Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Skeletal Muscle Function in Interstitial Lung Disease

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03800017
Recruitment Status : Not yet recruiting
First Posted : January 10, 2019
Last Update Posted : June 19, 2019
Sponsor:
Information provided by (Responsible Party):
Jordan Guenette, University of British Columbia

Brief Summary:
Dyspnea (i.e. breathlessness) and exercise intolerance are common symptoms for patients with interstitial lung disease (ILD), yet it is not known why. It has been suggested that muscle dysfunction may contribute to dyspnea and exercise intolerance in ILD. Our study aims to: i) examine differences in the structure and function of the leg muscles in ILD patients, ii) determine if leg muscle fatigue contributes to dyspnea and exercise limitation in patients with ILD, and iii) determine the effects of breathing extra oxygen on leg muscle fatigue, as well as ability to exercise in ILD patients.

Condition or disease Intervention/treatment Phase
Interstitial Lung Disease Idiopathic Pulmonary Fibrosis Hypersensitivity Pneumonitis Scleroderma Nonspecific Interstitial Pneumonia Biological: Hyperoxia Not Applicable

  Show Detailed Description

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Basic Science
Official Title: Investigating the Role of Skeletal Muscle Dysfunction on Dyspnea and Exercise Intolerance in Interstitial Lung Disease
Estimated Study Start Date : September 1, 2019
Estimated Primary Completion Date : August 31, 2021
Estimated Study Completion Date : August 31, 2021


Arm Intervention/treatment
Experimental: Hyperoxia
During exercise on visit 4, participants in both groups (i.e., ILD patients and controls) will breathe supplemental oxygen (i.e., 60% oxygen) during constant-load exercise.
Biological: Hyperoxia
Participants breathe 60% oxygen during exercise

Placebo Comparator: Healthy Controls
During exercise on visit 3, participants in both groups (i.e., ILD patients and controls) will breathe ambient air (i.e., 20.93% oxygen) during constant-load exercise.
Biological: Hyperoxia
Participants breathe 60% oxygen during exercise




Primary Outcome Measures :
  1. Change in standardized dyspnea score during the constant load exercise test (visit 3) [ Time Frame: Dyspnea will be measured once every minute during exercise on visit 3 (up to 7 weeks after baseline) until participants reach volitional exhaustion (assessed for up to 30 minutes) ]
    Dyspnea rating, measured using the Borg 0-10 category ratio scale, will be assessed every 1 minute during the constant-load exercise test on visit 3.

  2. Change in standardized dyspnea score during the constant load exercise test (visit 4) [ Time Frame: Dyspnea will be measured once every minute during exercise on visit 4 (up to 8 weeks after baseline) until participants reach volitional exhaustion (assessed for up to 30 minutes) ]
    Dyspnea rating, measured using the Borg 0-10 category ratio scale, will be assessed every 1 minute during the constant-load exercise test on visit 4.

  3. Change in leg muscle strength measured following the constant load exercise test (visit 3) [ Time Frame: Leg muscle strength will be measured before and after exercise (assessed for up to 40 minutes) on visit 3 (up to 8 weeks after baseline) ]
    Leg muscle strength will be measured before (at rest) and 3 min after the constant-load exercise test on visit 3 using the femoral magnetic stimulation technique.

  4. Change in leg muscle strength measured following the constant load exercise test (visit 4) [ Time Frame: Leg muscle strength will be measured before and after exercise (assessed for up to 40 minutes) on visit 4 (up to 8 weeks after baseline) ]
    Leg muscle strength will be measured before (at rest) and 3 min after the constant-load exercise test on visit 4 using the femoral magnetic stimulation technique.


Secondary Outcome Measures :
  1. Quadriceps muscle oxidative capacity measured using near-infrared spectroscopy [ Time Frame: On visit 2, approximately 3 weeks post-baseline (visit 1) ]
    Quadriceps muscle oxidative capacity will measured using near-infrared spectroscopy. Parameters will be measured over 5 minutes once on visit 2

  2. Quadriceps muscle volume measured using magnetic resonance imaging [ Time Frame: On visit 2, approximately 3 weeks post-baseline (visit 1) ]
    Quadriceps muscle volume will be measured using magnetic resonance imaging. Parameters will be measured over 15 minutes once on visit 2



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   40 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria for ILD Patients:

  • Age 40-80 years (inclusive)
  • A multidisciplinary diagnosis of idiopathic pulmonary fibrosis (IPF), idiopathic fibrotic nonspecific interstitial pneumonia (NSIP), chronic hypersensitivity pneumonitis (HP), or unclassifiable ILD with a differential diagnosis that consists of the above diagnoses
  • Fibrosis on high resolution computed tomography (HRCT): honeycombing, reticulation, or traction bronchiectasis
  • Appropriate candidate for pulmonary rehabilitation
  • 6 minute walk distance 50m or more
  • Oxygen saturation ≥ 92% by pulse oximetry at rest while breathing room air
  • Clinically stable for the preceding 6 weeks
  • Can fluently read and write in English

Inclusion Criteria for Healthy Controls:

  • Age 40-80 (inclusive)
  • Normal pulmonary function (80-120% predicted)
  • No lung or cardiovascular disease
  • Can fluently read and write in English

Exclusion Criteria for the ILD patients:

  • Contraindication to exercise testing (e.g. significant cardiovascular, musculoskeletal, neurological disease)
  • Other significant extra-pulmonary disease that, based on clinical assessment, could impair exercise capacity and/or oxygenation
  • Forced vital capacity (FVC) less than 50% or Diffusion capacity for carbon monoxide (DLCO) less than 25%
  • Concurrent or recent participation (less than 6 months) in a pulmonary rehabilitation program
  • Use of prednisone greater than 10 mg/day for more than 2 weeks within 3 months of the first study visit
  • Significant emphysema (less than 10% volume on HRCT or FEV1/FVC less than 0.70)

Exclusion Criteria for Healthy Controls:

  • Currently smoking or previously smoked more than 10 pack-years
  • Any medical conditions that prevents them for exercising safely
  • Cardiac pacemaker or any metal or electronic inside the body

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03800017


Contacts
Layout table for location contacts
Contact: Yannick Molgat-seon, PhD 1-604-682-2344 ext 63258 yannick.molgat-seon@hli.ubc.ca
Contact: Satvir S Dhillon, MSc 1-604-806-8835 Satvir.Dhillon@hli.ubc.ca

Sponsors and Collaborators
University of British Columbia
Investigators
Layout table for investigator information
Principal Investigator: Jordan A Guenette, PhD University of British Columbia

Layout table for additonal information
Responsible Party: Jordan Guenette, Associate Professor, University of British Columbia
ClinicalTrials.gov Identifier: NCT03800017     History of Changes
Other Study ID Numbers: H18-02059
First Posted: January 10, 2019    Key Record Dates
Last Update Posted: June 19, 2019
Last Verified: June 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Pneumonia
Lung Diseases
Pulmonary Fibrosis
Idiopathic Pulmonary Fibrosis
Idiopathic Interstitial Pneumonias
Lung Diseases, Interstitial
Alveolitis, Extrinsic Allergic
Hypersensitivity
Respiratory Tract Diseases
Respiratory Tract Infections
Immune System Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate