Muscle AtrophyPOEMSNCT04199936
Postoperative Electrical Muscle Stimulation (POEMS)
A study testing Electrical Muscle stimulation in people with Muscle Atrophy and Postoperative Complications, run by University of Nottingham at 1 site in United Kingdom.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Muscle Atrophy, Postoperative Complications
- What is being tested?
- Electrical Muscle stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 18 Nov 2020to 1 Aug 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 10Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site, 1 recruiting
- Recruiting
Royal Derby Hospital
Derby, Derbyshire, DE22 3NE
Edward J O Hardy, MBBCh, 01332340131, Edward.hardy@nhs.net
About this study
Official title: 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.
Read the 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.
- Conditions
- Muscle Atrophy, Postoperative Complications
- Being tested
- Electrical Muscle stimulation
- Keywords
- muscle, atrophy, postoperative, disuse, electrical muscle stimulation
- Medical subject headings
- Muscular Atrophy, Postoperative Complications, Atrophy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Electrical Muscle stimulationDevice
Electrical muscle stimulation
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Device: Electrical Muscle stimulation |
| Control leg | No intervention | Quadriceps muscle group of postoperative patients leg not selected to undergo electrical muscle stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Vastus Lateralis muscle thickness (cm)
Ultrasound scan (USS) measurement of Vastus Lateralis muscle thickness in stimulated vs non stimulated legs of postoperative patients
Measured: 5 days
Vastus Lateralis muscle fibre length
USS measurement of Vastus Lateralis muscle fibre length in stimulated vs non stimulated legs of postoperative patients
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 5 days
Secondary outcomes (5)
Lean muscle mass
DXA measurements of lean muscle mass in upper leg of stimulated vs non stimulated legs of postoperative patients
Measured: 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
Measured: 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
Measured: 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
Measured: 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.
Measured: 5 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Dec 2019
- Study start18 Nov 2020
- Primary completion30 Jun 2021 (estimated)
- Study completion1 Aug 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Muscle AtrophyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Single centre pilot study (randomised internal control trial)
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Nottingham
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jon N Lund, MBBCh, DM, Principal investigator, University of Nottingham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04199936
- Sponsor's protocol ID
- 19089
- Other IDs
- 274048
- Acronym
- POEMS
- Status last verified
- Apr 2021
- First submitted
- 26 Nov 2019
- Last updated
- 4 May 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: No plan to share individual participant data
Study at a glance
From the registry record, last updated by the sponsor on 4 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Postoperative Electrical Muscle Stimulation (POEMS) to Attenuate Muscle Atrophy
- ClinicalTrials.gov ID
- NCT04199936
- Acronym / sponsor ID
- POEMS / 19089
- Conditions
- Muscle Atrophy, Postoperative Complications
- Keywords
- muscle, atrophy, postoperative, disuse, electrical muscle stimulation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- University of NottinghamUniversity, hospital or other
- Study start
- 18 Nov 2020 (actual)
- Primary completion
- 30 Jun 2021 (estimated)
- Study completion
- 1 Aug 2021 (estimated)
- First posted
- 16 Dec 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Single centre pilot study (randomised internal control trial)
| Arm | Type | Receives |
|---|---|---|
| EMG leg | Experimental | Device: Electrical Muscle stimulationQuadriceps muscle group of postoperative patients randomly selected leg which will undergo electrical muscle stimulation for upto 2 hours on each postoperative day |
| Control leg | No intervention | –Quadriceps muscle group of postoperative patients leg not selected to undergo electrical muscle stimulation |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Electrical Muscle stimulationElectrical muscle stimulation | Device | EMG leg |
Primary outcome
Vastus Lateralis muscle thickness (cm)
Time frame: 5 days
Ultrasound scan (USS) measurement of Vastus Lateralis muscle thickness in stimulated vs non stimulated legs of postoperative patients
Vastus Lateralis muscle fibre length
Time frame: 5 days
USS measurement of Vastus Lateralis muscle fibre length in stimulated vs non stimulated legs of postoperative patients
Vastus Lateralis muscle fibre pennation angle
Time frame: 5 days
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
Time frame: 5 days
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
Time frame: 5 days
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)
Time frame: 5 days
Changes in MUNE (as derived from surface EMG) in stimulated vs non stimulated legs of postoperative patients
5 secondary outcomes
Lean muscle mass
Time frame: 5 days
Physical activity levels in postoperative patients
Time frame: 5 days
Dietary intake in postoperative patients
Time frame: 5 days
Inflammatory response following major abdominal surgery
Time frame: 5 days
Acceptability of electrical muscle stimulation in postoperative patients
Time frame: 5 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 May 2021.
- Individual participant dataSharing planned: No. No plan to share individual participant data
Related trials for Muscle Atrophy
RecruitingPhase 4
ASsessing The REAl-world Safety & Effectiveness of Spinal Muscular Atrophy Participants Treated With Intrathecal Onasemnogene Abeparvovec-brve (OAV101B) (ITVISMA®): A U.S. Pragmatic Multicenter Study (STREAM)
Spinal Muscular Atrophy
Not yet recruitingEarly Phase 1
SPX-01 Gene Therapy in Pediatric Patients With Spinal Muscular Atrophy Type 1 (RISE)
Spinal Muscular Atrophy (SMA)
Active, not recruitingObservational study
Extracellular RNA Biomarkers of Myotonic Dystrophy
Myotonic Dystrophy
Recruiting
Muscle Deterioration in Hospitalized Cancer Patient
Oncologic Diseases
Active, not recruitingObservational study
Extracellular RNA Biomarkers of Duchenne Muscular Dystrophy
Duchenne Muscular Dystrophy
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jon N Lund, MBBCh, DM principal investigator
University of Nottingham
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Electrical Muscle stimulation in people with Muscle Atrophy and Postoperative Complications, run by University of Nottingham at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 4 May 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Edward J Hardy, MBBCh (07890429460, edward.hardy@nhs.net), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Vastus Lateralis muscle thickness (cm) (time frame: 5 days). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 May 2021.