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

Active, not recruiting
Clinical Trial NCT07044843 is an interventional study for COPD that is active, not recruiting. It started on July 23, 2025 with plans to enroll 54 participants. Led by Eastern Switzerland University of Applied Sciences, it is expected to complete by December 31, 2025. The latest data from ClinicalTrials.gov was last updated on August 7, 2025.
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.

Official Title

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

Conditions
COPD
Other Study IDs
  • inRehaExO2_normoxia_hyperoxia
NCT ID Number
NCT07044843
Start Date (Actual)
2025-07-23
Last Update Posted
2025-08-07
Completion Date (Estimated)
2025-12-31
Enrollment (Estimated)
54
Study Type
Interventional
PHASE
N/A
Status
Active, not recruiting
Keywords
Oxygen
Exercise
Rehabilitation
Primary Purpose
Treatment
Design Allocation
Randomized
Interventional Model
Sequential
Masking
Quadruple
Arms / Interventions
Participant Group/ArmIntervention/Treatment
Sham ComparatorNormoxia
Sham air (ambient air) (5l/min) will be applied with the oxygen concentrator EverFloTM via nasal cannula.
Standard Ambiant Air Will Be Breathed During Endurance Training.
ambiant air
Active ComparatorHyperoxia
Standardized supplemental oxygen therapy (SSOT) (5l/min) will be applied with the oxygen concentrator EverFloTM via nasal cannula during training
Oxygen
SSOT and sham air (5l/min) will be applied with the oxygen concentrator EverFloTM via nasal cannula during training
ExperimentalHypoxia
This group will train at moderate altitude.
Standard Ambiant Air Will Be Breathed During Endurance Training.
ambiant air
Primary Outcome Measures
Outcome MeasureMeasure DescriptionTime Frame
Change in cycling CWRET time normoxia vs hypoxia vs hyperoxia
from baseline to 3 weeks
Secondary Outcome Measures
Outcome MeasureMeasure DescriptionTime Frame
6 minute walk test (6MWT)
6 minute walk distance (6MWD), SpO2 and heart rate at the end of the 6 minute walk test (6MWT) from baseline to 3 weeks at normoxia vs hypoxia vs hyperoxia
3 weeks
Hospital Anxiety and Depression Scale (HADS) normoxia vs hypoxia vs hyperoxia
HADS-A (Anxiety): 7 items HADS-D (Depression): 7 items Each item is scored from 0 to 3, resulting in: Minimum score per subscale: 0 Maximum score per subscale: 21 Interpretation: Higher scores indicate worse psychological status. Scores of 0-7: Normal Scores of 8-10: Borderline abnormal Scores of 11-21: Abnormal (clinically relevant anxiety or depression)
3 weeks
mMRC score at normoxia vs hypoxia vs hyperoxia
The scale ranges from 0 to 4. Each grade reflects a different level of functional limitation due to dyspnea. Minimum score: 0 Maximum score: 4 Interpretation: Higher scores indicate more severe dyspnea (worse outcome).
3 weeks
CAT score (COPD assessments tool) normoxia vs hypoxia vs hyperoxia
It consists of 8 items, each scored from 0 to 5. The total score ranges from: Minimum score: 0 Maximum score: 40 Interpretation: Higher scores indicate greater symptom burden and worse health status. Score bands for interpretation: 0-10: Low impact 11-20: Medium impact 21-30: High impact 31-40: Very high impact
3 weeks
Chronic respiratory questionnaire (CRQ) normoxia vs hypoxia vs hyperoxia
The CRQ consists of 20 items across four domains: Dyspnea (5 items) Fatigue (4 items) Emotional function (7 items) Mastery (4 items) Each item is scored on a 7-point Likert scale: Minimum score per item: 1 Maximum score per item: 7 Interpretation: Higher scores indicate better health-related quality of life (less impairment). Mean scores are calculated per domain and as a total score.
3 weeks
Change in cycling CWRET time normoxia vs hypoxia vs hyperoxia
3 months
Eligibility Criteria

Eligible Ages
Adult, Older Adult
Minimum Age
18 Years
Eligible Sexes
All
  • 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.

  • 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.
Eastern Switzerland University of Applied Sciences logoEastern Switzerland University of Applied Sciences
No contact data.
2 Study Locations in 2 Countries
National center for cardiology and internal medicine, Bishkek, Kyrgyzstan

Canton of St. Gallen

Eastern Switzerland University of Applied Sciences, Sankt Gallen, Canton of St. Gallen, 9001, Switzerland