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| Name | Class |
|---|---|
| National Center of Cardiology and Internal Medicine named after academician M.Mirrakhimov | OTHER_GOV |
| University of Zurich | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Normoxia | Sham Comparator | Sham air (ambient air) (5l/min) will be applied with the oxygen concentrator EverFloTM via nasal cannula. |
|
| Hyperoxia | Active Comparator | Standardized supplemental oxygen therapy (SSOT) (5l/min) will be applied with the oxygen concentrator EverFloTM via nasal cannula during training |
|
| Hypoxia | Experimental | This group will train at moderate altitude. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Oxygen | Other | SSOT and sham air (5l/min) will be applied with the oxygen concentrator EverFloTM via nasal cannula during training |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in cycling CWRET time normoxia vs hypoxia vs hyperoxia | from baseline to 3 weeks |
| Measure | Description | Time 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| National center for cardiology and internal medicine | Bishkek | Kyrgyzstan | ||||
| Eastern Switzerland University of Applied Sciences |
individual patient data will be shared upon personal request to the corresponding author
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| Standard ambiant air will be breathed during endurance training. | Other | ambiant air |
|
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 |
| Sankt Gallen |
| Canton of St. Gallen |
| 9001 |
| Switzerland |
| ID | Term |
|---|---|
| D029424 | Pulmonary Disease, Chronic Obstructive |
| D009043 | Motor Activity |
| ID | Term |
|---|---|
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001519 | Behavior |
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| ID | Term |
|---|---|
| D010100 | Oxygen |
| ID | Term |
|---|---|
| D018011 | Chalcogens |
| D004602 | Elements |
| D007287 | Inorganic Chemicals |
| D005740 | Gases |
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