Clinical trial NCT04254146: 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
Overall status: UNKNOWN
Phase: NA
Conditions: Rheumatoid Arthritis
Keywords: Rheumatoid Arthritis
Brain Derived Neurotrophic Factor
acute exercise
Lead sponsor: Gazi University
Sponsor class: OTHER
First posted: 2020-02-05
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: BDNF levels
timeFrame: 1 minute
Secondary outcomes:
measure: Beck Depression Inventory
timeFrame: 2 minutes
measure: Hospital Anxiety and Depression Scale
timeFrame: 2 minutes
Other outcomes:
Locations:
city: Elazığ
country: Turkey
facility: Gülnihal Deniz
city: Elazığ
country: Turkey
facility: Songul Baglan Yentur
city: Elazığ
country: Turkey
facility: Süleyman Serdar Koca
city: Elazığ
country: Turkey
facility: Zübeyde Ercan
Study officials:
affiliation: Firat University
name: Süleyman S Koca
role: STUDY_DIRECTOR
References:
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.
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.