<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/NCT03293056</url>
  </required_header>
  <id_info>
    <org_study_id>012017</org_study_id>
    <nct_id>NCT03293056</nct_id>
  </id_info>
  <brief_title>HIIH Versus HMC: Randomized Clinical Trial</brief_title>
  <acronym>HIITxHMC</acronym>
  <official_title>Effectiveness of High-intensity Interval Versus Intensity Continuous Hydrogymnastics for Improvement of Health Outcomes: Randomized Clinical Trial.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Universidade Federal do vale do São Francisco</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Conselho Nacional de Desenvolvimento Científico e Tecnológico</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Universidade Federal do vale do São Francisco</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>
      Introduction: water aerobics involves the practice of specific aquatic exercises that are&#xD;
      based on the use of water resistance as a load and on thrust as an impact reducer, making it&#xD;
      possible to perform physical exercise with a lower risk of injury even at a high intensity.&#xD;
      Objective: The overall objective of this study will be to compare the effectiveness of high&#xD;
      intensity interval versus moderate continuous water aerobics to improve health outcomes in&#xD;
      apparently healthy individuals.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Method: randomized clinical trial will be performed in the premises of the College of&#xD;
      Physical Education of the Federal University of the São Francisco Valley. 100 adults, of both&#xD;
      sexes, will be randomized into two groups, high intensity interval hydrogynastic (HIAI) or&#xD;
      moderate continuous aquatic gymnastics (HCM). Individuals will be evaluated for primary&#xD;
      endpoints of muscle strength and endurance, aerobic fitness, flexibility and body&#xD;
      composition. The secondary outcomes evaluated will be the quality of life, functionality and&#xD;
      perception of improvement by a Likert-type Improvement Scale, at the following moments:&#xD;
      initial, final and follow-up of one month after the end of the training. Individuals will be&#xD;
      assisted for three months, often weekly twice, with sessions lasting 50 min. In order to&#xD;
      identify differences between and within the groups, an equation of generalized estimates will&#xD;
      be used as regression model with the syntax according to the multivariate model.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">January 1, 2019</start_date>
  <completion_date type="Anticipated">December 31, 2023</completion_date>
  <primary_completion_date type="Anticipated">December 31, 2023</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>
    <intervention_model_description>Parallel Assignment: highintensity interval training water versus aerobic continuous</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Double (Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Aerobic Fitness</measure>
    <time_frame>three months after randomization</time_frame>
    <description>This maximal/submaximal test will be performed on cyclergometer, Balke test.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Body Composition</measure>
    <time_frame>three months after randomization</time_frame>
    <description>The body composition (density and percentage of body fat) will be estimated by prediction equations (JACKSON et al., 1980).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Strength Muscular</measure>
    <time_frame>three months after randomization</time_frame>
    <description>Strength Muscular will be measured by 1RM test in two exercises, involving the segments of the upper limbs (supine) and lower limbs (leg press).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Endurance Muscular</measure>
    <time_frame>three months after randomization</time_frame>
    <description>Muscle endurance will be assessed by the test in which the individual performs the maximum number of repetitions of given exercises for one minute. The exercises will be of arm and abdominal flexion.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Quality Life</measure>
    <time_frame>three months after randomization</time_frame>
    <description>Quality of life by assessed by WHOQOL-breaf</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Functionality</measure>
    <time_frame>three months after randomization</time_frame>
    <description>Functionality will be assessed by IVCF-20</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Perception of Improvement</measure>
    <time_frame>three months after randomization</time_frame>
    <description>Perception of Improvement will be measured by an Likert-type Improvement Scale</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">75</enrollment>
  <condition>Healthy People</condition>
  <arm_group>
    <arm_group_label>High-intensity Interval Hydrogynmastics</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>High-intensity Interval training Hydrogynmastics, 2x/week, for 3 months.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Hydrogynmastics Continuous Moderate</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Hydrogynmastics Continuous Moderate training (HCM), 2x/week, for 3 months.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>High-intensity interval Hydrogynmastics</intervention_name>
    <description>The HIIH to PSE group during the high intensity (HI) period should remain between 16 to 18 points, while in the moderate intensity (MI) intervals around 11. The dynamic exercises will progression, in the first month will be 1 min of HI and 2 min of MI, in the second month of 1 min of HI and 1 min of MI and in the last month of 1 min of HI and 30 s of MI, until completing 30 min in total.</description>
    <arm_group_label>High-intensity Interval Hydrogynmastics</arm_group_label>
    <other_name>HIIH</other_name>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Hydrogynmastics Continuous Moderate</intervention_name>
    <description>For the HCM group the PSE will be around 11 points during the 30 min of moderate continuous exercise. In both groups the form of intensity monitoring that will be through the PSE, in which this scale will be printed in banner form and affixed next to the physical education teacher during the classes.</description>
    <arm_group_label>Hydrogynmastics Continuous Moderate</arm_group_label>
    <other_name>HCM</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  age between 18 and 60 years;&#xD;
&#xD;
          -  sedentary and who did not perform physiotherapy and physical activity in the last&#xD;
             three months;&#xD;
&#xD;
          -  clinical and cognitive conditions for swimming pool activities and aerobic exercise;&#xD;
             who have not undergone highly complex surgical procedures in the last six months;&#xD;
&#xD;
          -  to be able of walking without help equipment and without musculoskeletal or skeletal&#xD;
             diseases;&#xD;
&#xD;
          -  without contraindications to the practice of exercises; such as: urinary and / or&#xD;
             fecal incontinence and dermatological diseases;&#xD;
&#xD;
          -  below obesity II with BMI &lt;40.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  if they have up to three consecutive fouls during the hydrogymnastics period;&#xD;
&#xD;
          -  if they present any adverse effects, such as: allergy or any dermatitis;&#xD;
&#xD;
          -  unable to continue the study due to change of address or hospitalization.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>85 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Rodrigo GS Carvalho, PhD</last_name>
    <phone>8721016856</phone>
    <email>rodrigo.carvalho@univasf.edu.br</email>
  </overall_contact>
  <location>
    <facility>
      <name>Physical Education College</name>
      <address>
        <city>Petrolina</city>
        <state>Pernambuco</state>
        <zip>56304917</zip>
        <country>Brazil</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Rodrigo GS Carvalho, PhD</last_name>
      <phone>8721016856</phone>
      <email>rodrigo.carvalho@univasf.edu.br</email>
    </contact>
  </location>
  <location_countries>
    <country>Brazil</country>
  </location_countries>
  <verification_date>May 2023</verification_date>
  <study_first_submitted>September 21, 2017</study_first_submitted>
  <study_first_submitted_qc>September 21, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 26, 2017</study_first_posted>
  <last_update_submitted>May 9, 2023</last_update_submitted>
  <last_update_submitted_qc>May 9, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">May 11, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Universidade Federal do vale do São Francisco</investigator_affiliation>
    <investigator_full_name>Rodrigo Gustavo da Silva Carvalho</investigator_full_name>
    <investigator_title>Rodrigo Gustavo da Silva Carvalho</investigator_title>
  </responsible_party>
  <keyword>aerobic exercises</keyword>
  <keyword>training</keyword>
  <keyword>aquatic</keyword>
  <patient_data>
    <sharing_ipd>No</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/NCT03293056
org study id: 012017
nct id: NCT03293056
lead sponsor: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
Introduction: water aerobics involves the practice of specific aquatic exercises that are
      based on the use of water resistance as a load and on thrust as an impact reducer, making it
      possible to perform physical exercise with a lower risk of injury even at a high intensity.
      Objective: The overall objective of this study will be to compare the effectiveness of high
      intensity interval versus moderate continuous water aerobics to improve health outcomes in
      apparently healthy individuals.
Method: randomized clinical trial will be performed in the premises of the College of
      Physical Education of the Federal University of the São Francisco Valley. 100 adults, of both
      sexes, will be randomized into two groups, high intensity interval hydrogynastic (HIAI) or
      moderate continuous aquatic gymnastics (HCM). Individuals will be evaluated for primary
      endpoints of muscle strength and endurance, aerobic fitness, flexibility and body
      composition. The secondary outcomes evaluated will be the quality of life, functionality and
      perception of improvement by a Likert-type Improvement Scale, at the following moments:
      initial, final and follow-up of one month after the end of the training. Individuals will be
      assisted for three months, often weekly twice, with sessions lasting 50 min. In order to
      identify differences between and within the groups, an equation of generalized estimates will
      be used as regression model with the syntax according to the multivariate model.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Parallel Assignment: highintensity interval training water versus aerobic continuous
primary purpose: Treatment
masking: Double (Investigator, Outcomes Assessor)
measure: Aerobic Fitness
time frame: three months after randomization
description: This maximal/submaximal test will be performed on cyclergometer, Balke test.
measure: Body Composition
time frame: three months after randomization
description: The body composition (density and percentage of body fat) will be estimated by prediction equations (JACKSON et al., 1980).
measure: Strength Muscular
time frame: three months after randomization
description: Strength Muscular will be measured by 1RM test in two exercises, involving the segments of the upper limbs (supine) and lower limbs (leg press).
measure: Endurance Muscular
time frame: three months after randomization
description: Muscle endurance will be assessed by the test in which the individual performs the maximum number of repetitions of given exercises for one minute. The exercises will be of arm and abdominal flexion.
measure: Quality Life
time frame: three months after randomization
description: Quality of life by assessed by WHOQOL-breaf
measure: Functionality
time frame: three months after randomization
description: Functionality will be assessed by IVCF-20
measure: Perception of Improvement
time frame: three months after randomization
description: Perception of Improvement will be measured by an Likert-type Improvement Scale
arm group label: High-intensity Interval Hydrogynmastics
arm group type: Experimental
description: High-intensity Interval training Hydrogynmastics, 2x/week, for 3 months.
arm group label: Hydrogynmastics Continuous Moderate
arm group type: Active Comparator
description: Hydrogynmastics Continuous Moderate training (HCM), 2x/week, for 3 months.
intervention type: Other
intervention name: High-intensity interval Hydrogynmastics
description: The HIIH to PSE group during the high intensity (HI) period should remain between 16 to 18 points, while in the moderate intensity (MI) intervals around 11. The dynamic exercises will progression, in the first month will be 1 min of HI and 2 min of MI, in the second month of 1 min of HI and 1 min of MI and in the last month of 1 min of HI and 30 s of MI, until completing 30 min in total.
arm group label: High-intensity Interval Hydrogynmastics
other name: HIIH
intervention type: Other
intervention name: Hydrogynmastics Continuous Moderate
description: For the HCM group the PSE will be around 11 points during the 30 min of moderate continuous exercise. In both groups the form of intensity monitoring that will be through the PSE, in which this scale will be printed in banner form and affixed next to the physical education teacher during the classes.
arm group label: Hydrogynmastics Continuous Moderate
other name: HCM
criteria: 
gender: All
minimum age: 18 Years
maximum age: 85 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Rodrigo GS Carvalho, PhD
phone: 8721016856
email: rodrigo.carvalho@univasf.edu.br
facility: 
status: Recruiting
contact: 
country: Brazil
responsible party type: Principal Investigator
investigator affiliation: Universidade Federal do vale do São Francisco
investigator full name: Rodrigo Gustavo da Silva Carvalho
investigator title: Rodrigo Gustavo da Silva Carvalho
sharing ipd: No