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

Status: Recruiting
Location: See location...
Intervention Type: Other
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

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 \&gt; 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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
Switzerland
Kantonsspital Winterthur
RECRUITING
Winterthur
Contact Information
Primary
Stéphanie Saxer, PHD
stephanie.saxer@ost.ch
+41 58 257 12 97
Backup
Spencer Rezek
spencer.rezek@ost.ch
+41522663867
Time Frame
Start Date: 2025-01-06
Estimated Completion Date: 2027-08-01
Participants
Target number of participants: 32
Treatments
Placebo_comparator: 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.
Experimental: 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..
Sponsors
Leads: Eastern Switzerland University of Applied Sciences
Collaborators: Kantonsspital Winterthur KSW, University Hospital, Zürich

This content was sourced from clinicaltrials.gov