Actively Recruiting
Effects of Oxygen Supplementation During the 6-Minute Walk Test in Chronic Respiratory Failure or Exertional Hypoxemia
Led by Istituti Clinici Scientifici Maugeri SpA · Updated on 2026-04-02
114
Participants Needed
6
Research Sites
129 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Effects of Oxygen Supplementation During the 6-Minute Walk Test in Chronic Respiratory Failure or Exertional Hypoxemia
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults aged 18 years or older
- Diagnosis of chronic respiratory disease admitted for pulmonary rehabilitation
- Diagnosis of chronic obstructive pulmonary disease with exertional hypoxemia
- Diagnosis of chronic obstructive pulmonary disease with chronic respiratory failure requiring long-term oxygen therapy
- Diagnosis of 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
You will not qualify if you...
- Presence of 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
AI-Screening
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Trial Site Locations
Total: 6 locations
1
ICS Maugeri IRCCS, Respiratory rehabilitation of the Institute of Lumezzane
Lumezzane, Brescia, Italy, 25065
Actively Recruiting
2
ICS Maugeri IRCCS, Respiratory rehabilitation of the Institute of Veruno
Veruno, Novara, Italy, 28013
Not Yet Recruiting
3
ICS Maugeri IRCCS, Respiratory rehabilitation of the Institute of Montescano
Montescano, Pavia, Italy, 27040
Actively Recruiting
4
ICS Maugeri IRCCS, Respiratory rehabilitation of the Institute of Bari
Bari, Italy, 70124
Actively Recruiting
5
ICS Maugeri IRCCS, Respiratory rehabilitation of the Institute of Pavia
Pavia, Italy, 27100
Actively Recruiting
6
Istituti Clinici Maugeri , Respiratory rehabilitation of the Institute of Marina di Ginosa
Taranto, Italy, 74025
Not Yet Recruiting
Research Team
M
Mara Paneroni, PhD, MSc
CONTACT
T
Tiziana Bachetti, Pharm
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
CROSSOVER
Primary Purpose
TREATMENT
Number of Arms
2
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