Extra oxygen during outpatient pulmonary rehabilitation for people with COPD who desaturate with exercise
Hyperoxia During Outpatient Pulmonary Rehabilitation in Chronic Lung Disease - Does it Matter?
This trial will see if giving supplemental oxygen during a 3-month outpatient pulmonary rehabilitation program helps people with COPD who lose oxygen during exercise.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 32 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Eastern Switzerland University of Applied Sciences Academic / other |
| Locations | 1 site (Winterthur, Canton of Zurich) |
| Trial ID | NCT06776731 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Adults with COPD who are stable, have resting SpO2 ≥ 88%, and show exercise-induced desaturation (≥4% drop or SpO2 < 90% on a six-minute walk test) and who are enrolled in outpatient pulmonary rehabilitation are ideal candidates.
Not a fit: Patients with severe resting hypoxemia (SpO2 < 88%), those already on long-term oxygen therapy, or those unable to participate in standard exercise training are unlikely to benefit from this intervention.
Why it matters
Potential benefit: If successful, using ambulatory oxygen during rehab could improve exercise endurance and make pulmonary rehabilitation more effective for COPD patients who desaturate with activity.
How similar studies have performed: Previous trials of ambulatory oxygen for COPD patients who desaturate during exercise have shown mixed but sometimes positive short-term gains in exercise capacity, while long-term benefits remain unclear.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Winterthur, Canton of Zurich
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.