COPD
Conditions
Keywords
Oxygen, Exercise, Rehabilitation
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.
Interventions
OTHEROxygen
SSOT and sham air (5l/min) will be applied with the oxygen concentrator EverFloTM via nasal cannula during training
OTHERStandard ambiant air will be breathed during endurance training.
ambiant air
Sponsors
Eastern Switzerland University of Applied Sciences
National Center of Cardiology and Internal Medicine named after academician M.Mirrakhimov
University of Zurich
Study design
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in cycling CWRET time normoxia vs hypoxia vs hyperoxia | from baseline to 3 weeks |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 6 minute walk test (6MWT) | 3 weeks | 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 |
| Hospital Anxiety and Depression Scale (HADS) normoxia vs hypoxia vs hyperoxia | 3 weeks | 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) |
| mMRC score at normoxia vs hypoxia vs hyperoxia | 3 weeks | 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). |
| CAT score (COPD assessments tool) normoxia vs hypoxia vs hyperoxia | 3 weeks | 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 |
| Chronic respiratory questionnaire (CRQ) normoxia vs hypoxia vs hyperoxia | 3 weeks | 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. |
| Change in cycling CWRET time normoxia vs hypoxia vs hyperoxia | 3 months | — |
Countries
Kyrgyzstan, Switzerland
Outcome results
None listed