NCT06964438

Postoperative Electrical Muscle Stimulation Two

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

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 45 (estimated)
• Sponsor: University of Nottingham · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

The main objective of this trial is to assess whether neuromuscular stimulation (NMES) can minimise muscle loss following abdominal surgery for cancer; and whether such effect is further improved by simultaneous protein supplementation. The main questions it aims to answer are: * Does NMES training reduce the volume of muscle lost from the vastus lateralis (VL) muscle (in the thigh) after surgery as measured on ultrasound scan 5 days after surgery? * Does NMES training together with protein supplementation lead to greater reduction of VL muscle volume loss on ultrasound 5 days after surgery then NMES alone? Researchers will allocate participants into three groups (using a randomisation software). All participants will visit the hospital once before surgery for starting point measurements including ultrasound. Whilst they are in hospital, from the first until the fourth day after surgery, they will have the following interventions: * Group 1 (the control group) will receive usual post-operative care with no additional interventions; * Group 2 will receive normal postoperative care and twice daily NMES training sessions and a flavoured (placebo) drink * Group 3 will receive normal post operative care as well as twice daily NMES training sessions and two protein rich drinks per day. On the fifth day after surgery all participants will have repeat measurements including ultrasound to assess the extent of muscle loss they had since surgery.

Conditions

• Surgery
• Colorectal Cancer
• Muscle Atrophy
• Cancer Gi

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2025-05-01
• Primary completion: 2026-06-01
• Completion: 2026-07-01
• First posted: 2025-05-09
• Last updated: 2025-05-09