<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT04500444</url>
  </required_header>
  <id_info>
    <org_study_id>1301</org_study_id>
    <nct_id>NCT04500444</nct_id>
  </id_info>
  <brief_title>Effects of Aerobic Exercise Training With and Without Blood Flow Restriction in Fibromyalgia</brief_title>
  <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</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Istanbul University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Istanbul University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      In our study, we aimed to evaluate and compare the effects of low-intensity aerobic exercise&#xD;
      training with blood flow restriction and without blood flow restriction, on pain, functional&#xD;
      status, quality of life and catecholamine metabolite levels in 24-hour urine in adults with&#xD;
      Fibromyalgia.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Fibromyalgia is a chronic disorder characterized by widespread pain, fatigue, sleep&#xD;
      disturbance, cognitive disorder and other physical symptoms that negatively affect physical&#xD;
      and sensory functions and impair quality of life. [1]&#xD;
&#xD;
      Fibromyalgia is seen in the society at 2-4%, and the ratio of women to men is 9:1. It is seen&#xD;
      most often between the ages of 45 and 60. Neuroendocrine deviations arise with the&#xD;
      contribution of central sensitization and / or peripheral pain mechanisms as a result of&#xD;
      environmentally related physiological and psychological stresses of people with genetic&#xD;
      predisposition.[2]&#xD;
&#xD;
      The depletion of biogenic amines in the central nervous system is blamed on the basis of&#xD;
      major symptoms such as musculoskeletal pain, muscle fatigue, sleep disturbance, and comorbid&#xD;
      chronic depression, anxiety, migraine, which are clinically observed in fibromyalgia.&#xD;
      Decreased levels of aminergic neurotransmitters is detected in cerebrospinal fluid (CSF) of&#xD;
      fibromyalgia patients, especially serotonin, dopamine, norepinephrine.[3]&#xD;
&#xD;
      Studies have found that different exercise programs have positive effects on pain and&#xD;
      functionality in fibromyalgia cases, and no side effects of these exercise programs have been&#xD;
      observed. Aerobic exercise training is one of the most studied exercise modalities in&#xD;
      fibromyalgia patients.[4]&#xD;
&#xD;
      However, an increase in post-exercise pain was also found in patients with fibromyalgia due&#xD;
      to a decrease in muscle blood flow, defect in muscle contraction physiology and a change in&#xD;
      post-exercise pain modulation. In addition, it has been reported that the hormone response&#xD;
      given to the exercise is impaired. All of these disorders can decrease patients' compliance&#xD;
      to exercise.[5]&#xD;
&#xD;
      Exercise with blood flow restriction - Blood Flow Restriction Training (BFRT) - is an&#xD;
      increasingly popular exercise modality that creates a physiological effect equivalent to a&#xD;
      high exercise intensity when exercising at low exercise intensities. In current studies,&#xD;
      although a similar response to high-intensity aerobic exercise was obtained by performing&#xD;
      low-intensity blood flow-restricted aerobic exercise training in other patient groups, a&#xD;
      recommendation regarding the use of BFRT in a specific disease such as fibromyalgia is&#xD;
      lacking.[6]&#xD;
&#xD;
      In our study, we aimed to evaluate and compare the effects of low-intensity aerobic exercise&#xD;
      training with blood flow restriction and without blood flow restriction, on pain, functional&#xD;
      status, quality of life and catecholamine and melatonin metabolite levels in 24-hour urine in&#xD;
      adults with Fibromyalgia.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">November 13, 2019</start_date>
  <completion_date type="Anticipated">December 18, 2020</completion_date>
  <primary_completion_date type="Anticipated">September 18, 2020</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Double (Participant, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in Fibromyalgia Impact Questionnaire (FIQ) score</measure>
    <time_frame>Baseline, Immediately after the intervention , 3 months after the intervention period</time_frame>
    <description>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.&#xD;
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.&#xD;
The total score will be between 0-100. 100 points indicate the highest exposure to the disease.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in Central Sensitization Inventory Score</measure>
    <time_frame>Baseline, Immediately after the intervention , 3 months after the intervention period</time_frame>
    <description>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.&#xD;
The Central Sensitization Inventory (CSI) consists of two parts:&#xD;
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.&#xD;
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.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Visual Analog Scale for Pain</measure>
    <time_frame>Baseline, Immediately after the intervention , 3 months after the intervention period</time_frame>
    <description>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.&#xD;
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.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Beck Depression Inventory Score</measure>
    <time_frame>Baseline, Immediately after the intervention , 3 months after the intervention period</time_frame>
    <description>Beck Depression Criterion (BDI) is a commonly used evaluation criterion for diagnosis and follow-up parameters in assessing depression status.&#xD;
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.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Chronic Pain Acceptance Questionnaire - 8 Score</measure>
    <time_frame>Baseline, Immediately after the intervention , 3 months after the intervention period</time_frame>
    <description>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.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">50</enrollment>
  <condition>Fibromyalgia</condition>
  <arm_group>
    <arm_group_label>Blood-Flow Restriction Group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>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.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control Group</arm_group_label>
    <arm_group_type>Sham Comparator</arm_group_type>
    <description>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.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>exercise training</intervention_name>
    <description>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.</description>
    <arm_group_label>Blood-Flow Restriction Group</arm_group_label>
    <arm_group_label>Control Group</arm_group_label>
    <other_name>low intensity aerobic training</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Being between 18 and 55 years old&#xD;
&#xD;
          2. Symptoms lasting longer than 3 months&#xD;
&#xD;
          3. According to the 2016 ACR criteria, the Common Pain Scale Score is ≥7 and the Symptom&#xD;
             Severity Score is ≥5 or according to the 2016 ACR criteria, the Symptom Severity Score&#xD;
             is ≥9 and the Common Pain Scale Score is between 4-6.&#xD;
&#xD;
          4. Fibromyalgia Impact Questionnaire (FIQ) score between 35 and 65 (out of 100)&#xD;
&#xD;
          5. To be able to come to the hospital for treatment 4 days a week for 6 weeks.&#xD;
&#xD;
          6. No change in the medical treatment received due to fibromyalgia syndrome during the&#xD;
             study&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Presence of known central nervous system or peripheral nervous system disease,&#xD;
             progressive neurological deficit&#xD;
&#xD;
          2. Peripheral venous insufficiency and coagulopathies&#xD;
&#xD;
          3. Serious cardiovascular pathologies&#xD;
&#xD;
          4. Sensory loss, loss of position sensation, unhealed fracture or open surgical wound&#xD;
&#xD;
          5. Uncontrolled hypertension, diabetes&#xD;
&#xD;
          6. Cognitive disorder causing simple commands difficulty&#xD;
&#xD;
          7. Pregnancy&#xD;
&#xD;
          8. Having entered the menopause&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>55 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Ayşegül Ketenci</last_name>
    <role>Principal Investigator</role>
    <affiliation>Professor</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Mert Zure, MD</last_name>
    <phone>+905356193965</phone>
    <email>mertzure@gmail.com</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Ayşegül Ketenci, Professor</last_name>
    <email>draysegulketenci@gmail.com</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Istanbul University Istanbul Faculty of Medicine</name>
      <address>
        <city>İstanbul</city>
        <zip>34093</zip>
        <country>Turkey</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Mert Zure</last_name>
      <email>mertzure@gmail.com</email>
    </contact>
  </location>
  <location_countries>
    <country>Turkey</country>
  </location_countries>
  <reference>
    <citation>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.</citation>
    <PMID>31453551</PMID>
  </reference>
  <reference>
    <citation>Hauser 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.</citation>
    <PMID>27189527</PMID>
  </reference>
  <reference>
    <citation>Singh 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.</citation>
    <PMID>31004261</PMID>
  </reference>
  <reference>
    <citation>Michiels 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.</citation>
    <PMID>11167310</PMID>
  </reference>
  <reference>
    <citation>Bidonde 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.</citation>
    <PMID>25229499</PMID>
  </reference>
  <reference>
    <citation>Genc 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.</citation>
    <PMID>26311959</PMID>
  </reference>
  <reference>
    <citation>Patterson 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.</citation>
    <PMID>28642225</PMID>
  </reference>
  <verification_date>August 2020</verification_date>
  <study_first_submitted>August 3, 2020</study_first_submitted>
  <study_first_submitted_qc>August 4, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">August 5, 2020</study_first_posted>
  <last_update_submitted>August 4, 2020</last_update_submitted>
  <last_update_submitted_qc>August 4, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">August 5, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Istanbul University</investigator_affiliation>
    <investigator_full_name>Mert Zure</investigator_full_name>
    <investigator_title>Medical Doctor</investigator_title>
  </responsible_party>
  <keyword>blood flow restriction training</keyword>
  <keyword>fibromyalgia</keyword>
  <keyword>aerobic training</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Fibromyalgia</mesh_term>
    <mesh_term>Myofascial Pain Syndromes</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <pending_results>
    <submitted>May 14, 2022</submitted>
    <returned>February 10, 2023</returned>
  </pending_results>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT04500444
org study id: 1301
nct id: NCT04500444
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
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.
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.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Participant, Outcomes Assessor)
measure: Change in Fibromyalgia Impact Questionnaire (FIQ) score
time frame: Baseline, Immediately after the intervention , 3 months after the intervention period
description: 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.
measure: Change in Central Sensitization Inventory Score
time frame: Baseline, Immediately after the intervention , 3 months after the intervention period
description: 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.
measure: Change in Visual Analog Scale for Pain
time frame: Baseline, Immediately after the intervention , 3 months after the intervention period
description: 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.
measure: Change in Beck Depression Inventory Score
time frame: Baseline, Immediately after the intervention , 3 months after the intervention period
description: 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.
measure: Change in Chronic Pain Acceptance Questionnaire - 8 Score
time frame: Baseline, Immediately after the intervention , 3 months after the intervention period
description: 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.
arm group label: Blood-Flow Restriction Group
arm group type: Experimental
description: 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.
arm group label: Control Group
arm group type: Sham Comparator
description: 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.
intervention type: Other
intervention name: exercise training
description: 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.
arm group label: Blood-Flow Restriction Group
arm group label: Control Group
other name: low intensity aerobic training
criteria: 
gender: Female
minimum age: 18 Years
maximum age: 55 Years
healthy volunteers: No
last name: Ayşegül Ketenci
role: Principal Investigator
affiliation: Professor
last name: Mert Zure, MD
phone: +905356193965
email: mertzure@gmail.com
last name: Ayşegül Ketenci, Professor
email: draysegulketenci@gmail.com
facility: 
status: Recruiting
contact: 
country: Turkey
citation: 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.
PMID: 31453551
citation: Hauser 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.
PMID: 27189527
citation: Singh 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.
PMID: 31004261
citation: Michiels 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.
PMID: 11167310
citation: Bidonde 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.
PMID: 25229499
citation: Genc 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.
PMID: 26311959
citation: Patterson 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.
PMID: 28642225
responsible party type: Principal Investigator
investigator affiliation: Istanbul University
investigator full name: Mert Zure
investigator title: Medical Doctor
mesh term: Fibromyalgia
mesh term: Myofascial Pain Syndromes
sharing ipd: No
submitted: May 14, 2022
returned: February 10, 2023