Muscle Atrophy Clinical Trials

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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: Recruiting
Location: See location...
Intervention Type: Device, Dietary supplement
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
United Kingdom
Royal Derby Hospital
RECRUITING
Derby
Contact Information
Primary
Sawsan Abdul-Hamid, MBBS
sawsan.abdul-hamid@nottingham.ac.uk
00441332724687
Backup
Beth Phillips, PhD
beth.phillips@nottingham.ac.uk
Time Frame
Start Date: 2025-06-05
Estimated Completion Date: 2027-03-01
Participants
Target number of participants: 45
Treatments
No_intervention: Group 1 - Control
Standard postoperative care days 1-4
Experimental: Group 2 - NMES (no protein drink)
Standard postoperative care days 1-4 PLUS twice daily NMES training sessions PLUS placebo drink twice daily (no protein supplement)
Experimental: Group 3 - NMES + protein drink
Standard postoperative care days 1-4 PLUS twice daily NMES training sessions PLUS protein drink twice daily
Related Therapeutic Areas
Sponsors
Leads: University of Nottingham
Collaborators: University Hospitals of Derby and Burton NHS Foundation Trust

This content was sourced from clinicaltrials.gov