Postoperative Electrical Muscle Stimulation Two

NCT06964438 | Not Yet Recruiting

• 2 other identifiers: 24058347923
• Study Type: interventional
• Target: 45
• Locations: 0 countries
• Sites: N/A

Brief Summary

Undesirable loss of skeletal muscle mass (atrophy) is a common feature of many diseases as well as ageing, bed rest and physical inactivity. Losing muscle can lead to a reduction in one's ability to perform physical activities, and reduce independence and overall health. Muscle mass loss occurs very quickly (i.e., within a few days) after surgery. The investigators previous work has shown that neuromuscular electrical stimulation (NMES) of the thigh muscles on one side of the body can help maintain muscle mass and strength on the stimulated side after surgery. Since then, additional work has been carried out to find the most effective form of stimulation to build muscle. The current study aims to use this refined stimulation protocol in a clinical trial on the wards after major abdominal surgery. The intervention will involve delivering stimulation to both thighs in the few days after surgery, so that the investigators can assess whether this stimulation can preserve muscle mass and strength, and also, patients' ability to perform physical activities after surgery. In addition, the study will aim to find out whether any benefit provided by electrical stimulation can be increased further by taking a protein supplement at the same time.

Conditions

Surgery; Colorectal Cancer; Muscle Atrophy; Cancer Gi

Keywords

electrical stimulation; neuromuscular electrical stimulation; NMES; rehabilitation; general surgery; colorectal surgery; laparotomy; laparoscopy; postoperative recovery; gastrointestinal cancer; gastrointestinal surgery

Outcome Measures

Primary Outcomes (1)

• Post-operative vastus lateralis (VL) muscle mass loss

  Vastus lateralis (VL) muscle mass loss as measured on ultrasound cross sectional area

  Pre-operatively and 5 days post-operatively

Secondary Outcomes (12)

• Post-operative knee extensor strength losses

  Pre-operatively and 5 days post-operatively

• Post-operative functional losses determined by short physical performance battery standardized physical function assessment tool

  Pre-operatively and 5 days post-operatively

• Post-operative functional losses determined by Timed Up and Go standardized physical function assessment tool

  Pre-operatively and 5 days post-operatively

• Post-operative functional losses determined by 6 minute walk test standardized physical function assessment tool

  Pre-operatively and 5 days post-operatively

• Post-operative changes in muscle architecture as measured by pennation angle

  Pre-operatively and 5 days post-operatively

Other Outcomes (1)

• Feasibility and acceptability of incorporating NMES into postoperative recovery

  Days 1-4 post-operatively

Study Arms (3)

Group 1 - Control

NO INTERVENTION

Standard postoperative care days 1-4

Group 2 - NMES (no protein drink)

EXPERIMENTAL

Standard postoperative care days 1-4 PLUS twice daily NMES training sessions PLUS placebo drink twice daily (no protein supplement)

Device: Neuromuscular Electrical Stimulation

Group 3 - NMES + protein drink

EXPERIMENTAL

Standard postoperative care days 1-4 PLUS twice daily NMES training sessions PLUS protein drink twice daily

Device: Neuromuscular Electrical Stimulation; Dietary Supplement: Protein supplement drink

Interventions

Neuromuscular Electrical Stimulation DEVICE

Neuromuscular Electrical Stimulation training twice daily (30 minutes per session), during postoperative days 1-4. The training will be carried out using a handheld device. Training will be carried out by the participant themselves, with researcher supervision until independently able to do so.

Also known as: NMES, electrical stimulation, ES, electrical muscle stimulation, EMS

Group 2 - NMES (no protein drink); Group 3 - NMES + protein drink

Protein supplement drink DIETARY_SUPPLEMENT

Whey protein isolate drink, to provide a total of 60 g protein per day (2 x30 g). The supplement will be provided in a powder form to participants. Participants will be asked to consume the supplement around the time of NMES training.

Group 3 - NMES + protein drink

Eligibility Criteria

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

You may qualify if:

• Adult patients (age 18 or over at the time of diagnosis made at MDT (multi-disciplinary team meeting)
• MDT outcome of colorectal or gastric cancer or non-invasive neoplasia (tissue-proven, or radiologically diagnosed and clinically suspected) with the intention to treat with curative abdominal surgery
• Agreed management plan for open or minimally invasive (laparoscopic or robot assisted) segmental abdominal (colonic or gastric) resection at the Royal Derby Hospital
• Sufficient mobility and fitness to complete normal ERAS (enhanced recovery after surgery) protocols following surgery
• Basic conversational spoken English language
• Ability to give informed consent

You may not qualify if:

• Upper GI (gastrointestinal) cancer requiring thoracotomy/thoracoscopy
• Pre-existing neuromuscular disease (including Parkinsons disease)
• Pacemaker, implantable cardiac defibrillator or other implanted nerve stimulator device
• Metal prostheses or other metal-work in either upper legs (hip/knee/femur)
• Dementia or other cognitive problem or language barrier causing an inability to follow instructions and operate NMES machine
• Inability to give informed consent
• Disability preventing completion of ERAS after surgery (requiring Zimmer frame/wheeled frame/wheelchair to mobilise or bed-bound)
• Peripheral vascular disease
• Epilepsy
• Pre-existing diagnosis of chronic kidney disease or estimated glomerular filtration rate \<60 on screening visit
• Pre-existing diagnosis of liver disease
• Intubation or intensive care admission during study period (between day 0-5 post-op); (surgical high dependency unit patients will be included)
• Return to theatre for surgical complication within first 5-days post operation
• History of rhabdomyolysis
• Pregnancy

Sponsors & Collaborators

• University of Nottingham: lead
• University Hospitals of Derby and Burton NHS Foundation Trust: collaborator

MeSH Terms

Conditions

Colorectal Neoplasms; Muscular Atrophy; Gastrointestinal Neoplasms

Interventions

Electric Stimulation

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases; Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Atrophy; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Physical Stimulation; Investigative Techniques

Central Study Contacts

Sawsan Abdul-Hamid, MBBS

CONTACT

00441332724687; sawsan.abdul-hamid@nottingham.ac.uk

Beth Phillips, PhD

CONTACT

beth.phillips@nottingham.ac.uk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: Researchers running the trial and interacting with participant will not be blinded. Participant will be blinded regarding protein drink allocation but not regarding NMES allocation. The assessor of the primary outcome (ultrasound VL measurements) will be blinded.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 22, 2025
• First Posted: May 9, 2025
• Study Start: May 1, 2025
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): July 1, 2026
• Last Updated: May 9, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share