Extra oxygen during outpatient pulmonary rehabilitation for people with COPD who desaturate with exercise

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This interventional study assigns 32 adults with COPD who show exercise-induced desaturation to receive either supplemental oxygen or room air during exercise sessions of a 3-month ambulatory pulmonary rehabilitation program. Eligible participants must be at least 18 years old, clinically stable for more than three weeks, have resting SpO2 ≥ 88%, and demonstrate a ≥4% drop or fall below 90% during a six-minute walk test. The trial compares exercise endurance and tolerance during supervised training with oxygen versus placebo room air delivered during exercise. Patients on long-term oxygen or with resting hypoxemia below 88% are excluded.

Why it matters

Who can join: the full rules

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.

Where it's running

• Kantonsspital Winterthur
  Winterthur, Canton of Zurich, Switzerland Recruiting

Study contacts

• Principal investigator: Silvia Ulrich, Prof. — University of Zurich
• Study coordinator: Stéphanie Saxer, PHD
• Email: stephanie.saxer@ost.ch
• Phone: +41 58 257 12 97

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.