- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04254146
Effects of Acute Exercise on BDNF Levels in Rheumatoid Arthritis Patients
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.
Study Overview
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.
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 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
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Contact:
- Songul B Yentur
-
Principal Investigator:
- Songul B Yentur
-
Elazığ, Turkey, 23000
- Recruiting
- Gülnihal Deniz
-
Contact:
- Gülnihal Deniz
- Phone Number: 0424 2372028
- Email: fztgulnihal@hotmail.com
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Elazığ, Turkey, 23000
- Recruiting
- Süleyman Serdar Koca
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Contact:
- Süleyman S Koca
- Phone Number: 0424 2372005
- Email: kocassk@yahoo.com
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Elazığ, Turkey, 23000
- Recruiting
- Zübeyde Ercan
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Contact:
- Zübeyde Ercan
- Phone Number: 0424 2378295
- Email: zubeydeercan@firat.edu.tr
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-
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.
|
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 |
---|---|---|
BDNF levels
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 |
---|---|---|
Beck Depression Inventory
Time Frame: 2 minutes
|
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.
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2 minutes
|
Hospital Anxiety and Depression Scale
Time Frame: 2 minutes
|
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.
|
2 minutes
|
Collaborators and Investigators
Sponsor
Investigators
- Study Director: Süleyman S Koca, Firat University
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.
Study record dates
Study Major Dates
Study Start (Actual)
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
- 17-04
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
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