Royal Derby Hospital
Derby, Derbyshire, DE22 3NE, United Kingdom
Location status: Recruiting
NCT Number: NCT06964438
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.
Interested in participating?
Request Info18 year and older
All sexes
Interventional
Not applicable
Derby, Derbyshire, DE22 3NE, United Kingdom
Location status: Recruiting
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:
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:
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
Other names: NMES, electrical stimulation, ES, electrical muscle stimulation, EMS
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.
Time frame: Pre-operatively and 5 days post-operatively
Vastus lateralis (VL) muscle mass loss as measured on ultrasound cross sectional area
Time frame: Pre-operatively and 5 days post-operatively
Determined by knee-extensor strength via dynamometry.
Time frame: Pre-operatively and 5 days post-operatively
short physical performance battery
Time frame: Pre-operatively and 5 days post-operatively
Timed up and go,
Time frame: Pre-operatively and 5 days post-operatively
6 minute walk test
Time frame: Pre-operatively and 5 days post-operatively
Pennation angle on VL US
Time frame: Pre-operatively and 5 days post-operatively
fascicle length on VL Ultrasound
Time frame: Pre-operatively and 5 days post-operatively
Determined via surface electromyography
Time frame: Pre-operatively, 5 days post-operatively and 28 days post-operatively
Measured using the EuroQoL-5D questionnaire. The EuroQoL-5D-3L questionnaire is a standardised measure of health status developed by the EuroQol Group to provide a simple, generic measure of health for clinical and economic appraisal. It generates a simple descriptive profile and a single summary index value for health status.
Time frame: Days 1-4 post operatively
Measured using a thigh-worn accelerometer
Time frame: Pre-operatively, and on day 1 and 5 post-operatively
Blood samples to assess circulatory amino acid levels
Time frame: Pre-operatively, and on day 1 and 5 post-operatively
Blood samples to assess inflammatory marker levels
Time frame: Pre-operatively and 5 days post-operatively
Vastus lateralis (VL) muscle mass loss as measured on ultrasound muscle thickness
Time frame: Days 1-4 post-operatively
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.
Contact information is provided by the study sponsor or research team.
Beth Phillips, PhD
CONTACT
Sawsan Abdul-Hamid, MBBS
CONTACT
University of Nottingham
Other
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
Acronym: POEMS2
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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