xml: <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/NCT06001034</url>
    </required_header>
    <id_info>
      <org_study_id>1441-23</org_study_id>
      <secondary_id>0560-N-22</secondary_id>
      <nct_id>NCT06001034</nct_id>
    </id_info>
    <brief_title>Program of Supervised Occlusive Aerobic Training in People With Fibromyalgia.</brief_title>
    <official_title>A 9-week Program of Supervised Occlusive Aerobic Training in People With Fibromyalgia in a Hospital Setting, and Its Impact on Blood/Plasma Variables, Quality of Life and Functional Autonomy.</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>José Carlos Rodríguez Bautista</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>Universidad Pablo de Olavide</agency>
        <agency_class>Other</agency_class>
      </collaborator>
      <collaborator>
        <agency>Hospital Universitario de Valme</agency>
        <agency_class>Other</agency_class>
      </collaborator>
      <collaborator>
        <agency>Andaluz Health Service</agency>
        <agency_class>Other</agency_class>
      </collaborator>
    </sponsors>
    <source>Universidad Pablo de Olavide</source>
    <oversight_info>
      <has_dmc>Yes</has_dmc>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
      <is_us_export>No</is_us_export>
    </oversight_info>
    <brief_summary>
      <textblock>
        Occlusive training in people with fibromyalgia&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Intervention study in people with fibromyalgia with the implementation of a lower body&#xD;
        occlusive tool in aerobic exercise. The study aims to descriptively test the impact on&#xD;
        quality of life and functional autonomy of occlusive training in a controlled and&#xD;
        individualized way in two groups: group 1 aerobic exercise with use of occlusive tool and&#xD;
        group 2, aerobic exercise without occlusive tool in a period of 9 weeks twice a week.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Completed</overall_status>
    <start_date type="Actual">September 15, 2022</start_date>
    <completion_date type="Actual">May 20, 2023</completion_date>
    <primary_completion_date type="Actual">February 5, 2023</primary_completion_date>
    <phase>N/A</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <allocation>Non-Randomized</allocation>
      <intervention_model>Parallel Assignment</intervention_model>
      <intervention_model_description>Group 1: Aerobic exercise plus occlusive tool. Group 2: Aerobic exercise without occlusive tool.</intervention_model_description>
      <primary_purpose>Supportive Care</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Change in Coenzyme Q10 after a 9-week intervention period.</measure>
      <time_frame>Pre (before the start of the 9-week intervention period). Post (immediately after the 9-week intervention period).</time_frame>
      <description>Coenzyme Q10</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Change in total antioxidants after a 9-week intervention period.</measure>
      <time_frame>Pre (before the start of the 9-week intervention period). Post (immediately after the 9-week intervention period).</time_frame>
      <description>TAS</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Change in disease impact questionnaire WPI after a 9-week intervention period.</measure>
      <time_frame>Pre (before the start of the 9-week intervention period). Post (immediately after the 9-week intervention period).</time_frame>
      <description>WPI; score between (0-19). The higher the score, the greater the impact of the disease.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Change in disease impact questionnaire SSscore after a 9-week intervention period.</measure>
      <time_frame>Pre (before the start of the 9-week intervention period). Post (immediately after the 9-week intervention period).</time_frame>
      <description>SS score; score between (0-3) in the first half. Score between (0-40); between 1-10 (1 point), between 11-24 (2 points), more than 25 (3 points) in the second half. The higher the score, the greater the impact of the disease.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Change in disease impact questionnaire FIQ after a 9-week intervention period.</measure>
      <time_frame>Pre (before the start of the 9-week intervention period). Post (immediately after the 9-week intervention period).</time_frame>
      <description>FIQ; score between (0-100). The higher the score, the greater the impact of the disease</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Change in disease impact questionnaire MFI-20 after a 9-week intervention period.</measure>
      <time_frame>Pre (before the start of the 9-week intervention period). Post (immediately after the 9-week intervention period).</time_frame>
      <description>MFI-20; (0-60) no fatigue. (60-70), fatigue, lighter or more severe, depending on the depending on the rating closer to 60 or 70 points. (more than 70 points), severe fatigue.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Change in high density lipoproteins after a 9-week intervention period.</measure>
      <time_frame>Pre (before the start of the 9-week intervention period). Post (immediately after the 9-week intervention period).</time_frame>
      <description>HDL</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Change in low density lipoproteins after a 9-week intervention period.</measure>
      <time_frame>Pre (before the start of the 9-week intervention period). Post (immediately after the 9-week intervention period).</time_frame>
      <description>LDL</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Change in total cholesterol lipoproteins after a 9-week intervention period.</measure>
      <time_frame>Pre (before the start of the 9-week intervention period). Post (immediately after the 9-week intervention period).</time_frame>
      <description>CHOL</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Change in triglycerides after a 9-week intervention period.</measure>
      <time_frame>Pre (before the start of the 9-week intervention period). Post (immediately after the 9-week intervention period).</time_frame>
      <description>TG</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Changes in urea after a 9-week intervention period.</measure>
      <time_frame>Pre (before the start of the 9-week intervention period). Post (immediately after the 9-week intervention period).</time_frame>
      <description>Urea</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Changes in creatinine after a 9-week intervention period.</measure>
      <time_frame>Pre (before the start of the 9-week intervention period). Post (immediately after the 9-week intervention period).</time_frame>
      <description>Creatinine</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Change in gamma-glutamyl transferase after a 9-week intervention period.</measure>
      <time_frame>Pre (before the start of the 9-week intervention period). Post (immediately after the 9-week intervention period).</time_frame>
      <description>GGT</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Change in glutamic-pyruvic transaminase after a 9-week intervention period.</measure>
      <time_frame>Pre (before the start of the 9-week intervention period). Post (immediately after the 9-week intervention period).</time_frame>
      <description>GPT</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Change in glutamic oxaloacetic acid transaminase after a 9-week intervention period.</measure>
      <time_frame>Pre (before the start of the 9-week intervention period). Post (immediately after the 9-week intervention period).</time_frame>
      <description>GOT</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Change in alkaline phosphatase after a 9-week intervention period.</measure>
      <time_frame>Pre (before the start of the 9-week intervention period). Post (immediately after the 9-week intervention period).</time_frame>
      <description>ALP</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Change in funcional test after a 9-week intervention period.</measure>
      <time_frame>Pre (before the start of the 9-week intervention period). Post (immediately after the 9-week intervention period)</time_frame>
      <description>6-minute walking test</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Change in funcional test after a 9-week intervention period.</measure>
      <time_frame>Pre (before the start of the 9-week intervention period). Post (immediately after the 9-week intervention period)</time_frame>
      <description>incremental shuttle walking test</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Change in funcional test after a 9-week intervention period.</measure>
      <time_frame>Pre (before the start of the 9-week intervention period). Post (immediately after the 9-week intervention period).</time_frame>
      <description>30 second chair and stand test</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Change in funcional test after a 9-week intervention period.</measure>
      <time_frame>Pre (before the start of the 9-week intervention period). Post (immediately after the 9-week intervention period)</time_frame>
      <description>Time and go test</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Change in malondialdehyde after a 9-week intervention period.</measure>
      <time_frame>Pre (before the start of the 9-week intervention period). Post (immediately after the 9-week intervention period).</time_frame>
      <description>MDA (malondialdehyde)</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Change in distance traveled after a 9-week intervention period.</measure>
      <time_frame>From week 1 to week 9 of the intervention period.</time_frame>
      <description>Pedometer registration. Immediately after each session from week 1 to 9 of the intervention period. With a total of 18 recordings over the 9 weeks of the intervention period.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Change in visual pain scale VAS over a 9-week intervention period.</measure>
      <time_frame>From week 1 to week 9 of the intervention period.</time_frame>
      <description>Visual pain scale (1-10). 1 being lighter and 10 being more severe. Visual pain scale recording. Before and immediately after each session from week 1 to week 9 of the intervention period. With a total of 36 recordings during the 9 weeks of the intervention period.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Change in perceived exertion scale BORG over a 9-week intervention period.</measure>
      <time_frame>From week 1 to week 9 of the intervention period.</time_frame>
      <description>Perceived exertion scale. (1-10). 1 being lighter and 10 being more severe. Perceived exertion scale recording. Before and immediately after each session from week 1 to week 9 of the intervention period. With a total of 36 recordings during the 9 weeks of the intervention period.</description>
    </primary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Actual">37</enrollment>
    <condition>Fibromyalgia</condition>
    <arm_group>
      <arm_group_label>Group 1: Aerobic exercise plus occlusive tool.</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Performing low-impact aerobic exercise with an occlusive tool 2 days per week.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Group 2: Aerobic exercise without occlusive tool.</arm_group_label>
      <arm_group_type>No Intervention</arm_group_type>
      <description>Performing low-impact aerobic exercise without an occlusive tool 2 days per week.</description>
    </arm_group>
    <intervention>
      <intervention_type>Device</intervention_type>
      <intervention_name>Occlusion training</intervention_name>
      <description>Impact of supervised occlusive training for 2 days per week for 10 weeks on quality of life and functional autonomy in participants with fibromyalgia.</description>
      <arm_group_label>Group 1: Aerobic exercise plus occlusive tool.</arm_group_label>
      <other_name>Occlusive cuffing during aerobic exercise in participants with fibromyalgia</other_name>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
          A patient meets diagnostic criteria for fibromyalgia if the following three conditions are&#xD;
          present: (American Rheumatology Association). Wolfe et al., (2010).&#xD;
  &#xD;
            -  o 1) Widespread Pain Index (WPI) ≥ 7 and Symptom Severity Score (SS Score) ≥ 5 or WPI&#xD;
               3-6 and SS ≥ 9.&#xD;
  &#xD;
            -  Symptoms have been present, at a similar level, during the last three months.&#xD;
  &#xD;
            -  The patient has no other pathology that could explain the pain.&#xD;
  &#xD;
            -  Recent negative COVID-19 test.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Other associated pathologies that may hinder the development of the research.&#xD;
  &#xD;
            -  Mobility limitations.&#xD;
  &#xD;
            -  Injuries that add to those of the disease itself and hinder mobility.&#xD;
  &#xD;
            -  No medical evaluation of the diagnosis of the disease.&#xD;
  &#xD;
            -  Negative results in the inclusion tests.&#xD;
  &#xD;
            -  Cardiac pathologies.&#xD;
  &#xD;
            -  Blood pressure higher than 130-90 mmHg.&#xD;
  &#xD;
            -  No COVID-19 test.&#xD;
        </textblock>
      </criteria>
      <gender>Female</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>70 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>José Carlos Rodríguez Bautista, PhD currently</last_name>
      <role>Principal Investigator</role>
      <affiliation>Universidad Pablo de Olavide</affiliation>
    </overall_official>
    <location>
      <facility>
        <name>Universidad Pablo de Olavide</name>
        <address>
          <city>Sevilla</city>
          <zip>41013</zip>
          <country>Spain</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>Spain</country>
    </location_countries>
    <link>
      <url>https://upotv.upo.es/video/58da21db238583e0478b48f3</url>
      <description>30-second chair stand</description>
    </link>
    <link>
      <url>https://www.youtube.com/watch?v=8eRQexJzzUE</url>
      <description>Timed Up and Go test</description>
    </link>
    <link>
      <url>https://upotv.upo.es/video/5936500f238583f9658b464a</url>
      <description>6-Minute Walk test</description>
    </link>
    <link>
      <url>https://upotv.upo.es/video/5a72df02238583bd408b456a</url>
      <description>Incremental Shuttle Walk Test</description>
    </link>
    <reference>
      <citation>Latorre-Roman PA, Segura-Jimenez V, Aparicio VA, Santos E Campos MA, Garcia-Pinillos F, Herrador-Colmenero M, Alvarez-Gallardo IC, Delgado-Fernandez M. Ageing influence in the evolution of strength and muscle mass in women with fibromyalgia: the al-Andalus project. Rheumatol Int. 2015 Jul;35(7):1243-50. doi: 10.1007/s00296-015-3213-5. Epub 2015 Jan 24.</citation>
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    <reference>
      <citation>Bonaterra GA, Then H, Oezel L, Schwarzbach H, Ocker M, Thieme K, Di Fazio P, Kinscherf R. Morphological Alterations in Gastrocnemius and Soleus Muscles in Male and Female Mice in a Fibromyalgia Model. PLoS One. 2016 Mar 17;11(3):e0151116. doi: 10.1371/journal.pone.0151116. eCollection 2016.</citation>
      <PMID>26986947</PMID>
    </reference>
    <reference>
      <citation>Valim V, Oliveira LM, Suda AL, Silva LE, Faro M, Neto TL, Feldman D, Natour J. Peak oxygen uptake and ventilatory anaerobic threshold in fibromyalgia. J Rheumatol. 2002 Feb;29(2):353-7.</citation>
      <PMID>11842825</PMID>
    </reference>
    <reference>
      <citation>Koca I, Savas E, Ozturk ZA, Boyaci A, Tutoglu A, Alkan S, Yildiz H, Kimyon G. The evaluation in terms of sarcopenia of patients with fibromyalgia syndrome. Wien Klin Wochenschr. 2016 Nov;128(21-22):816-821. doi: 10.1007/s00508-015-0821-8. Epub 2015 Jul 4.</citation>
      <PMID>26142171</PMID>
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    <reference>
      <citation>Shang Y, Gurley K, Symons B, Long D, Srikuea R, Crofford LJ, Peterson CA, Yu G. Noninvasive optical characterization of muscle blood flow, oxygenation, and metabolism in women with fibromyalgia. Arthritis Res Ther. 2012 Nov 1;14(6):R236. doi: 10.1186/ar4079.</citation>
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      <citation>Sarifakioglu B, Guzelant AY, Guzel EC, Guzel S, Kiziler AR. Effects of 12-week combined exercise therapy on oxidative stress in female fibromyalgia patients. Rheumatol Int. 2014 Oct;34(10):1361-7. doi: 10.1007/s00296-014-2978-2. Epub 2014 Mar 9.</citation>
      <PMID>24610539</PMID>
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      <citation>Cordero MD, de Miguel M, Moreno-Fernandez AM. [Mitochondrial dysfunction in fibromyalgia and its implication in the pathogenesis of disease]. Med Clin (Barc). 2011 Mar 12;136(6):252-6. doi: 10.1016/j.medcli.2010.01.030. Epub 2010 Apr 24. Spanish.</citation>
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      <citation>Sprott H, Salemi S, Gay RE, Bradley LA, Alarcon GS, Oh SJ, Michel BA, Gay S. Increased DNA fragmentation and ultrastructural changes in fibromyalgic muscle fibres. Ann Rheum Dis. 2004 Mar;63(3):245-51. doi: 10.1136/ard.2002.004762.</citation>
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      <citation>Castro-Marrero J, Cordero MD, Saez-Francas N, Jimenez-Gutierrez C, Aguilar-Montilla FJ, Aliste L, Alegre-Martin J. Could mitochondrial dysfunction be a differentiating marker between chronic fatigue syndrome and fibromyalgia? Antioxid Redox Signal. 2013 Nov 20;19(15):1855-60. doi: 10.1089/ars.2013.5346. Epub 2013 May 29.</citation>
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      <citation>Ratter J, Radlinger L, Lucas C. Several submaximal exercise tests are reliable, valid and acceptable in people with chronic pain, fibromyalgia or chronic fatigue: a systematic review. J Physiother. 2014 Sep;60(3):144-50. doi: 10.1016/j.jphys.2014.06.011. Epub 2014 Jul 30.</citation>
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    <verification_date>August 2023</verification_date>
    <study_first_submitted>July 6, 2023</study_first_submitted>
    <study_first_submitted_qc>August 13, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 21, 2023</study_first_posted>
    <last_update_submitted>August 13, 2023</last_update_submitted>
    <last_update_submitted_qc>August 13, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 21, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor-Investigator</responsible_party_type>
      <investigator_affiliation>Universidad Pablo de Olavide</investigator_affiliation>
      <investigator_full_name>José Carlos Rodríguez Bautista</investigator_full_name>
      <investigator_title>PhD currently Sport Sciences in Physical Activity, Health and Quality of Life</investigator_title>
    </responsible_party>
    <keyword>occlusive 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>Yes</sharing_ipd>
      <ipd_description>Numeric code to each participant, concealing their personal data at all times.</ipd_description>
      <ipd_info_type>Study Protocol</ipd_info_type>
      <ipd_info_type>Analytic Code</ipd_info_type>
      <ipd_time_frame>The protocol before the start and the numerical codes at the end of the intervention period.</ipd_time_frame>
      <ipd_access_criteria>Shared use only from principal investigator with collaborating investigators of the study.</ipd_access_criteria>
    </patient_data>
    <provided_document_section>
      <provided_document>
        <document_type>Study Protocol and Statistical Analysis Plan</document_type>
        <document_has_protocol>Yes</document_has_protocol>
        <document_has_icf>No</document_has_icf>
        <document_has_sap>Yes</document_has_sap>
        <document_date>June 6, 2023</document_date>
        <document_url>https://ClinicalTrials.gov/ProvidedDocs/34/NCT06001034/Prot_SAP_000.pdf</document_url>
      </provided_document>
    </provided_document_section>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT06001034
  org study id: 1441-23
  secondary id: 0560-N-22
  nct id: NCT06001034
  lead sponsor: 
  collaborator: 
  collaborator: 
  collaborator: 
  has dmc: Yes
  is fda regulated drug: No
  is fda regulated device: No
  is us export: No
  Occlusive training in people with fibromyalgia
  Intervention study in people with fibromyalgia with the implementation of a lower body
        occlusive tool in aerobic exercise. The study aims to descriptively test the impact on
        quality of life and functional autonomy of occlusive training in a controlled and
        individualized way in two groups: group 1 aerobic exercise with use of occlusive tool and
        group 2, aerobic exercise without occlusive tool in a period of 9 weeks twice a week.
  allocation: Non-Randomized
  intervention model: Parallel Assignment
  intervention model description: Group 1: Aerobic exercise plus occlusive tool. Group 2: Aerobic exercise without occlusive tool.
  primary purpose: Supportive Care
  masking: None (Open Label)
  measure: Change in Coenzyme Q10 after a 9-week intervention period.
  time frame: Pre (before the start of the 9-week intervention period). Post (immediately after the 9-week intervention period).
  description: Coenzyme Q10
  measure: Change in total antioxidants after a 9-week intervention period.
  time frame: Pre (before the start of the 9-week intervention period). Post (immediately after the 9-week intervention period).
  description: TAS
  measure: Change in disease impact questionnaire WPI after a 9-week intervention period.
  time frame: Pre (before the start of the 9-week intervention period). Post (immediately after the 9-week intervention period).
  description: WPI; score between (0-19). The higher the score, the greater the impact of the disease.
  measure: Change in disease impact questionnaire SSscore after a 9-week intervention period.
  time frame: Pre (before the start of the 9-week intervention period). Post (immediately after the 9-week intervention period).
  description: SS score; score between (0-3) in the first half. Score between (0-40); between 1-10 (1 point), between 11-24 (2 points), more than 25 (3 points) in the second half. The higher the score, the greater the impact of the disease.
  measure: Change in disease impact questionnaire FIQ after a 9-week intervention period.
  time frame: Pre (before the start of the 9-week intervention period). Post (immediately after the 9-week intervention period).
  description: FIQ; score between (0-100). The higher the score, the greater the impact of the disease
  measure: Change in disease impact questionnaire MFI-20 after a 9-week intervention period.
  time frame: Pre (before the start of the 9-week intervention period). Post (immediately after the 9-week intervention period).
  description: MFI-20; (0-60) no fatigue. (60-70), fatigue, lighter or more severe, depending on the depending on the rating closer to 60 or 70 points. (more than 70 points), severe fatigue.
  measure: Change in high density lipoproteins after a 9-week intervention period.
  time frame: Pre (before the start of the 9-week intervention period). Post (immediately after the 9-week intervention period).
  description: HDL
  measure: Change in low density lipoproteins after a 9-week intervention period.
  time frame: Pre (before the start of the 9-week intervention period). Post (immediately after the 9-week intervention period).
  description: LDL
  measure: Change in total cholesterol lipoproteins after a 9-week intervention period.
  time frame: Pre (before the start of the 9-week intervention period). Post (immediately after the 9-week intervention period).
  description: CHOL
  measure: Change in triglycerides after a 9-week intervention period.
  time frame: Pre (before the start of the 9-week intervention period). Post (immediately after the 9-week intervention period).
  description: TG
  measure: Changes in urea after a 9-week intervention period.
  time frame: Pre (before the start of the 9-week intervention period). Post (immediately after the 9-week intervention period).
  description: Urea
  measure: Changes in creatinine after a 9-week intervention period.
  time frame: Pre (before the start of the 9-week intervention period). Post (immediately after the 9-week intervention period).
  description: Creatinine
  measure: Change in gamma-glutamyl transferase after a 9-week intervention period.
  time frame: Pre (before the start of the 9-week intervention period). Post (immediately after the 9-week intervention period).
  description: GGT
  measure: Change in glutamic-pyruvic transaminase after a 9-week intervention period.
  time frame: Pre (before the start of the 9-week intervention period). Post (immediately after the 9-week intervention period).
  description: GPT
  measure: Change in glutamic oxaloacetic acid transaminase after a 9-week intervention period.
  time frame: Pre (before the start of the 9-week intervention period). Post (immediately after the 9-week intervention period).
  description: GOT
  measure: Change in alkaline phosphatase after a 9-week intervention period.
  time frame: Pre (before the start of the 9-week intervention period). Post (immediately after the 9-week intervention period).
  description: ALP
  measure: Change in funcional test after a 9-week intervention period.
  time frame: Pre (before the start of the 9-week intervention period). Post (immediately after the 9-week intervention period)
  description: 6-minute walking test
  measure: Change in funcional test after a 9-week intervention period.
  time frame: Pre (before the start of the 9-week intervention period). Post (immediately after the 9-week intervention period)
  description: incremental shuttle walking test
  measure: Change in funcional test after a 9-week intervention period.
  time frame: Pre (before the start of the 9-week intervention period). Post (immediately after the 9-week intervention period).
  description: 30 second chair and stand test
  measure: Change in funcional test after a 9-week intervention period.
  time frame: Pre (before the start of the 9-week intervention period). Post (immediately after the 9-week intervention period)
  description: Time and go test
  measure: Change in malondialdehyde after a 9-week intervention period.
  time frame: Pre (before the start of the 9-week intervention period). Post (immediately after the 9-week intervention period).
  description: MDA (malondialdehyde)
  measure: Change in distance traveled after a 9-week intervention period.
  time frame: From week 1 to week 9 of the intervention period.
  description: Pedometer registration. Immediately after each session from week 1 to 9 of the intervention period. With a total of 18 recordings over the 9 weeks of the intervention period.
  measure: Change in visual pain scale VAS over a 9-week intervention period.
  time frame: From week 1 to week 9 of the intervention period.
  description: Visual pain scale (1-10). 1 being lighter and 10 being more severe. Visual pain scale recording. Before and immediately after each session from week 1 to week 9 of the intervention period. With a total of 36 recordings during the 9 weeks of the intervention period.
  measure: Change in perceived exertion scale BORG over a 9-week intervention period.
  time frame: From week 1 to week 9 of the intervention period.
  description: Perceived exertion scale. (1-10). 1 being lighter and 10 being more severe. Perceived exertion scale recording. Before and immediately after each session from week 1 to week 9 of the intervention period. With a total of 36 recordings during the 9 weeks of the intervention period.
  arm group label: Group 1: Aerobic exercise plus occlusive tool.
  arm group type: Experimental
  description: Performing low-impact aerobic exercise with an occlusive tool 2 days per week.
  arm group label: Group 2: Aerobic exercise without occlusive tool.
  arm group type: No Intervention
  description: Performing low-impact aerobic exercise without an occlusive tool 2 days per week.
  intervention type: Device
  intervention name: Occlusion training
  description: Impact of supervised occlusive training for 2 days per week for 10 weeks on quality of life and functional autonomy in participants with fibromyalgia.
  arm group label: Group 1: Aerobic exercise plus occlusive tool.
  other name: Occlusive cuffing during aerobic exercise in participants with fibromyalgia
  criteria: 
  gender: Female
  minimum age: 18 Years
  maximum age: 70 Years
  healthy volunteers: No
  last name: José Carlos Rodríguez Bautista, PhD currently
  role: Principal Investigator
  affiliation: Universidad Pablo de Olavide
  facility: 
  country: Spain
  url: https://upotv.upo.es/video/58da21db238583e0478b48f3
  description: 30-second chair stand
  url: https://www.youtube.com/watch?v=8eRQexJzzUE
  description: Timed Up and Go test
  url: https://upotv.upo.es/video/5936500f238583f9658b464a
  description: 6-Minute Walk test
  url: https://upotv.upo.es/video/5a72df02238583bd408b456a
  description: Incremental Shuttle Walk Test
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  PMID: 25617055
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  PMID: 26986947
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  PMID: 11842825
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  PMID: 26971801
  responsible party type: Sponsor-Investigator
  investigator affiliation: Universidad Pablo de Olavide
  investigator full name: José Carlos Rodríguez Bautista
  investigator title: PhD currently Sport Sciences in Physical Activity, Health and Quality of Life
  mesh term: Fibromyalgia
  mesh term: Myofascial Pain Syndromes
  sharing ipd: Yes
  ipd description: Numeric code to each participant, concealing their personal data at all times.
  ipd info type: Study Protocol
  ipd info type: Analytic Code
  ipd time frame: The protocol before the start and the numerical codes at the end of the intervention period.
  ipd access criteria: Shared use only from principal investigator with collaborating investigators of the study.
  provided document: 