<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/NCT04488445</url>
  </required_header>
  <id_info>
    <org_study_id>UZaragoza13091978</org_study_id>
    <nct_id>NCT04488445</nct_id>
  </id_info>
  <brief_title>Strength Training and Executive Functions: A Randomized Controlled Trial</brief_title>
  <acronym>ASTOEF</acronym>
  <official_title>Acute Effects of Strength Training Over Executive Functions in Adolescents: A Randomized Controlled Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Universidad de Zaragoza</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Universidad de Zaragoza</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>
      A group of 50 age-schooled adolescents was randomized into one intervention and another&#xD;
      control group of 25 subjects each. After estimating one maximum repetition for all the&#xD;
      participants in a previous session, the intervention group performed a resistance training&#xD;
      based on a resistance exercise of 3 sets of 3 to 5 repetitions (90% of an estimated 1 RM)&#xD;
      whereas the control group performed both stretching and balance exercises. Measures of&#xD;
      executive functions ( i.e. a cognitive function associated with academic performance) were&#xD;
      taken for all the participants before and after the training. Both independent and paired&#xD;
      t-test will serve to check differences between and within groups respectively.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      A group of 50 age-schooled adolescents was randomized into one intervention and another&#xD;
      control group of 25 subjects each. After estimating one maximum repetition for all the&#xD;
      participants in a previous session, the intervention group performed a resistance training&#xD;
      based on a resistance exercise of 3 sets of 3 to 5 repetitions (90% of an estimated 1 RM)&#xD;
      whereas the control group performed both stretching and balance exercises. Measures of&#xD;
      executive functions ( i.e. a cognitive function associated with academic performance) were&#xD;
      taken for all the participants before and after the training. Both independent and paired&#xD;
      t-test will serve to check differences between and within groups respectively. The selected&#xD;
      resistance exercise is based on a global muscle involvement.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">September 1, 2020</start_date>
  <completion_date type="Anticipated">January 30, 2021</completion_date>
  <primary_completion_date type="Actual">November 6, 2020</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>Health Services Research</primary_purpose>
    <masking>Single (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Time to successfully complete the executive function test</measure>
    <time_frame>up to 24 weeks</time_frame>
    <description>Executive function</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">50</enrollment>
  <condition>Executive Function Disorder</condition>
  <condition>Strength Training</condition>
  <condition>Adolescent Behavior</condition>
  <condition>Academic Achievement</condition>
  <arm_group>
    <arm_group_label>Strength Training</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The intervention group performs a resistance training based on a resistance exercise of 3 sets of 3 to 5 repetitions (90% of an estimated 1 RM) and 3 minutes of resting time between sets.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Stretching</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>The control group performs 3 exercises of stretching and balance during one minute each and three sets. One minute of resting time between sets.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Strength training</intervention_name>
    <description>3 sets of 3 to 5 repetitions with 4 minutes of rest between sets. 90% load of 1 maximum repetition of a resistance exercise</description>
    <arm_group_label>Strength Training</arm_group_label>
    <other_name>Resistance training</other_name>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Stretch and balance training</intervention_name>
    <description>3 sets of 3 exercises of stretching and balance of one minute each. One minute of resting time between sets.</description>
    <arm_group_label>Stretching</arm_group_label>
    <other_name>Stretching</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Healthy age-schooled adolescent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Not healthy, injured age-schooled adolescent&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>15 Years</minimum_age>
    <maximum_age>17 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Joaquín Calatayud, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Valencia</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Rubén López-Bueno, MSc</last_name>
    <phone>0034662416735</phone>
    <email>rlopezbu@unizar.es</email>
  </overall_contact>
  <location>
    <facility>
      <name>University of Zaragoza</name>
      <address>
        <city>Zaragoza</city>
        <state>Aragón</state>
        <zip>50009</zip>
        <country>Spain</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Rubén López-Bueno, MSc</last_name>
      <phone>0034661416735</phone>
      <email>rlopezbu@unizar.es</email>
    </contact>
  </location>
  <location_countries>
    <country>Spain</country>
  </location_countries>
  <verification_date>November 2020</verification_date>
  <study_first_submitted>July 18, 2020</study_first_submitted>
  <study_first_submitted_qc>July 22, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 28, 2020</study_first_posted>
  <last_update_submitted>November 8, 2020</last_update_submitted>
  <last_update_submitted_qc>November 8, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">November 10, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Universidad de Zaragoza</investigator_affiliation>
    <investigator_full_name>Rubén López-Bueno</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <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/NCT04488445
org study id: UZaragoza13091978
nct id: NCT04488445
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
A group of 50 age-schooled adolescents was randomized into one intervention and another
      control group of 25 subjects each. After estimating one maximum repetition for all the
      participants in a previous session, the intervention group performed a resistance training
      based on a resistance exercise of 3 sets of 3 to 5 repetitions (90% of an estimated 1 RM)
      whereas the control group performed both stretching and balance exercises. Measures of
      executive functions ( i.e. a cognitive function associated with academic performance) were
      taken for all the participants before and after the training. Both independent and paired
      t-test will serve to check differences between and within groups respectively.
A group of 50 age-schooled adolescents was randomized into one intervention and another
      control group of 25 subjects each. After estimating one maximum repetition for all the
      participants in a previous session, the intervention group performed a resistance training
      based on a resistance exercise of 3 sets of 3 to 5 repetitions (90% of an estimated 1 RM)
      whereas the control group performed both stretching and balance exercises. Measures of
      executive functions ( i.e. a cognitive function associated with academic performance) were
      taken for all the participants before and after the training. Both independent and paired
      t-test will serve to check differences between and within groups respectively. The selected
      resistance exercise is based on a global muscle involvement.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Health Services Research
masking: Single (Participant)
measure: Time to successfully complete the executive function test
time frame: up to 24 weeks
description: Executive function
arm group label: Strength Training
arm group type: Experimental
description: The intervention group performs a resistance training based on a resistance exercise of 3 sets of 3 to 5 repetitions (90% of an estimated 1 RM) and 3 minutes of resting time between sets.
arm group label: Stretching
arm group type: Placebo Comparator
description: The control group performs 3 exercises of stretching and balance during one minute each and three sets. One minute of resting time between sets.
intervention type: Behavioral
intervention name: Strength training
description: 3 sets of 3 to 5 repetitions with 4 minutes of rest between sets. 90% load of 1 maximum repetition of a resistance exercise
arm group label: Strength Training
other name: Resistance training
intervention type: Behavioral
intervention name: Stretch and balance training
description: 3 sets of 3 exercises of stretching and balance of one minute each. One minute of resting time between sets.
arm group label: Stretching
other name: Stretching
criteria: 
gender: All
minimum age: 15 Years
maximum age: 17 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Joaquín Calatayud, PhD
role: Principal Investigator
affiliation: University of Valencia
last name: Rubén López-Bueno, MSc
phone: 0034662416735
email: rlopezbu@unizar.es
facility: 
status: Recruiting
contact: 
country: Spain
responsible party type: Principal Investigator
investigator affiliation: Universidad de Zaragoza
investigator full name: Rubén López-Bueno
investigator title: Principal Investigator
sharing ipd: No