Comparing oxygen levels during pulmonary rehabilitation for chronic respiratory failure
Effect of Pulmonary Rehabilitation Under Different Oxygen Concentration Using High-flow Nasal Cannula
This study tests whether using higher or lower oxygen levels during exercise rehab helps people with chronic respiratory failure perform better and feel better overall.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 32 (estimated) |
| Ages | 20 Years to 90 Years |
| Sex | All |
| Sponsor | National Hospital Organization Minami Kyoto Hospital Academic / other |
| Locations | 1 site (Joyo, Kyoto) |
| Trial ID | NCT04481295 on ClinicalTrials.gov |
What this trial studies
This study aims to evaluate the effects of different oxygen saturation levels on exercise capacity in patients with chronic respiratory failure undergoing pulmonary rehabilitation. Participants will be randomized to receive either high oxygen saturation (94-96%) or low oxygen saturation (84-86%) during their rehabilitation sessions. The goal is to determine which oxygen level optimally supports exercise performance and overall rehabilitation outcomes. The study focuses on patients who have been on long-term oxygen therapy for more than three months.
Who should consider this trial
Good fit: Ideal candidates for this study are patients with chronic respiratory failure who have been receiving long-term oxygen therapy for over three months.
Not a fit: Patients with severe cardiovascular, liver, neurological diseases, or recent exacerbations of respiratory failure may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could help optimize pulmonary rehabilitation protocols, leading to improved exercise capacity and quality of life for patients with chronic respiratory failure.
How similar studies have performed: While there have been studies on pulmonary rehabilitation, this specific comparison of oxygen saturation levels during rehabilitation is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Subjects with chronic respiratory failure receiving long-term oxygen therapy for more than 3 months. Exclusion Criteria: * Subjects with severe cardiovascular disease, liver disease, neurological disease, and renal failure. * Subjects with a history of hospitalization for pneumonia or exacerbation of respiratory failure within the last month. * Subjects with changes in LTOT prescription flow within the last month * Subjects who cannot undergo pulmonary rehabilitation due to severe heart failure, arteriosclerosis obliterans or spinal disease.
Where this trial is running
Joyo, Kyoto
- National Hospital Organization Minami Kyoto Hospital — Joyo, Kyoto, Japan (Recruiting)
Study contacts
- Study coordinator: Yuichi Chihara
- Email: yc.r03107@gmail.com
- Phone: 81-774-52-0065
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.