Postoperative Electrical Muscle Stimulation Two
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of Nottingham
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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)
Trial design
Design model
Parallel
Treatments tested in this trial
Neuromuscular Electrical Stimulation
DeviceNeuromuscular 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.
Protein supplement drink
Dietary supplementWhey 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.
Treatment groups
45 Participants
are divided into 3 treatment groupsGroup A: Group 1 - ControlNo intervention 0 interventions
Group B: Group 2 - NMES (no protein drink)Experimental treatment 1 intervention
Group C: Group 3 - NMES + protein drinkExperimental treatment 2 interventions
Trial outcomes
Primary outcomes
1
Post-operative vastus lateralis (VL) muscle mass loss
Vastus lateralis (VL) muscle mass loss as measured on ultrasound cross sectional area
Time frame
Pre-operatively and 5 days post-operativelySecondary outcomes
1
Post-operative knee extensor strength losses
Determined by knee-extensor strength via dynamometry.
Time frame
Pre-operatively and 5 days post-operatively2
Post-operative functional losses determined by short physical performance battery standardized physical function assessment tool
short physical performance battery
Time frame
Pre-operatively and 5 days post-operatively3
Post-operative functional losses determined by Timed Up and Go standardized physical function assessment tool
Timed up and go,
Time frame
Pre-operatively and 5 days post-operatively4
Post-operative functional losses determined by 6 minute walk test standardized physical function assessment tool
6 minute walk test
Time frame
Pre-operatively and 5 days post-operativelyOther outcomes
1
Feasibility and acceptability of incorporating NMES into postoperative recovery
Assessed through compliance and participant feedback questionnaire. The questionnaire will compromise descriptive items rated on a visual analogue scale that has been designed by the researchers to assess various aspects of patient experience with the intervention.
Time frame
Days 1-4 post-operativelySponsors and contacts
Click on the lead sponsor to view all of their trials.
University of Nottingham
Lead sponsor
University Hospitals of Derby and Burton NHS Foundation Trust
Collaborator
Source ClinicalTrials.gov