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

Not Applicable

Recruiting

• Conditions: Chronic Obstructive Pulmonary Disease; Pulmonary Hypertension; Asthma; Chronic Lung Disease; Interstitial Lung Disease
• Interventions: Other: Oxygen

• Registration Number: NCT06174207
• Lead Sponsor: Eastern Switzerland University of Applied Sciences

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-12-08
• Study First Submitted QC: 2023-12-08
• Study First Posted: 2023-12-18
• Study Start: 2024-01-24
• Status Verified: 2024-07
• Last Update Submitted: 2024-07-22
• Last Update Posted: 2024-07-23
• Primary Completion: 2025-01-01
• Study Completion: 2025-04-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 25

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Placebo Group	Oxygen	Start with Constant Work Rate Exercise Test with 5l/min room air applied via nasal cannula.
Experimental Group	Oxygen	Start with Constant Work Rate Exercise Test with 5l/min Oxygen Therapy applied via nasal cannula.

Primary Outcome Measures

Name	Time	Method
Constant Work Rate Exercise Test	7 days	Endurance time measured with Constant Work Rate Exercise Test (CWRET) (75% of the maximal work rate from the maximal ramp exercise test)

Secondary Outcome Measures

Name	Time	Method
Borg Scale (0-10)	7 days	Borg scale (dyspnoea and fatigue) at rest and end-exercise CWRET
Heart Rate	7 days	Heart rate at rest and end-exercise CWRET
Blood Pressure	7 days	Blood pressure at rest and end-exercise CWRET
SpO2	7 days	SpO2 by finger pulse oximetry, brain and muscle tissue oxygenation by near infrared spectroscopy (NIRS) at rest and end-exercise CWRET

Trial Locations

Locations (1)

Kantonsspital Winterthur; 🇨🇭 Winterthur, Zürich, Switzerland