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

NCT06174207 | Completed

• 1 other identifier: RehaExO2
• Study Type: interventional
• Target: 23
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• SpO2

  7 days

• Heart Rate

  7 days

• Borg Scale (0-10)

  7 days

• Blood Pressure

  7 days

Study Arms (2)

Placebo Group

PLACEBO COMPARATOR

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

Other: Oxygen

Experimental Group

EXPERIMENTAL

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

Other: Oxygen

Interventions

Oxygen OTHER

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

Experimental Group; Placebo Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Eastern Switzerland University of Applied Sciences: lead
• University Hospital, Zürich: collaborator
• Kantonsspital Winterthur KSW: collaborator

Study Sites (1)

Kantonsspital Winterthur

Winterthur, Canton of Zurich, 8400, Switzerland

Location

MeSH Terms

Conditions

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

Interventions

Oxygen

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Bronchial Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases; Hypertension; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Chalcogens; Elements; Inorganic Chemicals; Gases

Study Officials

• Swantje Beyer, Dr.med.

  Kantonsspital Winterthur KSW

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 8, 2023
• First Posted: December 18, 2023
• Study Start: January 24, 2024
• Primary Completion: January 1, 2025
• Study Completion: January 17, 2025
• Last Updated: August 12, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

CH (1)