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Hyperoxia During Pulmonary Rehabilitation in Chronic Lung Disease - Does it Matter?

NCT06174207 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 23

Last updated 2025-08-12

No results posted yet for this study

Summary

Chronic respiratory diseases are a global burden. Treatment options have improved in recent years, pulmonary rehabilitation plays a key role. Oxygen therapy is recommended in patients with a low saturation at rest, but no clear guidance is given for patients who desaturate during exercise. The effect of ambulatory oxygen during exercise is not yet completely understood, especially in those patients with exercise-induced desaturation.

Aim: The goal of this study is to analyse the effect of supplemental oxygen given during a constant work rate exercise test (CWRET) on a cycle ergometer compared to sham air.

Methods: We plan to include 25 Patients respiratory patients undergoing pulmonary rehabilitation (male and female; aged \>18 years; stable condition \>3 weeks (e.g. no exacerbations); resting oxygen saturation (SpO2) ≥ 88%) with exercise induced hypoxemia defined by a fall in oxygen saturation by ≥ 4% during a 6-minute walking test. Patients will undergo an incremental exercise test with a ramp protocol (for evaluating the maximal workload) and two CWRET (75% of the maximal workload) with ambulatory oxygen or placebo (sham air) via standard nasal canula at a flow rate of 5l/min. Patients and assessors will be blinded. The difference endurance time of the CWRET with oxygen vs. sham air will be the primary outcome of this study.

Data will be summarized by means (SD) and medians (quartiles) for normal and non-normal distributions. Effects of treatment will be evaluated by mean differences with 95% confidence intervals, T-tests or Wilcoxon matched pair tests as appropriate. A p-value threshold of \<0.05 or a confidence interval not including zero will be considered as statistically significant. Analyses will be performed according to the intention to treat principle.

Conditions

Interventions

OTHER

Oxygen

Standard supplemental Oxygen therapy (5l/min) will be applied with an oxygen concentrator via nasal cannula.

Sponsors & Collaborators

  • University Hospital, Zürich

    collaborator OTHER

  • Kantonsspital Winterthur KSW

    collaborator OTHER

  • Eastern Switzerland University of Applied Sciences

    lead OTHER

Principal Investigators

  • Swantje Beyer, Dr.med. · Kantonsspital Winterthur KSW

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-01-24
Primary Completion
2025-01-01
Completion
2025-01-17

Countries

  • Switzerland

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06174207 on ClinicalTrials.gov