Oxygen Therapy During Exercise Training in Inpatient Rehabilitation in Chronic Lung Disease- Does it Matter?

NCT ID: NCT07044843

Last Updated: 2025-08-07

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 54 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-07-23
• Study Completion Date: 2025-12-31

Brief Summary

The aim of the current study is the effect of SSOT during a 3-weeks inpatient pulmonary rehabilitation program. Further aim is to analyze exercise endurance, distinguishing between those exercising whilst breathing air at 760m "normoxia", breathing air at approx. 1600m "hypoxia", or breathing SSOT at 760m "hyperoxia" conditions during inpatient pulmonary rehabilitation.

The objective of the study is to provide long-awaited data concerning the use of SSOT during training. To date, it is not clear whether patients with chronic lung diseases who reveal a SpO2 > 88% at rest but desaturate during exercise and thus may not qualify for long-term oxygen therapy undergoing PR benefit from supplemental oxygen.

Conditions

COPD

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Normoxia

Sham air (ambient air) (5l/min) will be applied with the oxygen concentrator EverFloTM via nasal cannula.

Group Type: SHAM_COMPARATOR

Standard ambiant air will be breathed during endurance training.

Intervention Type: OTHER

ambiant air

Hyperoxia

Standardized supplemental oxygen therapy (SSOT) (5l/min) will be applied with the oxygen concentrator EverFloTM via nasal cannula during training

Group Type: ACTIVE_COMPARATOR

Oxygen

Intervention Type: OTHER

SSOT and sham air (5l/min) will be applied with the oxygen concentrator EverFloTM via nasal cannula during training

Hypoxia

This group will train at moderate altitude.

Group Type: EXPERIMENTAL

Standard ambiant air will be breathed during endurance training.

Intervention Type: OTHER

ambiant air

Interventions

Oxygen

SSOT and sham air (5l/min) will be applied with the oxygen concentrator EverFloTM via nasal cannula during training

Intervention Type: OTHER

Standard ambiant air will be breathed during endurance training.

ambiant air

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• aged ≥ 18 years
• stable condition > 3 weeks (e.g. no exacerbations)
• resting SpO2 ≥ 88% and exercise induced hypoxemia defined by a fall in SpO2 by ≥ 4% and/or below 90% during a 6-minute walk test (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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Center of Cardiology and Internal Medicine named after academician M.Mirrakhimov

OTHER_GOV

Sponsor Role: collaborator

University of Zurich

OTHER

Sponsor Role: collaborator

Eastern Switzerland University of Applied Sciences

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

National center for cardiology and internal medicine

Bishkek, , Kyrgyzstan

Eastern Switzerland University of Applied Sciences

Sankt Gallen, Canton of St. Gallen, Switzerland

Countries

Kyrgyzstan; Switzerland

Other Identifiers

inRehaExO2_normoxia_hyperoxia

Identifier Type: -

Identifier Source: org_study_id