Clinical Research Directory

Browse clinical research sites, groups, and studies.

Sites Groups Studies

Back to Studies

NOT YET RECRUITING

NCT06964438

Postoperative Electrical Muscle Stimulation Two

Sponsor: University of Nottingham

View on ClinicalTrials.gov

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.

Official title: A Three-Arm Randomised Controlled Trial to Establish Effectiveness of NMES With or Without Protein Supplementation to Preserve Muscle Mass and Strength and Improve Functional Outcomes After Abdominal Surgery for GI Cancer

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

Start Date

2025-05

Completion Date

2026-07

Last Updated

2025-05-09

Healthy Volunteers

Conditions

Surgery Colorectal Cancer Muscle Atrophy Cancer Gi

Interventions

DEVICE

Neuromuscular Electrical Stimulation

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.

DIETARY_SUPPLEMENT

Protein supplement drink

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.

Inclusion Criteria: * 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 Exclusion Criteria: * 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 * Deep vein thrombosis within past 6-months * Allergy to whey protein * Patient refusal of whey protein products on grounds of dietary requirements or intolerance * Participating in another clinical trial concurrently or within the last 6 months * Known infection with blood borne virus