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

Sponsor
Istituti Clinici Scientifici Maugeri SpA
Study ID
NCT07451977
Status
Recruiting
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Conditions

  • Chronic Obstructive Pulmonary Disease (COPD)
  • Chronic Respiratory Failure
  • Hypoxemia
  • Interstitial Lung Disease

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Usual Oxygen During 6-Minute Walk Test — OTHER
    Participants perform the 6-minute walk test using the oxygen flow prescribed at rest for chronic respiratory failure, or room air for participants with exertional hypoxemia only. Oxygen is delivered through nasal cannula using standard equipment. Walking distance, oxygen saturation, heart rate, and symptoms are recorded during the test.
  • Supplemental Oxygen During 6-Minute Walk Test — OTHER
    Participants perform the 6-minute walk test using supplemental oxygen during exercise. Oxygen flow is set at double the resting prescription for participants with chronic respiratory failure, or at two liters per minute for participants with exertional hypoxemia. Oxygen is delivered through nasal cannula using standard equipment. Walking distance, oxygen saturation, heart rate, and symptoms are recorded during the test.

Study Details

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 hypoxemia only. The two tests will be performed in random order, at least 3 hours apart and no later than 24 hours apart from each other. The main outcome will be the difference between the distance walked in the two 6-minute walk test in the two conditions. Furthermore, will be also collected and compared: the oxygen saturation and heart rate every minute, the initial and final dyspnea and fatigue, as assessed by Borg scale, and the easiness of performance through a dedicated questionnaire. The estimated sample size will be 114 patients. This study will provide some basis for a more accurate prescription of exercise-related oxygen therapy, offering insights into the phenotype of patients who may derive the greatest benefit from this intervention. It will also stimulate discussion regarding the optimal timing and dosing of oxygen administration during exertion in patients with respiratory failure.

Key Dates

First listed
Mar 5, 2026
Start date
Apr 2, 2026
Status verified
Jun 2026
Primary completion
Jan 31, 2028
Completion
Sep 30, 2028

Study Design

Enrollment
114 participants (estimated)
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT

Arms

  • Active Comparator: 6-Minute Walk Test With Usual Oxygen or Room Air (O2REST)
    All participants perform the 6-minute walk test with standard oxygen flow (or room air for participants with exertional hypoxemia only). This arm represents the standard condition for comparison. The test may be administered as first or second test, in a random order, according to the crossover design.
  • Experimental: 6-Minute Walk Test With Supplemental Oxygen (O2PLUS)
    All participants perform the 6-minute walk test using a higher oxygen flow during exercise to evaluate the effects of supplemental oxygen on walking performance and symptoms. The test may be administered as first or second test, in a random order, according to the crossover design.

Primary Outcome Measure

Change in 6-Minute Walk Distance With Supplemental Oxygen [ Time Frame: Within 24 hours (during two 6-minute walk tests performed on the same day) ]

Central Contacts

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