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

Not Applicable

Not yet recruiting

• Conditions: Chronic Obstructive Pulmonary Disease (COPD)

• Registration Number: NCT06776731
• Lead Sponsor: Eastern Switzerland University of Applied Sciences

Brief Summary

Chronic obstructive pulmonary disease (COPD) is 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: Evaluate the effect of supplemental oxygen therapy during a 3-months long ambulatory pulmonary rehabilitation program on exercise endurance. Patients will either receive supplemental oxygen therapy or room air during exercise training.

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 \> 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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2024-12
• Study First Submitted: 2024-12-16
• Study Start: 2025-01-06
• Study First Submitted QC: 2025-01-13
• Last Update Submitted: 2025-01-13
• Study First Posted: 2025-01-15
• Last Update Posted: 2025-01-15
• Primary Completion: 2027-04-01
• Study Completion: 2027-08-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 32

Inclusion Criteria

• 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.

Exclusion Criteria

• Severe daytime resting hypoxemia (SpO2 < 88% )
• long-term oxygen therapy, 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: PARALLEL

Primary Outcome Measures

Name	Time	Method
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)	3 months

Secondary Outcome Measures

Name	Time	Method
6 minute walk test (6MWT)	3 months	6 minute walk distance (6MWD), SpO2 and heart rate at the end of the 6 minute walk test (6MWT) from baseline to 3 months at SSOT vs ambient air
Heart rate	3 months	Heart rate at rest and end-exercise CWRET from baseline to 3 months at SSOT vs ambient air
Borg scale	3 months	Borg scale (Dyspnoea and fatigue) at rest and end-exercise CWRET from baseline to 3 months at SSOT vs ambient air. Measure of perceived exertion from 1-10, ranges from 1 (very light exertion) to 10 (maximum exertion).
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)	6 months
SpO2	3 months	SpO2 by finger pulse oximetry, brain and muscle tissue oxygenation by NIRS at rest and end-exercise CWRET from baseline to 3 months at SSOT vs ambient air