<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/NCT03752892</url>
  </required_header>
  <id_info>
    <org_study_id>1L-IPF-RCT-RG2018</org_study_id>
    <nct_id>NCT03752892</nct_id>
  </id_info>
  <brief_title>Partitioned Training of Patients With Idiopathic Pulmonary Fibrosis</brief_title>
  <official_title>Randomized Controlled Trial of Partitioned Aerobic Exercise Training of Patients With Idiopathic Pulmonary Fibrosis</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>West Park Healthcare Centre</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>West Park Healthcare Centre</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>
      Idiopathic pulmonary fibrosis (IPF) is a lung disease that limits the ability to breathe&#xD;
      enough for a good workout. One way to improve the exercise training is to reduce the number&#xD;
      of muscles being trained together. By training one leg at a time, the patient does not have&#xD;
      to breathe as much allowing each leg a better workout. Our groundwork suggests it may work in&#xD;
      patients with IPF. This study will help decide whether one-legged exercise training is better&#xD;
      at improving a patient's exercise endurance compared to the usual way of exercising with both&#xD;
      legs at the same time.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Dyspnea is a major clinical manifestation of idiopathic pulmonary fibrosis (IPF). It becomes&#xD;
      more severe and more limiting as the condition progresses. Many professional respiratory&#xD;
      societies recommend that the standard of care for IPF includes pulmonary rehabilitation (PR).&#xD;
      However, some patients with IPF are so limited by dyspnea that they are unable to tolerate&#xD;
      levels of aerobic exercise training sufficient to induce the physiological adaptations that&#xD;
      will improve functional and health related outcomes. Therefore, there is a need for exercise&#xD;
      training interventions that will enhance the muscle training stimulus above that currently&#xD;
      possible in individuals with a marked ventilatory limitation.&#xD;
&#xD;
      Partitioning large muscle exercise using one-legged high intensity training is more effective&#xD;
      than conventional aerobic training when applied to patients with central ventilatory or&#xD;
      cardiac limitation. Effective partitioned exercise enables an increased muscle load with less&#xD;
      ventilatory load. It increases the training stimulus to the muscles as they work at a high&#xD;
      intensity, relative to their current aerobic state, necessary to increase their capacity. As&#xD;
      long as the active muscle mass can create the same demands on the central exercise components&#xD;
      of the heart and circulation as does conventional two-legged exercise, this simple,&#xD;
      inexpensive novel approach, will stimulate leg muscles sufficiently to improve overall&#xD;
      cardiorespiratory fitness. For example, in those with chronic obstructive pulmonary disease,&#xD;
      one-legged training has been shown to provide a muscle specific stimulus sufficient to&#xD;
      improve whole body peak oxygen uptake during pulmonary rehabilitation. A preliminary acute&#xD;
      study of patients with IPF has demonstrated that during a laboratory simulation of an&#xD;
      exercise training session, partitioning aerobic exercise extended exercise tolerance.&#xD;
      Participants achieved double the work whilst exercising with one leg compared with two-legged&#xD;
      cycle exercise. Partitioned training may therefore be an effective approach to exercise&#xD;
      training in patients with IPF enrolled in PR.&#xD;
&#xD;
      The advent of pharmacological agents that stabilize the clinical course of IPF presents a&#xD;
      window of opportunity for exercise rehabilitation to further improve function. The aim of&#xD;
      this proposed study is to determine whether, within the setting of PR, partitioned aerobic&#xD;
      exercise training with a one-legged cycle training regime is more effective than the&#xD;
      conventional two-legged regimen in increasing exercise tolerance. The study hypothesis is&#xD;
      that partitioned aerobic exercise training, using a one-legged training regime is more&#xD;
      effective than conventional two-legged exercise training in increasing exercise tolerance&#xD;
      (measured by constant power endurance) and cardiorespiratory fitness as measured by maximal&#xD;
      oxygen uptake. The results will inform the best approach to produce clinically meaningful&#xD;
      improvements in dyspnea and health status for those with IPF.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">March 1, 2019</start_date>
  <completion_date type="Anticipated">October 31, 2024</completion_date>
  <primary_completion_date type="Anticipated">March 31, 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>prospective, randomized controlled trial</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Single (Outcomes Assessor)</masking>
    <masking_description>assessor of the primary outcomes will be blind to the participant's group allocation</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Cycle exercise endurance time</measure>
    <time_frame>Change from Baseline at discharge from 8 weeks of pulmonary rehabilitation</time_frame>
    <description>tolerance (time) of a constant power high intensity cycle endurance test</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>health-related quality of life</measure>
    <time_frame>Change from Baseline at discharge from 8 weeks of pulmonary rehabilitation</time_frame>
    <description>using the questionnaire 'A Tool to Assess Quality of life in IPF' [ATAQ-IPF]</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">50</enrollment>
  <condition>Lung; Disease, Interstitial, With Fibrosis</condition>
  <arm_group>
    <arm_group_label>intervention -1-leg cycle training</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Primary aerobic training component one-legged, partitioned, cycle training. A progressive approach to combined intensity and duration will be taken. A cycle starting with intermittent high intensity one-legged exercise progressing to continuous duration of the target duration of 15 min for each leg and then restarting the cycle at a higher intensity.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>usual care - 2-leg cycle training</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Primary aerobic training component conventional two-legged cycle training. A progressive approach to combined intensity and duration will be taken. A cycle starting with intermittent high intensity exercise progressing to continuous duration of 30 min and then restarting the cycle at a higher intensity.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>intervention -1-leg cycle training</intervention_name>
    <description>partitioned aerobic exercise training</description>
    <arm_group_label>intervention -1-leg cycle training</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>usual care - 2-leg cycle training</intervention_name>
    <description>conventional aerobic exercise training</description>
    <arm_group_label>usual care - 2-leg cycle training</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  confirmed idiopathic pulmonary fibrosis&#xD;
&#xD;
          -  Clinically stable&#xD;
&#xD;
          -  enrolled in pulmonary rehabilitation&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  co-morbidities that might impair their ability to safely complete a pulmonary&#xD;
             rehabilitation program&#xD;
&#xD;
          -  complete a pulmonary rehabilitation program within the previous 6 months&#xD;
&#xD;
          -  experienced an exacerbation less than six weeks before participation&#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>Roger S Goldstein</last_name>
    <role>Principal Investigator</role>
    <affiliation>West Park Healthcare Centre</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Tom Dolmage</last_name>
    <phone>1-416-243-3600</phone>
    <phone_ext>2185</phone_ext>
    <email>tom.dolmage@westpark.org</email>
  </overall_contact>
  <location>
    <facility>
      <name>West Park Healthcare Centre</name>
      <address>
        <city>Toronto</city>
        <state>Ontario</state>
        <zip>M6M 2J5</zip>
        <country>Canada</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Tom Dolmage</last_name>
      <phone>4162433600</phone>
      <email>tom.dolmage@westpark.org</email>
    </contact>
  </location>
  <location_countries>
    <country>Canada</country>
  </location_countries>
  <verification_date>May 2023</verification_date>
  <study_first_submitted>November 20, 2018</study_first_submitted>
  <study_first_submitted_qc>November 21, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">November 26, 2018</study_first_posted>
  <last_update_submitted>May 5, 2023</last_update_submitted>
  <last_update_submitted_qc>May 5, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">May 8, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>West Park Healthcare Centre</investigator_affiliation>
    <investigator_full_name>Roger Goldstein</investigator_full_name>
    <investigator_title>Director, Program in Respiratory Rehabilitation</investigator_title>
  </responsible_party>
  <keyword>pulmonary rehabilitation</keyword>
  <keyword>exercise training</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Pulmonary Fibrosis</mesh_term>
    <mesh_term>Idiopathic Pulmonary Fibrosis</mesh_term>
    <mesh_term>Lung Diseases</mesh_term>
    <mesh_term>Lung Diseases, Interstitial</mesh_term>
    <mesh_term>Fibrosis</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/NCT03752892
org study id: 1L-IPF-RCT-RG2018
nct id: NCT03752892
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Idiopathic pulmonary fibrosis (IPF) is a lung disease that limits the ability to breathe
      enough for a good workout. One way to improve the exercise training is to reduce the number
      of muscles being trained together. By training one leg at a time, the patient does not have
      to breathe as much allowing each leg a better workout. Our groundwork suggests it may work in
      patients with IPF. This study will help decide whether one-legged exercise training is better
      at improving a patient's exercise endurance compared to the usual way of exercising with both
      legs at the same time.
Dyspnea is a major clinical manifestation of idiopathic pulmonary fibrosis (IPF). It becomes
      more severe and more limiting as the condition progresses. Many professional respiratory
      societies recommend that the standard of care for IPF includes pulmonary rehabilitation (PR).
      However, some patients with IPF are so limited by dyspnea that they are unable to tolerate
      levels of aerobic exercise training sufficient to induce the physiological adaptations that
      will improve functional and health related outcomes. Therefore, there is a need for exercise
      training interventions that will enhance the muscle training stimulus above that currently
      possible in individuals with a marked ventilatory limitation.

      Partitioning large muscle exercise using one-legged high intensity training is more effective
      than conventional aerobic training when applied to patients with central ventilatory or
      cardiac limitation. Effective partitioned exercise enables an increased muscle load with less
      ventilatory load. It increases the training stimulus to the muscles as they work at a high
      intensity, relative to their current aerobic state, necessary to increase their capacity. As
      long as the active muscle mass can create the same demands on the central exercise components
      of the heart and circulation as does conventional two-legged exercise, this simple,
      inexpensive novel approach, will stimulate leg muscles sufficiently to improve overall
      cardiorespiratory fitness. For example, in those with chronic obstructive pulmonary disease,
      one-legged training has been shown to provide a muscle specific stimulus sufficient to
      improve whole body peak oxygen uptake during pulmonary rehabilitation. A preliminary acute
      study of patients with IPF has demonstrated that during a laboratory simulation of an
      exercise training session, partitioning aerobic exercise extended exercise tolerance.
      Participants achieved double the work whilst exercising with one leg compared with two-legged
      cycle exercise. Partitioned training may therefore be an effective approach to exercise
      training in patients with IPF enrolled in PR.

      The advent of pharmacological agents that stabilize the clinical course of IPF presents a
      window of opportunity for exercise rehabilitation to further improve function. The aim of
      this proposed study is to determine whether, within the setting of PR, partitioned aerobic
      exercise training with a one-legged cycle training regime is more effective than the
      conventional two-legged regimen in increasing exercise tolerance. The study hypothesis is
      that partitioned aerobic exercise training, using a one-legged training regime is more
      effective than conventional two-legged exercise training in increasing exercise tolerance
      (measured by constant power endurance) and cardiorespiratory fitness as measured by maximal
      oxygen uptake. The results will inform the best approach to produce clinically meaningful
      improvements in dyspnea and health status for those with IPF.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: prospective, randomized controlled trial
primary purpose: Treatment
masking: Single (Outcomes Assessor)
masking description: assessor of the primary outcomes will be blind to the participant's group allocation
measure: Cycle exercise endurance time
time frame: Change from Baseline at discharge from 8 weeks of pulmonary rehabilitation
description: tolerance (time) of a constant power high intensity cycle endurance test
measure: health-related quality of life
time frame: Change from Baseline at discharge from 8 weeks of pulmonary rehabilitation
description: using the questionnaire 'A Tool to Assess Quality of life in IPF' [ATAQ-IPF]
arm group label: intervention -1-leg cycle training
arm group type: Experimental
description: Primary aerobic training component one-legged, partitioned, cycle training. A progressive approach to combined intensity and duration will be taken. A cycle starting with intermittent high intensity one-legged exercise progressing to continuous duration of the target duration of 15 min for each leg and then restarting the cycle at a higher intensity.
arm group label: usual care - 2-leg cycle training
arm group type: Active Comparator
description: Primary aerobic training component conventional two-legged cycle training. A progressive approach to combined intensity and duration will be taken. A cycle starting with intermittent high intensity exercise progressing to continuous duration of 30 min and then restarting the cycle at a higher intensity.
intervention type: Other
intervention name: intervention -1-leg cycle training
description: partitioned aerobic exercise training
arm group label: intervention -1-leg cycle training
intervention type: Other
intervention name: usual care - 2-leg cycle training
description: conventional aerobic exercise training
arm group label: usual care - 2-leg cycle training
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Roger S Goldstein
role: Principal Investigator
affiliation: West Park Healthcare Centre
last name: Tom Dolmage
phone: 1-416-243-3600
phone ext: 2185
email: tom.dolmage@westpark.org
facility: 
status: Recruiting
contact: 
country: Canada
responsible party type: Principal Investigator
investigator affiliation: West Park Healthcare Centre
investigator full name: Roger Goldstein
investigator title: Director, Program in Respiratory Rehabilitation
mesh term: Pulmonary Fibrosis
mesh term: Idiopathic Pulmonary Fibrosis
mesh term: Lung Diseases
mesh term: Lung Diseases, Interstitial
mesh term: Fibrosis
sharing ipd: No