<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/NCT01690728</url>
  </required_header>
  <id_info>
    <org_study_id>CBR-001</org_study_id>
    <nct_id>NCT01690728</nct_id>
  </id_info>
  <brief_title>Effect of Physical Activity on Weight Loss and Cardiovascular Risk Factors After Gastric Bypass</brief_title>
  <official_title>Effect of Physical Activity on Weight Loss and Cardiovascular Risk Factors After Gastric Bypass</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Hospital of South West Jutland</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Hospital of South West Jutland</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The aim of this study is to increase our knowledge about the effect of physical activity in&#xD;
      patients who have undergone gastric bypass surgery. The study will provide novel information&#xD;
      in two areas. The main objective is to study the effect of physical activity on the weight&#xD;
      loss and cardiovascular risk factors. This will be accomplished in a randomized clinical&#xD;
      trial in patients, who are eligible for gastric bypass (GB). Patients will be randomized to&#xD;
      six month of structured physical activity or standard postoperative counseling. The study&#xD;
      will include an exhaustive panel of blood tests related to cardiovascular risk and the most&#xD;
      extensive evaluation of structural and functional vascular test done in this patient group so&#xD;
      far. In addition the study will provide information of the effect of bariatric surgery per se&#xD;
      since both pre- and postoperative investigations are conducted. The study will learn us to&#xD;
      what degree it is possible to motivate this group of patients to increased physical activity.&#xD;
      All together this will enable us to improve the counseling of the patients undergoing GB.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The study will be conducted as a prospective, randomized, controlled, two-group, intervention&#xD;
      study. Patients will be recruited among individuals referred to the tertiary center for&#xD;
      bariatric surgery. The patients will be asked to participate in the study when they attend&#xD;
      the preoperative education for bariatric surgery. Randomization will be performed in blocks&#xD;
      ensuring an equal distribution of type 2 diabetes patients in the two study groups.&#xD;
&#xD;
      Participants will be investigated before gastric bypass surgery, six, 12 and 24 month&#xD;
      post-operative. Intervention, consisting of structured physical activity will take place from&#xD;
      six to 12 month after operation.&#xD;
&#xD;
      The intervention program will continue for six month. The supervised exercise program will&#xD;
      take place at the training center consisting of 40 min. sessions two times pr. week for 26&#xD;
      consecutive weeks.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">October 2012</start_date>
  <completion_date type="Actual">November 2016</completion_date>
  <primary_completion_date type="Actual">October 2015</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>Prevention</primary_purpose>
    <masking>Single (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Weight loss</measure>
    <time_frame>Measures 1-2 weeks before gastric bypass, change from baseline 6, 12 and 24 month post-surgery</time_frame>
    <description>The participants pre-operative weight are measured before gastric bypass surgery. This measure will take place within 2 weeks before surgery. Weight change from baseline will be measured 6, 12 and 24 months post-surgery.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Blood tests</measure>
    <time_frame>Measures 1-2 weeks before gastric bypass, 6, 12 and 24 month post-surgery</time_frame>
    <description>Exhaustive panel of blood tests related to cardiovascular risk. The participants are measured before gastric bypass surgery. This measure will take place within 2 weeks before surgery. Changes in blood analyses from baseline will be measured 6, 12 and 24 months post-surgery.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">60</enrollment>
  <condition>Morbid Obesity</condition>
  <condition>Inactivity</condition>
  <arm_group>
    <arm_group_label>Physical Activity</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>40 min exercise supervised by physiotherapists two times weekly in six month.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control Group</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>These participants follows the standard post surgery follow-up consisting of counseling by dietitians, nurses and doctors.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Physical Activity</intervention_name>
    <description>The intervention program will continue for six month consisting of two weekly sessions of 40 min exercise supervised by physiotherapists. The supervised exercise program will take place at the training center Fitness.dk in Esbjerg and Kolding. It will be in cooperation with physiotherapists at the Therapy Department of Sydvestjysk Sygehus Esbjerg and the Therapy Department of Fredericia and Kolding Sygehus, Sygehus Lillebælt. The exercise program at the two centers will be equal. In addition the patients will be provided with free access to a fitness center. The patient will be encouraged to do at least 3.5 hours of moderate to vigorous physical activity per week.</description>
    <arm_group_label>Physical Activity</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age 25 - 60 years&#xD;
&#xD;
          -  Able to understand and cooperate with the interventions in the study&#xD;
&#xD;
          -  Eligible for gastric bypass surgery&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Inability to perform physical activity at the intensity and quantity required in the&#xD;
             study, such as physical disabled patients including severe osteoarthritis&#xD;
&#xD;
          -  Use of vitamin K antagonists, oral contraceptives, or hormone replacement therapy&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>25 Years</minimum_age>
    <maximum_age>60 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Claus B Juhl, MD, ph.d.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Hospital of South West Jutland</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Center of Bariatric Research, Dep. of Endocrinology, Hospital of South West Denmark</name>
      <address>
        <city>Esbjerg</city>
        <zip>6700</zip>
        <country>Denmark</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Denmark</country>
  </location_countries>
  <verification_date>October 2022</verification_date>
  <study_first_submitted>September 14, 2012</study_first_submitted>
  <study_first_submitted_qc>September 19, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 24, 2012</study_first_posted>
  <last_update_submitted>October 18, 2022</last_update_submitted>
  <last_update_submitted_qc>October 18, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">October 20, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Hospital of South West Jutland</investigator_affiliation>
    <investigator_full_name>Lene Hymøller Mundbjerg</investigator_full_name>
    <investigator_title>M.D. PhD-student</investigator_title>
  </responsible_party>
  <keyword>Obesity</keyword>
  <keyword>Gastric bypass</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Obesity, Morbid</mesh_term>
    <mesh_term>Weight Loss</mesh_term>
  </condition_browse>
  <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/NCT01690728
org study id: CBR-001
nct id: NCT01690728
lead sponsor: 
has dmc: Yes
The aim of this study is to increase our knowledge about the effect of physical activity in
      patients who have undergone gastric bypass surgery. The study will provide novel information
      in two areas. The main objective is to study the effect of physical activity on the weight
      loss and cardiovascular risk factors. This will be accomplished in a randomized clinical
      trial in patients, who are eligible for gastric bypass (GB). Patients will be randomized to
      six month of structured physical activity or standard postoperative counseling. The study
      will include an exhaustive panel of blood tests related to cardiovascular risk and the most
      extensive evaluation of structural and functional vascular test done in this patient group so
      far. In addition the study will provide information of the effect of bariatric surgery per se
      since both pre- and postoperative investigations are conducted. The study will learn us to
      what degree it is possible to motivate this group of patients to increased physical activity.
      All together this will enable us to improve the counseling of the patients undergoing GB.
The study will be conducted as a prospective, randomized, controlled, two-group, intervention
      study. Patients will be recruited among individuals referred to the tertiary center for
      bariatric surgery. The patients will be asked to participate in the study when they attend
      the preoperative education for bariatric surgery. Randomization will be performed in blocks
      ensuring an equal distribution of type 2 diabetes patients in the two study groups.

      Participants will be investigated before gastric bypass surgery, six, 12 and 24 month
      post-operative. Intervention, consisting of structured physical activity will take place from
      six to 12 month after operation.

      The intervention program will continue for six month. The supervised exercise program will
      take place at the training center consisting of 40 min. sessions two times pr. week for 26
      consecutive weeks.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: Single (Outcomes Assessor)
measure: Weight loss
time frame: Measures 1-2 weeks before gastric bypass, change from baseline 6, 12 and 24 month post-surgery
description: The participants pre-operative weight are measured before gastric bypass surgery. This measure will take place within 2 weeks before surgery. Weight change from baseline will be measured 6, 12 and 24 months post-surgery.
measure: Blood tests
time frame: Measures 1-2 weeks before gastric bypass, 6, 12 and 24 month post-surgery
description: Exhaustive panel of blood tests related to cardiovascular risk. The participants are measured before gastric bypass surgery. This measure will take place within 2 weeks before surgery. Changes in blood analyses from baseline will be measured 6, 12 and 24 months post-surgery.
arm group label: Physical Activity
arm group type: Active Comparator
description: 40 min exercise supervised by physiotherapists two times weekly in six month.
arm group label: Control Group
arm group type: No Intervention
description: These participants follows the standard post surgery follow-up consisting of counseling by dietitians, nurses and doctors.
intervention type: Behavioral
intervention name: Physical Activity
description: The intervention program will continue for six month consisting of two weekly sessions of 40 min exercise supervised by physiotherapists. The supervised exercise program will take place at the training center Fitness.dk in Esbjerg and Kolding. It will be in cooperation with physiotherapists at the Therapy Department of Sydvestjysk Sygehus Esbjerg and the Therapy Department of Fredericia and Kolding Sygehus, Sygehus Lillebælt. The exercise program at the two centers will be equal. In addition the patients will be provided with free access to a fitness center. The patient will be encouraged to do at least 3.5 hours of moderate to vigorous physical activity per week.
arm group label: Physical Activity
criteria: 
gender: All
minimum age: 25 Years
maximum age: 60 Years
healthy volunteers: No
last name: Claus B Juhl, MD, ph.d.
role: Principal Investigator
affiliation: Hospital of South West Jutland
facility: 
country: Denmark
responsible party type: Principal Investigator
investigator affiliation: Hospital of South West Jutland
investigator full name: Lene Hymøller Mundbjerg
investigator title: M.D. PhD-student
mesh term: Obesity, Morbid
mesh term: Weight Loss
sharing ipd: No