Postoperative Electrical Muscle Stimulation (POEMS)

Postoperative Complications Clinical Trial

— POEMS  

Official title:

Postoperative Electrical Muscle Stimulation (POEMS) to Attenuate Muscle Atrophy

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04199936
• Other study ID #: 19089
• Secondary ID: 274048
• Status: Recruiting
• Phase: N/A
• Start date: November 18, 2020
• Est. completion date: August 1, 2021

Study information

• Verified date: April 2021
• Source: University of Nottingham
• Contact: Edward J Hardy, MBBCh
• Phone: 07890429460
• Email: edward.hardy[@]nhs.net
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: August 1, 2021
• Est. primary completion date: June 30, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Adult patients undergoing major segmental colonic resections or gastric/oesophageal resection

• Sufficient mobility and fitness to complete normal enhanced recovery protocols following surgery

• Ability to give informed consent

Exclusion Criteria:

• Pre-existing neuromuscular disease (including parkinson's disease)

• Pacemaker, implantable cardiac defibrillator or other implanted nerve stimulator device

• Metalwork in both upper legs

• Dementia

• Inability to give informed consent

• Disability preventing normal mobilisation after surgery

• Symptomatic peripheral vascular disease

• Chronic kidney failure of chronic heart failure

• Intubation for > 24 hours post operation

• Return to theatre for surgical complication within first 5 days post operation

Related Conditions & MeSH terms

• Atrophy
• Muscle Atrophy
• Muscular Atrophy
• Postoperative Complications

Intervention

Device:
• Electrical Muscle stimulation
Electrical muscle stimulation

Locations

Country	Name	City	State
United Kingdom	Royal Derby Hospital	Derby	Derbyshire

Sponsors (1)

Lead Sponsor	Collaborator
University of Nottingham

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Vastus Lateralis muscle fibre length	USS measurement of Vastus Lateralis muscle fibre length in stimulated vs non stimulated legs of postoperative patients	5 days
Primary	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
Primary	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
Primary	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
Primary	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
Secondary	Lean muscle mass	DXA measurements of lean muscle mass in upper leg of stimulated vs non stimulated legs of postoperative patients	5 days
Secondary	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	5 days
Secondary	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
Secondary	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
Secondary	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