FibromyalgiaNCT04500444
Effects of Aerobic Exercise Training With and Without Blood Flow Restriction in Fibromyalgia
A study testing exercise training in people with Fibromyalgia, run by Istanbul University at 1 site in Turkey (Türkiye).
Trial summary
In our study, we aimed to evaluate and compare the effects of low-intensity aerobic exercise training with blood flow restriction and without blood flow restriction, on pain, functional status, quality of life and catecholamine metabolite levels in 24-hour urine in adults with Fibromyalgia. Read more about this study
- Who is it for?
- Ages 18 to 55 years, women only
- Conditions the study is for
- Fibromyalgia
- What is being tested?
- exercise training
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 13 Nov 2019to 18 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 55 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Being between 18 and 55 years old
- Symptoms lasting longer than 3 months
- According to the 2016 ACR criteria, the Common Pain Scale Score is ≥7 and the Symptom Severity Score is ≥5 or according to the 2016 ACR criteria, the Symptom Severity Score is ≥9 and the Common Pain Scale Score is between 4-6.
- Fibromyalgia Impact Questionnaire (FIQ) score between 35 and 65 (out of 100)
- To be able to come to the hospital for treatment 4 days a week for 6 weeks.
- No change in the medical treatment received due to fibromyalgia syndrome during the study
Who cannot join
- Presence of known central nervous system or peripheral nervous system disease, progressive neurological deficit
- Peripheral venous insufficiency and coagulopathies
- Serious cardiovascular pathologies
- Sensory loss, loss of position sensation, unhealed fracture or open surgical wound
- Uncontrolled hypertension, diabetes
- Cognitive disorder causing simple commands difficulty
- Pregnancy
- Having entered the menopause
Trial locations and contacts
1 site in 1 country.
Ayşegül Ketenci, Professor contact
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Istanbul University Istanbul Faculty of Medicine
Istanbul, 34093
Mert Zure, mertzure@gmail.com
About this study
Official title: Effects of Blood Flow Restricted Aerobic Exercise on Pain, Functional Status, Quality of Life, and Hormonal Response to Exercise in Fibromyalgia Patients - Randomized Controlled Trial
In our study, we aimed to evaluate and compare the effects of low-intensity aerobic exercise training with blood flow restriction and without blood flow restriction, on pain, functional status, quality of life and catecholamine metabolite levels in 24-hour urine in adults with Fibromyalgia.
Read the detailed description
Fibromyalgia is a chronic disorder characterized by widespread pain, fatigue, sleep disturbance, cognitive disorder and other physical symptoms that negatively affect physical and sensory functions and impair quality of life. [1]
Fibromyalgia is seen in the society at 2-4%, and the ratio of women to men is 9:1. It is seen most often between the ages of 45 and 60. Neuroendocrine deviations arise with the contribution of central sensitization and / or peripheral pain mechanisms as a result of environmentally related physiological and psychological stresses of people with genetic predisposition.[2]
The depletion of biogenic amines in the central nervous system is blamed on the basis of major symptoms such as musculoskeletal pain, muscle fatigue, sleep disturbance, and comorbid chronic depression, anxiety, migraine, which are clinically observed in fibromyalgia. Decreased levels of aminergic neurotransmitters is detected in cerebrospinal fluid (CSF) of fibromyalgia patients, especially serotonin, dopamine, norepinephrine.[3]
Studies have found that different exercise programs have positive effects on pain and functionality in fibromyalgia cases, and no side effects of these exercise programs have been observed. Aerobic exercise training is one of the most studied exercise modalities in fibromyalgia patients.[4]
However, an increase in post-exercise pain was also found in patients with fibromyalgia due to a decrease in muscle blood flow, defect in muscle contraction physiology and a change in post-exercise pain modulation. In addition, it has been reported that the hormone response given to the exercise is impaired. All of these disorders can decrease patients' compliance to exercise.[5]
Exercise with blood flow restriction - Blood Flow Restriction Training (BFRT) - is an increasingly popular exercise modality that creates a physiological effect equivalent to a high exercise intensity when exercising at low exercise intensities. In current studies, although a similar response to high-intensity aerobic exercise was obtained by performing low-intensity blood flow-restricted aerobic exercise training in other patient groups, a recommendation regarding the use of BFRT in a specific disease such as fibromyalgia is lacking.[6]
In our study, we aimed to evaluate and compare the effects of low-intensity aerobic exercise training with blood flow restriction and without blood flow restriction, on pain, functional status, quality of life and catecholamine and melatonin metabolite levels in 24-hour urine in adults with Fibromyalgia.
- Conditions
- Fibromyalgia
- Being tested
- exercise training
- Keywords
- blood flow restriction training, fibromyalgia, aerobic training
- Medical subject headings
- Fibromyalgia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
exercise trainingOther
Also called low intensity aerobic training
An aerobic exercise program with blood flow restriction will be applied 4 times a week for a total of 6 weeks. The aerobic exercise training consists of a warm up period for 5 minutes, walking on treadmill at 4 km per hour speed for 20 minutes and cooling down for another 5 minutes.
| Study group | Role | What they receive |
|---|---|---|
| Blood-Flow Restriction Group | Experimental | An aerobic exercise program with blood flow restriction will be applied 4 times a week for a total of 6 weeks. The aerobic exercise training consists of a warm up period for 5 minutes, walking on treadmill at 4 km per hour speed for 20 minutes and cooling down for another 5 minutes. The blood flow restriction protocol will be applied to both lower extremities at the crotch level with 10 cm wide elastic bandages before warming up. Before the first application, patients will be evaluated by a specialist physician using ultrasonography and it will be ensured that the arterial blood flow is not restricted as the blood flow restriction restricts only venous blood flow. The pressure threshold at this point is the level to be used in subsequent training sessions and the same person (physician) will be bandaging in the same way during all subsequent training sessions. Receives: Other: exercise training |
| Control Group | Sham comparator | An aerobic exercise program with blood flow restriction will be applied 4 times a week for a total of 6 weeks. The aerobic exercise training consists of a warm up period for 5 minutes, walking on treadmill at 4 km per hour speed for 20 minutes and cooling down for another 5 minutes. The sham blood flow restriction protocol will be applied which consists of loose bandaging to both lower extremities at the crotch level with 10 cm wide elastic bandages before warming up. The same person (physician) will be bandaging in the same way during all subsequent training sessions. The pressure feeling of the patient must correspond to level 0 -not tight at all- before starting the exercise training. Receives: Other: exercise training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Fibromyalgia Impact Questionnaire (FIQ) score
The Fibromyalgia Impact Questionnaire (FIQ) was developed by clinicians at the Oregon Health Sciences University in the late 1980s to capture and evaluate the total spectrum of fibromyalgia-related problems and response to treatment. It was first used in 1991 and is still an indicator of therapeutic effectiveness today. it is used frequently.
It consists of 10 questions to measure physical, emotional, cognitive and motivational symptoms such as physical disability, pain, fatigue, joint stiffness, depression and anxiety in fibromyalgia. Each question has been scored within itself.
The total score will be between 0-100. 100 points indicate the highest exposure to the disease.
Measured: Baseline, Immediately after the intervention , 3 months after the intervention period
Secondary outcomes (4)
Change in Central Sensitization Inventory Score
Central Sensitization Inventory (CSI) is a scale used to detect patients with symptoms associated with central sensitization or types of central sensitization syndrome such as fibromyalgia, temporomandibular joint disease, tension type headache, migraine.
The Central Sensitization Inventory (CSI) consists of two parts:
Part A consists of 25 questions about central sensitization syndrome (CNS) symptoms; Section B examines the patient's condition of being diagnosed with certain CNS diseases or CNS related diseases such as anxiety and depression.
The patient answers 25 questions in section A with a score between 0 and 4. The total score will be between 0-100. Results above 40 points indicate central sensitization.
Measured: Baseline, Immediately after the intervention , 3 months after the intervention period
Change in Visual Analog Scale for Pain
This scale is used to assess pain subjectively. Scale consists of a 10 cm long horizontal line. The two ends are named differently. 0 means no pain, 10 means the most severe pain.
The patient is asked to mark a point on this line that corresponds to the severity of pain he feels. The distance between the marked point and the lowest end of the line is measured and the numerical value found shows the pain intensity of the patient.
Measured: Baseline, Immediately after the intervention , 3 months after the intervention period
Change in Beck Depression Inventory Score
Beck Depression Criterion (BDI) is a commonly used evaluation criterion for diagnosis and follow-up parameters in assessing depression status.
It contains 21 categories to measure physical, emotional, cognitive and motivational symptoms such as hopelessness, irritability, guilt, feeling of punishment, fatigue, and weight loss in each depression, and each category is scored between 0-3. The patient is asked to mark the most appropriate one for the four options in each category. Scoring progressively increases from the absence of symptoms to severe symptoms. 0-10 points: No depression, 11-17 points: Mild depression, 18-23 points: Moderate depression, 24 and above points: Severe depression.
Measured: Baseline, Immediately after the intervention , 3 months after the intervention period
Change in Chronic Pain Acceptance Questionnaire - 8 Score
CPAQ-8 is an 8-question survey. It measures the level of patient acceptance of pain and the level of continuing social, daily activities. Each question is scored between 0-5. The higher the score, the higher the pain acceptance level.
Measured: Baseline, Immediately after the intervention , 3 months after the intervention period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Aug 2020
- Study start13 Nov 2019
- Primary completion18 Sep 2020 (estimated)
- Study completion18 Dec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for FibromyalgiaStudies of the same condition, open and under way.
- More trials run by Istanbul 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Istanbul University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mert Zure, Istanbul University
- Investigators
- Ayşegül Ketenci, Principal investigator, Professor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04500444
- Sponsor's protocol ID
- 1301
- Status last verified
- Aug 2020
- First submitted
- 3 Aug 2020
- Last updated
- 5 Aug 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Evcik D, Ketenci A, Sindel D. The Turkish Society of Physical Medicine and Rehabilitation (TSPMR) guideline recommendations for the management of fibromyalgia syndrome. Turk J Phys Med Rehabil. 2019 May 28;65(2):111-123. doi: 10.5606/tftrd.2019.4815. eCollection 2019 Jun.
PubMed 31453551Hauser W, Ablin J, Fitzcharles MA, Littlejohn G, Luciano JV, Usui C, Walitt B. Fibromyalgia. Nat Rev Dis Primers. 2015 Aug 13;1:15022. doi: 10.1038/nrdp.2015.22.
PubMed 27189527Singh L, Kaur A, Bhatti MS, Bhatti R. Possible Molecular Mediators Involved and Mechanistic Insight into Fibromyalgia and Associated Co-morbidities. Neurochem Res. 2019 Jul;44(7):1517-1532. doi: 10.1007/s11064-019-02805-5. Epub 2019 Apr 19.
PubMed 31004261Michiels V, Cluydts R. Neuropsychological functioning in chronic fatigue syndrome: a review. Acta Psychiatr Scand. 2001 Feb;103(2):84-93. doi: 10.1034/j.1600-0447.2001.00017.x.
PubMed 11167310Bidonde J, Busch AJ, Bath B, Milosavljevic S. Exercise for adults with fibromyalgia: an umbrella systematic review with synthesis of best evidence. Curr Rheumatol Rev. 2014;10(1):45-79. doi: 10.2174/1573403x10666140914155304.
PubMed 25229499Genc A, Tur BS, Aytur YK, Oztuna D, Erdogan MF. Does aerobic exercise affect the hypothalamic-pituitary-adrenal hormonal response in patients with fibromyalgia syndrome? J Phys Ther Sci. 2015 Jul;27(7):2225-31. doi: 10.1589/jpts.27.2225. Epub 2015 Jul 22.
PubMed 26311959Patterson SD, Hughes L, Head P, Warmington S, Brandner C. Blood flow restriction training: a novel approach to augment clinical rehabilitation: how to do it. Br J Sports Med. 2017 Dec;51(23):1648-1649. doi: 10.1136/bjsports-2017-097738. Epub 2017 Jun 22. No abstract available.
PubMed 28642225
Study at a glance
From the registry record, last updated by the sponsor on 5 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Blood Flow Restricted Aerobic Exercise on Pain, Functional Status, Quality of Life, and Hormonal Response to Exercise in Fibromyalgia Patients - Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04500444
- Acronym / sponsor ID
- 1301
- Conditions
- Fibromyalgia
- Keywords
- blood flow restriction training, fibromyalgia, aerobic training
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Istanbul UniversityUniversity, hospital or other
- Study start
- 13 Nov 2019 (actual)
- Primary completion
- 18 Sep 2020 (estimated)
- Study completion
- 18 Dec 2020 (estimated)
- First posted
- 5 Aug 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.
In our study, we aimed to evaluate and compare the effects of low-intensity aerobic exercise training with blood flow restriction and without blood flow restriction, on pain, functional status, quality of life and catecholamine metabolite levels in 24-hour urine in adults with Fibromyalgia.
Detailed description
Fibromyalgia is a chronic disorder characterized by widespread pain, fatigue, sleep disturbance, cognitive disorder and other physical symptoms that negatively affect physical and sensory functions and impair quality of life. [1]
Fibromyalgia is seen in the society at 2-4%, and the ratio of women to men is 9:1. It is seen most often between the ages of 45 and 60. Neuroendocrine deviations arise with the contribution of central sensitization and / or peripheral pain mechanisms as a result of environmentally related physiological and psychological stresses of people with genetic predisposition.[2]
The depletion of biogenic amines in the central nervous system is blamed on the basis of major symptoms such as musculoskeletal pain, muscle fatigue, sleep disturbance, and comorbid chronic depression, anxiety, migraine, which are clinically observed in fibromyalgia. Decreased levels of aminergic neurotransmitters is detected in cerebrospinal fluid (CSF) of fibromyalgia patients, especially serotonin, dopamine, norepinephrine.[3]
Studies have found that different exercise programs have positive effects on pain and functionality in fibromyalgia cases, and no side effects of these exercise programs have been observed. Aerobic exercise training is one of the most studied exercise modalities in fibromyalgia patients.[4]
However, an increase in post-exercise pain was also found in patients with fibromyalgia due to a decrease in muscle blood flow, defect in muscle contraction physiology and a change in post-exercise pain modulation. In addition, it has been reported that the hormone response given to the exercise is impaired. All of these disorders can decrease patients' compliance to exercise.[5]
Exercise with blood flow restriction - Blood Flow Restriction Training (BFRT) - is an increasingly popular exercise modality that creates a physiological effect equivalent to a high exercise intensity when exercising at low exercise intensities. In current studies, although a similar response to high-intensity aerobic exercise was obtained by performing low-intensity blood flow-restricted aerobic exercise training in other patient groups, a recommendation regarding the use of BFRT in a specific disease such as fibromyalgia is lacking.[6]
In our study, we aimed to evaluate and compare the effects of low-intensity aerobic exercise training with blood flow restriction and without blood flow restriction, on pain, functional status, quality of life and catecholamine and melatonin metabolite levels in 24-hour urine in adults with Fibromyalgia.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Blood-Flow Restriction Group | Experimental | Other: exercise trainingAn aerobic exercise program with blood flow restriction will be applied 4 times a week for a total of 6 weeks. The aerobic exercise training consists of a warm up period for 5 minutes, walking on treadmill at 4 km per hour speed for 20 minutes and cooling down for another 5 minutes. The blood flow restriction protocol will be applied to both lower extremities at the crotch level with 10 cm wide elastic bandages before warming up. Before the first application, patients will be evaluated by a specialist physician using ultrasonography and it will be ensured that the arterial blood flow is not restricted as the blood flow restriction restricts only venous blood flow. The pressure threshold at this point is the level to be used in subsequent training sessions and the same person (physician) will be bandaging in the same way during all subsequent training sessions. |
| Control Group | Sham comparator | Other: exercise trainingAn aerobic exercise program with blood flow restriction will be applied 4 times a week for a total of 6 weeks. The aerobic exercise training consists of a warm up period for 5 minutes, walking on treadmill at 4 km per hour speed for 20 minutes and cooling down for another 5 minutes. The sham blood flow restriction protocol will be applied which consists of loose bandaging to both lower extremities at the crotch level with 10 cm wide elastic bandages before warming up. The same person (physician) will be bandaging in the same way during all subsequent training sessions. The pressure feeling of the patient must correspond to level 0 -not tight at all- before starting the exercise training. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Being between 18 and 55 years old
- Symptoms lasting longer than 3 months
- According to the 2016 ACR criteria, the Common Pain Scale Score is ≥7 and the Symptom Severity Score is ≥5 or according to the 2016 ACR criteria, the Symptom Severity Score is ≥9 and the Common Pain Scale Score is between 4-6.
- Fibromyalgia Impact Questionnaire (FIQ) score between 35 and 65 (out of 100)
- To be able to come to the hospital for treatment 4 days a week for 6 weeks.
Key exclusion criteria (8 listed)
- Presence of known central nervous system or peripheral nervous system disease, progressive neurological deficit
- Peripheral venous insufficiency and coagulopathies
- Serious cardiovascular pathologies
- Sensory loss, loss of position sensation, unhealed fracture or open surgical wound
- Uncontrolled hypertension, diabetes
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 |
|---|---|---|
| exercise trainingAlso: low intensity aerobic trainingAn aerobic exercise program with blood flow restriction will be applied 4 times a week for a total of 6 weeks. The aerobic exercise training consists of a warm up period for 5 minutes, walking on treadmill at 4 km per hour speed for 20 minutes and cooling down for another 5 minutes. | Other | Blood-Flow Restriction Group, Control Group |
Primary outcome
Change in Fibromyalgia Impact Questionnaire (FIQ) score
Time frame: Baseline, Immediately after the intervention , 3 months after the intervention period
The Fibromyalgia Impact Questionnaire (FIQ) was developed by clinicians at the Oregon Health Sciences University in the late 1980s to capture and evaluate the total spectrum of fibromyalgia-related problems and response to treatment. It was first used in 1991 and is still an indicator of therapeutic effectiveness today. it is used frequently. It consists of 10 questions to measure physical, emotional, cognitive and motivational symptoms such as physical disability, pain, fatigue, joint stiffness, depression and anxiety in fibromyalgia. Each question has been scored within itself. The total score will be between 0-100. 100 points indicate the highest exposure to the disease.
4 secondary outcomes
Change in Central Sensitization Inventory Score
Time frame: Baseline, Immediately after the intervention , 3 months after the intervention period
Change in Visual Analog Scale for Pain
Time frame: Baseline, Immediately after the intervention , 3 months after the intervention period
Change in Beck Depression Inventory Score
Time frame: Baseline, Immediately after the intervention , 3 months after the intervention period
Change in Chronic Pain Acceptance Questionnaire - 8 Score
Time frame: Baseline, Immediately after the intervention , 3 months after the intervention period
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Aug 2020.
- Background: PubMed 31453551Evcik D, Ketenci A, Sindel D. The Turkish Society of Physical Medicine and Rehabilitation (TSPMR) guideline recommendations for the management of fibromyalgia syndrome. Turk J Phys Med Rehabil. 2019 May 28;65(2):111-123. doi: 10.5606/tftrd.2019.4815. eCollection 2019 Jun.
- Background: PubMed 27189527Hauser W, Ablin J, Fitzcharles MA, Littlejohn G, Luciano JV, Usui C, Walitt B. Fibromyalgia. Nat Rev Dis Primers. 2015 Aug 13;1:15022. doi: 10.1038/nrdp.2015.22.
- Background: PubMed 31004261Singh L, Kaur A, Bhatti MS, Bhatti R. Possible Molecular Mediators Involved and Mechanistic Insight into Fibromyalgia and Associated Co-morbidities. Neurochem Res. 2019 Jul;44(7):1517-1532. doi: 10.1007/s11064-019-02805-5. Epub 2019 Apr 19.
- Background: PubMed 11167310Michiels V, Cluydts R. Neuropsychological functioning in chronic fatigue syndrome: a review. Acta Psychiatr Scand. 2001 Feb;103(2):84-93. doi: 10.1034/j.1600-0447.2001.00017.x.
- Background: PubMed 25229499Bidonde J, Busch AJ, Bath B, Milosavljevic S. Exercise for adults with fibromyalgia: an umbrella systematic review with synthesis of best evidence. Curr Rheumatol Rev. 2014;10(1):45-79. doi: 10.2174/1573403x10666140914155304.
- Background: PubMed 26311959Genc A, Tur BS, Aytur YK, Oztuna D, Erdogan MF. Does aerobic exercise affect the hypothalamic-pituitary-adrenal hormonal response in patients with fibromyalgia syndrome? J Phys Ther Sci. 2015 Jul;27(7):2225-31. doi: 10.1589/jpts.27.2225. Epub 2015 Jul 22.
- Background: PubMed 28642225Patterson SD, Hughes L, Head P, Warmington S, Brandner C. Blood flow restriction training: a novel approach to augment clinical rehabilitation: how to do it. Br J Sports Med. 2017 Dec;51(23):1648-1649. doi: 10.1136/bjsports-2017-097738. Epub 2017 Jun 22. No abstract available.
- Individual participant dataSharing planned: No
Related trials for Fibromyalgia
Active, not recruiting
Objective Measurement of Pain Regulation in Individuals Who Have Received Internet-delivered Exposure-based Cognitive Behavior Therapy
Fibromyalgia
Enrolling by invitationPhase 3
Open-Label Safety Study of AXS-14 in Subjects With Fibromyalgia
Fibromyalgia
Recruiting
Exercise Interventions and Dietary Advice in Fibromyalgia and IBS
Fibromyalgia, Irritable Bowel Syndrome
Recruiting
Whole-body Cryotherapy in Those With Chronic Fatigue: A Feasibility Study
ME/CFS, Fibromyalgia (FM)
Recruiting
Auricular Acupuncture for Autonomic Balance and Pain in Fibromyalgia
Fibromyalgia Syndrome
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.
Ayşegül Ketenci, Professor contact
Ayşegül Ketenci principal investigator
Professor
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing exercise training in people with Fibromyalgia, run by Istanbul 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 6 inclusion and 8 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 5 Aug 2020. 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. Some participants in this study may receive a placebo. 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 Mert Zure, MD (+905356193965, mertzure@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Fibromyalgia Impact Questionnaire (FIQ) score (time frame: Baseline, Immediately after the intervention , 3 months after the intervention period). 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 NCT04500444, which also lists 7 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 5 Aug 2020.