<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/NCT02236117</url>
  </required_header>
  <id_info>
    <org_study_id>CONEP 5231</org_study_id>
    <nct_id>NCT02236117</nct_id>
  </id_info>
  <brief_title>Aerobic Training on the Autonomic Modulation in Children</brief_title>
  <official_title>The Effects of 10 Weeks of Aerobic Training on the Autonomic Modulation in Prepubertal Children: a Randomized Control Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Universidade Estadual de Londrina</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Universidade Estadual de Londrina</source>
  <oversight_info>
    <has_dmc>No</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>
      The heart rate variability is a tool used to asses non-invasive cardiac autonomic. In fact,&#xD;
      many studies have been disseminated of heart rate variability in adults, however few results&#xD;
      in a literature this parameters in pediatric population, mainly with children submitted the&#xD;
      physical training. Thus, this Project aims to verify the effects of aerobic training, with 10&#xD;
      weeks, in prepubertal on the performance and heart rate variability in rest.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The randomized control trial in accordance with Consort - Statement (Moher et al., 2012) will&#xD;
      be done. Will be included 160 children, 80 in an experimental group and 80 children with no&#xD;
      intervention, of both genders.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">September 2015</start_date>
  <completion_date type="Actual">February 2017</completion_date>
  <primary_completion_date type="Actual">December 2016</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>Treatment</primary_purpose>
    <masking>Single (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Rest Heart Rate Variability in short term</measure>
    <time_frame>10 weeks</time_frame>
    <description>The cardiac autonomic modulation of the sinoatrial node will be estimated via heart rate variability (HRV) pre- after 5 weeks - post-10 weeks of training and after 8 weeks of finished the intervention (follow-up period). The duration of the RR interval recordings (RRinterval) will be obtained from each children using a portable heart rate monitor (Polar RS800) at a sampling rate of 1000 Hz. The recordings will be downloaded via commercial software and export for later analysis of time and frequency domain measures of HRV. The time domain indices examined will be: the mean RR interval, the root-mean-square difference of successive normal RR intervals (RMSSD), which reflects vagal modulation, and the standard deviation of all normal RR intervals (SDNN), which comprises both sympathetic and vagal cardiac modulations (Task Force, 1996).</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">160</enrollment>
  <condition>Healthy</condition>
  <arm_group>
    <arm_group_label>Intervention: Aerobic Training</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The children included in the experimental group will make 10 weeks of aerobic training. The intensity of the race will be based on individual speed obtained in the last stage completed the progressive test, known as the maximal aerobic speed (MAV) in km/h. The running speed of the exercise protocol will be minimum 80% of the MAV in the protocol of continuous training. The intermittent progressive training is n * (10*15 s) to 100% MAV, and n from 2 to 6 series between the first and tenth week. The training protocol was adapted from previously described (Mandigout et al, 2002, Gamelin et al, 2009.). Acceptance of the exercise in a pediatric population has been previously observed by pilot study.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>physical education classes</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Aerobic Training</intervention_name>
    <description>Will be included 160 children, 80 in an experimental group and 80 in a control group of both genders. The experimental group will realize aerobic training during 10 weeks (3×40min week-1; intensity, &gt;80% maximal aerobic velocity - MAV), while the control group will have involved with the physical education classes two times a week for 50 minutes each class. The aerobic protocol will be composed by 2 sessions of intermittent running and 1 session by continuous.</description>
    <arm_group_label>Intervention: Aerobic Training</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Children be with body weight and height between the 10th and 90th percentiles,&#xD;
             according to criteria adopted by the Centers for Disease Control and Prevention (CDC,&#xD;
             2002).&#xD;
&#xD;
          -  To characterize the infant state, all volunteers will conduct evaluation of secondary&#xD;
             sexual characters by criteria of Tanner (Marshall and Tanner, 1970), through visual&#xD;
             inspection by a single experienced paediatrician. Children must show the initial stage&#xD;
             of pubertal development, for girls (1 breast) and boys (genital 1) to be included and&#xD;
             characterized such prepubertal. Participants throughout the trial entering puberty&#xD;
             will be excluded from the final analysis.&#xD;
&#xD;
          -  The children will be healthy, without clinical or historical evidence of&#xD;
             cardiovascular disease, hypertension, insulin-dependent diabetes mellitus or obesity,&#xD;
             and were not taking any drugs.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  The participants can be not linked to sports practices at least one year before the&#xD;
             beginning the study, and can be involved only with the physical education classes two&#xD;
             times a week for 50 minutes each class.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>7 Years</minimum_age>
    <maximum_age>9 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Carla Silva, Doctor</last_name>
    <role>Principal Investigator</role>
    <affiliation>Universidade Estadual de Londrina</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Universidade Estadual de Londrina</name>
      <address>
        <city>Londrina</city>
        <state>Paraná</state>
        <zip>86057-970</zip>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Brazil</country>
  </location_countries>
  <verification_date>May 2017</verification_date>
  <study_first_submitted>August 25, 2014</study_first_submitted>
  <study_first_submitted_qc>September 9, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 10, 2014</study_first_posted>
  <last_update_submitted>May 17, 2017</last_update_submitted>
  <last_update_submitted_qc>May 17, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">May 19, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Universidade Estadual de Londrina</investigator_affiliation>
    <investigator_full_name>Carla Cristiane da Silva</investigator_full_name>
    <investigator_title>The Effects of 10 weeks of aerobic training on the autonomic modulation in prepubertal children: a randomized control trial</investigator_title>
  </responsible_party>
  <keyword>heart rate variability</keyword>
  <keyword>children</keyword>
  <keyword>progressive test</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/NCT02236117
org study id: CONEP 5231
nct id: NCT02236117
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The heart rate variability is a tool used to asses non-invasive cardiac autonomic. In fact,
      many studies have been disseminated of heart rate variability in adults, however few results
      in a literature this parameters in pediatric population, mainly with children submitted the
      physical training. Thus, this Project aims to verify the effects of aerobic training, with 10
      weeks, in prepubertal on the performance and heart rate variability in rest.
The randomized control trial in accordance with Consort - Statement (Moher et al., 2012) will
      be done. Will be included 160 children, 80 in an experimental group and 80 children with no
      intervention, of both genders.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Outcomes Assessor)
measure: Rest Heart Rate Variability in short term
time frame: 10 weeks
description: The cardiac autonomic modulation of the sinoatrial node will be estimated via heart rate variability (HRV) pre- after 5 weeks - post-10 weeks of training and after 8 weeks of finished the intervention (follow-up period). The duration of the RR interval recordings (RRinterval) will be obtained from each children using a portable heart rate monitor (Polar RS800) at a sampling rate of 1000 Hz. The recordings will be downloaded via commercial software and export for later analysis of time and frequency domain measures of HRV. The time domain indices examined will be: the mean RR interval, the root-mean-square difference of successive normal RR intervals (RMSSD), which reflects vagal modulation, and the standard deviation of all normal RR intervals (SDNN), which comprises both sympathetic and vagal cardiac modulations (Task Force, 1996).
arm group label: Intervention: Aerobic Training
arm group type: Experimental
description: The children included in the experimental group will make 10 weeks of aerobic training. The intensity of the race will be based on individual speed obtained in the last stage completed the progressive test, known as the maximal aerobic speed (MAV) in km/h. The running speed of the exercise protocol will be minimum 80% of the MAV in the protocol of continuous training. The intermittent progressive training is n * (10*15 s) to 100% MAV, and n from 2 to 6 series between the first and tenth week. The training protocol was adapted from previously described (Mandigout et al, 2002, Gamelin et al, 2009.). Acceptance of the exercise in a pediatric population has been previously observed by pilot study.
arm group label: physical education classes
arm group type: No Intervention
intervention type: Other
intervention name: Aerobic Training
description: Will be included 160 children, 80 in an experimental group and 80 in a control group of both genders. The experimental group will realize aerobic training during 10 weeks (3×40min week-1; intensity, >80% maximal aerobic velocity - MAV), while the control group will have involved with the physical education classes two times a week for 50 minutes each class. The aerobic protocol will be composed by 2 sessions of intermittent running and 1 session by continuous.
arm group label: Intervention: Aerobic Training
criteria: 
gender: All
minimum age: 7 Years
maximum age: 9 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Carla Silva, Doctor
role: Principal Investigator
affiliation: Universidade Estadual de Londrina
facility: 
country: Brazil
responsible party type: Principal Investigator
investigator affiliation: Universidade Estadual de Londrina
investigator full name: Carla Cristiane da Silva
investigator title: The Effects of 10 weeks of aerobic training on the autonomic modulation in prepubertal children: a randomized control trial
sharing ipd: No