Extra oxygen during the 6-minute walk for people with chronic respiratory failure or exercise-related low oxygen
Evaluation of the Effects of the Oxygen Supplementation During 6-minute Walking Test in Patients With Chronic Respiratory Failure or Exertional Hypoxiemia
This trial will test whether giving extra oxygen during a 6-minute walk helps people with chronic respiratory failure or exertional low oxygen from COPD or interstitial lung disease walk farther, breathe better, and feel easier during the test.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 114 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Istituti Clinici Scientifici Maugeri SpA Academic / other |
| Locations | 6 sites (Lumezzane, Brescia and 5 other locations) |
| Trial ID | NCT07451977 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Adults discharged from pulmonary rehabilitation with COPD or interstitial lung disease who are clinically stable, able to perform the 6-minute walk test, and who have exertional hypoxemia or chronic respiratory failure are ideal candidates.
Not a fit: Patients with resting oxygen needs over 4 L/min, lung diseases other than COPD or interstitial lung disease, recent cardiovascular/cerebrovascular events, or major orthopedic/neurological/cognitive limitations are unlikely to benefit from this protocol.
Why it matters
Potential benefit: If successful, the approach could help some patients walk farther with less breathlessness during exertion and inform clearer oxygen dosing for exercise.
How similar studies have performed: Acute studies have shown supplemental oxygen can improve exercise performance in COPD, but standardized titration during the 6-minute walk and longer-term benefits remain unproven.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Lumezzane, Brescia and 5 other locations
- ICS Maugeri IRCCS, Respiratory rehabilitation of the Institute of Lumezzane — Lumezzane, Brescia, Italy (Recruiting)
- ICS Maugeri IRCCS, Respiratory rehabilitation of the Institute of Veruno — Veruno, Novara, Italy (Not_yet_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)
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.