<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/NCT01706445</url>
  </required_header>
  <id_info>
    <org_study_id>kid'strainingCF</org_study_id>
    <secondary_id>CFtraining</secondary_id>
    <nct_id>NCT01706445</nct_id>
  </id_info>
  <brief_title>Combined Inspiratory Muscle and 'Whole Muscle' Training in Children With Cystic Fibrosis</brief_title>
  <sponsors>
    <lead_sponsor>
      <agency>Universidad Europea de Madrid</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Hospital Infantil Universitario Niño Jesús, Madrid, Spain</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Universidad Europea de Madrid</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      To study the effects of an 8-week combined inspiratory muscle training and exercise&#xD;
      (resistance+aerobic) program on of a lung volume, inspiratory muscle strength (maximal&#xD;
      inspiratory pressure, PImax) and cardiorespiratory fitness (maximal oxygen uptake, VO2peak)&#xD;
      (primary outcomes)and dynamic muscle strength, body composition and quality of life (QoL) in&#xD;
      children with Cystic Fibrosis (CF) (secondary outcomes).&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The investigators hypothesized that the combined training program would significantly benefit&#xD;
      most of the aforementioned variables (especially, primary outcomes).&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>September 2011</start_date>
  <primary_completion_date type="Actual">July 2012</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>Single Group Assignment</intervention_model>
    <masking>Single (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>cardiorespiratory fitness (VO2peak)</measure>
    <time_frame>this outcome will be assessed up to 12 weeks</time_frame>
    <description>maximum oxygen uptake (VO2peak), which is the best indicator of aerobic fitness in humans and an independent mortality predictor in children with cystic fibrosis</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>quality of life</measure>
    <time_frame>this outcome will be assessed up to 12 weeks</time_frame>
    <description>children's QoL with the Spanish Version (1.0) of the Cystic Fibrosis Questionnaire-Revised (CFQ-R).</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Maximal inspiratory pressure (PImax)</measure>
    <time_frame>september 2011-july 2012</time_frame>
    <description>an indicator of the strength of inspiratory muscles</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">20</enrollment>
  <condition>Cystic Fibrosis</condition>
  <arm_group>
    <arm_group_label>Control</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>intervention</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Exercise training</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Other</intervention_name>
    <description>inspiratory muscle training (IMT) + aerobic and strength training 8-week duration IMT twice a day (mostly at home) + 3 weekly sessions of inhospital resistance + aerobic training</description>
    <arm_group_label>intervention</arm_group_label>
    <other_name>Exercise training</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  boy/girl aged 6-17 years&#xD;
&#xD;
          -  living in the Madrid area&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  severe lung deterioration [forced expiratory volume (FEV1) &lt;50% of expected]&#xD;
&#xD;
          -  unstable clinical condition (hospitalization within the previous 3 months)&#xD;
&#xD;
          -  Burkholderia cepacia infection&#xD;
&#xD;
          -  any disorder (e.g. muscle-skeletal) impairing exercise.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>6 Years</minimum_age>
    <maximum_age>17 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Hospital Infantil Universitario Niño Jesús</name>
      <address>
        <city>Madrid</city>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Spain</country>
  </location_countries>
  <verification_date>October 2012</verification_date>
  <study_first_submitted>October 9, 2012</study_first_submitted>
  <study_first_submitted_qc>October 11, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 15, 2012</study_first_posted>
  <last_update_submitted>October 11, 2012</last_update_submitted>
  <last_update_submitted_qc>October 11, 2012</last_update_submitted_qc>
  <last_update_posted type="Estimate">October 15, 2012</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Universidad Europea de Madrid</investigator_affiliation>
    <investigator_full_name>Alejandro Lucia</investigator_full_name>
    <investigator_title>MD PhD</investigator_title>
  </responsible_party>
  <keyword>cystic fibrosis</keyword>
  <keyword>exercise</keyword>
  <keyword>children</keyword>
  <keyword>cardiorespiratory fitness</keyword>
  <keyword>muscle strength</keyword>
  <keyword>pulmonary function</keyword>
  <keyword>quality of life</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Cystic Fibrosis</mesh_term>
    <mesh_term>Fibrosis</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/NCT01706445
org study id: kid'strainingCF
secondary id: CFtraining
nct id: NCT01706445
lead sponsor: 
collaborator: 
has dmc: Yes
To study the effects of an 8-week combined inspiratory muscle training and exercise
      (resistance+aerobic) program on of a lung volume, inspiratory muscle strength (maximal
      inspiratory pressure, PImax) and cardiorespiratory fitness (maximal oxygen uptake, VO2peak)
      (primary outcomes)and dynamic muscle strength, body composition and quality of life (QoL) in
      children with Cystic Fibrosis (CF) (secondary outcomes).
The investigators hypothesized that the combined training program would significantly benefit
      most of the aforementioned variables (especially, primary outcomes).
allocation: Randomized
intervention model: Single Group Assignment
masking: Single (Outcomes Assessor)
measure: cardiorespiratory fitness (VO2peak)
time frame: this outcome will be assessed up to 12 weeks
description: maximum oxygen uptake (VO2peak), which is the best indicator of aerobic fitness in humans and an independent mortality predictor in children with cystic fibrosis
measure: quality of life
time frame: this outcome will be assessed up to 12 weeks
description: children's QoL with the Spanish Version (1.0) of the Cystic Fibrosis Questionnaire-Revised (CFQ-R).
measure: Maximal inspiratory pressure (PImax)
time frame: september 2011-july 2012
description: an indicator of the strength of inspiratory muscles
arm group label: Control
arm group type: No Intervention
arm group label: intervention
arm group type: Other
description: Exercise training
intervention type: Other
intervention name: Other
description: inspiratory muscle training (IMT) + aerobic and strength training 8-week duration IMT twice a day (mostly at home) + 3 weekly sessions of inhospital resistance + aerobic training
arm group label: intervention
other name: Exercise training
criteria: 
gender: All
minimum age: 6 Years
maximum age: 17 Years
healthy volunteers: No
facility: 
country: Spain
responsible party type: Principal Investigator
investigator affiliation: Universidad Europea de Madrid
investigator full name: Alejandro Lucia
investigator title: MD PhD
mesh term: Cystic Fibrosis
mesh term: Fibrosis