Skeletal Muscle Function in Interstitial Lung Disease

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age40-80
SponsorUniversity of British Columbia

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • Hyperoxia

    Biological/Vaccine

    Participants breathe 60% oxygen during exercise

Treatment groups

40 Participants
are divided into 2 treatment groups
Group A: HyperoxiaExperimental treatment 1 intervention
Group B: Healthy ControlsPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

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.

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)
2

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.

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)
3

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.

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)
4

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.

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)

Secondary outcomes

1

Quadriceps muscle oxidative capacity measured using near-infrared spectroscopy

Quadriceps muscle oxidative capacity will measured using near-infrared spectroscopy. Parameters will be measured over 5 minutes once on visit 2

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

Quadriceps muscle volume measured using magnetic resonance imaging

Quadriceps muscle volume will be measured using magnetic resonance imaging. Parameters will be measured over 15 minutes once on visit 2

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

Other outcomes

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