Postoperative Electrical Muscle Stimulation (POEMS)

NCT04199936 | Unknown

• 2 other identifiers: 19089274048
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Muscle Atrophy; Postoperative Complications

Keywords

muscle; atrophy; postoperative; disuse; electrical muscle stimulation

Outcome Measures

Primary Outcomes (6)

• 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 Outcomes (5)

• Lean muscle mass

  5 days

• Physical activity levels in postoperative patients

  5 days

• Dietary intake in postoperative patients

  5 days

• Inflammatory response following major abdominal surgery

  5 days

• Acceptability of electrical muscle stimulation in postoperative patients

  5 days

Study Arms (2)

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

Device: Electrical Muscle stimulation

Control leg

NO INTERVENTION

Quadriceps muscle group of postoperative patients leg not selected to undergo electrical muscle stimulation

Interventions

Electrical Muscle stimulation DEVICE

Electrical muscle stimulation

EMG leg

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Nottingham: lead

Study Sites (1)

Royal Derby Hospital

Derby, Derbyshire, DE22 3NE, United Kingdom

RECRUITING

MeSH Terms

Conditions

Muscular Atrophy; Postoperative Complications; Atrophy

Condition Hierarchy (Ancestors)

Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Pathologic Processes

Study Officials

• Jon N Lund, MBBCh, DM

  University of Nottingham

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Edward J Hardy, MBBCh

CONTACT

07890429460; edward.hardy@nhs.net

Bethan E Phillips, PhD

CONTACT

01332724676; beth.phillips@nottingham.ac.uk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Single centre pilot study (randomised internal control trial)

Study Record Dates

• First Submitted: November 26, 2019
• First Posted: December 16, 2019
• Study Start: November 18, 2020
• Primary Completion: June 30, 2021
• Study Completion: August 1, 2021
• Last Updated: May 4, 2021

Record last verified: 2021-04

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)