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

NCT06776731 | Recruiting

• 1 other identifier: outRehaExO2
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

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 \&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.

Conditions

Chronic Obstructive Pulmonary Disease (COPD)

Keywords

COPD; oxygen therapy; pulmonary rehabilitation; hyperoxia; exercise medicine

Outcome Measures

Primary Outcomes (1)

• Constant Work Rate Exercise Test Endurance time

  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 Outcomes (5)

• 6 minute walk test (6MWT)

  3 months

• SpO2

  3 months

• Heart rate

  3 months

• Borg scale

  3 months

• Constant Work Rate Exercise Test Endurance time

  6 months

Study Arms (2)

Endurance training with 5l/ min room air applied via nasal cannula.

PLACEBO COMPARATOR

Endurance training with 5l/ min room air applied via nasal cannula with an Everflo oxygen concentrator.

Other: Room Air (placebo)

Endurance training with 5l/ min Oxygen Therapy applied via nasal cannula.

EXPERIMENTAL

Endurance training with 5l/ min Oxygen Therapy applied via nasal cannula with an Everflo oxygen concentrator..

Other: Oxygen

Interventions

Oxygen OTHER

Standard supplemental Oxygen therapy (5l/min) will be applied with an oxygen concentrator via nasal cannula during endurance training.

Endurance training with 5l/ min Oxygen Therapy applied via nasal cannula.

Room Air (placebo) OTHER

Room air (5l/min) will be applied with an oxygen concentrator via nasal cannula during endurance training.

Endurance training with 5l/ min room air applied via nasal cannula.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Eastern Switzerland University of Applied Sciences: lead
• University Hospital, Zürich: collaborator
• Kantonsspital Winterthur KSW: collaborator

Study Sites (1)

Kantonsspital Winterthur

Winterthur, Canton of Zurich, 8400, Switzerland

RECRUITING

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive; Hyperoxia

Interventions

Oxygen

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Signs and Symptoms, Respiratory; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Chalcogens; Elements; Inorganic Chemicals; Gases

Study Officials

• Silvia Ulrich, Prof.

  University of Zurich

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Stéphanie Saxer, PHD

CONTACT

+41 58 257 12 97; stephanie.saxer@ost.ch

Spencer Rezek

CONTACT

+41522663867; spencer.rezek@ost.ch

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Randomised, multicentre, double-blinded, sham-controlled trial

Study Record Dates

• First Submitted: December 16, 2024
• First Posted: January 15, 2025
• Study Start: January 6, 2025
• Primary Completion (Estimated): April 1, 2027
• Study Completion (Estimated): August 1, 2027
• Last Updated: August 7, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will share

Locations

CH (1)