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

Asthma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06174207
• Other study ID #: RehaExO2
• Status: Not yet recruiting
• Phase: N/A
• Start date: January 1, 2024
• Est. completion date: April 30, 2025

Study information

• Verified date: December 2023
• Source: Eastern Switzerland University of Applied Sciences
• Contact: Stéphanie Saxer, PhD
• Phone: +41 58 257 12 97
• Email: stephanie.saxer[@]ost.ch
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Chronic respiratory diseases are a global burden. Treatment options have improved in recent years, pulmonary rehabilitation plays a key role. Oxygen therapy is recommended in patients with a low saturation at rest, but no clear guidance is given for patients who desaturate during exercise. The effect of ambulatory oxygen during exercise is not yet completely understood, especially in those patients with exercise-induced desaturation.

Aim: The goal of this study is to analyse the effect of supplemental oxygen given during a constant work rate exercise test (CWRET) on a cycle ergometer compared to sham air.

Methods: We plan to include 25 Patients respiratory patients undergoing pulmonary rehabilitation (male and female; aged >18 years; stable condition >3 weeks (e.g. no exacerbations); resting oxygen saturation (SpO2) ≥ 88%) with exercise induced hypoxemia defined by a fall in oxygen saturation by ≥ 4% during a 6-minute walking test. Patients will undergo an incremental exercise test with a ramp protocol (for evaluating the maximal workload) and two CWRET (75% of the maximal workload) with ambulatory oxygen or placebo (sham air) via standard nasal canula at a flow rate of 5l/min. Patients and assessors will be blinded. The difference endurance time of the CWRET with oxygen vs. sham 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 25
• Est. completion date: April 30, 2025
• Est. primary completion date: January 1, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• We will include male and female lung disease patients undergoing pulmonary rehabilitation: aged = 18 years; stable condition > 3 weeks (e.g. no exacerbations); resting oxygen saturation (SpO2) = 88% and exercise induced hypoxemia defined by a fall in SpO2 by = 4% during a 6-minute walking test (6MWT); informed consent as documented by signature.

Exclusion Criteria:

• Severe daytime resting hypoxemia (SpO2 < 88% or partial pressure of oxygen (PaO2) < 8 kPa); 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.

Related Conditions & MeSH terms

• Asthma
• Chronic Lung Disease
• Chronic Obstructive Pulmonary Disease
• Hyperoxia
• Hypertension, Pulmonary
• Interstitial Lung Disease
• Lung Diseases
• Lung Diseases, Interstitial
• Lung Diseases, Obstructive
• Pulmonary Disease, Chronic Obstructive
• Pulmonary Hypertension

Intervention

Other:
• Oxygen
Standard supplemental Oxygen therapy (5l/min) will be applied with an oxygen concentrator via nasal cannula.

Locations

Country	Name	City	State
n/a

Sponsors (3)

Lead Sponsor	Collaborator
Eastern Switzerland University of Applied Sciences	Kantonsspital Winterthur KSW, University Hospital, Zürich

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Constant Work Rate Exercise Test	Endurance time measured with Constant Work Rate Exercise Test (CWRET) (75% of the maximal work rate from the maximal ramp exercise test)	7 days
Secondary	SpO2	SpO2 by finger pulse oximetry, brain and muscle tissue oxygenation by near infrared spectroscopy (NIRS) at rest and end-exercise CWRET	7 days
Secondary	Heart Rate	Heart rate at rest and end-exercise CWRET	7 days
Secondary	Borg Scale (0-10)	Borg scale (dyspnoea and fatigue) at rest and end-exercise CWRET	7 days
Secondary	Blood Pressure	Blood pressure at rest and end-exercise CWRET	7 days