<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/NCT03308292</url>
  </required_header>
  <id_info>
    <org_study_id>P2016/UEM33</org_study_id>
    <nct_id>NCT03308292</nct_id>
  </id_info>
  <brief_title>Effects of an Exercise Program on Bone Density</brief_title>
  <official_title>Effects of Exercise in Different Sport Surfaces, Diet and Lifestyle in the Bone Density of Pre and Post Menopausal Women</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Universidad Europea de Madrid</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Universidad Europea de Madrid</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>
      Physical inactivity and low adherence to the Mediterranean diet cause alterations in body&#xD;
      composition, which increases the risk factors for cardiovascular and metabolic diseases. In&#xD;
      addition, exercise in different surfaces or water could affect the bone density specially in&#xD;
      women. Objective: The purpose of the study was to analyze the effect of a short-term aerobic&#xD;
      exercise program in different surfaces on the body composition and bone density of women&#xD;
      within at work, and to evaluate the quality of the Mediterranean diet and distribution of&#xD;
      macronutrients in the studied population. Material &amp; Methods: Randomized controlled trial. 63&#xD;
      women from a randomized work environment (IG, n=34) and a control group (CG, n=29)&#xD;
      participated in a short-term aerobic exercise programmed (12 weeks), for body composition and&#xD;
      bone density Dual-energy X-ray absorptiometry (DXA) was used and to evaluate diet, the&#xD;
      Mediterranean Diet Quality Questionnaire (KIDMED) and the Food Frequency Questionnaire for&#xD;
      macronutrient distribution were used.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 9, 2017</start_date>
  <completion_date type="Actual">July 23, 2017</completion_date>
  <primary_completion_date type="Actual">July 8, 2017</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>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Changes in bone density</measure>
    <time_frame>3 months</time_frame>
    <description>Change from baseline to 3 months using Dual-energy X-ray Absorptiometry</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Changes in body composition</measure>
    <time_frame>3 months</time_frame>
    <description>Change from baseline to 3 months using Dual-energy X-ray Absorptiometry</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Level of compliance with the exercise program</measure>
    <time_frame>3 months</time_frame>
    <description>Level of compliance with the program using the percentage of compliance to the exercise programme (36 sessions)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in Dietary pattern variables: macronutrients</measure>
    <time_frame>3 months</time_frame>
    <description>Evaluation of Changes in Dietary pattern variables from baseline to 3 months using questionaries</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in Dietary pattern variables: quality of diet</measure>
    <time_frame>3 months</time_frame>
    <description>Evaluation of Changes in Dietary pattern variables from baseline to 3 months using questionaries</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">63</enrollment>
  <condition>Bone Density</condition>
  <condition>Body Composition</condition>
  <arm_group>
    <arm_group_label>Control Group</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Intervention Group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>A moderate-intensity aerobic physical exercise programme was carried out during the months of March to May 2017 (12 weeks), with a frequency of three sessions per week (36 sessions in total) with a duration of 45 minutes per session. The intensity was controlled through the Borg 1982 modified scale of perceived exertion (RPE). It is a scale from 0 to 10, considering 0 as &quot;nothing at all&quot; and 10 as &quot;very very strong&quot;, setting the moderate intensity as value</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Exercise</intervention_name>
    <description>Aerobic exercise program</description>
    <arm_group_label>Intervention Group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Not diagnosed with any disease that contraindicates the practice of physical exercise&#xD;
&#xD;
          -  Do not perform physical activity with continuity&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Diagnosed with chronic disease including cardiovascular and respiratory diseases that&#xD;
             contraindicate the practice of physical exercise&#xD;
&#xD;
          -  Being pregnant before or during the intervention (for intervention and control group)&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>35 Years</minimum_age>
    <maximum_age>55 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <verification_date>October 2017</verification_date>
  <study_first_submitted>October 7, 2017</study_first_submitted>
  <study_first_submitted_qc>October 7, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">October 12, 2017</study_first_posted>
  <last_update_submitted>October 13, 2017</last_update_submitted>
  <last_update_submitted_qc>October 13, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">October 16, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Universidad Europea de Madrid</investigator_affiliation>
    <investigator_full_name>ÁLVARO FERNÁNDEZ LUNA</investigator_full_name>
    <investigator_title>Professor</investigator_title>
  </responsible_party>
  <patient_data>
    <sharing_ipd>Undecided</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/NCT03308292
org study id: P2016/UEM33
nct id: NCT03308292
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Physical inactivity and low adherence to the Mediterranean diet cause alterations in body
      composition, which increases the risk factors for cardiovascular and metabolic diseases. In
      addition, exercise in different surfaces or water could affect the bone density specially in
      women. Objective: The purpose of the study was to analyze the effect of a short-term aerobic
      exercise program in different surfaces on the body composition and bone density of women
      within at work, and to evaluate the quality of the Mediterranean diet and distribution of
      macronutrients in the studied population. Material & Methods: Randomized controlled trial. 63
      women from a randomized work environment (IG, n=34) and a control group (CG, n=29)
      participated in a short-term aerobic exercise programmed (12 weeks), for body composition and
      bone density Dual-energy X-ray absorptiometry (DXA) was used and to evaluate diet, the
      Mediterranean Diet Quality Questionnaire (KIDMED) and the Food Frequency Questionnaire for
      macronutrient distribution were used.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Changes in bone density
time frame: 3 months
description: Change from baseline to 3 months using Dual-energy X-ray Absorptiometry
measure: Changes in body composition
time frame: 3 months
description: Change from baseline to 3 months using Dual-energy X-ray Absorptiometry
measure: Level of compliance with the exercise program
time frame: 3 months
description: Level of compliance with the program using the percentage of compliance to the exercise programme (36 sessions)
measure: Changes in Dietary pattern variables: macronutrients
time frame: 3 months
description: Evaluation of Changes in Dietary pattern variables from baseline to 3 months using questionaries
measure: Changes in Dietary pattern variables: quality of diet
time frame: 3 months
description: Evaluation of Changes in Dietary pattern variables from baseline to 3 months using questionaries
arm group label: Control Group
arm group type: No Intervention
arm group label: Intervention Group
arm group type: Experimental
description: A moderate-intensity aerobic physical exercise programme was carried out during the months of March to May 2017 (12 weeks), with a frequency of three sessions per week (36 sessions in total) with a duration of 45 minutes per session. The intensity was controlled through the Borg 1982 modified scale of perceived exertion (RPE). It is a scale from 0 to 10, considering 0 as "nothing at all" and 10 as "very very strong", setting the moderate intensity as value
intervention type: Other
intervention name: Exercise
description: Aerobic exercise program
arm group label: Intervention Group
criteria: 
gender: Female
minimum age: 35 Years
maximum age: 55 Years
healthy volunteers: Accepts Healthy Volunteers
responsible party type: Principal Investigator
investigator affiliation: Universidad Europea de Madrid
investigator full name: ÁLVARO FERNÁNDEZ LUNA
investigator title: Professor
sharing ipd: Undecided