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| Name | Class |
|---|---|
| Royal Brisbane and Women's Hospital | OTHER_GOV |
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This study will investigate whether early exercise in critically ill patients will decrease inflammatory markers, increase pro-inflammatory markers and prevent loss of muscle mass.
This study will investigate the effects of an early targeted rehabilitation program on inflammatory markers and muscle mass in patients with sepsis syndromes in intensive care.
The Primary Hypothesis is that an early targeted rehabilitation ICU patients with sepsis syndromes over 7 days will Prevent loss of lean muscle mass by within 7 days of recruitment to the study. Decrease pro-inflammatory and increase anti-inflammatory cytokines within 7 days of recruitment to the study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control (usual practice) | Placebo Comparator |
| |
| Exercise | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Exercise | Other | The subjects will be given 2 x 30 minute sessions of exercise per day consisting of either passive, active, active assisted depending on level of sedation and stability of condition. According to level of sedation and stability they may also perform sitting exercises |
| Measure | Description | Time Frame |
|---|---|---|
| Fat free mass ie muscle mass (lean tissue) | Fat free mass will be measured by Multi-Frequency Bioelectrical Impedance Spectroscopy (BIS) (ImpediMed SFB7, ImpediMed Ltd, Brisbane, Australia). | Change from baseline to one week, then change from baseline to two weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Interleukin 6 | 5mls blood from arterial catheter, centrifuged at 1,500 for 10 minutes at 4 degrees C. The supernaturant will be collected and stored at -80 degrees C. The marker will be analyzed by an enzyme-linked immuno-assay. | Change from baseline to measurements taken daily for 7 days |
| Tumour necrosis factor alpha (TNF-alpha) |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Royal Brisbane & Womens Hospital | Brisbane | Queensland | 4029 | Australia |
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| ID | Term |
|---|---|
| D018746 | Systemic Inflammatory Response Syndrome |
| D018805 | Sepsis |
| D012772 | Shock, Septic |
| D014115 | Toxemia |
| D016470 | Bacteremia |
| ID | Term |
|---|---|
| D007249 | Inflammation |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D012769 | Shock |
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| ID | Term |
|---|---|
| D015444 | Exercise |
| ID | Term |
|---|---|
| D009043 | Motor Activity |
| D009068 | Movement |
| D009142 | Musculoskeletal Physiological Phenomena |
| D055687 | Musculoskeletal and Neural Physiological Phenomena |
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| Usual practice | Other | These patients will not receive exercise early in their intensive care admission |
|
5mls blood from arterial catheter, centrifuged at 1,500 for 10 minutes at 4 degrees C. The supernaturant will be collected and stored at -80 degrees C. The marker will be analyzed by an enzyme-linked immuno-assay. |
| Change from baseline to measurements taken daily for 7 days |
| Interleukin 10 | 5mls blood from arterial catheter, centrifuged at 1,500 for 10 minutes at 4 degrees C. The supernaturant will be collected and stored at -80 degrees C. The marker will be analyzed by an enzyme-linked immuno-assay. | Change from baseline to measurements taken daily for 7 days |
| Vital signs - observation only | Recording of vital signs ie heart rate, ECG, blood pressure, oxygen saturation from the IntelliVue bedside monitor MP70 (Phillips) | Fifteen minutes pre and post every exercise session recorded every 10 seconds |
| D007239 |
| Infections |
| D001424 | Bacterial Infections |
| D001423 | Bacterial Infections and Mycoses |