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The investigators aim to study the effect of SOT in subjects with chronic lung disease in submaximal exercise.
Participants with lung disease who live in Switzerland will have 6-minute walk distance (6MWD) test with and without SOT at approximately 3l/min via nasal cannula according to a randomized cross-over design.
The trial aims to test that the 6MWD with SOT is non-inferior to a 6MWD in the same participant under ambient air.
Our effect size was estimated with a difference of less or equal to 35m compared under SOT compared to ambient air.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ambient air | Experimental | Patient will perform tests at University Hospital Zurich on ambient air |
|
| SOT via basal cannula | Active Comparator | Supplemental Oxygen Therapy (SOT) will be provided via nasal cannula from a small oxygen concentrator while the patient performs tests at University Hospital Zurich. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 6-minute walk distance (6MWD) test on ambient air | Other | 6-minute walk distance (6MWD) test will be performed on ambient air according to clinical standards |
|
| Measure | Description | Time Frame |
|---|---|---|
| 6-minute walk distance (6MWD) with supplemental oxygen therapy (SOT) vs. ambient air | Change in 6MWD in meter between SOT via nasal cannula vs. ambient air | after 6 minutes |
| Measure | Description | Time Frame |
|---|---|---|
| SpO2 at rest and peak 6MWD with SOT vs. ambient air | Change of the arterial oxygen saturation by pulse oximetry (SpO2) at rest and at peak 6MWD with SOT vs. ambient air | after 6 minutes |
| Heart rate at rest and peak 6MWD with SOT vs. ambient air |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Silvia Ulrich, Prof. Dr. | University Hospital Zurich, Department of Pulmonology | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospital Zürich | Zurich | Canton of Zurich | 8091 | Switzerland |
Data will be provided upon request and based on a clear intention reviewed by an ethical review board
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Each participant is its own control
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| 6-minute walk distance test with supplemental oxygen (approximately 3l/min, nasal) | Other | 6-minute walk distance (6MWD) test will be performed according to clinical standards additionally with supplemental oxygen therapy (approximately 3l/min, nasal) |
|
Change of heart rate (bpm) at rest and at peak 6MWD with SOT vs. ambient air
| after 6 minutes |
| Borg dyspnea scale at rest and peak 6MWD with SOT vs. ambient air | Change of Borg dyspnea scale at rest and at peak 6MWD with SOT vs. ambient air | 6 minutes |
| Borg leg fatigue scale at rest and peak 6MWD with SOT vs. ambient air | Change of Borg leg fatigue scale at rest and at peak 6MWD with SOT vs. ambient air | after 6 minutes |
| Blood pressure at rest and peak 6MWD with SOT vs. ambient air | Change of Blood pressure (mmHg) at rest and at peak 6MWD with SOT vs. ambient air | after 6 minutes |
| ID | Term |
|---|---|
| D017563 | Lung Diseases, Interstitial |
| D008173 | Lung Diseases, Obstructive |
| ID | Term |
|---|---|
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
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