<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/NCT03266575</url>
  </required_header>
  <id_info>
    <org_study_id>17-000852</org_study_id>
    <nct_id>NCT03266575</nct_id>
  </id_info>
  <brief_title>Pulmonary Rehabilitation in End-Stage Liver Disease</brief_title>
  <official_title>Does Pulmonary Rehabilitation Improve Frailty and Sarcopenia in End Stage Liver Disease?</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Mayo Clinic</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Mayo Clinic</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>
      The purpose of this study is to assess the impact of exercise on sarcopenia and frailty. The&#xD;
      exercise that will be performed in this study will include either pulmonary rehabilitation or&#xD;
      a formal home based video strengthening program&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Participants will be randomized into two groups. The Pulmonary Rehabilitation group will&#xD;
      undergo exercise under a supervised setting for a total duration of 12 weeks. Patients will&#xD;
      perform endurance (treadmill or cycle ergometer), strength (weight resistance) and&#xD;
      flexibility training twice a week for a period of an hour per session. Exercises will be&#xD;
      supervised by physiotherapists or exercise physiologists. Compliance and performance will be&#xD;
      monitored by the trainer. They will receive a pedometer for home use. The Home based program&#xD;
      group will perform REST for 10 minutes daily, increasing to 20 minutes daily, after the&#xD;
      second week, in their home environment. The total duration of the intervention will be 12&#xD;
      weeks. Patients will be provided with pedometers, REST video and binder, with instructions on&#xD;
      how to perform exercises, and resistance bands.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">February 1, 2018</start_date>
  <completion_date type="Anticipated">December 2024</completion_date>
  <primary_completion_date type="Anticipated">December 2024</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>randomized to pulmonary rehab vs home based exercise rpogram</intervention_model_description>
    <primary_purpose>Supportive Care</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in 6 minute walk test</measure>
    <time_frame>baseline, 3 months</time_frame>
    <description>Participants will walk on a straight, flat surface for 6 minutes at a self-determined pace.</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">50</enrollment>
  <condition>End Stage Liver Disease</condition>
  <arm_group>
    <arm_group_label>Pulmonary Rehabilitation</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Participants will participate in formal Pulmonary Rehabilitation Exercise program</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Home based program</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Participants will participate in a Home based Exercise program</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Pulmonary Rehabilitation Exercise</intervention_name>
    <description>Participants will undergo Pulmonary Rehabilitation exercise. Participants will perform endurance (treadmill or cycle ergometer), strength (weight resistance) and flexibility training twice a week for a period of an hour per session</description>
    <arm_group_label>Pulmonary Rehabilitation</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Home Based Exercise</intervention_name>
    <description>Participants will undergo Home based exercise program consisting of strength and conditioning. Participants will perform REST for 10 minutes daily, increasing to 20 minutes daily, after the second week, in their home environment. The total duration of the intervention will be 12 weeks. Participants will be provided with pedometers, REST video and binder, with instructions on how to perform exercises, and resistance bands.</description>
    <arm_group_label>Home based program</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  wait listed for liver transplantation with poor 6 MWT&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  age &lt; 18 years&#xD;
&#xD;
          -  recent hospitalization (within 14 days) due to decompensation, variceal bleeding in&#xD;
             the previous 1 month&#xD;
&#xD;
          -  large esophageal varices without primary prophylaxis&#xD;
&#xD;
          -  active excessive alcohol intake (in the previous 3 months)&#xD;
&#xD;
          -  current overt uncontrolled hepatic encephalopathy&#xD;
&#xD;
          -  hepatopulmonary syndrome with uncontrolled hypoxia&#xD;
&#xD;
          -  portopulmonary hypertension&#xD;
&#xD;
          -  inability to perform exercise&#xD;
&#xD;
          -  marked symptomatic comorbidities (cardiac, pulmonary, renal).&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Kymberly D Watt</last_name>
    <role>Principal Investigator</role>
    <affiliation>Mayo Clinic</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Mayo Clinic in Rochester</name>
      <address>
        <city>Rochester</city>
        <state>Minnesota</state>
        <zip>55905</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Kymberly Watt, MD</last_name>
      <phone>507-266-1586</phone>
      <email>watt.kymberly@mayo.edu</email>
    </contact>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <link>
    <url>https://www.mayo.edu/research/clinical-trials</url>
    <description>Mayo Clinic Clinical Trials</description>
  </link>
  <verification_date>November 2022</verification_date>
  <study_first_submitted>March 30, 2017</study_first_submitted>
  <study_first_submitted_qc>August 29, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 30, 2017</study_first_posted>
  <last_update_submitted>November 24, 2022</last_update_submitted>
  <last_update_submitted_qc>November 24, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">November 28, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Mayo Clinic</investigator_affiliation>
    <investigator_full_name>Kymberly D. Watt</investigator_full_name>
    <investigator_title>MD</investigator_title>
  </responsible_party>
  <keyword>Frailty</keyword>
  <keyword>Sarcopenia</keyword>
  <keyword>Pulmonary Rehabilitation</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Liver Diseases</mesh_term>
    <mesh_term>End Stage Liver Disease</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/NCT03266575
org study id: 17-000852
nct id: NCT03266575
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The purpose of this study is to assess the impact of exercise on sarcopenia and frailty. The
      exercise that will be performed in this study will include either pulmonary rehabilitation or
      a formal home based video strengthening program
Participants will be randomized into two groups. The Pulmonary Rehabilitation group will
      undergo exercise under a supervised setting for a total duration of 12 weeks. Patients will
      perform endurance (treadmill or cycle ergometer), strength (weight resistance) and
      flexibility training twice a week for a period of an hour per session. Exercises will be
      supervised by physiotherapists or exercise physiologists. Compliance and performance will be
      monitored by the trainer. They will receive a pedometer for home use. The Home based program
      group will perform REST for 10 minutes daily, increasing to 20 minutes daily, after the
      second week, in their home environment. The total duration of the intervention will be 12
      weeks. Patients will be provided with pedometers, REST video and binder, with instructions on
      how to perform exercises, and resistance bands.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: randomized to pulmonary rehab vs home based exercise rpogram
primary purpose: Supportive Care
masking: None (Open Label)
measure: Change in 6 minute walk test
time frame: baseline, 3 months
description: Participants will walk on a straight, flat surface for 6 minutes at a self-determined pace.
arm group label: Pulmonary Rehabilitation
arm group type: Active Comparator
description: Participants will participate in formal Pulmonary Rehabilitation Exercise program
arm group label: Home based program
arm group type: Active Comparator
description: Participants will participate in a Home based Exercise program
intervention type: Behavioral
intervention name: Pulmonary Rehabilitation Exercise
description: Participants will undergo Pulmonary Rehabilitation exercise. Participants will perform endurance (treadmill or cycle ergometer), strength (weight resistance) and flexibility training twice a week for a period of an hour per session
arm group label: Pulmonary Rehabilitation
intervention type: Behavioral
intervention name: Home Based Exercise
description: Participants will undergo Home based exercise program consisting of strength and conditioning. Participants will perform REST for 10 minutes daily, increasing to 20 minutes daily, after the second week, in their home environment. The total duration of the intervention will be 12 weeks. Participants will be provided with pedometers, REST video and binder, with instructions on how to perform exercises, and resistance bands.
arm group label: Home based program
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Kymberly D Watt
role: Principal Investigator
affiliation: Mayo Clinic
facility: 
status: Recruiting
contact: 
country: United States
url: https://www.mayo.edu/research/clinical-trials
description: Mayo Clinic Clinical Trials
responsible party type: Principal Investigator
investigator affiliation: Mayo Clinic
investigator full name: Kymberly D. Watt
investigator title: MD
mesh term: Liver Diseases
mesh term: End Stage Liver Disease
sharing ipd: No