<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/NCT02211573</url>
  </required_header>
  <id_info>
    <org_study_id>03/14</org_study_id>
    <nct_id>NCT02211573</nct_id>
  </id_info>
  <brief_title>Aquatic Aerobic Training, Cardiorespiratory and Metabolic Variables in Coronary Artery Disease</brief_title>
  <official_title>Effects of Aquatic Aerobic Training on Body Composition and Cardiorespiratory and Metabolic Variables in Patients With Coronary Artery Disease</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>
      Although approaches to reduce cardiovascular disease, coronary artery disease (CAD) remains&#xD;
      the leading cause of mortality in the industrialized world. In order to reduce the&#xD;
      deleterious effects of the atherosclerotic process, proposals for non-pharmacological&#xD;
      treatment have been used, such as cardiac rehabilitation programs, with emphasis on exercise&#xD;
      -based therapy. Traditionally aerobic exercises like biking, walking and jogging are&#xD;
      conducted, however, alternative ways such as aquatic exercise training have been proposed,&#xD;
      however, the cardiorespiratory adaptations in this population are not well documented in the&#xD;
      literature. Thus, the aim of this study was to evaluate the effects of aquatic aerobic&#xD;
      training (AAT) on body composition, autonomic modulation of heart rate (HR) and&#xD;
      cardiorespiratory and metabolic variables in patients with CAD. This was a longitudinal&#xD;
      clinical trial with a sample allocated for convenience, in which twenty-one patients were&#xD;
      male, with a diagnosis of CAD, which were divided into control group (CG were studied, n=8),&#xD;
      who was only assessed, and training group (TG, n=13). All patients underwent assessment of&#xD;
      body composition, heart rate variability (HRV) at rest in the supine posture, and&#xD;
      cardiopulmonary exercise testing (CPET), performed before and after the AAT program. The&#xD;
      training protocol consisted of three sessions per week on alternate days for 16 weeks,&#xD;
      totaling 48 sessions, which had lasted approximately one hour. The exercise intensity was&#xD;
      prescribed between 80 and 110% of the first ventilatory threshold (VT1) obtained in CPET.&#xD;
      Given that these parameters represent risk markers for cardiovascular events in the&#xD;
      population studied, the results suggest that the AAT proposed in this study may be an&#xD;
      important therapeutic strategy to be incorporated into cardiac rehabilitation programs.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      1. Personal Data recording:&#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;
        2. Assessments:&#xD;
&#xD;
           All experimental procedures were performed in the morning in order to minimize the&#xD;
           influence of circadian cycle. The temperature of the experimental room was maintained&#xD;
           between 22 ° C and 24 ° C with relative humidity between 40% and 60%. Patients were&#xD;
           familiarized with the experimental protocol, and instructed not to ingest stimulant&#xD;
           drinks such as coffee, tea and soft drinks, do not drink alcohol, do not perform&#xD;
           strenuous exercise (48 hours before surgery), and to perform a light meal at least four&#xD;
           hours before the collections.&#xD;
&#xD;
           Aiming to verify if the baseline conditions were suitable for the beginning of the&#xD;
           experimental procedures, the patients remained 15 minutes of rest in the supine&#xD;
           position, and recorded blood pressure (BP) and HR.&#xD;
&#xD;
           After this, were performed:&#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;
             -  Recording of HR and NN during rest in the supine position, sitting, standing and&#xD;
                during respiratory sinus arrhythmia maneuver.&#xD;
&#xD;
             -  Spirometric test and&#xD;
&#xD;
             -  Cardiopulmonary exercise test (CPET). This is a submaximal CPET performed on a&#xD;
                treadmill, in order to verify and identify possible changes in hemodynamic,&#xD;
                electrocardiographic induced to physical exertion, their aerobic functional&#xD;
                capacity as well as to prescribe physical training protocol.&#xD;
&#xD;
        3. Training:&#xD;
&#xD;
           After this assessment the volunteers were trained by a aerobic water based physical&#xD;
           training program for 4 weeks.&#xD;
&#xD;
        4. Second assessment:&#xD;
&#xD;
      Components of the first assessment have been repeated at the end of each month of physical&#xD;
      training.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>May 2013</start_date>
  <completion_date type="Actual">March 2014</completion_date>
  <primary_completion_date type="Actual">October 2013</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>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Double (Participant, 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>baseline and 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="Actual">21</enrollment>
  <condition>Arteriosclerosis, Coronary</condition>
  <arm_group>
    <arm_group_label>Control group</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Patients of this group don't performed physical training</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Exercise, Aerobic (Water based)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients of this group were submitted to an aerobic water based physical training</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Exercise, Aerobic (Water based)</intervention_name>
    <description>Patients of this group were submitted to an aerobic water based physical training</description>
    <arm_group_label>Exercise, Aerobic (Water based)</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>
  <location>
    <facility>
      <name>Universidade Metodista de Piracicaba</name>
      <address>
        <city>Piracicaba</city>
        <state>São Paulo</state>
        <zip>55</zip>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Brazil</country>
  </location_countries>
  <verification_date>August 2014</verification_date>
  <study_first_submitted>August 5, 2014</study_first_submitted>
  <study_first_submitted_qc>August 5, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 7, 2014</study_first_posted>
  <last_update_submitted>August 5, 2014</last_update_submitted>
  <last_update_submitted_qc>August 5, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">August 7, 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.</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Coronary Artery Disease</mesh_term>
    <mesh_term>Myocardial Ischemia</mesh_term>
    <mesh_term>Coronary Disease</mesh_term>
    <mesh_term>Arteriosclerosis</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/NCT02211573
org study id: 03/14
nct id: NCT02211573
lead sponsor: 
has dmc: No
Although approaches to reduce cardiovascular disease, coronary artery disease (CAD) remains
      the leading cause of mortality in the industrialized world. In order to reduce the
      deleterious effects of the atherosclerotic process, proposals for non-pharmacological
      treatment have been used, such as cardiac rehabilitation programs, with emphasis on exercise
      -based therapy. Traditionally aerobic exercises like biking, walking and jogging are
      conducted, however, alternative ways such as aquatic exercise training have been proposed,
      however, the cardiorespiratory adaptations in this population are not well documented in the
      literature. Thus, the aim of this study was to evaluate the effects of aquatic aerobic
      training (AAT) on body composition, autonomic modulation of heart rate (HR) and
      cardiorespiratory and metabolic variables in patients with CAD. This was a longitudinal
      clinical trial with a sample allocated for convenience, in which twenty-one patients were
      male, with a diagnosis of CAD, which were divided into control group (CG were studied, n=8),
      who was only assessed, and training group (TG, n=13). All patients underwent assessment of
      body composition, heart rate variability (HRV) at rest in the supine posture, and
      cardiopulmonary exercise testing (CPET), performed before and after the AAT program. The
      training protocol consisted of three sessions per week on alternate days for 16 weeks,
      totaling 48 sessions, which had lasted approximately one hour. The exercise intensity was
      prescribed between 80 and 110% of the first ventilatory threshold (VT1) obtained in CPET.
      Given that these parameters represent risk markers for cardiovascular events in the
      population studied, the results suggest that the AAT proposed in this study may be an
      important therapeutic strategy to be incorporated into cardiac rehabilitation programs.
1. Personal Data recording:

             -  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.

        2. Assessments:

           All experimental procedures were performed in the morning in order to minimize the
           influence of circadian cycle. The temperature of the experimental room was maintained
           between 22 ° C and 24 ° C with relative humidity between 40% and 60%. Patients were
           familiarized with the experimental protocol, and instructed not to ingest stimulant
           drinks such as coffee, tea and soft drinks, do not drink alcohol, do not perform
           strenuous exercise (48 hours before surgery), and to perform a light meal at least four
           hours before the collections.

           Aiming to verify if the baseline conditions were suitable for the beginning of the
           experimental procedures, the patients remained 15 minutes of rest in the supine
           position, and recorded blood pressure (BP) and HR.

           After this, were performed:

             -  Analysis of body composition by bioelectrical impedance analysis.

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

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

             -  Spirometric test 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. Training:

           After this assessment the volunteers were trained by a aerobic water based physical
           training program for 4 weeks.

        4. Second assessment:

      Components of the first assessment have been repeated at the end of each month of physical
      training.
allocation: Non-Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Participant, 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: baseline and 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: Control group
arm group type: No Intervention
description: Patients of this group don't performed physical training
arm group label: Exercise, Aerobic (Water based)
arm group type: Experimental
description: Patients of this group were submitted to an aerobic water based physical training
intervention type: Other
intervention name: Exercise, Aerobic (Water based)
description: Patients of this group were submitted to an aerobic water based physical training
arm group label: Exercise, Aerobic (Water based)
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
facility: 
country: Brazil
responsible party type: Principal Investigator
investigator affiliation: Universidade Metodista de Piracicaba
investigator full name: Elie Fiogbé
investigator title: Professor
mesh term: Coronary Artery Disease
mesh term: Myocardial Ischemia
mesh term: Coronary Disease
mesh term: Arteriosclerosis