<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/NCT02215603</url>
  </required_header>
  <id_info>
    <org_study_id>ProlongedSitting</org_study_id>
    <nct_id>NCT02215603</nct_id>
  </id_info>
  <brief_title>Effects of Disrupting Prolonged Sitting With Different Physical Activity Protocols on Metabolic Risk Factors in Sedentary Adults</brief_title>
  <sponsors>
    <lead_sponsor>
      <agency>Rigshospitalet, Denmark</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Coordenação de Aperfeiçoamento de Pessoal de Nível Superior.</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Rigshospitalet, Denmark</source>
  <brief_summary>
    <textblock>
      Great controversy exists with respect to the optimal or the minimum volume, intensity, and&#xD;
      frequency of physical activity capable of attenuating the hazards of prolonged sitting on the&#xD;
      metabolic profile. Thus, our study aims to comprehensively investigate the effects of&#xD;
      disrupting prolonged sitting with different physical activity protocols on metabolic risk&#xD;
      factors in sedentary males.&#xD;
&#xD;
      Ten sedentary males will take part in this randomized cross-over trial consisting of four&#xD;
      27-h conditions. All conditions will be identical except for the physical activity: prolonged&#xD;
      sitting intervention (SIT) participants will sit continuously for 9 hours; prolonged&#xD;
      sitting+interval standing intervention (STAND), participants will stand for 15 min every 30&#xD;
      minutes (total 270 min) during the 9 hours of sitting; prolonged sitting+moderate-intensity&#xD;
      exercise bout (MVPA) participants will perform a 30-min moderate-intensity exercise bout on a&#xD;
      treadmill (energy-matched to STAND), after which they will sit for the remaining time; and&#xD;
      prolonged sitting+moderate-intensity exercise bout +interval standing intervention&#xD;
      (MVPA-STAND), participants will perform a 30-min moderate-intensity exercise bout on a&#xD;
      treadmill (energy-matched to STAND), after which they will stand for 15 min every 30 minutes&#xD;
      (total 240 min) during the remaining 8 hours of sitting. Blood glucose, insulin, lipids and&#xD;
      cytokines will be determined.&#xD;
&#xD;
      The investigators expect that disrupting prolonged sitting with intermittent standing and a&#xD;
      moderate-exercise bout will positively affect the metabolic profile of the participants.&#xD;
      Furthermore, we will investigate if combined, these strategies will have an additive effect.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>August 2014</start_date>
  <completion_date type="Anticipated">December 2016</completion_date>
  <primary_completion_date type="Anticipated">June 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>Crossover Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Area under the curve of glucose and insulin postprandial responses</measure>
    <time_frame>27 h</time_frame>
    <description>Glucose and insulin levels will be assessed 10 min before, and 30, 60, 120 and 180 min after each main meal. These postprandial responses will be defined as the area under the curve (AUC) assessed over the 3-h period after each main meal (3-h AUC) and the cumulative AUC after all main meals (12-h AUC).</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Glucose levels</measure>
    <time_frame>27 hours</time_frame>
    <description>Glucose incursions will measured using the glucose monitoring (CGM) system throughout the 27 hours. Mean, maximum and minimum glucose values during the 27h will be the outcome measures (mmol/l).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Area under the curve of lipid postprandial responses</measure>
    <time_frame>27 h</time_frame>
    <description>Lipid levels will be assessed 10 min before, and 30, 60, 120 and 180 min after each main meal. These postprandial responses will be defined as the area under the curve (AUC) assessed over the 3-h period after each main meal (3-h AUC) and the cumulative AUC after all main meals (12-h AUC).</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Area under the curve of cytokine postprandial responses</measure>
    <time_frame>27 h</time_frame>
    <description>Cytokine levels (TNF-alpha, IL-6, IL-10, and IL1-ra) will be assessed 10 min before, and 30, 60, 120 and 180 min after each main meal. These postprandial responses will be defined as the area under the curve (AUC) assessed over the 3-h period after each main meal (3-h AUC) and the cumulative AUC after all main meals (12-h AUC).</description>
  </other_outcome>
  <number_of_arms>4</number_of_arms>
  <enrollment type="Anticipated">10</enrollment>
  <condition>Prolonged Sitting</condition>
  <condition>Breaking Prolonged Sitting With Physical Activity</condition>
  <arm_group>
    <arm_group_label>Prolonged sitting</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>9 h of prolonged sitting</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Prolonged sitting + interval standing bouts</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Stand bout for 15-min every 30 minutes during the 9 hours of sitting</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Moderate exercise bout + Prolonged sitting</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>30-min moderate-intensity exercise bout followed by 8 h of sitting</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Moderate exercise bout + Prolonged sitting +Standing bouts</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>30-min moderate-intensity exercise bout and stand bout for 15-min every 30 minutes during the remaining 8 hours of sitting</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Breaking prolonged sitting with physical activity</intervention_name>
    <arm_group_label>Moderate exercise bout + Prolonged sitting</arm_group_label>
    <arm_group_label>Moderate exercise bout + Prolonged sitting +Standing bouts</arm_group_label>
    <arm_group_label>Prolonged sitting + interval standing bouts</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Males,&#xD;
&#xD;
          -  age 25-55 y,&#xD;
&#xD;
          -  BMI &gt;18 and &lt;35 kg/m2&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Clinically diagnosed diabetes,&#xD;
&#xD;
          -  dyslipidaemia,&#xD;
&#xD;
          -  hypertension,&#xD;
&#xD;
          -  use of glucose- and/or lipid-lowering medication,&#xD;
&#xD;
          -  smoking,&#xD;
&#xD;
          -  evidence of thyroid, liver, lung, heart or kidney disease,&#xD;
&#xD;
          -  non-sedentary occupation and primary means of commuting to work (i.e., cycling) in the&#xD;
             last 4 months,&#xD;
&#xD;
          -  VO2max levels above the considered average fitness according to age,&#xD;
&#xD;
          -  contraindication to increased levels of physical activity.&#xD;
      </textblock>
    </criteria>
    <gender>Male</gender>
    <minimum_age>25 Years</minimum_age>
    <maximum_age>55 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Fabiana Benatti</last_name>
    <phone>+45 35450898</phone>
    <email>fabiana.braga.benatti@regionh.dk</email>
  </overall_contact>
  <location>
    <facility>
      <name>Centre of Inflammation and Metabolism</name>
      <address>
        <city>Copenhagen</city>
        <zip>2100</zip>
        <country>Denmark</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Inge Holm</last_name>
    </contact>
    <investigator>
      <last_name>Bente Pedersen, PhD</last_name>
      <role>Principal Investigator</role>
    </investigator>
    <investigator>
      <last_name>Fabiana Benatti, PhD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>Denmark</country>
  </location_countries>
  <verification_date>January 2016</verification_date>
  <study_first_submitted>August 7, 2014</study_first_submitted>
  <study_first_submitted_qc>August 11, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 13, 2014</study_first_posted>
  <last_update_submitted>January 12, 2016</last_update_submitted>
  <last_update_submitted_qc>January 12, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">January 13, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Rigshospitalet, Denmark</investigator_affiliation>
    <investigator_full_name>Anders Rasmussen Rinnov</investigator_full_name>
    <investigator_title>PhD</investigator_title>
  </responsible_party>
  <!-- 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/NCT02215603
org study id: ProlongedSitting
nct id: NCT02215603
lead sponsor: 
collaborator: 
Great controversy exists with respect to the optimal or the minimum volume, intensity, and
      frequency of physical activity capable of attenuating the hazards of prolonged sitting on the
      metabolic profile. Thus, our study aims to comprehensively investigate the effects of
      disrupting prolonged sitting with different physical activity protocols on metabolic risk
      factors in sedentary males.

      Ten sedentary males will take part in this randomized cross-over trial consisting of four
      27-h conditions. All conditions will be identical except for the physical activity: prolonged
      sitting intervention (SIT) participants will sit continuously for 9 hours; prolonged
      sitting+interval standing intervention (STAND), participants will stand for 15 min every 30
      minutes (total 270 min) during the 9 hours of sitting; prolonged sitting+moderate-intensity
      exercise bout (MVPA) participants will perform a 30-min moderate-intensity exercise bout on a
      treadmill (energy-matched to STAND), after which they will sit for the remaining time; and
      prolonged sitting+moderate-intensity exercise bout +interval standing intervention
      (MVPA-STAND), participants will perform a 30-min moderate-intensity exercise bout on a
      treadmill (energy-matched to STAND), after which they will stand for 15 min every 30 minutes
      (total 240 min) during the remaining 8 hours of sitting. Blood glucose, insulin, lipids and
      cytokines will be determined.

      The investigators expect that disrupting prolonged sitting with intermittent standing and a
      moderate-exercise bout will positively affect the metabolic profile of the participants.
      Furthermore, we will investigate if combined, these strategies will have an additive effect.
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Area under the curve of glucose and insulin postprandial responses
time frame: 27 h
description: Glucose and insulin levels will be assessed 10 min before, and 30, 60, 120 and 180 min after each main meal. These postprandial responses will be defined as the area under the curve (AUC) assessed over the 3-h period after each main meal (3-h AUC) and the cumulative AUC after all main meals (12-h AUC).
measure: Glucose levels
time frame: 27 hours
description: Glucose incursions will measured using the glucose monitoring (CGM) system throughout the 27 hours. Mean, maximum and minimum glucose values during the 27h will be the outcome measures (mmol/l).
measure: Area under the curve of lipid postprandial responses
time frame: 27 h
description: Lipid levels will be assessed 10 min before, and 30, 60, 120 and 180 min after each main meal. These postprandial responses will be defined as the area under the curve (AUC) assessed over the 3-h period after each main meal (3-h AUC) and the cumulative AUC after all main meals (12-h AUC).
measure: Area under the curve of cytokine postprandial responses
time frame: 27 h
description: Cytokine levels (TNF-alpha, IL-6, IL-10, and IL1-ra) will be assessed 10 min before, and 30, 60, 120 and 180 min after each main meal. These postprandial responses will be defined as the area under the curve (AUC) assessed over the 3-h period after each main meal (3-h AUC) and the cumulative AUC after all main meals (12-h AUC).
arm group label: Prolonged sitting
arm group type: No Intervention
description: 9 h of prolonged sitting
arm group label: Prolonged sitting + interval standing bouts
arm group type: Experimental
description: Stand bout for 15-min every 30 minutes during the 9 hours of sitting
arm group label: Moderate exercise bout + Prolonged sitting
arm group type: Experimental
description: 30-min moderate-intensity exercise bout followed by 8 h of sitting
arm group label: Moderate exercise bout + Prolonged sitting +Standing bouts
arm group type: Experimental
description: 30-min moderate-intensity exercise bout and stand bout for 15-min every 30 minutes during the remaining 8 hours of sitting
intervention type: Behavioral
intervention name: Breaking prolonged sitting with physical activity
arm group label: Moderate exercise bout + Prolonged sitting
arm group label: Moderate exercise bout + Prolonged sitting +Standing bouts
arm group label: Prolonged sitting + interval standing bouts
criteria: 
gender: Male
minimum age: 25 Years
maximum age: 55 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Fabiana Benatti
phone: +45 35450898
email: fabiana.braga.benatti@regionh.dk
facility: 
status: Recruiting
contact: 
investigator: 
investigator: 
country: Denmark
responsible party type: Principal Investigator
investigator affiliation: Rigshospitalet, Denmark
investigator full name: Anders Rasmussen Rinnov
investigator title: PhD