Rheumatoid ArthritisNCT05546294
The Effects of Exercise on Serum BDNF and Irisin Levels in Patients With Rheumatoid Arthritis
A study testing Aerobic and home exercise and Home exercise in people with Rheumatoid Arthritis and Sleep Quality, run by Afyonkarahisar Health Sciences University at 1 site in Turkey (Türkiye).
Trial summary
The aim of our study is to investigate the effects of aerobic exercise on sleep quality, fatigue, quality of life, depression and serum BDNF and irisin levels, which are important biomarkers of sleep in patients with rheumatoid arthritis. Read more about this study
- Who is it for?
- Ages 20 to 60 years
- Conditions the study is for
- Rheumatoid Arthritis, Sleep Quality, Aerobic Exercise
- What is being tested?
- Aerobic and home exercise and Home exercise
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 151 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Mar 2021to 20 Feb 2023
- 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 20 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Male and female gender between the ages of 20 and 60 who were diagnosed with rheumatoid arthritis according to the 2010 ACR/EULAR diagnostic criteria,
- Patients with Disease Activity Score (DAS28) ≤3.2 (low disease activity or remission) (no change in anti-rheumatic drugs or steroid dose in the last 3 months),
- Patients who were being followed at Afyonkarahisar Health Sciences University Department of Physical Medicine and Rehabilitation,
Who cannot join
- Active malignancy and/or a history of malignancy within the past 5 years,
- Uncontrolled cardiopulmonary disease (such as severe hypertension, chronic obstructive pulmonary disease, stage 3 or 4 heart failure, significant left ventricular outflow obstruction, dissecting aneurysm, embolism or thrombophlebitis history),
- Patients who cannot tolerate cardiorespiratory exercise training due to unstable angina pectoris, dangerous cardiac arrhythmias and myocardial infarction in the last 3 months,
- Pregnancy or planning a pregnancy in the near future,
- History of major surgery (including joint surgery) within the last six months,
- Regular physical activity at least 3 days a week in the last 3 months,
- Orthopedic, neurological or mental disease that may affect exercise,
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Afyonkarahisar Health Sciences University
Afyonkarahisar, 03200
About this study
Official title: The Effects of Aerobic Exercise on Sleep Quality, Fatigue, Quality of Life, Depression, Serum BDNF and Irisin Levels in Patients With Rheumatoid Arthritis: A Prospective Randomized Controlled Study
The aim of our study is to investigate the effects of aerobic exercise on sleep quality, fatigue, quality of life, depression and serum BDNF and irisin levels, which are important biomarkers of sleep in patients with rheumatoid arthritis.
Read the detailed description
Rheumatoid arthritis (RA) is a chronic, progressive, autoimmune disease characterized primarily by inflammation of synovial joints and tendon sheaths of synovial nature.
Sleep disturbance in RA patients has a negative impact on their quality of life in addition to their mental and physical health. Exercise has been identified as an important non-pharmacological factor in improving sleep quality and mood in patients with rheumatoid arthritis.
Irisin is a myokine and adipokine that has anti-inflammatory effects and can help regulate energy expenditure. It is secreted from skeletal muscles after exercise, as well as from other tissues such as the liver, nerves, heart, kidneys and skin. It has been observed that serum irisin levels are decreased in RA patients with poor sleep quality compared to RA patients with good sleep quality.
BDNF, one of the biochemical parameters evaluating sleep, is a signal protein encoded by the BDNF gene located on chromosome 11. It belongs to the neurotrophin family, which regulates the survival, development and function of neurons. Neuronal activity is a powerful stimulant that elicits BDNF production. Thus, activation of brain areas associated with motor control during exercise contributes to increased BDNF production in the brain and additionally in plasma. During acute exercise, irisin stimulates BDNF expression in the hippocampus of the brain. In addition to the circadian variation of plasma BDNF, the blood concentration of BDNF has been shown to increase acutely in response to aerobic exercise that does not include resistance exercise. Moreover, it has been reported that people with higher basal serum BDNF concentrations have lower REM sleep and therefore less sleep disturbances.
This investigation was designed as prospective randomized controlled study. Participants were randomized into 3 groups; RA patients receiving aerobic and home exercise, RA patients receiving only home exercise and healthy control group.
As evaluation parameters, DAS28 Score, SF (Short form) -36 Quality of Life Scale, Pittsburgh Sleep Quality Index (PSQI), Fatigue Severity Scale (FSS), Beck Depression Inventory (BDI), 6 Minute Walk Test and Borg Scale will be evaluated with. It was planned that the evaluations were made and recorded by a blinded physician to the all patients with rheumatoid arthritis at the beginning of the treatment and at the end of the treatment.In the healthy control group, the evaluation parameters will be examined only once at the beginning of the study.
At the beginning of the treatment and at the end of the treatment (4th week), serum BDNF and irisin levels will be tested using the ELISA kit, with blood samples taken from the RA patients in the early morning. It will be checked whether there is a difference between the basal serum BDNF and irisin levels of rheumatoid arthritis patients with the blood sample taken only once in the early morning from the healthy control group.
- Conditions
- Rheumatoid Arthritis, Sleep Quality, Aerobic Exercise
- Being tested
- Aerobic and home exercise, Home exercise, Healthy control group
- Keywords
- Rheumatoid Arthritis, Sleep Quality, Serum BDNF, Serum Irisin, Quality of Life, Fatigue, Depression
- Medical subject headings
- Arthritis, Rheumatoid, Sleep Initiation and Maintenance Disorders, Fatigue, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Aerobic and home exerciseDevice
A total of 20 sessions of aerobic exercises using bicycle ergometer, five times a week and once a day for four weeks, were applied to the patients.Maximum heart rate was calculated for each subject (220 - age) and a heart rate monitor will be used to follow subjects' heart rate during aerobic exercise.
Then the patients were showed a daily home exercise program to apply once a day at their home.
As a daily home exercise program:ROM exercises and strengthening exercises for major muscle groups (such as abdominal muscles, erector spinae, hamstring, quadriceps, hip flexors, strengthening exercises for all extremities) were showed.
At the beginning of the treatment and at the end of the treatment (4th week), serum BDNF and irisin levels will be tested using the ELISA kit, with blood samples taken from the RA patients in the early morning.
Home exerciseOther
The patients were showed only a daily home exercise program to apply once a day at their home.
As a daily home exercise program:ROM exercises and strengthening exercises for major muscle groups (such as abdominal muscles, erector spinae, hamstring, quadriceps, hip flexors, strengthening exercises for all extremities) were showed.
At the beginning of the treatment and at the end of the treatment (4th week), serum BDNF and irisin levels will be tested using the ELISA kit, with blood samples taken from the RA patients in the early morning.
Healthy control groupOther
Serum BDNF and irisin levels will be tested using the ELISA kit, with blood samples taken only once from healthy control group in the early morning. It will be checked whether there is a difference between the basal serum BDNF and irisin levels of rheumatoid arthritis patients and healthy control group.
| Study group | Role | What they receive |
|---|---|---|
| RA patients receiving aerobic and home exercise | Experimental | A total of 20 sessions of aerobic exercises using bicycle ergometer, five times a week and once a day for four weeks, were applied to the patients. Then the patients were showed a daily home exercise program to apply once a day at their home. Receives: Device: Aerobic and home exercise |
| RA patients receiving only home exercise | Active comparator | The patients were showed only a daily home exercise program to apply once a day at their home. Receives: Other: Home exercise |
| Healthy control group | Other | There is no intervention to this group. Receives: Other: Healthy control group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline disease activity score (DAS28) at 4th week
DAS 28 is a scale consisting of 4 parameters; tender and swollen joint counts from 28 joints (shoulders, elbows, wrists, MCFs,PIPs and knee joints), blood sedimentation (mm/hour) or CRP (mg/liter) value and patient global assessment (between 0 and 100; Best imaginable health condition-100, The worst possible health condition -0) A mathematical formula is used to calculate the overall score. DAS28 can range from 0 to 9.4.Generally, a DAS28 score of;
- More than 5.1 indicates high disease activity
- Between 3.2 and 5.1 indicates moderate disease activity
- Between 2.6 and less than 3.2 indicates low disease activity
- Lower than 2.6 indicates disease remission
It is only applied to Rheumatoid Arthritis patients.
Measured: Up to 4th week
Secondary outcomes (6)
Change from baseline quality of life (short form 36 (SF-36)) at 4th week
This is a self-administered scale, which is widely used to measure the quality of life. It was developed to measure the quality of life in patients who have physical illnesses; however, it can also be successfully used in healthy individuals and patients who have psychiatric diseases. SF-36 includes 36 items and surveys eight domains of health, such as physical functionality, physical role limitations, pain, general health, vitality, social functionality, emotional role limitations, and mental health. Total score was between 0 ( disability) and 100 (no disability). Every subgroup of the questionnaire has a score scale between 0 and 100. Every increase in the subgroup of SF-36 questionnaire, which is a positive scoring system, indicates increase in quality of life related to health.
It is applied to all RA patients at the baseline and 4th week, and only applied once to healthy control group at the baseline.
Measured: Up to 4th week
Change from baseline Fatigue Severity Scale (FSS) at 4th week
The scale evaluates the fatigue severity of the participants in the last week. Answers are scored on a seven point scale where 1 = strongly disagree and 7 = strongly agree. The minimum score possible is nine and the highest is 63. The higher the score, the more severe the fatigue is and the more it affects the person's activities.
It is applied to all RA patients at the baseline and 4th week, and only applied once to healthy control group at the baseline.
Measured: Up to 4th week
Change from baseline Beck's Depression Inventory (BDI) at 4th week
The Beck Depression Inventory (BDI) is a 21-item (Each question had a set of at least four possible responses, ranging in intensity), self-report rating inventory that measures characteristic attitudes and symptoms of depression. It is composed of items relating to symptoms of depression such as hopelessness and irritability, cognitions such as guilt or feelings of being punished, as well as physical symptoms such as fatigue, weight loss, and lack of interest in sex.
- 0-9: indicates minimal depression
- 10-18: indicates mild depression
- 19-29: indicates moderate depression
- 30-63: indicates severe depression. Higher total scores indicate more severe depressive symptoms.
It is applied to all RA patients at the baseline and 4th week, and only applied once to healthy control group at the baseline.
Measured: Up to 4th week
Change from baseline Pittsburgh Sleep Quality Index (PSQI) at 4th week
The Pittsburgh Sleep Quality Index (PSQI) is a self-report questionnaire that assesses sleep quality over a 1-month time interval.Consisting of 19 items, the PSQI measures several different aspects of sleep, offering seven component scores and one composite score. The component scores consist of subjective sleep quality, sleep latency (i.e., how long it takes to fall asleep), sleep duration, habitual sleep efficiency (i.e., the percentage of time in bed that one is asleep), sleep disturbances, use of sleeping medication, and daytime dysfunction.
Each item is weighted on a 0-3 interval scale. The global PSQI score is then calculated by totaling the seven component scores, providing an overall score ranging from 0 to 21, where lower scores denote a healthier sleep quality.
It is applied to all RA patients at the baseline and 4th week, and only applied once to healthy control group at the baseline.
Measured: Up to 4th week
Change from baseline Six Minute Walk Test (6MWT) at 4th week
Walking distance, starting and ending blood pressure, heart rate, and oxygen saturation values will be recorded by applying a 6-minute walking test in a 40-meter corridor to the patients who will be applied bicycle ergometry.
It is only applied to RA patients receiving aerobic exercise.
Measured: Up to 4th week
Change from baseline Borg Rating Of Perceived Exertion Scale (Borg RPE Scale) at 4th week
Borg rating of perceived exertion (RPE) is an outcome measure scale used in knowing exercise intensity prescription. It is a scale of 6-20; it has a high correlation to heart rate and multiplying each number by 10 gives the training heart rate as at the time of scoring.
In Borg RPE;
- 9 = 'very light' exercise which equals walking slowly for a few minutes at the own pace of a healthy individual.
- 13 = 'somewhat hard' but the individual is still able to continue the activity.
- 17 = 'very hard'. A healthy person can continue but must push themselves beyond their comfort of being very fatigued.
- 19 = extremely strenuous exercise.for most people, the hardest they have ever experienced.
It is only applied to RA patients receiving aerobic exercise.
Measured: Up to 4th week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2022
- Study start1 Mar 2021
- Primary completion1 Dec 2022
- Study completion20 Feb 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Rheumatoid ArthritisStudies of the same condition, open and under way.
- 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 151 participants (actual)
Sponsor and investigators
- Lead sponsor
- Afyonkarahisar Health Sciences University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hatice Kudret Miroğlu, Afyonkarahisar Health Sciences University
- Investigators
- Ümit DÜNDAR, MD, Principal investigator, Afyonkarahisar Health Sciences UniversityHatice Kudret MİROĞLU, MD, Principal investigator, Afyonkarahisar Health Sciences University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05546294
- Sponsor's protocol ID
- RAİRİSİNBDNF2021
- Status last verified
- Feb 2023
- First submitted
- 15 Sep 2022
- Last updated
- 28 Feb 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Baillet A, Zeboulon N, Gossec L, Combescure C, Bodin LA, Juvin R, Dougados M, Gaudin P. Efficacy of cardiorespiratory aerobic exercise in rheumatoid arthritis: meta-analysis of randomized controlled trials. Arthritis Care Res (Hoboken). 2010 Jul;62(7):984-92. doi: 10.1002/acr.20146.
PubMed 20589690Gamal RM, Mohamed ME, Hammam N, El Fetoh NA, Rashed AM, Furst DE. Preliminary study of the association of serum irisin levels with poor sleep quality in rheumatoid arthritis patients. Sleep Med. 2020 Mar;67:71-76. doi: 10.1016/j.sleep.2019.10.021. Epub 2019 Nov 30.
PubMed 31918120Tan X, van Egmond LT, Cedernaes J, Benedict C. The role of exercise-induced peripheral factors in sleep regulation. Mol Metab. 2020 Dec;42:101096. doi: 10.1016/j.molmet.2020.101096. Epub 2020 Oct 9.
PubMed 33045432
Study at a glance
From the registry record, last updated by the sponsor on 28 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Aerobic Exercise on Sleep Quality, Fatigue, Quality of Life, Depression, Serum BDNF and Irisin Levels in Patients With Rheumatoid Arthritis: A Prospective Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT05546294
- Acronym / sponsor ID
- RAİRİSİNBDNF2021
- Conditions
- Rheumatoid Arthritis, Sleep Quality, Aerobic Exercise
- Keywords
- Rheumatoid Arthritis, Sleep Quality, Serum BDNF, Serum Irisin, Quality of Life, Fatigue, Depression
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 151 participants (actual)
- Lead sponsor
- Afyonkarahisar Health Sciences UniversityUniversity, hospital or other
- Study start
- 1 Mar 2021 (actual)
- Primary completion
- 1 Dec 2022 (actual)
- Study completion
- 20 Feb 2023 (actual)
- First posted
- 19 Sep 2022 (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.
The aim of our study is to investigate the effects of aerobic exercise on sleep quality, fatigue, quality of life, depression and serum BDNF and irisin levels, which are important biomarkers of sleep in patients with rheumatoid arthritis.
Detailed description
Rheumatoid arthritis (RA) is a chronic, progressive, autoimmune disease characterized primarily by inflammation of synovial joints and tendon sheaths of synovial nature.
Sleep disturbance in RA patients has a negative impact on their quality of life in addition to their mental and physical health. Exercise has been identified as an important non-pharmacological factor in improving sleep quality and mood in patients with rheumatoid arthritis.
Irisin is a myokine and adipokine that has anti-inflammatory effects and can help regulate energy expenditure. It is secreted from skeletal muscles after exercise, as well as from other tissues such as the liver, nerves, heart, kidneys and skin. It has been observed that serum irisin levels are decreased in RA patients with poor sleep quality compared to RA patients with good sleep quality.
BDNF, one of the biochemical parameters evaluating sleep, is a signal protein encoded by the BDNF gene located on chromosome 11. It belongs to the neurotrophin family, which regulates the survival, development and function of neurons. Neuronal activity is a powerful stimulant that elicits BDNF production. Thus, activation of brain areas associated with motor control during exercise contributes to increased BDNF production in the brain and additionally in plasma. During acute exercise, irisin stimulates BDNF expression in the hippocampus of the brain. In addition to the circadian variation of plasma BDNF, the blood concentration of BDNF has been shown to increase acutely in response to aerobic exercise that does not include resistance exercise. Moreover, it has been reported that people with higher basal serum BDNF concentrations have lower REM sleep and therefore less sleep disturbances.
This investigation was designed as prospective randomized controlled study. Participants were randomized into 3 groups; RA patients receiving aerobic and home exercise, RA patients receiving only home exercise and healthy control group.
As evaluation parameters, DAS28 Score, SF (Short form) -36 Quality of Life Scale, Pittsburgh Sleep Quality Index (PSQI), Fatigue Severity Scale (FSS), Beck Depression Inventory (BDI), 6 Minute Walk Test and Borg Scale will be evaluated with. It was planned that the evaluations were made and recorded by a blinded physician to the all patients with rheumatoid arthritis at the beginning of the treatment and at the end of the treatment.In the healthy control group, the evaluation parameters will be examined only once at the beginning of the study.
At the beginning of the treatment and at the end of the treatment (4th week), serum BDNF and irisin levels will be tested using the ELISA kit, with blood samples taken from the RA patients in the early morning. It will be checked whether there is a difference between the basal serum BDNF and irisin levels of rheumatoid arthritis patients with the blood sample taken only once in the early morning from the healthy control group.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| RA patients receiving aerobic and home exercise | Experimental | Device: Aerobic and home exerciseA total of 20 sessions of aerobic exercises using bicycle ergometer, five times a week and once a day for four weeks, were applied to the patients. Then the patients were showed a daily home exercise program to apply once a day at their home. |
| RA patients receiving only home exercise | Active comparator | Other: Home exerciseThe patients were showed only a daily home exercise program to apply once a day at their home. |
| Healthy control group | Other | Other: Healthy control groupThere is no intervention to this group. |
Who may qualify
- Ages
- 20 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Male and female gender between the ages of 20 and 60 who were diagnosed with rheumatoid arthritis according to the 2010 ACR/EULAR diagnostic criteria,
- Patients with Disease Activity Score (DAS28) ≤3.2 (low disease activity or remission) (no change in anti-rheumatic drugs or steroid dose in the last 3 months),
- Patients who were being followed at Afyonkarahisar Health Sciences University Department of Physical Medicine and Rehabilitation,
Key exclusion criteria (7 listed)
- Active malignancy and/or a history of malignancy within the past 5 years,
- Uncontrolled cardiopulmonary disease (such as severe hypertension, chronic obstructive pulmonary disease, stage 3 or 4 heart failure, significant left ventricular outflow obstruction, dissecting aneurysm, embolism or thrombophlebitis history),
- Patients who cannot tolerate cardiorespiratory exercise training due to unstable angina pectoris, dangerous cardiac arrhythmias and myocardial infarction in the last 3 months,
- Pregnancy or planning a pregnancy in the near future,
- History of major surgery (including joint surgery) within the last six months,
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 and home exerciseA total of 20 sessions of aerobic exercises using bicycle ergometer, five times a week and once a day for four weeks, were applied to the patients.Maximum heart rate was calculated for each subject (220 - age) and a heart rate monitor will be used to follow subjects' heart rate during aerobic exercise. Then the patients were showed a daily home exercise program to apply once a day at their home. As a daily home exercise program:ROM exercises and strengthening exercises for major muscle groups (such as abdominal muscles, erector spinae, hamstring, quadriceps, hip flexors, strengthening exercises for all extremities) were showed. At the beginning of the treatment and at the end of the treatment (4th week), serum BDNF and irisin levels will be tested using the ELISA kit, with blood samples taken from the RA patients in the early morning. | Device | RA patients receiving aerobic and home exercise |
| Home exerciseThe patients were showed only a daily home exercise program to apply once a day at their home. As a daily home exercise program:ROM exercises and strengthening exercises for major muscle groups (such as abdominal muscles, erector spinae, hamstring, quadriceps, hip flexors, strengthening exercises for all extremities) were showed. At the beginning of the treatment and at the end of the treatment (4th week), serum BDNF and irisin levels will be tested using the ELISA kit, with blood samples taken from the RA patients in the early morning. | Other | RA patients receiving only home exercise |
| Healthy control groupSerum BDNF and irisin levels will be tested using the ELISA kit, with blood samples taken only once from healthy control group in the early morning. It will be checked whether there is a difference between the basal serum BDNF and irisin levels of rheumatoid arthritis patients and healthy control group. | Other | Healthy control group |
Primary outcome
Change from baseline disease activity score (DAS28) at 4th week
Time frame: Up to 4th week
DAS 28 is a scale consisting of 4 parameters; tender and swollen joint counts from 28 joints (shoulders, elbows, wrists, MCFs,PIPs and knee joints), blood sedimentation (mm/hour) or CRP (mg/liter) value and patient global assessment (between 0 and 100; Best imaginable health condition-100, The worst possible health condition -0) A mathematical formula is used to calculate the overall score. DAS28 can range from 0 to 9.4.Generally, a DAS28 score of; * More than 5.1 indicates high disease activity * Between 3.2 and 5.1 indicates moderate disease activity * Between 2.6 and less than 3.2 indicates low disease activity * Lower than 2.6 indicates disease remission It is only applied to Rheumatoid Arthritis patients.
6 secondary outcomes
Change from baseline quality of life (short form 36 (SF-36)) at 4th week
Time frame: Up to 4th week
Change from baseline Fatigue Severity Scale (FSS) at 4th week
Time frame: Up to 4th week
Change from baseline Beck's Depression Inventory (BDI) at 4th week
Time frame: Up to 4th week
Change from baseline Pittsburgh Sleep Quality Index (PSQI) at 4th week
Time frame: Up to 4th week
Change from baseline Six Minute Walk Test (6MWT) at 4th week
Time frame: Up to 4th week
Change from baseline Borg Rating Of Perceived Exertion Scale (Borg RPE Scale) at 4th week
Time frame: Up to 4th week
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Feb 2023.
- Background: PubMed 20589690Baillet A, Zeboulon N, Gossec L, Combescure C, Bodin LA, Juvin R, Dougados M, Gaudin P. Efficacy of cardiorespiratory aerobic exercise in rheumatoid arthritis: meta-analysis of randomized controlled trials. Arthritis Care Res (Hoboken). 2010 Jul;62(7):984-92. doi: 10.1002/acr.20146.
- Background: PubMed 31918120Gamal RM, Mohamed ME, Hammam N, El Fetoh NA, Rashed AM, Furst DE. Preliminary study of the association of serum irisin levels with poor sleep quality in rheumatoid arthritis patients. Sleep Med. 2020 Mar;67:71-76. doi: 10.1016/j.sleep.2019.10.021. Epub 2019 Nov 30.
- Background: PubMed 33045432Tan X, van Egmond LT, Cedernaes J, Benedict C. The role of exercise-induced peripheral factors in sleep regulation. Mol Metab. 2020 Dec;42:101096. doi: 10.1016/j.molmet.2020.101096. Epub 2020 Oct 9.
- 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.
Ümit DÜNDAR, MD principal investigator
Afyonkarahisar Health Sciences University
Hatice Kudret MİROĞLU, MD principal investigator
Afyonkarahisar Health Sciences University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Aerobic and home exercise and Home exercise in people with Rheumatoid Arthritis and Sleep Quality, run by Afyonkarahisar Health Sciences University at 1 site 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 7 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: finished, as of the sponsor's last update on 28 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline disease activity score (DAS28) at 4th week (time frame: Up to 4th week). 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 NCT05546294, which also lists 3 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 28 Feb 2023; AzTrials last refreshed its copy on 7 Nov 2026.