Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 347923 | Other Identifier | IRAS |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| University Hospitals of Derby and Burton NHS Foundation Trust | OTHER |
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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) |
|
| Group 3 - NMES + protein drink | Experimental | Standard postoperative care days 1-4 PLUS twice daily NMES training sessions PLUS protein drink twice daily |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Post-operative knee extensor strength losses | Determined by knee-extensor strength via dynamometry. | Pre-operatively and 5 days post-operatively |
| Post-operative functional losses determined by short physical performance battery standardized physical function assessment tool |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Days 1-4 post-operatively |
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Sawsan Abdul-Hamid, MBBS | Contact | 00441332724687 | sawsan.abdul-hamid@nottingham.ac.uk | |
| Beth Phillips, PhD | Contact | beth.phillips@nottingham.ac.uk |
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Royal Derby Hospital | Recruiting | Derby | Derbyshire | DE22 3NE | United Kingdom |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D015179 | Colorectal Neoplasms |
| D009133 | Muscular Atrophy |
| D005770 | Gastrointestinal Neoplasms |
| ID | Term |
|---|---|
| D007414 | Intestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
Not provided
Not provided
| ID | Term |
|---|---|
| D004558 | Electric Stimulation |
| ID | Term |
|---|---|
| D010812 | Physical Stimulation |
| D008919 | Investigative Techniques |
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
|
|
| 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. |
|
short physical performance battery |
| Pre-operatively and 5 days post-operatively |
| Post-operative functional losses determined by Timed Up and Go standardized physical function assessment tool | Timed up and go, | Pre-operatively and 5 days post-operatively |
| Post-operative functional losses determined by 6 minute walk test standardized physical function assessment tool | 6 minute walk test | Pre-operatively and 5 days post-operatively |
| Post-operative changes in muscle architecture as measured by pennation angle | Pennation angle on VL US | Pre-operatively and 5 days post-operatively |
| Post-operative changes in muscle architecture as measured by fascicle length | fascicle length on VL Ultrasound | Pre-operatively and 5 days post-operatively |
| Post-operative declines in neuromuscular function | Determined via surface electromyography | Pre-operatively and 5 days post-operatively |
| Post-operative loss of independence and quality of life | 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. | Pre-operatively, 5 days post-operatively and 28 days post-operatively |
| Physical activity profiles of patients following major GI surgery | Measured using a thigh-worn accelerometer | Days 1-4 post operatively |
| Circulating amino acid profiles | Blood samples to assess circulatory amino acid levels | Pre-operatively, and on day 1 and 5 post-operatively |
| Systemic markers of inflammation | Blood samples to assess inflammatory marker levels | Pre-operatively, and on day 1 and 5 post-operatively |
| Post-operative vastus lateralis (VL) muscle mass loss | Vastus lateralis (VL) muscle mass loss as measured on ultrasound muscle thickness | Pre-operatively and 5 days post-operatively |
| D004066 |
| Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D012002 | Rectal Diseases |
| D020879 | Neuromuscular Manifestations |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D001284 | Atrophy |
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D012816 | Signs and Symptoms |