Extra oxygen during the 6-minute walk for people with chronic respiratory failure or exercise-related low oxygen

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This multicenter crossover trial enrolls patients completing inpatient pulmonary rehabilitation who have chronic respiratory failure or exertional hypoxemia from COPD or interstitial lung disease. Each participant performs two 6-minute walk tests in random order: one with their usual resting oxygen flow (or room air if they only desaturate on exertion) and one with a higher flow (double the prescribed flow or 2 L/min for those without resting oxygen). Tests are separated by at least three hours and outcomes include walking distance, gas exchange (SpO2 and gases), heart rate, symptom ratings, and perceived ease of performance. The study will also compare responses across disease types to see if effects differ between COPD and interstitial lung disease.

Why it matters

Who can join: the full rules

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

Where it's running

• ICS Maugeri IRCCS, Respiratory rehabilitation of the Institute of Lumezzane
  Lumezzane, Brescia, Italy Recruiting
• ICS Maugeri IRCCS, Respiratory rehabilitation of the Institute of Montescano
  Montescano, Pavia, Italy Recruiting
• ICS Maugeri IRCCS, Respiratory rehabilitation of the Institute of Bari
  Bari, Italy Recruiting
• ICS Maugeri IRCCS, Respiratory rehabilitation of the Institute of Pavia
  Pavia, Italy Recruiting
• ICS Maugeri IRCCS, Respiratory rehabilitation of the Institute of Veruno
  Veruno, Novara, Italy Not yet recruiting
• Istituti Clinici Maugeri , Respiratory rehabilitation of the Institute of Marina di Ginosa
  Taranto, Italy Not yet recruiting

Study contacts

• Principal investigator: Mara Paneroni, PhD, MSc — ICS Maugeri IRCCS, Respiratory rehabilitation of the Institute of Lumezzane
• Study coordinator: Mara Paneroni, PhD, MSc
• Email: mara.paneroni@icsmaugeri.it
• Phone: +39 030 8253

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.