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

NCT ID: NCT06776731

Last Updated: 2025-08-07

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 32 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-01-06
• Study Completion Date: 2027-08-01

Brief Summary

Chronic obstructive pulmonary disease (COPD) is 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: Evaluate the effect of supplemental oxygen therapy during a 3-months long ambulatory pulmonary rehabilitation program on exercise endurance. Patients will either receive supplemental oxygen therapy or room air during exercise training.

Methods: A total of 32 patients with a confirmed diagnosis of COPD undergoing pulmonary rehabilitation will be included (male and female : 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% and/ or below 90% during a 6-minute walking test). 3-months comprehensive PR for both intervention and control group including: education and awareness, instruction on inhalation therapies, smoking cessation counselling, respiratory and skeletal muscle training in groups, guided walks / cycle ergometer training. The intervention group will be trained using SSOT and the control group will receive sham air (ambient air). Patients and assessors will be blinded. Between group difference in cycling constant work rate exercise test (CWRET) time from baseline to 3 months SSOT (5l/min) vs ambient 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 (COPD)

Study Design

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

Study Groups

Endurance training with 5l/ min room air applied via nasal cannula.

Endurance training with 5l/ min room air applied via nasal cannula with an Everflo oxygen concentrator.

Group Type: PLACEBO_COMPARATOR

Room Air (placebo)

Intervention Type: OTHER

Room air (5l/min) will be applied with an oxygen concentrator via nasal cannula during endurance training.

Endurance training with 5l/ min Oxygen Therapy applied via nasal cannula.

Endurance training with 5l/ min Oxygen Therapy applied via nasal cannula with an Everflo oxygen concentrator..

Group Type: EXPERIMENTAL

Oxygen

Intervention Type: OTHER

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

Interventions

Oxygen

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

Intervention Type: OTHER

Room Air (placebo)

Room air (5l/min) will be applied with an oxygen concentrator via nasal cannula during endurance training.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• We will include male and female with a confirmed diagnosis of COPD (post-bronchodilator forced expiratory volume in one second (FEV1) / forced vital capacity (FVC) ratio of <0.7; a greater than 10 pack-year smoking history)
• undergoing pulmonary rehabilitation
• aged ≥ 18 years
• stable condition > 3 weeks (e.g. no exacerbations)
• resting oxygen saturation (SpO2) ≥ 88%
• exercise induced hypoxemia defined by a fall in SpO2 by ≥ 4% and/ or below 90% during a 6MWT
• informed consent as documented by signature.

Exclusion Criteria

• Severe daytime resting hypoxemia (SpO2 < 88% )
• long-term oxygen therapy, 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

Silvia Ulrich, Prof.

Role: PRINCIPAL_INVESTIGATOR

University of Zurich

Locations

Kantonsspital Winterthur

Winterthur, Canton of Zurich, Switzerland

Site Status: RECRUITING

Countries

Switzerland

Central Contacts

Stéphanie Saxer, PHD

Role: CONTACT

stephanie.saxer@ost.ch

+41 58 257 12 97

Spencer Rezek

Role: CONTACT

spencer.rezek@ost.ch

+41522663867

Facility Contacts

Spencer Rezek, PhD cand.

Role: primary

spencer.rezek@ksw.ch

+41754383867

Other Identifiers

outRehaExO2

Identifier Type: -

Identifier Source: org_study_id