Rheumatoid ArthritisNCT04254146
Effects of Acute Exercise on BDNF Levels in Rheumatoid Arthritis Patients
A study testing Aerobic exercise in people with Rheumatoid Arthritis, run by Gazi University at 4 sites in Turkey (Türkiye).
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Rheumatoid Arthritis
- What is being tested?
- Aerobic exercise
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 4 sitesTurkey (Türkiye)
- Study dates
- 31 Jan 2020to 2 Dec 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
4 sites in 1 country.
Turkey (Türkiye)4 sites, 4 recruiting
- Recruiting
Gülnihal Deniz
Elâzığ, 23000
Gülnihal Deniz, 0424 2372028, fztgulnihal@hotmail.com
- Recruiting
Songul Baglan Yentur
Elâzığ, 23000
Songul B Yentur, +90 506 272 6511, songulbaglan23@hotmail.com
Songul B Yentur
- Recruiting
Süleyman Serdar Koca
Elâzığ, 23000
Süleyman S Koca, 0424 2372005, kocassk@yahoo.com
- Recruiting
Zübeyde Ercan
Elâzığ, 23000
Zübeyde Ercan, 0424 2378295, zubeydeercan@firat.edu.tr
About this study
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.
Read the 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.
- Conditions
- Rheumatoid Arthritis
- Being tested
- Aerobic exercise
- Keywords
- Rheumatoid Arthritis, Brain Derived Neurotrophic Factor, acute exercise
- Medical subject headings
- Arthritis, Rheumatoid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| Study group | Experimental | Aerobic exercise will be performed for a single session Receives: Other: Aerobic exercise |
| Control group | Active comparator | Aerobic exercise will be performed to healthy population for a single session Receives: Other: Aerobic exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1 minute
Secondary outcomes (2)
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.
Measured: 2 minutes
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.
Measured: 2 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2020
- Study start31 Jan 2020
- Primary completion2 Oct 2020 (estimated)
- Study completion2 Dec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Rheumatoid ArthritisStudies of the same condition, open and under way.
- More trials run by Gazi UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Gazi University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Songul Baglan Yentur, Gazi University
- Investigators
- Süleyman S Koca, Study director, Firat University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04254146
- Sponsor's protocol ID
- 17-04
- Status last verified
- Jun 2020
- First submitted
- 31 Jan 2020
- Last updated
- 18 Jun 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 18484150Szuhany 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.
PubMed 25455510
Study at a glance
From the registry record, last updated by the sponsor on 18 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Acute Exercise on BDNF Levels in Rheumatoid Arthritis Patients
- ClinicalTrials.gov ID
- NCT04254146
- Acronym / sponsor ID
- 17-04
- Conditions
- Rheumatoid Arthritis
- Keywords
- Rheumatoid Arthritis, Brain Derived Neurotrophic Factor, acute exercise
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Gazi UniversityUniversity, hospital or other
- Study start
- 31 Jan 2020 (actual)
- Primary completion
- 2 Oct 2020 (estimated)
- Study completion
- 2 Dec 2020 (estimated)
- First posted
- 5 Feb 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Study group | Experimental | Other: Aerobic exerciseAerobic exercise will be performed for a single session |
| Control group | Active comparator | Other: Aerobic exerciseAerobic exercise will be performed to healthy population for a single session |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Aerobic exerciseAerobic 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. | Other | Control group, Study group |
Primary outcome
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.
2 secondary outcomes
Beck Depression Inventory
Time frame: 2 minutes
Hospital Anxiety and Depression Scale
Time frame: 2 minutes
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jun 2020.
- Background: PubMed 18484150Grimsholm 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.
- Background: PubMed 25455510Szuhany 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Süleyman S Koca study director
Firat University
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Aerobic exercise in people with Rheumatoid Arthritis, run by Gazi University at 4 sites in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 18 Jun 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Songul B Yentur (0424 237 8282, songulbaglan23@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
BDNF levels (time frame: 1 minute). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04254146, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jun 2020.