<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/NCT03750929</url>
  </required_header>
  <id_info>
    <org_study_id>MYO-HCFMUSP-05</org_study_id>
    <nct_id>NCT03750929</nct_id>
  </id_info>
  <brief_title>Aerobic Capacity and Strength Exercise in Takayasu's Arteritis</brief_title>
  <official_title>Aerobic Capacity and Strength Exercise in Takayasu's Arteritis: Impact on Clinical, Laboratory and Vascular Parameters</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Sao Paulo</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Sao Paulo</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>
  </oversight_info>
  <brief_summary>
    <textblock>
      Takayasu's arteritis is a primary systemic vasculitis that affects large vessels and their&#xD;
      main branches. The objectives of the present study were to assess: a) the aerobic capacity&#xD;
      (CA); b) security of the acute strength exercise session; c) correlation between CA, as well&#xD;
      as strength exercise session, with demographic, clinical, therapeutic, comorbid parameters,&#xD;
      and presence and degree of vascular damage; d) serum levels of the cytokines&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Takayasu's arteritis (TA) is a primary systemic vasculitis that affects large vessels and&#xD;
      their main branches. It mainly affects young women. Blood vessel inflammation may result in&#xD;
      stenosis, occlusions, ectasias and/or aneurysms and, consequently, difference of blood&#xD;
      pressure between limbs and vascular claudication. Aerobic capacity (CA) is the measure of&#xD;
      oxygen uptake, transport and use by the body, characterizing the individual's ability to&#xD;
      perform activity. It is also a tool that can predict cardiovascular diseases. Our group has&#xD;
      been a pioneer in demonstrating that CA is decreased in the small sample of the young women&#xD;
      with TA. In addition, the safety and efficacy of aerobic exercises in this sample of patients&#xD;
      were shown, as well as the influence of these sessions on the pro-inflammatory and angiogenic&#xD;
      serum levels of the cytokines. However, due to the small samples, it was not possible to&#xD;
      correlate CA with clinical and laboratory parameters and also with the presence of vascular&#xD;
      damage. Moreover, to date, no studies have evaluated securityof an acute strength exercise&#xD;
      session in TA.Therefore, thes objectives of the present study were to evaluate: a) the CA; b)&#xD;
      security of the acute strength exercise session; c) correlation between CA, as well as&#xD;
      strength exercise session, with demographic, clinical, therapeutic, comorbid parameters, and&#xD;
      presence and degree of vascular damage; d) serum levels of the cytokine.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">October 1, 2018</start_date>
  <completion_date type="Actual">April 29, 2021</completion_date>
  <primary_completion_date type="Actual">April 29, 2021</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>Other</primary_purpose>
    <masking>Single (Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Security of acute session of combined physical exercises</measure>
    <time_frame>One week before the exercises</time_frame>
    <description>Acute aerobic with strength muscle test exercise</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Healthy Assessment Questionnaire (HAQ)</measure>
    <time_frame>Twice (within 1 week before and until 30 minutes after acute combined physical exercises)</time_frame>
    <description>Especific questionnaire to assess the quality of life. Pontuaction: 0.00 (best) - 3.00 (worst).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Laboratory analysis (Serum levels of the protein C-reactive)</measure>
    <time_frame>Twice (within 1 week before and until 30 minutes after acute combined physical exercises)</time_frame>
    <description>Protein C-reactive (&lt; 5 mg/dL or not) will be analyzed to evaluate degree of disease activity</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Indian Takayasu's Arteritis Activity Score (ITAS 2010)</measure>
    <time_frame>Twice (within 1 week before and until 30 minutes after acute combined physical exercises)</time_frame>
    <description>Analyzing TA disease activity. Questionnaire with 44 items with 33 features arising from the cardiovascular system. Seven key items are weighted to score 2 and all others score 1 only. Activity was defined as ITAS 2010 score of ≥ 2 YES items</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cardiopulmonary test</measure>
    <time_frame>Once (within 1 week before acute combined physical exercises)</time_frame>
    <description>Patients will undertake a maximal graded exercise test on a treadmill, with increments in velocity and grade at every minute until volitional exhaustion (VO2) (mL/kg/minutes). VO2peak will be considered as the average of the final 30 seconds of the test.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Laboratory analysis (Erythrocyte rate sedimentation)</measure>
    <time_frame>Twice (within 1 week before and until 30 minutes after acute combined physical exercises)</time_frame>
    <description>Erythrocyte rate sedimentation (reference: &lt; 20 mm/ first hour) will be analyzed to evaluate degree of disease activity</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Strength muscle tests 1</measure>
    <time_frame>Twice (within 1 week before and until 30 minutes after acute combined physical exercises)</time_frame>
    <description>The dynamic 1 maximum repetition for the bench-press exercises. The value of maximum repetition depending on each patient (unit: Newton).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Strength muscle tests 2</measure>
    <time_frame>Twice (within 1 week before and until 30 minutes after acute combined physical exercises)</time_frame>
    <description>The dynamic 1 maximum repetition for the leg-press press exercises. The value of maximum repetition depending on each patient (unit: Newton).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Strength muscle tests 3</measure>
    <time_frame>Twice (within 1 week before and until 30 minutes after acute combined physical exercises)</time_frame>
    <description>The dynamic 1 maximum repetition for the arm curl (with the dominant arm). The value of maximum repetition depending on each patient (unit: Newton).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Strength muscle tests 4</measure>
    <time_frame>Twice (within 1 week before and until 30 minutes after acute combined physical exercises)</time_frame>
    <description>Isometric strength (assessed by handgrip, with the dominant arm) will be assessed. The value of maximum strenght will depend on each patient (unit: Newton).</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">12</enrollment>
  <condition>Physical Activity</condition>
  <condition>Takayasu Arteritis</condition>
  <arm_group>
    <arm_group_label>Non physical exercises</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Patients will not be submmitted to combined acute physical exercises (strength and aerobic)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Physical exercises</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients will be submmitted to combined acute physical exercises (strength and aerobic) that consist on: supine, paddling, leg press 45º, knee extensor, flexor knee (two sets of 15 to 20 repetitions, with loads between 30% and 40% of a maximum repetition, with 30 seconds of interval). We will perform in the first exercise for upper and lower limbs, for heating, after starting the training where 4 series of 8 to 12 maximum repetitions will be performed, using the load between 70% and 80% of 1 maximum repetitions, already evaluated. The recovery between sets will be 90 seconds and between exercises will be 120 seconds.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Combined acute physical exercises (strength and aerobic)</intervention_name>
    <description>Patients will be submmitted to combined acute physical exercises (strength and aerobic)</description>
    <arm_group_label>Physical exercises</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Classification criteria of Takayasu's arteritis&#xD;
&#xD;
          -  Sedentarism&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Peripherical arterial diseases&#xD;
&#xD;
          -  Non-controlled cardiovascular diseases&#xD;
&#xD;
          -  Neurological diseases&#xD;
&#xD;
          -  Patients with walking problem&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <gender_based>Yes</gender_based>
    <gender_description>Participant eligibility is based on self-representation of gender identity</gender_description>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>50 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Samuel K Shinjo</last_name>
    <role>Principal Investigator</role>
    <affiliation>Universidade de Sao Paulo - Rheumatology Division</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Samuel Katsuyuki Shinjo</name>
      <address>
        <city>Sao Paulo</city>
        <zip>01246903</zip>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Brazil</country>
  </location_countries>
  <verification_date>April 2021</verification_date>
  <study_first_submitted>November 16, 2018</study_first_submitted>
  <study_first_submitted_qc>November 21, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">November 23, 2018</study_first_posted>
  <last_update_submitted>April 29, 2021</last_update_submitted>
  <last_update_submitted_qc>April 29, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">April 30, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Sao Paulo</investigator_affiliation>
    <investigator_full_name>Samuel Katsuyuki Shinjo, PhD</investigator_full_name>
    <investigator_title>Professor, PhD</investigator_title>
  </responsible_party>
  <keyword>Takayasus's arteritis</keyword>
  <keyword>Physical exercises</keyword>
  <keyword>Rheumatic diseases</keyword>
  <keyword>Systemic vasculitis</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Arteritis</mesh_term>
    <mesh_term>Takayasu Arteritis</mesh_term>
    <mesh_term>Aortic Arch Syndromes</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
  </patient_data>
  <!-- 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/NCT03750929
org study id: MYO-HCFMUSP-05
nct id: NCT03750929
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
Takayasu's arteritis is a primary systemic vasculitis that affects large vessels and their
      main branches. The objectives of the present study were to assess: a) the aerobic capacity
      (CA); b) security of the acute strength exercise session; c) correlation between CA, as well
      as strength exercise session, with demographic, clinical, therapeutic, comorbid parameters,
      and presence and degree of vascular damage; d) serum levels of the cytokines
Takayasu's arteritis (TA) is a primary systemic vasculitis that affects large vessels and
      their main branches. It mainly affects young women. Blood vessel inflammation may result in
      stenosis, occlusions, ectasias and/or aneurysms and, consequently, difference of blood
      pressure between limbs and vascular claudication. Aerobic capacity (CA) is the measure of
      oxygen uptake, transport and use by the body, characterizing the individual's ability to
      perform activity. It is also a tool that can predict cardiovascular diseases. Our group has
      been a pioneer in demonstrating that CA is decreased in the small sample of the young women
      with TA. In addition, the safety and efficacy of aerobic exercises in this sample of patients
      were shown, as well as the influence of these sessions on the pro-inflammatory and angiogenic
      serum levels of the cytokines. However, due to the small samples, it was not possible to
      correlate CA with clinical and laboratory parameters and also with the presence of vascular
      damage. Moreover, to date, no studies have evaluated securityof an acute strength exercise
      session in TA.Therefore, thes objectives of the present study were to evaluate: a) the CA; b)
      security of the acute strength exercise session; c) correlation between CA, as well as
      strength exercise session, with demographic, clinical, therapeutic, comorbid parameters, and
      presence and degree of vascular damage; d) serum levels of the cytokine.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Other
masking: Single (Investigator)
measure: Security of acute session of combined physical exercises
time frame: One week before the exercises
description: Acute aerobic with strength muscle test exercise
measure: Healthy Assessment Questionnaire (HAQ)
time frame: Twice (within 1 week before and until 30 minutes after acute combined physical exercises)
description: Especific questionnaire to assess the quality of life. Pontuaction: 0.00 (best) - 3.00 (worst).
measure: Laboratory analysis (Serum levels of the protein C-reactive)
time frame: Twice (within 1 week before and until 30 minutes after acute combined physical exercises)
description: Protein C-reactive (< 5 mg/dL or not) will be analyzed to evaluate degree of disease activity
measure: Indian Takayasu's Arteritis Activity Score (ITAS 2010)
time frame: Twice (within 1 week before and until 30 minutes after acute combined physical exercises)
description: Analyzing TA disease activity. Questionnaire with 44 items with 33 features arising from the cardiovascular system. Seven key items are weighted to score 2 and all others score 1 only. Activity was defined as ITAS 2010 score of ≥ 2 YES items
measure: Cardiopulmonary test
time frame: Once (within 1 week before acute combined physical exercises)
description: Patients will undertake a maximal graded exercise test on a treadmill, with increments in velocity and grade at every minute until volitional exhaustion (VO2) (mL/kg/minutes). VO2peak will be considered as the average of the final 30 seconds of the test.
measure: Laboratory analysis (Erythrocyte rate sedimentation)
time frame: Twice (within 1 week before and until 30 minutes after acute combined physical exercises)
description: Erythrocyte rate sedimentation (reference: < 20 mm/ first hour) will be analyzed to evaluate degree of disease activity
measure: Strength muscle tests 1
time frame: Twice (within 1 week before and until 30 minutes after acute combined physical exercises)
description: The dynamic 1 maximum repetition for the bench-press exercises. The value of maximum repetition depending on each patient (unit: Newton).
measure: Strength muscle tests 2
time frame: Twice (within 1 week before and until 30 minutes after acute combined physical exercises)
description: The dynamic 1 maximum repetition for the leg-press press exercises. The value of maximum repetition depending on each patient (unit: Newton).
measure: Strength muscle tests 3
time frame: Twice (within 1 week before and until 30 minutes after acute combined physical exercises)
description: The dynamic 1 maximum repetition for the arm curl (with the dominant arm). The value of maximum repetition depending on each patient (unit: Newton).
measure: Strength muscle tests 4
time frame: Twice (within 1 week before and until 30 minutes after acute combined physical exercises)
description: Isometric strength (assessed by handgrip, with the dominant arm) will be assessed. The value of maximum strenght will depend on each patient (unit: Newton).
arm group label: Non physical exercises
arm group type: No Intervention
description: Patients will not be submmitted to combined acute physical exercises (strength and aerobic)
arm group label: Physical exercises
arm group type: Experimental
description: Patients will be submmitted to combined acute physical exercises (strength and aerobic) that consist on: supine, paddling, leg press 45º, knee extensor, flexor knee (two sets of 15 to 20 repetitions, with loads between 30% and 40% of a maximum repetition, with 30 seconds of interval). We will perform in the first exercise for upper and lower limbs, for heating, after starting the training where 4 series of 8 to 12 maximum repetitions will be performed, using the load between 70% and 80% of 1 maximum repetitions, already evaluated. The recovery between sets will be 90 seconds and between exercises will be 120 seconds.
intervention type: Other
intervention name: Combined acute physical exercises (strength and aerobic)
description: Patients will be submmitted to combined acute physical exercises (strength and aerobic)
arm group label: Physical exercises
criteria: 
gender: All
gender based: Yes
gender description: Participant eligibility is based on self-representation of gender identity
minimum age: 18 Years
maximum age: 50 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Samuel K Shinjo
role: Principal Investigator
affiliation: Universidade de Sao Paulo - Rheumatology Division
facility: 
country: Brazil
responsible party type: Principal Investigator
investigator affiliation: University of Sao Paulo
investigator full name: Samuel Katsuyuki Shinjo, PhD
investigator title: Professor, PhD
mesh term: Arteritis
mesh term: Takayasu Arteritis
mesh term: Aortic Arch Syndromes
sharing ipd: Undecided