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

Eastern Switzerland University of Applied Sciences

Status: Active, not recruiting

Conditions: COPD

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

Study type: Interventional

Funder types: Other

Identifiers

NCT07044843

inRehaExO2_normoxia_hyperoxia

Details and patient eligibility

About

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.

Enrollment: 54 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Sequential Assignment

Masking: Quadruple Blind

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54 participants in 3 patient groups

Normoxia

Sham Comparator group

Description:

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

Treatment:

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

Hyperoxia

Active Comparator group

Description:

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

Treatment:

Other: Oxygen

Hypoxia

Experimental group

Description:

This group will train at moderate altitude.

Treatment:

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