Skeletal Muscle Function in Interstitial Lung Disease

NCT03800017 | Recruiting

• 1 other identifier: H18-02059
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Interstitial Lung Disease; Idiopathic Pulmonary Fibrosis; Hypersensitivity Pneumonitis; Scleroderma; Nonspecific Interstitial Pneumonia

Outcome Measures

Primary Outcomes (4)

• Change in standardized dyspnea score during the constant load exercise test (visit 3)

  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.

  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)

• Change in standardized dyspnea score during the constant load exercise test (visit 4)

  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.

  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)

• Change in leg muscle strength measured following the constant load exercise test (visit 3)

  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.

  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)

• Change in leg muscle strength measured following the constant load exercise test (visit 4)

  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.

  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)

Secondary Outcomes (2)

• Quadriceps muscle oxidative capacity measured using near-infrared spectroscopy

  On visit 2, approximately 3 weeks post-baseline (visit 1)

• Quadriceps muscle volume measured using magnetic resonance imaging

  On visit 2, approximately 3 weeks post-baseline (visit 1)

Study Arms (2)

Hyperoxia

EXPERIMENTAL

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

Healthy Controls

PLACEBO COMPARATOR

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

Interventions

Hyperoxia BIOLOGICAL

Participants breathe 60% oxygen during exercise

Healthy Controls; Hyperoxia

Eligibility Criteria

• Age: 40 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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)
• 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

Sponsors & Collaborators

• University of British Columbia: lead

Study Sites (1)

St. Paul's Hospital

Vancouver, British Columbia, V6Z1Y6, Canada

RECRUITING

MeSH Terms

Conditions

Lung Diseases, Interstitial; Idiopathic Pulmonary Fibrosis; Alveolitis, Extrinsic Allergic; Scleroderma, Diffuse

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Pulmonary Fibrosis; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases; Scleroderma, Systemic; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Skin Diseases

Study Officials

• Jordan A Guenette, PhD

  University of British Columbia

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Olivia Ferguson, MSc

CONTACT

1-604-806-8835; Olivia.Ferguson@hli.ubc.ca

Satvir S Dhillon, MSc

CONTACT

1-604-806-8835; Satvir.Dhillon@hli.ubc.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: November 21, 2018
• First Posted: January 10, 2019
• Study Start: August 7, 2024
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: January 16, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)