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Effects of Oxygen Supplementation During the 6-Minute Walk Test in Chronic Respiratory Failure or Exertional Hypoxemia
Sponsor: Istituti Clinici Scientifici Maugeri SpA
Summary
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.
Official title: Evaluation of the Effects of the Oxygen Supplementation During 6-minute Walking Test in Patients With Chronic Respiratory Failure or Exertional Hypoxiemia
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
114
Start Date
2026-04-07
Completion Date
2028-09-30
Last Updated
2026-04-02
Healthy Volunteers
No
Conditions
Interventions
Usual Oxygen During 6-Minute Walk Test
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
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.
Locations (6)
ICS Maugeri IRCCS, Respiratory rehabilitation of the Institute of Lumezzane
Lumezzane, Brescia, Italy
ICS Maugeri IRCCS, Respiratory rehabilitation of the Institute of Veruno
Veruno, Novara, Italy
ICS Maugeri IRCCS, Respiratory rehabilitation of the Institute of Montescano
Montescano, Pavia, 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