Postoperative Electrical Muscle Stimulation (POEMS) (POEMS)

Postoperative Electrical Muscle Stimulation (POEMS) to Attenuate Muscle Atrophy

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.

Study Overview

• Status: Recruiting
• Conditions: Postoperative Complications; Muscle Atrophy
• Intervention / Treatment: Device: Electrical Muscle stimulation

Detailed 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.

• Study Type: Interventional
• Enrollment (Anticipated): 20
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Edward J Hardy, MBBCh; Phone Number: 07890429460; Email: edward.hardy@nhs.net
• Study Contact Backup: Name: Bethan E Phillips, PhD; Phone Number: 01332724676; Email: beth.phillips@nottingham.ac.uk

Study Locations

• United Kingdom
  • Derbyshire
    • Derby, Derbyshire, United Kingdom, DE22 3NE
      • Recruiting
      • Royal Derby Hospital
      • Contact: Edward J O Hardy, MBBCh; Phone Number: 01332340131; Email: Edward.hardy@nhs.net

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: EMG leg; Quadriceps muscle group of postoperative patients randomly selected leg which will undergo electrical muscle stimulation for upto 2 hours on each postoperative day	Device: Electrical Muscle stimulation; Electrical muscle stimulation
No Intervention: Control leg; Quadriceps muscle group of postoperative patients leg not selected to undergo electrical muscle stimulation

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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	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

Collaborators and Investigators

• Sponsor: University of Nottingham
• Investigators: Principal Investigator: Jon N Lund, MBBCh, DM, University of Nottingham

Study record dates

Study Major Dates

• Study Start (Actual): November 18, 2020
• Primary Completion (Anticipated): June 30, 2021
• Study Completion (Anticipated): August 1, 2021

Study Registration Dates

• First Submitted: November 26, 2019
• First Submitted That Met QC Criteria: December 12, 2019
• First Posted (Actual): December 16, 2019

Study Record Updates

• Last Update Posted (Actual): May 4, 2021
• Last Update Submitted That Met QC Criteria: April 28, 2021
• Last Verified: April 1, 2021

More Information

Terms related to this study

• Keywords: muscle; atrophy; postoperative; electrical muscle stimulation; disuse
• Additional Relevant MeSH Terms: Pathologic Processes; Nervous System Diseases; Neurologic Manifestations; Neuromuscular Manifestations; Pathological Conditions, Anatomical; Muscular Atrophy; Postoperative Complications; Atrophy
• Other Study ID Numbers: 19089; 274048 (Other Identifier: IRAS (NHS ethics) application number)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: No plan to share individual participant data

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No