Postoperative Electrical Muscle Stimulation (POEMS) to Attenuate Muscle Atrophy
试验速览
- 阶段
- 不适用
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Vastus Lateralis muscle thickness (cm)
研究概览
简要总结
Patients lose a significant amount of muscle following major abdominal surgery. This is partly due to a catabolic response to the surgical insult and inflammation, but is also probably due to a lack of muscle use secondary to immobility.
This study will aim to assess whether some or even all of postoperative muscle loss in the upper leg muscle group is preventable through electrical muscle stimulation to mimic physical activity.
详细描述
Following major gastrointestinal surgery patients may loose around 6 % of their skeletal muscle mass in the first 5 days. Whilst some of this loss is as a result of inflammation and starvation, some is due to muscle disuse.
Studies have shown that patients spend 96% of their time being sedentary in the first 5 days following major abdominal surgery and by day 5 are still taking a median of less than 500 steps per day. Studies of healthy volunteers who undergo similar muscle disuse loose approximately 3.5% of skeletal muscle mass over the same time period, indicating that around half of postoperative muscle loss may be due to immobility.
Through the use of electrical muscle stimulation, this study will aim to mimic high levels of exercise in the quadriceps of patients who have undergo major gastrointestinal surgery to see whether this reduces or prevents muscle loss. Patients muscles will be measured using ultrasound and DXA and neuromuscular function will be measured using electromyography.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- Single (Outcomes Assessor)
盲法说明
ultrasound images, DXA scans and EMG results will be given coded labeling by a separate researcher so that investigator analysing results will be blinded to whether scans / EMG results are from intervention or control leg, or start of finish.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult patients undergoing major segmental colonic resections or gastric/oesophageal resection
- •Sufficient mobility and fitness to complete normal enhanced recovery protocols following surgery
- •Ability to give informed consent
排除标准
- •Pre-existing neuromuscular disease (including parkinson's disease)
- •Pacemaker, implantable cardiac defibrillator or other implanted nerve stimulator device
- •Metalwork in both upper legs
- •Inability to give informed consent
- •Disability preventing normal mobilisation after surgery
- •Symptomatic peripheral vascular disease
- •Chronic kidney failure of chronic heart failure
- •Intubation for > 24 hours post operation
- •Return to theatre for surgical complication within first 5 days post operation
研究组 & 干预措施
EMG leg
Quadriceps muscle group of postoperative patients randomly selected leg which will undergo electrical muscle stimulation for upto 2 hours on each postoperative day
干预措施: Electrical Muscle stimulation (Device)
Control leg
Quadriceps muscle group of postoperative patients leg not selected to undergo electrical muscle stimulation
结局指标
主要结局
Vastus Lateralis muscle thickness (cm)
时间窗: 5 days
Ultrasound scan (USS) measurement of Vastus Lateralis muscle thickness in stimulated vs non stimulated legs of postoperative patients
Vastus Lateralis muscle fibre length
时间窗: 5 days
USS measurement of Vastus Lateralis muscle fibre length in stimulated vs non stimulated legs of postoperative patients
Vastus Lateralis muscle fibre pennation angle
时间窗: 5 days
USS measurement of Vastus Lateralis muscle fibre pennation angle in stimulated vs non stimulated legs of postoperative patients
Compound muscle action potentials (CMAP) as measured by surface electromyography
时间窗: 5 days
Changes in compound muscle action potentials (as detected by EMG) in stimulated vs non stimulated legs of postoperative patients
Near Fibre Motor Unit Potentials as measured by surface EMG
时间窗: 5 days
Changes in motor unit potentials (as detected by EMG) in stimulated vs non stimulated legs of postoperative patients
Motor unit number estimates ((MUNE) as derived from surface EMG analysis)
时间窗: 5 days
Changes in MUNE (as derived from surface EMG) in stimulated vs non stimulated legs of postoperative patients
次要结局
- Lean muscle mass(5 days)
- Physical activity levels in postoperative patients(5 days)
- Dietary intake in postoperative patients(5 days)
- Inflammatory response following major abdominal surgery(5 days)
- Acceptability of electrical muscle stimulation in postoperative patients(5 days)