Clinical trial NCT04199936: Postoperative Electrical Muscle Stimulation (POEMS)
Official title: Postoperative Electrical Muscle Stimulation (POEMS) to Attenuate Muscle Atrophy
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Muscle Atrophy
Postoperative Complications
Keywords: muscle
atrophy
postoperative
disuse
electrical muscle stimulation
Lead sponsor: University of Nottingham
Sponsor class: OTHER
First posted: 2019-12-16
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Single centre pilot study (randomised internal control trial)
Primary purpose: BASIC_SCIENCE

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.

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

Primary outcomes:
measure: Vastus Lateralis muscle thickness (cm)
timeFrame: 5 days
measure: Vastus Lateralis muscle fibre length
timeFrame: 5 days
measure: Vastus Lateralis muscle fibre pennation angle
timeFrame: 5 days
measure: Compound muscle action potentials (CMAP) as measured by surface electromyography
timeFrame: 5 days
measure: Near Fibre Motor Unit Potentials as measured by surface EMG
timeFrame: 5 days
measure: Motor unit number estimates ((MUNE) as derived from surface EMG analysis)
timeFrame: 5 days
Secondary outcomes:
measure: Lean muscle mass
timeFrame: 5 days
measure: Physical activity levels in postoperative patients
timeFrame: 5 days
measure: Dietary intake in postoperative patients
timeFrame: 5 days
measure: Inflammatory response following major abdominal surgery
timeFrame: 5 days
measure: Acceptability of electrical muscle stimulation in postoperative patients
timeFrame: 5 days
Other outcomes:
Locations:
city: Derby
country: United Kingdom
facility: Royal Derby Hospital
state: Derbyshire
Study officials:
affiliation: University of Nottingham
name: Jon N Lund, MBBCh, DM
role: PRINCIPAL_INVESTIGATOR
References: