Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
Register:
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ClinicalTrials.gov |
Last refreshed on:
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8 January 2024 |
Main ID: |
NCT03800017 |
Date of registration:
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21/11/2018 |
Prospective Registration:
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Yes |
Primary sponsor: |
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Public title:
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Skeletal Muscle Function in Interstitial Lung Disease
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Scientific title:
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Investigating the Role of Skeletal Muscle Dysfunction on Dyspnea and Exercise Intolerance in Interstitial Lung Disease |
Date of first enrolment:
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January 1, 2024 |
Target sample size:
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40 |
Recruitment status: |
Not yet recruiting |
URL:
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https://clinicaltrials.gov/ct2/show/NCT03800017 |
Study type:
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Interventional |
Study design:
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Allocation: Non-Randomized. Intervention model: Parallel Assignment. Primary purpose: Basic Science. Masking: Single (Participant).
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Phase:
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N/A
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Contacts
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Name:
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Olivia Ferguson, MSc |
Address:
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Telephone:
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1-604-806-8835 |
Email:
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Olivia.Ferguson@hli.ubc.ca |
Affiliation:
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Name:
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Jordan A Guenette, PhD |
Address:
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Telephone:
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Email:
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Affiliation:
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University of British Columbia |
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Key inclusion & exclusion criteria
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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
Age minimum:
40 Years
Age maximum:
80 Years
Gender:
All
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Health Condition(s) or Problem(s) studied
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Hypersensitivity Pneumonitis
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Interstitial Lung Disease
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Nonspecific Interstitial Pneumonia
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Idiopathic Pulmonary Fibrosis
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Scleroderma
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Intervention(s)
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Biological: Hyperoxia
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Primary Outcome(s)
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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)]
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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)]
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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)]
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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)]
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Secondary Outcome(s)
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Quadriceps muscle oxidative capacity measured using near-infrared spectroscopy
[Time Frame: On visit 2, approximately 3 weeks post-baseline (visit 1)]
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Quadriceps muscle volume measured using magnetic resonance imaging
[Time Frame: On visit 2, approximately 3 weeks post-baseline (visit 1)]
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Secondary ID(s)
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H18-02059
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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