Skeletal Muscle Function in Interstitial Lung Disease (NCT03800017) | Clinical Trial Compass
RecruitingNot Applicable
Skeletal Muscle Function in Interstitial Lung Disease
Canada40 participantsStarted 2024-08-07
Plain-language 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.
Who can participate
Age range
40 Years – 80 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
* Significan…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Change in standardized dyspnea score during the constant load exercise test (visit 3)
Timeframe: 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)
Timeframe: 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)
Timeframe: 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)
Timeframe: 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)