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

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.

Study Overview

• Status: Completed
• Conditions: Chronic Obstructive Pulmonary Disease; Asthma; Pulmonary Hypertension; Interstitial Lung Disease; Chronic Lung Disease
• Intervention / Treatment: Other: Oxygen

• Study Type: Interventional
• Enrollment (Actual): 23
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Switzerland
  • Zürich
    • Winterthur, Zürich, Switzerland, 8400
      • Kantonsspital Winterthur

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• We will include male and female lung disease patients undergoing pulmonary rehabilitation: aged ≥ 18 years; stable condition > 3 weeks (e.g. no exacerbations); resting oxygen saturation (SpO2) ≥ 88% and exercise induced hypoxemia defined by a fall in SpO2 by ≥ 4% during a 6-minute walking test (6MWT); informed consent as documented by signature.

Exclusion Criteria:

• Severe daytime resting hypoxemia (SpO2 < 88% or partial pressure of oxygen (PaO2) < 8 kPa); unstable condition requiring adaptation of pharmacologic and other treatment modalities or requirement of intensive care or relevant severe concomitant disease; inability to follow the procedures of the study, e.g. due to language problems, psychological disorders, neurological or orthopedic problems with walking disability or inability to ride a bicycle; women who are pregnant or breast feeding; enrolment in another clinical trial with active treatment.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo Group; Start with Constant Work Rate Exercise Test with 5l/min room air applied via nasal cannula.	Other: Oxygen; Standard supplemental Oxygen therapy (5l/min) will be applied with an oxygen concentrator via nasal cannula.
Experimental: Experimental Group; Start with Constant Work Rate Exercise Test with 5l/min Oxygen Therapy applied via nasal cannula.	Other: Oxygen; Standard supplemental Oxygen therapy (5l/min) will be applied with an oxygen concentrator via nasal cannula.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Constant Work Rate Exercise Test	Endurance time measured with Constant Work Rate Exercise Test (CWRET) (75% of the maximal work rate from the maximal ramp exercise test)	7 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
SpO2	SpO2 by finger pulse oximetry, brain and muscle tissue oxygenation by near infrared spectroscopy (NIRS) at rest and end-exercise CWRET	7 days
Heart Rate	Heart rate at rest and end-exercise CWRET	7 days
Blood Pressure	Blood pressure at rest and end-exercise CWRET	7 days
Borg Scale (0-10)	Borg scale (dyspnoea and fatigue) at rest and end-exercise CWRET	7 days

Collaborators and Investigators

• Sponsor: Eastern Switzerland University of Applied Sciences
• Collaborators: University Hospital, Zürich; Kantonsspital Winterthur KSW
• Investigators: Principal Investigator: Swantje Beyer, Dr.med., Kantonsspital Winterthur KSW

Study record dates

Study Major Dates

• Study Start (Actual): January 24, 2024
• Primary Completion (Actual): January 1, 2025
• Study Completion (Actual): January 17, 2025

Study Registration Dates

• First Submitted: December 8, 2023
• First Submitted That Met QC Criteria: December 8, 2023
• First Posted (Actual): December 18, 2023

Study Record Updates

• Last Update Posted (Actual): August 12, 2025
• Last Update Submitted That Met QC Criteria: August 7, 2025
• Last Verified: August 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Vascular Diseases; Cardiovascular Diseases; Pathologic Processes; Chronic Disease; Disease Attributes; Respiratory Tract Diseases; Signs and Symptoms, Respiratory; Hypertension; Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive; Lung Diseases, Interstitial; Hypertension, Pulmonary; Hyperoxia
• Other Study ID Numbers: RehaExO2

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Individual patient data will be shared upon request to the principal investigator

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No