Effects of Acute Exercise on BDNF Levels in Rheumatoid Arthritis Patients

NCT ID: NCT04254146

Last Updated: 2020-06-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-01-31

Study Completion Date

2020-12-02

Brief Summary

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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

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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.

Conditions

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Rheumatoid Arthritis

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Study group

Aerobic exercise will be performed for a single session

Group Type EXPERIMENTAL

Aerobic exercise

Intervention Type OTHER

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 group

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

Group Type ACTIVE_COMPARATOR

Aerobic exercise

Intervention Type OTHER

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.

Interventions

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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.

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Gazi University

OTHER

Sponsor Role lead

Responsible Party

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Songul Baglan Yentur

Research Assistant

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Süleyman S Koca

Role: STUDY_DIRECTOR

Firat University

Locations

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Gülnihal Deniz

Elâzığ, , Turkey (Türkiye)

Site Status RECRUITING

Songul Baglan Yentur

Elâzığ, , Turkey (Türkiye)

Site Status RECRUITING

Süleyman Serdar Koca

Elâzığ, , Turkey (Türkiye)

Site Status RECRUITING

Zübeyde Ercan

Elâzığ, , Turkey (Türkiye)

Site Status RECRUITING

Countries

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Turkey (Türkiye)

Central Contacts

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Songul B Yentur

Role: CONTACT

0424 237 8282

Facility Contacts

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Gülnihal Deniz

Role: primary

0424 2372028

Songul B Yentur

Role: primary

+90 506 272 6511

Songul B Yentur

Role: backup

Süleyman S Koca

Role: primary

0424 2372005

Zübeyde Ercan

Role: primary

0424 2378295

References

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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.

Reference Type BACKGROUND
PMID: 18484150 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 25455510 (View on PubMed)

Other Identifiers

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17-04

Identifier Type: -

Identifier Source: org_study_id

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