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

NCT ID: NCT06174207

Last Updated: 2025-08-12

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 23 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-01-24
• Study Completion Date: 2025-01-17

Brief 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

Chronic Obstructive Pulmonary Disease; Asthma; Pulmonary Hypertension; Interstitial Lung Disease; Chronic Lung Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Placebo Group

Start with Constant Work Rate Exercise Test with 5l/min room air applied via nasal cannula.

Group Type: PLACEBO_COMPARATOR

Oxygen

Intervention Type: OTHER

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

Experimental Group

Start with Constant Work Rate Exercise Test with 5l/min Oxygen Therapy applied via nasal cannula.

Group Type: EXPERIMENTAL

Oxygen

Intervention Type: OTHER

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

Interventions

Oxygen

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

Intervention Type: OTHER

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Hospital, Zürich

OTHER

Sponsor Role: collaborator

Kantonsspital Winterthur KSW

OTHER

Sponsor Role: collaborator

Eastern Switzerland University of Applied Sciences

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Swantje Beyer, Dr.med.

Role: PRINCIPAL_INVESTIGATOR

Kantonsspital Winterthur KSW

Locations

Kantonsspital Winterthur

Winterthur, Canton of Zurich, Switzerland

Countries

Switzerland

Other Identifiers

RehaExO2

Identifier Type: -

Identifier Source: org_study_id