inventory
Turkish version of Beck Depression Inventory (BDI) will be used to determine the depression levels of subjects. It consists of 21 items regarding pessimism, guilt, sleep, appetite and fatigue and each item is scored between 0 and 3. Higher scores shows the severity of depression.Score > 18 of BDI was considered as a cut-off value for depression.
Hospital Anxiety and Depression Scale
Hospital Anxiety and Depression Scale (HADS), developed by Zigmond and Snaith, determines anxiety disorders and depression among patients in nonpsychiatric clinics. It consists of 14 items and each item is scored from 0 to 3. Seven items are associated with anxiety and seven relate to depression. Score ranges from 0 to 21. Bjelland et al. identified score of 8 as a cut-off point.

Full Information

First Posted
January 31, 2020
Last Updated
June 17, 2020
Sponsor
Gazi University
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1. Study Identification

Unique Protocol Identification Number
NCT04254146
Brief Title
Effects of Acute Exercise on BDNF Levels in Rheumatoid Arthritis Patients
Official Title
Effects of Acute Exercise on BDNF Levels in Rheumatoid Arthritis Patients
Study Type
Interventional

2. Study Status

Record Verification Date
June 2020
Overall Recruitment Status
Unknown status
Study Start Date
January 31, 2020 (Actual)
Primary Completion Date
October 2, 2020 (Anticipated)
Study Completion Date
December 2, 2020 (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
Data Monitoring Committee
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 levels following acute exercise and potential correlation between BDNF levels and depression. Methods: This study included 30 RA patients and 30 age and sex matched healthy controls.Depression levels were evaluated with Beck Depression Inventory (BDI) and Hospital Anxiety and Depression Scale (HADS). Blood samples from all subjects were taken and centrifuged before and immediately after the exercise intervention.
Detailed Description
Background: Rheumatoid Arthritis (RA) is a chronic, inflammatory, rheumatic disease that genetic and environmental factors play role in its pathogenesis. There may be other symptoms caused by both the inflammation and the chronic disease effect, as well as the symptoms associated with the disease, such as depression, fatigue, physical inactivity and decreased quality of life. Major depression risk was revealed 16.8% of RA patients in a meta-analysis. Depression prevalence was found 38.8% by the assessment with Patient Health Questionnaire (PHQ-9) and between 14.8% and 48% by the assessment with Hospital Anxiety and Depression Scale. BDNF is a neurotrofic factor that may show healing, survival-promoting and protective effects on neurons in central and peripheral nervous system. Acute or chronic exercise programmes were found to increase BDNF levels in human and animal studies. Aim of this study is to investigate the variation of BDNF levels following acute exercise and potential correlation between BDNF levels and depression. Methods: This study included 30 RA patients and 30 age and sex matched healthy controls.Patients who were aged between 18-65 years, got diagnosed according to American College of Rheumatology criteria and were being followed at Firat University Department of Rheumatology were included in the study. Also, patients who had regular exercise habits, malignancy, pregnancy, incorporation, took anti-TNF treatment, had changes of medical treatment in last 3 months, diagnosed with Fibromyalgia Syndrome and Osteoarthritis for lower extremity, had cardiac symptoms according to New York Heart Association and had dysfunction that can prevent physical activity were excluded from the study. Healthy participants who were aged 18- 65 years old and not to have exercise habits were included in this study. Participants included in the study were asked and recorded age, body mass index (BMI), smoking/ alcohol habits, duration of the disease, vocation and having another chronic disease. Next, depression levels were evaluated with Beck Depression Inventory (BDI) and Hospital Anxiety and Depression Scale (HADS). Blood samples from all subjects were taken and centrifuged before and immediately after the exercise intervention.Aerobic exercise was 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) was used to follow subjects' heart rate during aerobic exercise.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rheumatoid Arthritis
Keywords
Rheumatoid Arthritis, Brain Derived Neurotrophic Factor, acute exercise

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Non-Randomized
Enrollment
60 (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
BDNF levels
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
Beck Depression Inventory
Description
Turkish version of Beck Depression Inventory (BDI) will be used to determine the depression levels of subjects. It consists of 21 items regarding pessimism, guilt, sleep, appetite and fatigue and each item is scored between 0 and 3. Higher scores shows the severity of depression.Score > 18 of BDI was considered as a cut-off value for depression.
Time Frame
2 minutes
Title
Hospital Anxiety and Depression Scale
Description
Hospital Anxiety and Depression Scale (HADS), developed by Zigmond and Snaith, determines anxiety disorders and depression among patients in nonpsychiatric clinics. It consists of 14 items and each item is scored from 0 to 3. Seven items are associated with anxiety and seven relate to depression. Score ranges from 0 to 21. Bjelland et al. identified score of 8 as a cut-off point.
Time Frame
2 minutes

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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Süleyman S Koca
Organizational Affiliation
Firat University
Official's Role
Study Director
Facility Information:
Facility Name
Gülnihal Deniz
City
Elazığ
ZIP/Postal Code
23000
Country
Turkey
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Gülnihal Deniz
Phone
0424 2372028
Email
fztgulnihal@hotmail.com
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
First Name & Middle Initial & Last Name & Degree
Songul B Yentur
Ext
Yentur
First Name & Middle Initial & Last Name & Degree
Songul B Yentur
Facility Name
Süleyman Serdar Koca
City
Elazığ
ZIP/Postal Code
23000
Country
Turkey
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Süleyman S Koca
Phone
0424 2372005
Email
kocassk@yahoo.com
Facility Name
Zübeyde Ercan
City
Elazığ
ZIP/Postal Code
23000
Country
Turkey
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Zübeyde Ercan
Phone
0424 2378295
Email
zubeydeercan@firat.edu.tr

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

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Effects of Acute Exercise on BDNF Levels in Rheumatoid Arthritis Patients

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