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Effects of Oxygen Supplementation During the 6-Minute Walk Test in Chronic Respiratory Failure or Exertional Hypoxemia

RecruitingNAAges 18 Years - anyAllIstituti Clinici Scientifici Maugeri SpA
NCT07451977 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

The aim of this multicenter crossover trial is to describe the effect of adding a therapeutic dose of exertional oxygen therapy, in terms of exercise performance, gas exchange, heart rate, symptoms perception and subjective easiness of performance, in a cohort of subjects hospitalized in specialized pulmonary rehabilitation centers with a diagnosis of chronic respiratory failure and/or exertional hypoxemia due to chronic obstructive pulmonary disease or interstitial lung disease. Researchers will compare the walking performance during 6-minute walk test performed with the liters of oxygen administered as prescribed at rest (for patients with chronic respiratory failure) or in room air (for patients with exertional hypoxemia only), to the performance during a 6-minute walk test performed with the double the flow rate prescribed at rest, or with 2 L/min for patients with exertional hypoxe

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📋 Eligibility rules (as published)
Inclusion Criteria: * Adults aged 18 years or older * Diagnosis of chronic respiratory disease admitted for pulmonary rehabilitation * One of the following conditions at discharge: * Chronic obstructive pulmonary disease with exertional hypoxemia * Chronic obstructive pulmonary disease with chronic respiratory failure requiring long-term oxygen therapy * Interstitial lung disease with chronic respiratory failure requiring long-term oxygen therapy * Clinically stable condition for at least one month * Optimized medical therapy during hospitalization * Ability to perform the 6-minute walk test * Signed informed consent Exclusion Criteria: * Lung diseases other than chronic obstructive pulmonary disease or interstitial lung disease * Resting oxygen flow requirement greater than 4 liters per minute * Orthopedic, neurological, or cognitive conditions that may limit walking performance * Recent cardiovascular or cerebrovascular events within the previous 3 months
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What it tests

  • Usual Oxygen During 6-Minute Walk Test
  • Supplemental Oxygen During 6-Minute Walk Test
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Where

6 sites
ICS Maugeri IRCCS, Respiratory rehabilitation of the Institute of Lumezzane
Lumezzane, Italy
ICS Maugeri IRCCS, Respiratory rehabilitation of the Institute of Veruno
Veruno, Italy
ICS Maugeri IRCCS, Respiratory rehabilitation of the Institute of Montescano
Montescano, Italy
ICS Maugeri IRCCS, Respiratory rehabilitation of the Institute of Bari
Bari, Italy
ICS Maugeri IRCCS, Respiratory rehabilitation of the Institute of Pavia
Pavia, Italy
Istituti Clinici Maugeri , Respiratory rehabilitation of the Institute of Marina di Ginosa
Taranto, Italy
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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