<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/NCT02198872</url>
  </required_header>
  <id_info>
    <org_study_id>03/13</org_study_id>
    <secondary_id>190729/2011-2</secondary_id>
    <nct_id>NCT02198872</nct_id>
  </id_info>
  <brief_title>Aquatic and Land Aerobic Training, Cardiorespiratory and Metabolic Variables in Cardiorespiratory Diseases</brief_title>
  <official_title>Effects of Aquatic and Land Aerobic Training on Body Composition and Cardiorespiratory and Metabolic Variables in Patients With Cardiorespiratory Diseases</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Universidade Metodista de Piracicaba</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Universidade Metodista de Piracicaba</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      In the pathophysiological process of coronary artery disease (CAD), are present, autonomic&#xD;
      dysfunction and reduced functional capacity. Studies showed that physical training (PT) is&#xD;
      critical in the treatment of CAD by promoting beneficial effects. Although water based&#xD;
      exercises program have been documented in patients with various cardiovascular diseases, the&#xD;
      most of studies among patients with CAD used land based exercises programs. OBJECTIVE: To&#xD;
      evaluate and compare the effects of aerobic water (WPT) and land (LPT) based PT on autonomic&#xD;
      modulation of heart rate (HR), body composition and cardiorespiratory and metabolic variables&#xD;
      in patients with CAD. METHODS : 40 men between 50 and 70 years old with CAD diagnosed by&#xD;
      coronary angiography showing obstruction greater than 50% and underwent angioplasty will be&#xD;
      evaluated in 4 stages; 1) immediately after angioplasty, clinical assessment, body&#xD;
      composition analysis and recording of HR and NN intervals during rest. 2) The components of&#xD;
      step 1) will be repeated after three month, adding the record of HR and NN before, during and&#xD;
      after the Valsalva maneuver, spirometry and cardiopulmonary exercise testing. 3) Volunteers&#xD;
      will be randomly divided into two groups, WPT and LPT for 48 sessions. 4) The components of&#xD;
      step 2) are repeated after each period of 12 sessions. Thus, it is expected that WPT promote&#xD;
      beneficial physiological adaptations in CAD patients with obstruction greater than 50%.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      1. Immediately after angioplasty, the volunteers will be subject to an assessment&#xD;
           (Assessment 0), which will consist of:&#xD;
&#xD;
             -  History: personal data, lifestyle and food, family history, current and previous&#xD;
                history of disease.&#xD;
&#xD;
             -  Physical examination: cardiac and lung auscultation,measurement of heart rate (HR),&#xD;
                blood pressure (BP), body weight and height.&#xD;
&#xD;
             -  Analysis of body composition by bioelectrical impedance analysis.&#xD;
&#xD;
             -  Registration of HR and NN intervals (NN) during rest, in the supine and sitting&#xD;
                positions.&#xD;
&#xD;
             -  biochemical blood tests: complete blood count, blood glucose, total cholesterol,&#xD;
                LDL and HDL cholesterol, triglycerides, and C-reactive protein ultrasensitive.&#xD;
&#xD;
             -  Recording of HR and NN during rest in the supine position, sitting, standing and&#xD;
                during respiratory sinus arrhythmia maneuver.&#xD;
&#xD;
        2. Three months after the &quot;Assessment 0&quot;, the volunteers will be subject to an assessment&#xD;
           (initial Assessment) prior to physical training program. Will be repeated all&#xD;
           assessments performed in the &quot;Assessment 0&quot; plus the record of HR and R-Ri before,&#xD;
           during and after the Valsalva maneuver, spirometry and cardiopulmonary exercise test&#xD;
           (CPET). This is a submaximal CPET performed on a treadmill, in order to verify and&#xD;
           identify possible changes in hemodynamic, electrocardiographic induced to physical&#xD;
           exertion, their aerobic functional capacity as well as to prescribe physical training&#xD;
           protocol.&#xD;
&#xD;
        3. After this assessment, the volunteers will be randomly assigned to one of two groups,&#xD;
           aerobic water (WPT) or land (LPT) based physical training.&#xD;
&#xD;
        4. Components of &quot;Initial Assessment&quot; will be repeated at the end of each month of physical&#xD;
           training (Revaluation 1, 2 and 3) and the end (Final Assessment).&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date>September 2014</start_date>
  <completion_date type="Anticipated">February 2018</completion_date>
  <primary_completion_date type="Anticipated">July 2015</primary_completion_date>
  <phase>Early Phase 1</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 (Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in autonomic system modulation</measure>
    <time_frame>baseline and 16 weeks</time_frame>
    <description>Change in autonomic system modulation in assess by comparing the heart rate variability at baseline and after a 16 weeks of aerobic water and land based physical training.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in body composition</measure>
    <time_frame>16 weeks</time_frame>
    <description>Change in body composition is assess by comparing the body composition at baseline and after a 16 weeks of aerobic water and land based physical training.</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Oxygen uptake</measure>
    <time_frame>16 Weeks</time_frame>
    <description>Change in oxygen uptake is assessed by comparing the oxygen uptake at baseline and after a 16 weeks of aerobic water and land based physical training.</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">40</enrollment>
  <condition>Arteriosclerosis, Coronary</condition>
  <arm_group>
    <arm_group_label>Exercise, Aerobic (Water based)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients of this group will be submitted to an aerobic water based physical training</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Land Group</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Patients of this group perform physical training on bicycle.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Exercise, Aerobic (Water based)</intervention_name>
    <description>Patients of this group will be submitted to an aerobic water based physical training</description>
    <arm_group_label>Exercise, Aerobic (Water based)</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Land Group</intervention_name>
    <description>Patients of this group perform physical training on bicycle.</description>
    <arm_group_label>Land Group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  diagnosis by angiography&#xD;
&#xD;
          -  sedentaries&#xD;
&#xD;
          -  family story of cardiac disease&#xD;
&#xD;
          -  obesity&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  frequent arrhythmias at rest&#xD;
&#xD;
          -  triggered by physical effort&#xD;
&#xD;
          -  unstable angina&#xD;
&#xD;
          -  chronic obstructive pulmonary disease&#xD;
&#xD;
          -  insulin-dependent diabet&#xD;
&#xD;
          -  renal failure&#xD;
&#xD;
          -  sequel of stroke&#xD;
&#xD;
          -  uncontrolled hypothyroidism&#xD;
&#xD;
          -  water phobia&#xD;
&#xD;
          -  skin infections, allergic reactions to chlorine,&#xD;
&#xD;
          -  urinary incontinence and&#xD;
&#xD;
          -  musculoskeletal and neuromuscular disorders precluding physical tests and training&#xD;
             sessions&#xD;
      </textblock>
    </criteria>
    <gender>Male</gender>
    <minimum_age>50 Years</minimum_age>
    <maximum_age>70 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Elie Fiogbé, Ms</last_name>
    <role>Principal Investigator</role>
    <affiliation>Universidade Metodista de Piracicaba</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Elie Fiogbé, Ms</last_name>
    <phone>+5519983616077</phone>
    <email>felie1883@yahoo.fr</email>
  </overall_contact>
  <location>
    <facility>
      <name>Universidade Metodista de Piracicaba</name>
      <address>
        <city>Piracicaba</city>
        <state>São Paulo</state>
        <zip>55</zip>
        <country>Brazil</country>
      </address>
    </facility>
    <contact>
      <last_name>Elie, Fiogbé</last_name>
      <email>felie1883@yahoo.fr</email>
    </contact>
    <investigator>
      <last_name>Elie Fiogbé, Ms</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>Brazil</country>
  </location_countries>
  <verification_date>July 2014</verification_date>
  <study_first_submitted>July 15, 2014</study_first_submitted>
  <study_first_submitted_qc>July 23, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 24, 2014</study_first_posted>
  <last_update_submitted>July 23, 2014</last_update_submitted>
  <last_update_submitted_qc>July 23, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">July 24, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Universidade Metodista de Piracicaba</investigator_affiliation>
    <investigator_full_name>Elie Fiogbé</investigator_full_name>
    <investigator_title>Professor</investigator_title>
  </responsible_party>
  <keyword>Autonomic Nervous System, Body composition, Oxygen Uptake,</keyword>
  <keyword>Water Based Physical Training, Land Based Physical Training.</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Arteriosclerosis</mesh_term>
    <mesh_term>Coronary Artery Disease</mesh_term>
    <mesh_term>Myocardial Ischemia</mesh_term>
  </condition_browse>
  <!-- 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/NCT02198872
org study id: 03/13
secondary id: 190729/2011-2
nct id: NCT02198872
lead sponsor: 
has dmc: No
In the pathophysiological process of coronary artery disease (CAD), are present, autonomic
      dysfunction and reduced functional capacity. Studies showed that physical training (PT) is
      critical in the treatment of CAD by promoting beneficial effects. Although water based
      exercises program have been documented in patients with various cardiovascular diseases, the
      most of studies among patients with CAD used land based exercises programs. OBJECTIVE: To
      evaluate and compare the effects of aerobic water (WPT) and land (LPT) based PT on autonomic
      modulation of heart rate (HR), body composition and cardiorespiratory and metabolic variables
      in patients with CAD. METHODS : 40 men between 50 and 70 years old with CAD diagnosed by
      coronary angiography showing obstruction greater than 50% and underwent angioplasty will be
      evaluated in 4 stages; 1) immediately after angioplasty, clinical assessment, body
      composition analysis and recording of HR and NN intervals during rest. 2) The components of
      step 1) will be repeated after three month, adding the record of HR and NN before, during and
      after the Valsalva maneuver, spirometry and cardiopulmonary exercise testing. 3) Volunteers
      will be randomly divided into two groups, WPT and LPT for 48 sessions. 4) The components of
      step 2) are repeated after each period of 12 sessions. Thus, it is expected that WPT promote
      beneficial physiological adaptations in CAD patients with obstruction greater than 50%.
1. Immediately after angioplasty, the volunteers will be subject to an assessment
           (Assessment 0), which will consist of:

             -  History: personal data, lifestyle and food, family history, current and previous
                history of disease.

             -  Physical examination: cardiac and lung auscultation,measurement of heart rate (HR),
                blood pressure (BP), body weight and height.

             -  Analysis of body composition by bioelectrical impedance analysis.

             -  Registration of HR and NN intervals (NN) during rest, in the supine and sitting
                positions.

             -  biochemical blood tests: complete blood count, blood glucose, total cholesterol,
                LDL and HDL cholesterol, triglycerides, and C-reactive protein ultrasensitive.

             -  Recording of HR and NN during rest in the supine position, sitting, standing and
                during respiratory sinus arrhythmia maneuver.

        2. Three months after the "Assessment 0", the volunteers will be subject to an assessment
           (initial Assessment) prior to physical training program. Will be repeated all
           assessments performed in the "Assessment 0" plus the record of HR and R-Ri before,
           during and after the Valsalva maneuver, spirometry and cardiopulmonary exercise test
           (CPET). This is a submaximal CPET performed on a treadmill, in order to verify and
           identify possible changes in hemodynamic, electrocardiographic induced to physical
           exertion, their aerobic functional capacity as well as to prescribe physical training
           protocol.

        3. After this assessment, the volunteers will be randomly assigned to one of two groups,
           aerobic water (WPT) or land (LPT) based physical training.

        4. Components of "Initial Assessment" will be repeated at the end of each month of physical
           training (Revaluation 1, 2 and 3) and the end (Final Assessment).
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Investigator, Outcomes Assessor)
measure: Change in autonomic system modulation
time frame: baseline and 16 weeks
description: Change in autonomic system modulation in assess by comparing the heart rate variability at baseline and after a 16 weeks of aerobic water and land based physical training.
measure: Change in body composition
time frame: 16 weeks
description: Change in body composition is assess by comparing the body composition at baseline and after a 16 weeks of aerobic water and land based physical training.
measure: Oxygen uptake
time frame: 16 Weeks
description: Change in oxygen uptake is assessed by comparing the oxygen uptake at baseline and after a 16 weeks of aerobic water and land based physical training.
arm group label: Exercise, Aerobic (Water based)
arm group type: Experimental
description: Patients of this group will be submitted to an aerobic water based physical training
arm group label: Land Group
arm group type: Active Comparator
description: Patients of this group perform physical training on bicycle.
intervention type: Other
intervention name: Exercise, Aerobic (Water based)
description: Patients of this group will be submitted to an aerobic water based physical training
arm group label: Exercise, Aerobic (Water based)
intervention type: Other
intervention name: Land Group
description: Patients of this group perform physical training on bicycle.
arm group label: Land Group
criteria: 
gender: Male
minimum age: 50 Years
maximum age: 70 Years
healthy volunteers: No
last name: Elie Fiogbé, Ms
role: Principal Investigator
affiliation: Universidade Metodista de Piracicaba
last name: Elie Fiogbé, Ms
phone: +5519983616077
email: felie1883@yahoo.fr
facility: 
contact: 
investigator: 
country: Brazil
responsible party type: Principal Investigator
investigator affiliation: Universidade Metodista de Piracicaba
investigator full name: Elie Fiogbé
investigator title: Professor
mesh term: Arteriosclerosis
mesh term: Coronary Artery Disease
mesh term: Myocardial Ischemia