Automatic oxygen adjustment for exercise in patients with low oxygen levels
Automatic Oxygen Titration Versus Constant Oxygen Flow Rates During Exercise Training in Hypoxemic People With Chronic Lung Disease - a Randomized, Double-blind, Controlled Cross-over Pilot Study
This study is testing if an automatic oxygen system can help people with chronic lung disease breathe easier and exercise longer compared to using a constant flow of oxygen.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 15 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Sponsor | Schön Klinik Berchtesgadener Land Academic / other |
| Locations | 1 site (Schönau am Königssee, Bavaria) |
| Trial ID | NCT06545851 on ClinicalTrials.gov |
What this trial studies
This study investigates the effects of an automatic oxygen titration system compared to constant oxygen flow rates in patients with chronic lung disease and hypoxaemia during exercise training. The aim is to determine if automatic adjustments to oxygen delivery can reduce the perception of dyspnoea and improve exercise endurance. Participants will undergo a cycle-based peak work rate test and will be randomly assigned to receive either automatic or constant oxygen flow during their rehabilitation program. The study is designed as a double-blind, controlled cross-over trial to ensure unbiased results.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 to 80 with chronic lung disease and hypoxaemia who are participating in a pulmonary rehabilitation program.
Not a fit: Patients experiencing acute exacerbations of their pulmonary disease may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could enhance exercise tolerance and quality of life for patients with chronic lung disease by reducing breathlessness during physical activity.
How similar studies have performed: Previous studies have shown short-term benefits of automatic oxygen delivery, but this specific approach during endurance exercise is novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Chronic lung disease * Hypoxemia (pO2\< 55mmHg) under room air conditions (rest or during exercise) or SpO2\<88% during exercise * established Long-term oxygen therapy or given indication for a Long-term oxygen therapy/ supplemental oxygen therapy for exercise * Age: 18 to 80 years * Participation in an inpatient pulmonary rehabilitation program (Schoen Klinik BGL, Germany) * Written informed consent Exclusion Criteria: \- Acute exacerbation of underlying pulmonary disease requiring cessation of exercise training.
Where this trial is running
Schönau am Königssee, Bavaria
- Klinikum Berchtesgadener Land, Schön Kliniken — Schönau am Königssee, Bavaria, Germany (Recruiting)
Study contacts
- Principal investigator: Andreas Rembert Koczulla, Prof. Dr. — Philipps University Marburg
- Study coordinator: Andreas Rembert Koczulla, Prof. Dr.
- Email: rkoczulla@schoen-klinik.de
- Phone: 0049-8652-932730
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.