<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/NCT03802357</url>
  </required_header>
  <id_info>
    <org_study_id>AAT Training</org_study_id>
    <nct_id>NCT03802357</nct_id>
  </id_info>
  <brief_title>Effects of Different Exercise Training Modalities in Alpha-1 Antitrypsin Deficiency Patients</brief_title>
  <official_title>Effects of Moderate vs. High Intensity Exercise Training During Pulmonary Rehabilitation in Alpha-1 Antitrypsin Deficiency Patients</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Schön Klinik Berchtesgadener Land</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Schön Klinik Berchtesgadener Land</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>
      Pulmonary rehabilitation (PR) including exercise training is highly effective by improving&#xD;
      health-related quality of life, exercise capacity and symptoms in patients with chronic&#xD;
      obstructive pulmonary disease (COPD). Therefore, PR is a main component in the management of&#xD;
      COPD. In a former study patients with Alpha-1 Antitrypsin deficiency (A1ATD)-related COPD&#xD;
      (genotype PiZZ) have been found to show smaller improvements in exercise capacity after a&#xD;
      3-week inpatient PR program compared to COPD patients without A1ATD (genotype PiMM)[1]. These&#xD;
      between-group differences were mirrored by missing adaptations of the fatigue-resistant&#xD;
      skeletal muscle fibre type I in A1ATD patients. This was in contrast to COPD patients without&#xD;
      A1ATD who increased the proportion of this fibre type after PR. Myofibre type I is crucial&#xD;
      because it enables patients for physical endurance activities (walking, cycling etc.) during&#xD;
      their daily life.&#xD;
&#xD;
      The aim of this study is to compare the effects of an exercise Training program with high vs.&#xD;
      moderate Training intensity in order to find a Training modality which improves Training&#xD;
      effects in A1ATD patients.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">January 10, 2019</start_date>
  <completion_date type="Anticipated">December 31, 2021</completion_date>
  <primary_completion_date type="Anticipated">October 31, 2021</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>
    <intervention_model_description>Patients will be randomized into two Intervention Groups (high vs. moderate Training intensity).</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Endurance shuttle walk test (ESWT)</measure>
    <time_frame>Change in the duration of the ESWT from day 1 to day 21</time_frame>
    <description>The ESWT is performed at 85% of the Peak gate Speed, measured during the Initial incremental shuttle walk test.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Oxygen saturation</measure>
    <time_frame>Change in the oxygen saturation at isotime from day 1 to day 21</time_frame>
    <description>Outcome will be assessed at the the time Point of the end of the shortest ESWT (&quot;isotime&quot;).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Heart rate</measure>
    <time_frame>Change in the heart rate at isotime from day 1 to day 21</time_frame>
    <description>Outcome will be assessed at the the time Point of the end of the shortest ESWT (&quot;isotime&quot;).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Partial pressure of carbon dioxide (CO2)</measure>
    <time_frame>Change in the partial pressure of CO2 at isotime from day 1 to day 21</time_frame>
    <description>Parameter will be measured by Sentec (R) device. Outcome will be assessed at the the time Point of the end of the shortest ESWT (&quot;isotime&quot;).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Lactate concentration</measure>
    <time_frame>Change in lactate concentration at isotime from day 1 to day 21</time_frame>
    <description>Outcome will be assessed at the the time Point of the end of the shortest ESWT (&quot;isotime&quot;).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Perceived Dyspnea</measure>
    <time_frame>Change in perceived dyspnea at isotime from day 1 to day 21</time_frame>
    <description>Dyspnea will be rated on a 0 to 10-point BORG scale where lower values represent less dyspnea and vice versa. The total score will be assessed at the the time Point of the end of the shortest ESWT (&quot;isotime&quot;).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Strength capacity in knee extension</measure>
    <time_frame>Change in strength from day 1 to day 21</time_frame>
    <description>Strength will be measured by a Hand Held Dynamometer (Microfet (R)).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Balance performance</measure>
    <time_frame>Change in balance performance from day 1 to day 21</time_frame>
    <description>absolute path length will be measured on a force plate (Leonardo (R)) during the Tandem stance</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">30</enrollment>
  <condition>Chronic Obstructive Pulmonary Disease</condition>
  <condition>Alpha 1-Antitrypsin Deficiency</condition>
  <arm_group>
    <arm_group_label>High training intensity</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Exercise Training with high intensities consists of a cycling Interval Training at 100% of the individual Peak work rate, resistance Training for 3 sets à 8 repetitions and squats on a Vibration plate.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>moderate training intensity</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Exercise Training with moderate intensities consists of a cycling endurance Training at 60% of the individual Peak work rate, resistance Training for 3 sets à 20 repetitions and squats on the floor.</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Exercise training</intervention_name>
    <description>Patients perform an exercise Training program of 3 weeks Duration including endurance Training, resistance Training and squat Training. This program is part of an inpatient pulmonary Rehabilitation.</description>
    <arm_group_label>High training intensity</arm_group_label>
    <arm_group_label>moderate training intensity</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  COPD patients with A1ATD (genotype PiZZ)&#xD;
&#xD;
          -  COPD patients without A1ATD (genotype PiMM)&#xD;
&#xD;
          -  Global initiative for chronic obstructive lung disease (GOLD) stage III-IV&#xD;
&#xD;
          -  Medical Treatment according to recent A1ATD guidelines&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  General exclusion criteria for physical Training such as acute coronary Syndrome,&#xD;
             acute myo- or pericarditis, acute lung embolism, acute heart failure, orthopedic&#xD;
             comorbidities which prevent patients from participating in exercise Training program.&#xD;
&#xD;
          -  No written informed consent&#xD;
&#xD;
          -  Non-compliance&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>40 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Klaus Kenn, Prof. Dr.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Schoen Klinik Berchtesgadener Land</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Klaus Kenn, Prof. Dr.</last_name>
    <phone>0865293</phone>
    <phone_ext>1540</phone_ext>
    <email>kkenn@schoen-klinik.de</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Inga Jarosch, Dr.</last_name>
    <phone>0865293</phone>
    <phone_ext>1730</phone_ext>
    <email>ijarosch@schoen-klinik.de</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Schoen Klinik Berchtesgadener Land</name>
      <address>
        <city>Schönau Am Königssee</city>
        <zip>83471</zip>
        <country>Germany</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Klaus Kenn, Prof. Dr.</last_name>
      <phone>0865293</phone>
      <phone_ext>1540</phone_ext>
      <email>kkenn@schoen-klinik.de</email>
    </contact>
    <contact_backup>
      <last_name>Inga Jarosch, Dr.</last_name>
      <phone>0865293</phone>
      <phone_ext>1730</phone_ext>
      <email>ijarosch@schoen-klinik.de</email>
    </contact_backup>
  </location>
  <location_countries>
    <country>Germany</country>
  </location_countries>
  <verification_date>January 2019</verification_date>
  <study_first_submitted>January 10, 2019</study_first_submitted>
  <study_first_submitted_qc>January 10, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 14, 2019</study_first_posted>
  <last_update_submitted>January 14, 2019</last_update_submitted>
  <last_update_submitted_qc>January 14, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">January 16, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Schön Klinik Berchtesgadener Land</investigator_affiliation>
    <investigator_full_name>Klaus Kenn</investigator_full_name>
    <investigator_title>Head physician</investigator_title>
  </responsible_party>
  <keyword>Pulmonary rehabilitation</keyword>
  <keyword>Exercise training</keyword>
  <keyword>Alpha-1 Antitrypsin deficiency</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Alpha 1-Antitrypsin Deficiency</mesh_term>
    <mesh_term>Lung Diseases, Obstructive</mesh_term>
    <mesh_term>Pulmonary Disease, Chronic Obstructive</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/NCT03802357
org study id: AAT Training
nct id: NCT03802357
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Pulmonary rehabilitation (PR) including exercise training is highly effective by improving
      health-related quality of life, exercise capacity and symptoms in patients with chronic
      obstructive pulmonary disease (COPD). Therefore, PR is a main component in the management of
      COPD. In a former study patients with Alpha-1 Antitrypsin deficiency (A1ATD)-related COPD
      (genotype PiZZ) have been found to show smaller improvements in exercise capacity after a
      3-week inpatient PR program compared to COPD patients without A1ATD (genotype PiMM)[1]. These
      between-group differences were mirrored by missing adaptations of the fatigue-resistant
      skeletal muscle fibre type I in A1ATD patients. This was in contrast to COPD patients without
      A1ATD who increased the proportion of this fibre type after PR. Myofibre type I is crucial
      because it enables patients for physical endurance activities (walking, cycling etc.) during
      their daily life.

      The aim of this study is to compare the effects of an exercise Training program with high vs.
      moderate Training intensity in order to find a Training modality which improves Training
      effects in A1ATD patients.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Patients will be randomized into two Intervention Groups (high vs. moderate Training intensity).
primary purpose: Treatment
masking: None (Open Label)
measure: Endurance shuttle walk test (ESWT)
time frame: Change in the duration of the ESWT from day 1 to day 21
description: The ESWT is performed at 85% of the Peak gate Speed, measured during the Initial incremental shuttle walk test.
measure: Oxygen saturation
time frame: Change in the oxygen saturation at isotime from day 1 to day 21
description: Outcome will be assessed at the the time Point of the end of the shortest ESWT ("isotime").
measure: Heart rate
time frame: Change in the heart rate at isotime from day 1 to day 21
description: Outcome will be assessed at the the time Point of the end of the shortest ESWT ("isotime").
measure: Partial pressure of carbon dioxide (CO2)
time frame: Change in the partial pressure of CO2 at isotime from day 1 to day 21
description: Parameter will be measured by Sentec (R) device. Outcome will be assessed at the the time Point of the end of the shortest ESWT ("isotime").
measure: Lactate concentration
time frame: Change in lactate concentration at isotime from day 1 to day 21
description: Outcome will be assessed at the the time Point of the end of the shortest ESWT ("isotime").
measure: Perceived Dyspnea
time frame: Change in perceived dyspnea at isotime from day 1 to day 21
description: Dyspnea will be rated on a 0 to 10-point BORG scale where lower values represent less dyspnea and vice versa. The total score will be assessed at the the time Point of the end of the shortest ESWT ("isotime").
measure: Strength capacity in knee extension
time frame: Change in strength from day 1 to day 21
description: Strength will be measured by a Hand Held Dynamometer (Microfet (R)).
measure: Balance performance
time frame: Change in balance performance from day 1 to day 21
description: absolute path length will be measured on a force plate (Leonardo (R)) during the Tandem stance
arm group label: High training intensity
arm group type: Experimental
description: Exercise Training with high intensities consists of a cycling Interval Training at 100% of the individual Peak work rate, resistance Training for 3 sets à 8 repetitions and squats on a Vibration plate.
arm group label: moderate training intensity
arm group type: Active Comparator
description: Exercise Training with moderate intensities consists of a cycling endurance Training at 60% of the individual Peak work rate, resistance Training for 3 sets à 20 repetitions and squats on the floor.
intervention type: Procedure
intervention name: Exercise training
description: Patients perform an exercise Training program of 3 weeks Duration including endurance Training, resistance Training and squat Training. This program is part of an inpatient pulmonary Rehabilitation.
arm group label: High training intensity
arm group label: moderate training intensity
criteria: 
gender: All
minimum age: 40 Years
maximum age: 80 Years
healthy volunteers: No
last name: Klaus Kenn, Prof. Dr.
role: Principal Investigator
affiliation: Schoen Klinik Berchtesgadener Land
last name: Klaus Kenn, Prof. Dr.
phone: 0865293
phone ext: 1540
email: kkenn@schoen-klinik.de
last name: Inga Jarosch, Dr.
phone: 0865293
phone ext: 1730
email: ijarosch@schoen-klinik.de
facility: 
status: Recruiting
contact: 
contact backup: 
country: Germany
responsible party type: Principal Investigator
investigator affiliation: Schön Klinik Berchtesgadener Land
investigator full name: Klaus Kenn
investigator title: Head physician
mesh term: Alpha 1-Antitrypsin Deficiency
mesh term: Lung Diseases, Obstructive
mesh term: Pulmonary Disease, Chronic Obstructive
sharing ipd: No