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

NCT07044843 | Active Not Recruiting

• 1 other identifier: inRehaExO2_normoxia_hyperoxia
• Study Type: interventional
• Target: 54
• Locations: 2 countries
• Sites: 2

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

Keywords

Oxygen; Exercise; Rehabilitation

Outcome Measures

Primary Outcomes (1)

• Change in cycling CWRET time normoxia vs hypoxia vs hyperoxia

  from baseline to 3 weeks

Secondary Outcomes (6)

• 6 minute walk test (6MWT)

  3 weeks

• Hospital Anxiety and Depression Scale (HADS) normoxia vs hypoxia vs hyperoxia

  3 weeks

• mMRC score at normoxia vs hypoxia vs hyperoxia

  3 weeks

• CAT score (COPD assessments tool) normoxia vs hypoxia vs hyperoxia

  3 weeks

• Chronic respiratory questionnaire (CRQ) normoxia vs hypoxia vs hyperoxia

  3 weeks

Study Arms (3)

Normoxia

SHAM COMPARATOR

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

Other: Standard ambiant air will be breathed during endurance training.

Hyperoxia

ACTIVE COMPARATOR

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

Other: Oxygen

Hypoxia

EXPERIMENTAL

This group will train at moderate altitude.

Other: Standard ambiant air will be breathed during endurance training.

Interventions

Oxygen OTHER

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

Hyperoxia

Standard ambiant air will be breathed during endurance training. OTHER

ambiant air

Hypoxia; Normoxia

Eligibility Criteria

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

You may qualify if:

• 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.

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
• National Center of Cardiology and Internal Medicine named after academician M.Mirrakhimov: collaborator
• University of Zurich: collaborator

Study Sites (2)

National center for cardiology and internal medicine

Bishkek, Kyrgyzstan

Location

Eastern Switzerland University of Applied Sciences

Sankt Gallen, Canton of St. Gallen, 9001, Switzerland

Location

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive; Motor Activity

Interventions

Oxygen

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Chalcogens; Elements; Inorganic Chemicals; Gases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 20, 2025
• First Posted: July 1, 2025
• Study Start: July 23, 2025
• Primary Completion: December 31, 2025
• Study Completion: December 31, 2025
• Last Updated: August 7, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

CH (1); KY (1)