Postoperative Electrical Muscle Stimulation (POEMS) (POEMS)
Primary Purpose
Muscle Atrophy, Postoperative Complications
Status
Unknown status
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Electrical Muscle stimulation
Sponsored by
About this trial
This is an interventional basic science trial for Muscle Atrophy focused on measuring muscle, atrophy, postoperative, disuse, electrical muscle stimulation
Eligibility Criteria
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
Sites / Locations
- Royal Derby HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
EMG leg
Control leg
Arm Description
Quadriceps muscle group of postoperative patients randomly selected leg which will undergo electrical muscle stimulation for upto 2 hours on each postoperative day
Quadriceps muscle group of postoperative patients leg not selected to undergo electrical muscle stimulation
Outcomes
Primary Outcome Measures
Vastus Lateralis muscle thickness (cm)
Ultrasound scan (USS) measurement of Vastus Lateralis muscle thickness in stimulated vs non stimulated legs of postoperative patients
Vastus Lateralis muscle fibre length
USS measurement of Vastus Lateralis muscle fibre length in stimulated vs non stimulated legs of postoperative patients
Vastus Lateralis muscle fibre pennation angle
USS measurement of Vastus Lateralis muscle fibre pennation angle in stimulated vs non stimulated legs of postoperative patients
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
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
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
Secondary Outcome Measures
Lean muscle mass
DXA measurements of lean muscle mass in upper leg of stimulated vs non stimulated legs of postoperative patients
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
Dietary intake in postoperative patients
Dietary intake of patients following major gastrointestinal resection surgery, as recorded by patient food diary on each postoperative day
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
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.
Full Information
NCT ID
NCT04199936
First Posted
November 26, 2019
Last Updated
April 28, 2021
Sponsor
University of Nottingham
1. Study Identification
Unique Protocol Identification Number
NCT04199936
Brief Title
Postoperative Electrical Muscle Stimulation (POEMS)
Acronym
POEMS
Official Title
Postoperative Electrical Muscle Stimulation (POEMS) to Attenuate Muscle Atrophy
Study Type
Interventional
2. Study Status
Record Verification Date
April 2021
Overall Recruitment Status
Unknown status
Study Start Date
November 18, 2020 (Actual)
Primary Completion Date
June 30, 2021 (Anticipated)
Study Completion Date
August 1, 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Nottingham
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Muscle Atrophy, Postoperative Complications
Keywords
muscle, atrophy, postoperative, disuse, electrical muscle stimulation
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Single centre pilot study (randomised internal control trial)
Masking
Outcomes Assessor
Masking Description
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.
Allocation
Randomized
Enrollment
20 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
EMG leg
Arm Type
Experimental
Arm Description
Quadriceps muscle group of postoperative patients randomly selected leg which will undergo electrical muscle stimulation for upto 2 hours on each postoperative day
Arm Title
Control leg
Arm Type
No Intervention
Arm Description
Quadriceps muscle group of postoperative patients leg not selected to undergo electrical muscle stimulation
Intervention Type
Device
Intervention Name(s)
Electrical Muscle stimulation
Intervention Description
Electrical muscle stimulation
Primary Outcome Measure Information:
Title
Vastus Lateralis muscle thickness (cm)
Description
Ultrasound scan (USS) measurement of Vastus Lateralis muscle thickness in stimulated vs non stimulated legs of postoperative patients
Time Frame
5 days
Title
Vastus Lateralis muscle fibre length
Description
USS measurement of Vastus Lateralis muscle fibre length in stimulated vs non stimulated legs of postoperative patients
Time Frame
5 days
Title
Vastus Lateralis muscle fibre pennation angle
Description
USS measurement of Vastus Lateralis muscle fibre pennation angle in stimulated vs non stimulated legs of postoperative patients
Time Frame
5 days
Title
Compound muscle action potentials (CMAP) as measured by surface electromyography
Description
Changes in compound muscle action potentials (as detected by EMG) in stimulated vs non stimulated legs of postoperative patients
Time Frame
5 days
Title
Near Fibre Motor Unit Potentials as measured by surface EMG
Description
Changes in motor unit potentials (as detected by EMG) in stimulated vs non stimulated legs of postoperative patients
Time Frame
5 days
Title
Motor unit number estimates ((MUNE) as derived from surface EMG analysis)
Description
Changes in MUNE (as derived from surface EMG) in stimulated vs non stimulated legs of postoperative patients
Time Frame
5 days
Secondary Outcome Measure Information:
Title
Lean muscle mass
Description
DXA measurements of lean muscle mass in upper leg of stimulated vs non stimulated legs of postoperative patients
Time Frame
5 days
Title
Physical activity levels in postoperative patients
Description
Physical activity levels of patients following major gastrointestinal resection surgery on each postoperative day as measured by physical activity monitor
Time Frame
5 days
Title
Dietary intake in postoperative patients
Description
Dietary intake of patients following major gastrointestinal resection surgery, as recorded by patient food diary on each postoperative day
Time Frame
5 days
Title
Inflammatory response following major abdominal surgery
Description
Inflammatory response (as measured by IL6, TNFalfa and CRP) following major gastrointestinal resection surgery and its correlation with degree of skeletal muscle loss
Time Frame
5 days
Title
Acceptability of electrical muscle stimulation in postoperative patients
Description
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.
Time Frame
5 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Edward J Hardy, MBBCh
Phone
07890429460
Email
edward.hardy@nhs.net
First Name & Middle Initial & Last Name or Official Title & Degree
Bethan E Phillips, PhD
Phone
01332724676
Email
beth.phillips@nottingham.ac.uk
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jon N Lund, MBBCh, DM
Organizational Affiliation
University of Nottingham
Official's Role
Principal Investigator
Facility Information:
Facility Name
Royal Derby Hospital
City
Derby
State/Province
Derbyshire
ZIP/Postal Code
DE22 3NE
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Edward J O Hardy, MBBCh
Phone
01332340131
Email
Edward.hardy@nhs.net
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
No plan to share individual participant data
Learn more about this trial
Postoperative Electrical Muscle Stimulation (POEMS)
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