The Efficacy of Modulated Mid-frequency (Whole-body Electromyostimulation) and Nutritional Therapy in Patients With Solid Tumors of the Gastrointestinal Tract (Excluding Liver and Pancreatic Carcinomas)
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 88
- 试验地点
- 2
- 主要终点
- Muscle mass of the quadriceps muscle
研究概览
简要总结
The purpose of this study is to assess the efficacy of modulated mid-frequency whole-body electromyostimulation (WB-EMS) combined with nutritional therapy in patients with gastrointestinal cancer.
详细描述
This study aims to combine the applicability and effectiveness of a form of strength training with targeted nutritional training. For this purpose, training with electromyostimulation (application of modulated mid-frequency; WB-EMS) is carried out, which pursues the effect of cell activation and the improvement of muscle strength. The primary aim of the multimodal intervention presented here is to increase muscle mass and improve energy utilisation and metabolism. Patients should experience increased mobility and independence as a result of this intervention. In the study, patients are randomly assigned to one of two groups, with one group receiving an application of electricity and the other group performing standardised exercise therapy without electricity. Otherwise, the groups do not differ in the applications or tests. In addition, nutritional coaching takes place in both groups with digital nutritional coaching.
Patients with a malignant tumour of the oesophagus, stomach, duodenum or colon or rectum with medical therapy administered before or after surgery (neoadjuvant and adjuvant therapy) and after surgery without further therapy can participate in the study.
The aim is to compare the use of electromyostimulation in this multimodal approach regarding its effectiveness in terms of muscle growth compared to the conventional multimodal approach. The research hypothesis is that the additional training stimulus provided by the application of electricity leads to significantly higher muscle growth than conventional training without electricity.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
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
- •Patients with oesophageal, gastric, duodenal, colon or rectal cancer following surgery without further therapy and with neoadjuvant and adjuvant therapy
- •medical clearance for exercise training
- •written declaration of consent from the study participant
排除标准
- •Participation in another study on the topic of exercise or nutrition
- •Electronic implants such as pacemakers, pumps, and coronary stents
- •Cardiac arrhythmia
- •Implants in the area of application (e.g. breast implants)
- •Pregnancy
- •Wounds and open skin diseases in the area of application of the electrodes
- •Unhealed operations or bone fractures
- •Acute inflammatory diseases (e.g. inflammation of the intervertebral discs, bones, vessels, or soft tissue)
- •Directly after herniated discs or other instabilities such as large abdominal wall hernias
- •Blood clots (thromboses)
- •Bone diseases with high-grade osteoporosis
- •Increased risk of haemorrhage
- •Fever and illnesses that can be aggravated by physical exertion
- •Untreated high blood pressure
- •Blindness
- •Continuous parenteral nutrition
- •Metal and electronic parts in the body (e.g. prostheses, metal vascular clips, hearing aids/inner ear/cochlear implants, magnetic dental prostheses, pacemakers, contraceptives)
研究组 & 干预措施
WB-EMS
Intervention group receives multimodal therapy with whole-body electromyostimulation and exercise therapy (WB-EMS) as well as conventional nutritional counseling with guidelines and digital nutritional coaching
干预措施: mid-frequency whole-body electromyostimulation (WB-EMS) (Other)
WB-EMS
Intervention group receives multimodal therapy with whole-body electromyostimulation and exercise therapy (WB-EMS) as well as conventional nutritional counseling with guidelines and digital nutritional coaching
干预措施: nutritional therapy (Other)
CONTROL
Control group receives multimodal therapy with moderate conventional exercise training in a group and conventional nutritional counselling with guidelines and digital nutritional coaching
干预措施: conventional exercise training (Other)
CONTROL
Control group receives multimodal therapy with moderate conventional exercise training in a group and conventional nutritional counselling with guidelines and digital nutritional coaching
干预措施: nutritional therapy (Other)
结局指标
主要结局
Muscle mass of the quadriceps muscle
时间窗: Baseline and week 12
Muscle mass of the quadriceps muscle (vastus lateralis / rectus femoris), cross-sectional diameter (CSD) using ultrasound. Muscle ultrasound represents a cheap and user-friendly, yet robust and reliable, method to monitor muscle mass.
次要结局
- Fatigue(Baseline and week 12)
- Body composition(Baseline and week 12)
- Lower limb performance(Baseline and week 12)
- health-related Quality of life(Baseline and week 12)
- Performance Status(Baseline and week 12)
- Upper limb performance(Baseline and week 12)
- Endurance capacity(Baseline and week 12)
研究者
Helen Schörghofer
Helen Schörghofer
University of Cologne