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| Name | Class |
|---|---|
| Medical Research Council | OTHER_GOV |
| Royal Brompton & Harefield NHS Foundation Trust | OTHER |
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The primary hypothesis for this study is that Myostatin and FHL-1 are important in the development of ICUAP and that changes in activity levels of muscle will modify the levels of expression and activity of these proteins.
ICUAP is an increasingly recognised clinical problem associated with significant morbidity and mortality. However the pathogenesis of the diseae is poorly understood and as yet no treatment exists. We believe that both myostatin and FHL-1 will be important in the development of this disease. This is based recent research and that both these proteins are likely to be regulated by sepsis and immobility (two major risk factors for ICUAP. There is evidence from invitro work that the two are likely to interact. We have designed an interventional trial to investigate the above hypothesis. Patients admitted to ICU and at risk of developing muscle wasting will be selected and receive electrical muscle stimulation of the quadriceps muscle for 1 week. Physiological measurements of peripheral and respiratory muscle strength and quadriceps size will be made pre and post intervention. And muscle biopsies, blood and urine collected from both legs pre and post intervention. The relevant molecular pathways can then be examined.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Active stimulation | Experimental | This group will receive active muscle stimulation for 1 week to the quadriceps muscle - the leg will be randomly assigned. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Active muscle stimulation | Other | Neuromuscular Electrical stimulation will be applied to one leg (randomly assigned). |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in muscle myostatin and FHL-1 | 1 week |
| Measure | Description | Time Frame |
|---|---|---|
| Change in quadriceps cross sectional area | 1 week | |
| Change in quadriceps strength | 1 week | |
| Change in blood myostatin, miRNA and other markers of muscle breakdown |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| M Polkey | Royal Brompton Hospital and Imperial College | Principal Investigator |
| Susannah Bloch | Imperial College London | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| National Heart and Lung Institute, Imperial College | London | United Kingdom |
| Type | Date | Date Unknown |
|---|---|---|
| Release | Feb 8, 2016 | |
| Reset | Mar 4, 2016 | |
| Release | Aug 16, 2016 | |
| Unrelease | Yes | |
| Release | Nov 10, 2016 | |
| Reset | Jan 9, 2017 | |
| Release | Aug 7, 2019 | |
| Reset | Sep 12, 2019 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Feb 8, 2016 | Mar 4, 2016 | |||
| Aug 16, 2016 |
| ID | Term |
|---|---|
| D009133 | Muscular Atrophy |
| D016638 | Critical Illness |
| ID | Term |
|---|---|
| D020879 | Neuromuscular Manifestations |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D001284 | Atrophy |
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| 1 week |
| Changes in muscle protein synthesis and breakdown pathways as measured in the muscle biopsy samples. | 1 week |
| Change in muscle breakdown and synthesis pathways as a factor of amount of muscle stimulation received. | 1 week |
| Change in muscle phenotype and change in cross sectional area for individual fiber types | 1 week |
| Yes |
| Nov 10, 2016 | Jan 9, 2017 |
| Aug 7, 2019 | Sep 12, 2019 |
| D020763 |
| Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D012816 | Signs and Symptoms |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |