Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
NCT07451977

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

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

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
Not Eligible

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

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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

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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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