<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/NCT02196623</url>
  </required_header>
  <id_info>
    <org_study_id>HA 7037/2-1</org_study_id>
    <nct_id>NCT02196623</nct_id>
  </id_info>
  <brief_title>Hypoxia and Exercise in the Elderly</brief_title>
  <official_title>Hypoxia and Aerobic Exercise Interactions in Age-related Metabolic Muscle Dysfunction</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Hannover Medical School</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>German Diabetes Center</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Hannover Medical School</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Ageing is the primary risk factor for most chronic diseases including type 2 diabetes&#xD;
      mellitus. Sarcopenia and muscular mitochondrial dysfunction with aging are crucial mechanisms&#xD;
      leading to decreased exercise tolerance and worsened insulin sensitivity. Thus, metabolic&#xD;
      disease and frailty, which limits physical mobility as well as quality of life, share common&#xD;
      cellular mechanisms.&#xD;
&#xD;
      The investigators will test the hypothesis that a combination of normobaric hypoxia and&#xD;
      exercise training elicits a synergistic effect on age-associated metabolic skeletal muscle&#xD;
      dysfunction and the investigators will address the molecular mechanisms. In a randomized&#xD;
      clinical study, the investigators will compare normoxic and hypoxic training conditions in&#xD;
      elderly subjects. Outcome measures will focus on whole body insulin sensitivity and&#xD;
      mitochondrial responses in skeletal muscle before and after the 8-week training intervention.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">June 2015</start_date>
  <completion_date type="Actual">January 2019</completion_date>
  <primary_completion_date type="Actual">September 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>Double (Participant, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Insulin sensitivity</measure>
    <time_frame>At baseline and after 8 weeks</time_frame>
    <description>Insulin sensitivity is assessed via the hyperinsulinemic euglycemic glucose clamp and expressed as the glucose infusion rate (GIR) in ml</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Maximum oxygen uptake</measure>
    <time_frame>At baseline and after 8 weeks</time_frame>
    <description>Maximum oxygen uptake is measured during an incremental exhaustive exercise test and is expressed in ml/min/kg</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mitochondrial number</measure>
    <time_frame>At baseline and after 8 weeks</time_frame>
    <description>Mitochondrial number and selected gene expression assessed from muscle biopsies from the vastus lateralis.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Fat and carbohydrate oxidation during exercise</measure>
    <time_frame>At baseline and after 8 weeks</time_frame>
    <description>Fat and carbohydrate oxidation during exercise is assessed during an incremental exercise test by measurements of gas exchange and expressed as g/min</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Body fat and body fat free mass</measure>
    <time_frame>At baseline and after 8 weeks</time_frame>
    <description>Measured via by air-displacement plethysmography (ADP) and expressed in kg</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Health related quality of life</measure>
    <time_frame>At baseline and after 8 weeks</time_frame>
    <description>Assessed using the short form 36 (SF-36) questionnaires</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">29</enrollment>
  <condition>Elderly Persons</condition>
  <arm_group>
    <arm_group_label>Hypoxic Exercise</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Supervised, progressive aerobic exercise for 8 weeks under hypoxic conditions</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Normoxic exercise</arm_group_label>
    <arm_group_type>Sham Comparator</arm_group_type>
    <description>Supervised, progressive aerobic exercise for 8 weeks under normoxic conditions</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Hypoxic exercise</intervention_name>
    <description>Supervised, progressive aerobic exercise program for 8 weeks under hypoxic conditions</description>
    <arm_group_label>Hypoxic Exercise</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Normoxic Exercise</intervention_name>
    <description>Supervised, progressive aerobic exercise program for 8 weeks under normoxic conditions</description>
    <arm_group_label>Normoxic exercise</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  55 to 75 years of age&#xD;
&#xD;
          -  body mass index: 20 - 35 kg/m2&#xD;
&#xD;
          -  weight stable during last 6 months before screening (weight change &lt; 2% body weight)&#xD;
&#xD;
          -  HOMA-index of insulin resistance ≥ 2 to 4 units&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  more than 1 hour of scheduled exercise training per week&#xD;
&#xD;
          -  known diagnosis of type 2 diabetes or measured HbA1c &gt; 6,5%&#xD;
&#xD;
          -  known drug or alcohol abuse&#xD;
&#xD;
          -  any contraindication to perform exercise training&#xD;
&#xD;
          -  acute or chronic infections&#xD;
&#xD;
          -  increased bleeding risk by history, INR &gt; 1,3, use of anticoagulants&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>55 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Sven Haufe, Dr.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Hannover Medical School</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Hannover Medical School</name>
      <address>
        <city>Hannover</city>
        <state>Lower Saxony</state>
        <zip>30625</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Germany</country>
  </location_countries>
  <verification_date>August 2017</verification_date>
  <study_first_submitted>July 18, 2014</study_first_submitted>
  <study_first_submitted_qc>July 18, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 22, 2014</study_first_posted>
  <last_update_submitted>January 23, 2019</last_update_submitted>
  <last_update_submitted_qc>January 23, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">January 24, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Hypoxia</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/NCT02196623
org study id: HA 7037/2-1
nct id: NCT02196623
lead sponsor: 
collaborator: 
has dmc: No
Ageing is the primary risk factor for most chronic diseases including type 2 diabetes
      mellitus. Sarcopenia and muscular mitochondrial dysfunction with aging are crucial mechanisms
      leading to decreased exercise tolerance and worsened insulin sensitivity. Thus, metabolic
      disease and frailty, which limits physical mobility as well as quality of life, share common
      cellular mechanisms.

      The investigators will test the hypothesis that a combination of normobaric hypoxia and
      exercise training elicits a synergistic effect on age-associated metabolic skeletal muscle
      dysfunction and the investigators will address the molecular mechanisms. In a randomized
      clinical study, the investigators will compare normoxic and hypoxic training conditions in
      elderly subjects. Outcome measures will focus on whole body insulin sensitivity and
      mitochondrial responses in skeletal muscle before and after the 8-week training intervention.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Participant, Outcomes Assessor)
measure: Insulin sensitivity
time frame: At baseline and after 8 weeks
description: Insulin sensitivity is assessed via the hyperinsulinemic euglycemic glucose clamp and expressed as the glucose infusion rate (GIR) in ml
measure: Maximum oxygen uptake
time frame: At baseline and after 8 weeks
description: Maximum oxygen uptake is measured during an incremental exhaustive exercise test and is expressed in ml/min/kg
measure: Mitochondrial number
time frame: At baseline and after 8 weeks
description: Mitochondrial number and selected gene expression assessed from muscle biopsies from the vastus lateralis.
measure: Fat and carbohydrate oxidation during exercise
time frame: At baseline and after 8 weeks
description: Fat and carbohydrate oxidation during exercise is assessed during an incremental exercise test by measurements of gas exchange and expressed as g/min
measure: Body fat and body fat free mass
time frame: At baseline and after 8 weeks
description: Measured via by air-displacement plethysmography (ADP) and expressed in kg
measure: Health related quality of life
time frame: At baseline and after 8 weeks
description: Assessed using the short form 36 (SF-36) questionnaires
arm group label: Hypoxic Exercise
arm group type: Experimental
description: Supervised, progressive aerobic exercise for 8 weeks under hypoxic conditions
arm group label: Normoxic exercise
arm group type: Sham Comparator
description: Supervised, progressive aerobic exercise for 8 weeks under normoxic conditions
intervention type: Other
intervention name: Hypoxic exercise
description: Supervised, progressive aerobic exercise program for 8 weeks under hypoxic conditions
arm group label: Hypoxic Exercise
intervention type: Other
intervention name: Normoxic Exercise
description: Supervised, progressive aerobic exercise program for 8 weeks under normoxic conditions
arm group label: Normoxic exercise
criteria: 
gender: All
minimum age: 55 Years
maximum age: 75 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Sven Haufe, Dr.
role: Principal Investigator
affiliation: Hannover Medical School
facility: 
country: Germany
responsible party type: Sponsor
mesh term: Hypoxia