<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/NCT03800914</url>
  </required_header>
  <id_info>
    <org_study_id>LTU HIIT in ILD</org_study_id>
    <nct_id>NCT03800914</nct_id>
  </id_info>
  <brief_title>High Intensity Interval Training in Fibrotic Interstitial Lung Disease</brief_title>
  <acronym>HIIT in fILD</acronym>
  <official_title>High Intensity Interval Training in Fibrotic Interstitial Lung Disease: a Randomized Controlled Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Monash University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Monash University</source>
  <oversight_info>
    <has_dmc>Yes</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 fibrotic interstitial lung diseases (fILD) is a group of debilitating chronic lung&#xD;
      conditions that are characterised by scarring of lung tissue, dyspnoea on exertion and&#xD;
      significant physical impairment. Exercise training is recommended for people with fILD in&#xD;
      improving breathlessness and exercise tolerance. However, despite the best efforts of&#xD;
      patients and clinicians, many of those who participate are not attaining its benefits. The&#xD;
      current exercise training strategies of moderate intensity continuous training may not be&#xD;
      well suited to fILD. High intensity interval training (HIIT), short bouts of high-intensity&#xD;
      exercise regularly interspersed with periods of rest or light exercise may be an alternate&#xD;
      exercise training option for people with fILD.&#xD;
&#xD;
      The study will determine to whether HIIT is better than the current method of continuous&#xD;
      exercise training at moderate intensity in improving exercise tolerance, breathlessness and&#xD;
      quality of life in people with fILD. A randomised controlled, assessor blinded trial will be&#xD;
      conducted. A total 130 people with fILD will be randomly assigned to moderate intensity&#xD;
      continuous training or HIIT. If this trial demonstrates that HIIT is effective, it will&#xD;
      provide an exercise training strategy that can readily be implemented in practice that will&#xD;
      maximise the outcomes of exercise training for people with fILD.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Interstitial lung disease (ILD) is a chronic lung condition characterized by scarring of lung&#xD;
      tissue. This stiffening of the lungs impairs breathing and reduces the amount of oxygen being&#xD;
      delivered throughout the body limiting the ability to perform daily and physical activity.&#xD;
      Around two-thirds of people with ILD have fibrotic ILD (fILD), a type of ILD, which typically&#xD;
      has worse impairment and disability than other types of ILD. There is no cure for these&#xD;
      conditions, although there are two new pharmacological therapies that slow the decline in&#xD;
      lung function in Idiopathic Pulmonary Fibrosis (IPF), the most common type of fILD. These&#xD;
      treatments however do not provide improvement in breathlessness, exercise capacity or&#xD;
      health-related quality of life (HRQoL).&#xD;
&#xD;
      Exercise training, or Pulmonary Rehabilitation (PR), has shown to be effective at improving&#xD;
      exercise tolerance and HRQoL in ILD. The investigators recently demonstrated that, at a group&#xD;
      level, exercise training exerts a positive effect across varying subtypes of ILD, including&#xD;
      IPF, the most rapidly progressive of all the fILDs. However less than half of those with IPF&#xD;
      who undertook the exercise training achieved meaningful improvements in exercise capacity. In&#xD;
      addition, a large proportion of people with IPF were unable to keep up with the recommended&#xD;
      exercise training level, often due to excessive dyspnoea or desaturation. This suggests the&#xD;
      current exercise training strategies used in PR, which were adopted from guidelines for&#xD;
      patients with chronic obstructive pulmonary disease (COPD), may not provide the optimal&#xD;
      exercise stimuli for fILD. High intensity interval training (HIIT), which is short bouts of&#xD;
      high intensity exercise regularly interspersed with periods of rest or light exercise, may be&#xD;
      an alternate exercise training option for people with fILD. However, it is unknown whether&#xD;
      this kind of exercise training achieves superior benefits to the traditional model of PR.&#xD;
&#xD;
      The aim of this project is to determine whether HIIT is better than the current method of&#xD;
      continuous exercise training at moderate intensity, in improving exercise capacity,&#xD;
      breathlessness and HRQoL in people with fILD. A total 130 people with fILD will be recruited.&#xD;
      The trial will be conducted at four hospital sites across Australia. People who agree to take&#xD;
      part in the study will be randomly allocated into two groups. Group 1 will undergo the&#xD;
      traditional PR model of moderate intensity continuous exercise training and group 2 will&#xD;
      undergo HIIT. Participants in both groups will participate in exercise training twice weekly&#xD;
      for eight weeks. The participants will be monitored continuously during exercise by an&#xD;
      experienced physiotherapist or exercise physiologist. At the beginning and the end of the&#xD;
      eight weeks of exercise training, and six months later, participants will undergo&#xD;
      measurements of exercise capacity and health status. This study will determine whether HIIT&#xD;
      is effective, providing an important exercise training strategy that can be readily used for&#xD;
      people with fILD to achieve positive benefits from PR.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">July 17, 2019</start_date>
  <completion_date type="Anticipated">December 2022</completion_date>
  <primary_completion_date type="Anticipated">December 2022</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>Single (Outcomes Assessor)</masking>
    <masking_description>Blinded assessor</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Change in endurance time</measure>
    <time_frame>Baseline, nine weeks and 6 months following intervention</time_frame>
    <description>Endurance time measured during constant work rate test (CWRT) at 75% of the peak work rate achieved on a baseline cardiopulmonary exercise test (CPET).</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in dyspnea measured using the Dyspnea-12 questionnaire</measure>
    <time_frame>Baseline, nine weeks and 6 months following intervention</time_frame>
    <description>Dyspnea-12 is a uni-dimensional 12-item questionnaire divided in 2 domains: physical items (1 to 7) and affective items (8-12). Each item evaluate breathing experience and can be scored as: None (0), Mild (1), Moderate (2) or Severe (3). Results of this questionnaire will be reported as total score that can range from 0 to 36 and separate scores that can range from 0 to 21 for physical component and 0 to 15 for affective component. Higher scores indicate worse dyspnea.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in fatigue evaluated by the Fatigue Severity Scale</measure>
    <time_frame>Baseline, nine weeks and 6 months following intervention</time_frame>
    <description>Fatigue Severity Scale (FSS), a self reported rating scale including 9 items to measure how fatigue affects motivation, exercise, physical functioning, carrying out duties and how fatigue interferes with work, family, or social life. Each item is scored on a 7 point scale in which 1 = strongly disagree and 7= strongly agree. Total score range from 9 to 63. Higher scores indicate greater fatigue severity.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in health related quality of life using the St George's Respiratory Questionnaire idiopathic pulmonary fibrosis specific version (SGRQ-I)</measure>
    <time_frame>Baseline, nine weeks and 6 months following intervention</time_frame>
    <description>The SGRQ-I is a disease specific HRQoL measure with similar psychometric properties to the original SGRQ that is designed to be more relevant in patients with IPF. The questionnaire is divided in 3 domains: Symptoms (frequency and severity), Activity (activities that cause or are limited by breathlessness) and Impact (social functioning and psychological disturbances resulting from airways disease). Values of each domain as well as the total score value will be reported. Each item is weighted based on empirical data. Total score and scores in each domain can range from 0 to 100. Higher scores indicate more limitations in quality of life.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in health related quality of life using the chronic respiratory disease questionnaire (CRQ)</measure>
    <time_frame>Baseline, nine weeks and 6 months following intervention</time_frame>
    <description>The CRQ consists of 20 items across 4 domains: Dyspnea (activities that cause breathlessness and are performed frequently), fatigue, emotional function and mastery ( the patient's feeling of control over their disease). Each domain includes four to seven items, and each item is scored on a 7-point Likert score. Total scores for each domain range from 4-35. Values of each domain will be reported. Lower scores indicate more limitations in quality of life.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in anxiety and depression measured by the Hospital Anxiety and Depression Scale</measure>
    <time_frame>Baseline, nine weeks and 6 months following intervention</time_frame>
    <description>Hospital Anxiety and Depression Scale (HADS), a scale with 14 items divided into two domains : anxiety symptoms (7 items) and depression symptoms (7 items). Each item can be scored from 0 to 3. Scores from each domain can vary from 0 to 21 and are stratified as follows: 0-7 (indicates absence of anxiety/depression symptoms); 8-10 ( presence of symptoms of anxiety and depression in moderate degree - borderline); 11 or more (significant number of anxiety/depression symptoms - confirmed cases). Score of each domain as well as number of confirmed cases will be reported.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in functional exercise capacity assessed by 6-minute walk distance</measure>
    <time_frame>Baseline, nine weeks and 6 months following intervention</time_frame>
    <description>Distance in meters achieved on a 6-minute walk test</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in skeletal muscle size</measure>
    <time_frame>Baseline, nine weeks and 6 months following intervention</time_frame>
    <description>Change in cross-sectional area of the Quadriceps will be measured by B-mode ultrasonography</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Dyspnea related disability - measured with modified medical research council scale (MMRC)</measure>
    <time_frame>Baseline, nine weeks and 6 months following intervention</time_frame>
    <description>The MMRC rates dyspnea according to different levels activity on a 5-point scale (grade 0-4), with grade 4 representing the greatest level of dyspnea impairment.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Global rating of change</measure>
    <time_frame>Baseline, nine weeks and 6 months following intervention</time_frame>
    <description>The global rating of change will assess the participants' overall self-perceived change in health by asking the participant to rate their change as either 'worse', 'about the same' or 'better'. The extent of change ( (i.e., worsening or improvement) is then graded on a Likert scale from one to seven.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in physical activity</measure>
    <time_frame>Baseline, nine weeks and 6 months following intervention</time_frame>
    <description>Time spent sedentary and in physical activity of various intensities will be measured by a wrist-worn, tri-axial accelerometer.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">130</enrollment>
  <condition>Fibrotic Interstitial Lung Disease</condition>
  <arm_group>
    <arm_group_label>High Intensity Interval Training</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants will undergo a twice-weekly supervised exercise training program for eight weeks. Each session will involve 36 minutes of interval aerobic exercise on a cycle ergometer alternating every 30 seconds between 100% of peak work rate, achieved on the cardiopulmonary exercise test (CPET), plus upper and lower resistance training.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Traditional pulmonary rehabilitation</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Participants will undergo a twice-weekly supervised exercise training program for eight weeks. Each session will involve 30 minutes of continuous aerobic exercise on a cycle ergometer at 60% of the peak work rate achieved on the CPET, plus upper and lower resistance training.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>High intensity interval training</intervention_name>
    <description>36 minutes of interval exercise on cycle ergometer alternating every 30 seconds between 100% peak work rate achieved on cardiopulmonary exercise test and unloaded cycling</description>
    <arm_group_label>High Intensity Interval Training</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Traditional pulmonary rehabilitation</intervention_name>
    <description>30 minutes of continuous exercise on cycle ergometer at 60% peak work rate achieved on cardiopulmonary exercise test.</description>
    <arm_group_label>Traditional pulmonary rehabilitation</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Diagnosis of fibrotic interstitial lung disease (fILD)&#xD;
&#xD;
          -  Able to read and speak English&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Resting oxygen saturation (SpO2) is &lt; 85%&#xD;
&#xD;
          -  Severe pulmonary hypertension (WHO class IV)&#xD;
&#xD;
          -  Attendance at Pulmonary rehabilitation (PR) within last 12 months&#xD;
&#xD;
          -  Comorbidities which preclude exercise training&#xD;
&#xD;
          -  History of syncope on exertion&#xD;
&#xD;
          -  Significant cognitive impairment&#xD;
&#xD;
          -  Anticipated transplant or death within the duration of the study period&#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>Anne Holland</last_name>
    <role>Study Director</role>
    <affiliation>Monash University</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Anne Holland</last_name>
    <phone>+61 3 99030214</phone>
    <email>anne.holland@monash.edu</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Leona Dowman</last_name>
    <email>leonadowman@gmail.com</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Royal Prince Alfred Hospital</name>
      <address>
        <city>Sydney</city>
        <state>New South Wales</state>
        <zip>2050</zip>
        <country>Australia</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
  </location>
  <location>
    <facility>
      <name>Prince Charles Hospital</name>
      <address>
        <city>Brisbane</city>
        <state>Queensland</state>
        <zip>4032</zip>
        <country>Australia</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
  </location>
  <location>
    <facility>
      <name>Austin Health</name>
      <address>
        <city>Heidelberg</city>
        <state>Victoria</state>
        <zip>3084</zip>
        <country>Australia</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Alfred Health</name>
      <address>
        <city>Melbourne</city>
        <state>Victoria</state>
        <zip>3004</zip>
        <country>Australia</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location_countries>
    <country>Australia</country>
  </location_countries>
  <verification_date>August 2021</verification_date>
  <study_first_submitted>January 9, 2019</study_first_submitted>
  <study_first_submitted_qc>January 9, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 11, 2019</study_first_posted>
  <last_update_submitted>August 30, 2021</last_update_submitted>
  <last_update_submitted_qc>August 30, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">September 1, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Monash University</investigator_affiliation>
    <investigator_full_name>Anne E Holland PhD, FThorSoc</investigator_full_name>
    <investigator_title>Professor</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Lung Diseases</mesh_term>
    <mesh_term>Lung Diseases, Interstitial</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/NCT03800914
org study id: LTU HIIT in ILD
nct id: NCT03800914
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
The fibrotic interstitial lung diseases (fILD) is a group of debilitating chronic lung
      conditions that are characterised by scarring of lung tissue, dyspnoea on exertion and
      significant physical impairment. Exercise training is recommended for people with fILD in
      improving breathlessness and exercise tolerance. However, despite the best efforts of
      patients and clinicians, many of those who participate are not attaining its benefits. The
      current exercise training strategies of moderate intensity continuous training may not be
      well suited to fILD. High intensity interval training (HIIT), short bouts of high-intensity
      exercise regularly interspersed with periods of rest or light exercise may be an alternate
      exercise training option for people with fILD.

      The study will determine to whether HIIT is better than the current method of continuous
      exercise training at moderate intensity in improving exercise tolerance, breathlessness and
      quality of life in people with fILD. A randomised controlled, assessor blinded trial will be
      conducted. A total 130 people with fILD will be randomly assigned to moderate intensity
      continuous training or HIIT. If this trial demonstrates that HIIT is effective, it will
      provide an exercise training strategy that can readily be implemented in practice that will
      maximise the outcomes of exercise training for people with fILD.
Interstitial lung disease (ILD) is a chronic lung condition characterized by scarring of lung
      tissue. This stiffening of the lungs impairs breathing and reduces the amount of oxygen being
      delivered throughout the body limiting the ability to perform daily and physical activity.
      Around two-thirds of people with ILD have fibrotic ILD (fILD), a type of ILD, which typically
      has worse impairment and disability than other types of ILD. There is no cure for these
      conditions, although there are two new pharmacological therapies that slow the decline in
      lung function in Idiopathic Pulmonary Fibrosis (IPF), the most common type of fILD. These
      treatments however do not provide improvement in breathlessness, exercise capacity or
      health-related quality of life (HRQoL).

      Exercise training, or Pulmonary Rehabilitation (PR), has shown to be effective at improving
      exercise tolerance and HRQoL in ILD. The investigators recently demonstrated that, at a group
      level, exercise training exerts a positive effect across varying subtypes of ILD, including
      IPF, the most rapidly progressive of all the fILDs. However less than half of those with IPF
      who undertook the exercise training achieved meaningful improvements in exercise capacity. In
      addition, a large proportion of people with IPF were unable to keep up with the recommended
      exercise training level, often due to excessive dyspnoea or desaturation. This suggests the
      current exercise training strategies used in PR, which were adopted from guidelines for
      patients with chronic obstructive pulmonary disease (COPD), may not provide the optimal
      exercise stimuli for fILD. High intensity interval training (HIIT), which is short bouts of
      high intensity exercise regularly interspersed with periods of rest or light exercise, may be
      an alternate exercise training option for people with fILD. However, it is unknown whether
      this kind of exercise training achieves superior benefits to the traditional model of PR.

      The aim of this project is to determine whether HIIT is better than the current method of
      continuous exercise training at moderate intensity, in improving exercise capacity,
      breathlessness and HRQoL in people with fILD. A total 130 people with fILD will be recruited.
      The trial will be conducted at four hospital sites across Australia. People who agree to take
      part in the study will be randomly allocated into two groups. Group 1 will undergo the
      traditional PR model of moderate intensity continuous exercise training and group 2 will
      undergo HIIT. Participants in both groups will participate in exercise training twice weekly
      for eight weeks. The participants will be monitored continuously during exercise by an
      experienced physiotherapist or exercise physiologist. At the beginning and the end of the
      eight weeks of exercise training, and six months later, participants will undergo
      measurements of exercise capacity and health status. This study will determine whether HIIT
      is effective, providing an important exercise training strategy that can be readily used for
      people with fILD to achieve positive benefits from PR.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Outcomes Assessor)
masking description: Blinded assessor
measure: Change in endurance time
time frame: Baseline, nine weeks and 6 months following intervention
description: Endurance time measured during constant work rate test (CWRT) at 75% of the peak work rate achieved on a baseline cardiopulmonary exercise test (CPET).
measure: Change in dyspnea measured using the Dyspnea-12 questionnaire
time frame: Baseline, nine weeks and 6 months following intervention
description: Dyspnea-12 is a uni-dimensional 12-item questionnaire divided in 2 domains: physical items (1 to 7) and affective items (8-12). Each item evaluate breathing experience and can be scored as: None (0), Mild (1), Moderate (2) or Severe (3). Results of this questionnaire will be reported as total score that can range from 0 to 36 and separate scores that can range from 0 to 21 for physical component and 0 to 15 for affective component. Higher scores indicate worse dyspnea.
measure: Changes in fatigue evaluated by the Fatigue Severity Scale
time frame: Baseline, nine weeks and 6 months following intervention
description: Fatigue Severity Scale (FSS), a self reported rating scale including 9 items to measure how fatigue affects motivation, exercise, physical functioning, carrying out duties and how fatigue interferes with work, family, or social life. Each item is scored on a 7 point scale in which 1 = strongly disagree and 7= strongly agree. Total score range from 9 to 63. Higher scores indicate greater fatigue severity.
measure: Change in health related quality of life using the St George's Respiratory Questionnaire idiopathic pulmonary fibrosis specific version (SGRQ-I)
time frame: Baseline, nine weeks and 6 months following intervention
description: The SGRQ-I is a disease specific HRQoL measure with similar psychometric properties to the original SGRQ that is designed to be more relevant in patients with IPF. The questionnaire is divided in 3 domains: Symptoms (frequency and severity), Activity (activities that cause or are limited by breathlessness) and Impact (social functioning and psychological disturbances resulting from airways disease). Values of each domain as well as the total score value will be reported. Each item is weighted based on empirical data. Total score and scores in each domain can range from 0 to 100. Higher scores indicate more limitations in quality of life.
measure: Change in health related quality of life using the chronic respiratory disease questionnaire (CRQ)
time frame: Baseline, nine weeks and 6 months following intervention
description: The CRQ consists of 20 items across 4 domains: Dyspnea (activities that cause breathlessness and are performed frequently), fatigue, emotional function and mastery ( the patient's feeling of control over their disease). Each domain includes four to seven items, and each item is scored on a 7-point Likert score. Total scores for each domain range from 4-35. Values of each domain will be reported. Lower scores indicate more limitations in quality of life.
measure: Change in anxiety and depression measured by the Hospital Anxiety and Depression Scale
time frame: Baseline, nine weeks and 6 months following intervention
description: Hospital Anxiety and Depression Scale (HADS), a scale with 14 items divided into two domains : anxiety symptoms (7 items) and depression symptoms (7 items). Each item can be scored from 0 to 3. Scores from each domain can vary from 0 to 21 and are stratified as follows: 0-7 (indicates absence of anxiety/depression symptoms); 8-10 ( presence of symptoms of anxiety and depression in moderate degree - borderline); 11 or more (significant number of anxiety/depression symptoms - confirmed cases). Score of each domain as well as number of confirmed cases will be reported.
measure: Change in functional exercise capacity assessed by 6-minute walk distance
time frame: Baseline, nine weeks and 6 months following intervention
description: Distance in meters achieved on a 6-minute walk test
measure: Changes in skeletal muscle size
time frame: Baseline, nine weeks and 6 months following intervention
description: Change in cross-sectional area of the Quadriceps will be measured by B-mode ultrasonography
measure: Dyspnea related disability - measured with modified medical research council scale (MMRC)
time frame: Baseline, nine weeks and 6 months following intervention
description: The MMRC rates dyspnea according to different levels activity on a 5-point scale (grade 0-4), with grade 4 representing the greatest level of dyspnea impairment.
measure: Global rating of change
time frame: Baseline, nine weeks and 6 months following intervention
description: The global rating of change will assess the participants' overall self-perceived change in health by asking the participant to rate their change as either 'worse', 'about the same' or 'better'. The extent of change ( (i.e., worsening or improvement) is then graded on a Likert scale from one to seven.
measure: Change in physical activity
time frame: Baseline, nine weeks and 6 months following intervention
description: Time spent sedentary and in physical activity of various intensities will be measured by a wrist-worn, tri-axial accelerometer.
arm group label: High Intensity Interval Training
arm group type: Experimental
description: Participants will undergo a twice-weekly supervised exercise training program for eight weeks. Each session will involve 36 minutes of interval aerobic exercise on a cycle ergometer alternating every 30 seconds between 100% of peak work rate, achieved on the cardiopulmonary exercise test (CPET), plus upper and lower resistance training.
arm group label: Traditional pulmonary rehabilitation
arm group type: Active Comparator
description: Participants will undergo a twice-weekly supervised exercise training program for eight weeks. Each session will involve 30 minutes of continuous aerobic exercise on a cycle ergometer at 60% of the peak work rate achieved on the CPET, plus upper and lower resistance training.
intervention type: Other
intervention name: High intensity interval training
description: 36 minutes of interval exercise on cycle ergometer alternating every 30 seconds between 100% peak work rate achieved on cardiopulmonary exercise test and unloaded cycling
arm group label: High Intensity Interval Training
intervention type: Other
intervention name: Traditional pulmonary rehabilitation
description: 30 minutes of continuous exercise on cycle ergometer at 60% peak work rate achieved on cardiopulmonary exercise test.
arm group label: Traditional pulmonary rehabilitation
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Anne Holland
role: Study Director
affiliation: Monash University
last name: Anne Holland
phone: +61 3 99030214
email: anne.holland@monash.edu
last name: Leona Dowman
email: leonadowman@gmail.com
facility: 
status: Not yet recruiting
facility: 
status: Not yet recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
country: Australia
responsible party type: Principal Investigator
investigator affiliation: Monash University
investigator full name: Anne E Holland PhD, FThorSoc
investigator title: Professor
mesh term: Lung Diseases
mesh term: Lung Diseases, Interstitial