An official European Respiratory Society/American Thoracic Society technical standard: field walking tests in chronic respiratory disease.
Anne E Holland, Martijn A Spruit, Thierry Troosters...
https://pubmed.ncbi.nlm.nih.gov/25359355/Actively Recruiting
Led by Istituti Clinici Scientifici Maugeri SpA · Updated on 2026-06-23
114
Participants Needed
6
Research Sites
34 weeks
Total Duration
Researchers are investigating how adding a therapeutic dose of oxygen during exercise affects people with chronic respiratory failure or exertional hypoxemia due to chronic obstructive pulmonary disease COPD or interstitial lung disease. This multicenter crossover trial aims to evaluate exercise performance, gas exchange, heart rate, symptom perception, and ease of performing exercise in patients hospitalized in pulmonary rehabilitation centers. The study will compare walking ability during two conditions using the 6-minute walk test to understand the benefits of different oxygen levels during exertion. Participants will perform two 6-minute walk tests in random order within 24 hours. One test uses their usual oxygen flow prescribed at rest or room air for those with exertional hypoxemia, while the other uses double the prescribed oxygen flow or 2 liters per minute for patients with exertional hypoxemia. Oxygen is delivered through nasal cannulas with a stroller carrying the oxygen supply. Tests are separated by at least 3 hours. The study groups include patients with COPD with exertional hypoxemia, COPD with chronic respiratory failure on long-term oxygen therapy, and interstitial lung disease with chronic respiratory failure on long-term oxygen therapy. Participants will be assessed for walking distance, oxygen saturation, heart rate, blood pressure, and symptoms such as breathlessness and fatigue before, during, and after the tests. A questionnaire will capture how easy participants found the test. Researchers will analyze the difference in walking distance between conditions as the primary outcome. The study will also examine how clinical and anthropometric factors influence responses to oxygen therapy. The total planned enrollment is 114 patients, and the trial will provide insights for better oxygen therapy prescriptions during exercise.
CONDITIONS
Effects of Oxygen Supplementation During the 6-Minute Walk Test in Chronic Respiratory Failure or Exertional Hypoxemia
M
Mara Paneroni, PhD, MSc
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Istituti Clinici Scientifici Maugeri SpA
Lead Sponsor
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Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - 1 day
Participants perform a 6-minute walk test with their usual oxygen flow prescribed at rest or room air for those with exertional hypoxemia. Oxygen is delivered via nasal cannula with a stroller carrying the oxygen.
1 visit (in-person)
Duration - 1 day
Participants perform a second 6-minute walk test using supplemental oxygen at double the resting prescription or 2 liters per minute for exertional hypoxemia. The test is done in random order and separated by at least 3 hours from the first test.
1 visit (in-person)
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
CROSSOVER
Primary Purpose
TREATMENT
Number of Arms
2
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https://pubmed.ncbi.nlm.nih.gov/27940278/Istituti Clinici Scientifici Maugeri SpA
Lead Sponsor