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| ID | Type | Description | Link |
|---|---|---|---|
| 274048 | Other Identifier | IRAS (NHS ethics) application number |
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Patients lose a significant amount of muscle following major abdominal surgery. This is partly due to a catabolic response to the surgical insult and inflammation, but is also probably due to a lack of muscle use secondary to immobility.
This study will aim to assess whether some or even all of postoperative muscle loss in the upper leg muscle group is preventable through electrical muscle stimulation to mimic physical activity.
Following major gastrointestinal surgery patients may loose around 6 % of their skeletal muscle mass in the first 5 days. Whilst some of this loss is as a result of inflammation and starvation, some is due to muscle disuse.
Studies have shown that patients spend 96% of their time being sedentary in the first 5 days following major abdominal surgery and by day 5 are still taking a median of less than 500 steps per day. Studies of healthy volunteers who undergo similar muscle disuse loose approximately 3.5% of skeletal muscle mass over the same time period, indicating that around half of postoperative muscle loss may be due to immobility.
Through the use of electrical muscle stimulation, this study will aim to mimic high levels of exercise in the quadriceps of patients who have undergo major gastrointestinal surgery to see whether this reduces or prevents muscle loss. Patients muscles will be measured using ultrasound and DXA and neuromuscular function will be measured using electromyography.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| EMG leg | Experimental | Quadriceps muscle group of postoperative patients randomly selected leg which will undergo electrical muscle stimulation for upto 2 hours on each postoperative day |
|
| Control leg | No Intervention | Quadriceps muscle group of postoperative patients leg not selected to undergo electrical muscle stimulation |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Electrical Muscle stimulation | Device | Electrical muscle stimulation |
|
| Measure | Description | Time Frame |
|---|---|---|
| Vastus Lateralis muscle thickness (cm) | Ultrasound scan (USS) measurement of Vastus Lateralis muscle thickness in stimulated vs non stimulated legs of postoperative patients | 5 days |
| Vastus Lateralis muscle fibre length | USS measurement of Vastus Lateralis muscle fibre length in stimulated vs non stimulated legs of postoperative patients | 5 days |
| Vastus Lateralis muscle fibre pennation angle | USS measurement of Vastus Lateralis muscle fibre pennation angle in stimulated vs non stimulated legs of postoperative patients | 5 days |
| Compound muscle action potentials (CMAP) as measured by surface electromyography | Changes in compound muscle action potentials (as detected by EMG) in stimulated vs non stimulated legs of postoperative patients | 5 days |
| Near Fibre Motor Unit Potentials as measured by surface EMG | Changes in motor unit potentials (as detected by EMG) in stimulated vs non stimulated legs of postoperative patients | 5 days |
| Motor unit number estimates ((MUNE) as derived from surface EMG analysis) | Changes in MUNE (as derived from surface EMG) in stimulated vs non stimulated legs of postoperative patients | 5 days |
| Measure | Description | Time Frame |
|---|---|---|
| Lean muscle mass | DXA measurements of lean muscle mass in upper leg of stimulated vs non stimulated legs of postoperative patients | 5 days |
| Physical activity levels in postoperative patients | Physical activity levels of patients following major gastrointestinal resection surgery on each postoperative day as measured by physical activity monitor |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Edward J Hardy, MBBCh | Contact | 07890429460 | edward.hardy@nhs.net | |
| Bethan E Phillips, PhD | Contact | 01332724676 | beth.phillips@nottingham.ac.uk |
| Name | Affiliation | Role |
|---|---|---|
| Jon N Lund, MBBCh, DM | University of Nottingham | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Royal Derby Hospital | Recruiting | Derby | Derbyshire | DE22 3NE | United Kingdom |
No plan to share individual participant data
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| ID | Term |
|---|---|
| D009133 | Muscular Atrophy |
| D011183 | Postoperative Complications |
| D001284 | Atrophy |
| ID | Term |
|---|---|
| D020879 | Neuromuscular Manifestations |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D020763 | Pathological Conditions, Anatomical |
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Single centre pilot study (randomised internal control trial)
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ultrasound images, DXA scans and EMG results will be given coded labeling by a separate researcher so that investigator analysing results will be blinded to whether scans / EMG results are from intervention or control leg, or start of finish.
| 5 days |
| Dietary intake in postoperative patients | Dietary intake of patients following major gastrointestinal resection surgery, as recorded by patient food diary on each postoperative day | 5 days |
| Inflammatory response following major abdominal surgery | Inflammatory response (as measured by IL6, TNFalfa and CRP) following major gastrointestinal resection surgery and its correlation with degree of skeletal muscle loss | 5 days |
| Acceptability of electrical muscle stimulation in postoperative patients | Patient experience of electrical muscle stimulation following major gastrointestinal resection surgery as measured by visual analogue score measures of patient comfort, distress, harmful effects and enjoyment. | 5 days |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D012816 | Signs and Symptoms |
| D010335 | Pathologic Processes |