Modulated Mid-frequency Whole-body Electromyostimulation and Nutritional Therapy in Gastrointestinal Cancer Patients
- Conditions
- Oesophageal CancerGastric CancerColorectal CancerDuodenal Cancer
- Interventions
- Other: mid-frequency whole-body electromyostimulation (WB-EMS)Other: conventional exercise trainingOther: nutritional therapy
- Registration Number
- NCT06414122
- Lead Sponsor
- University of Cologne
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 88
- 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
- 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
- Epilepsy
- 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)
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description WB-EMS nutritional therapy 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 WB-EMS mid-frequency whole-body electromyostimulation (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 CONTROL conventional exercise training Control group receives multimodal therapy with moderate conventional exercise training in a group and conventional nutritional counselling with guidelines and digital nutritional coaching CONTROL nutritional therapy Control group receives multimodal therapy with moderate conventional exercise training in a group and conventional nutritional counselling with guidelines and digital nutritional coaching
- Primary Outcome Measures
Name Time Method Muscle mass of the quadriceps muscle 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.
- Secondary Outcome Measures
Name Time Method Fatigue Baseline and week 12 Fatigue symptoms, using the 13-item Functional Assessment of Chronic Illness Therapy - Fatigue Scale (FACIT Fatigue Scale). The FACIT-Fatigue is a 13-item measure that assesses self-reported fatigue and its impact on daily activities and function. Score range 0-52 (higher = better)
Body composition Baseline and week 12 Body composition including skeletal muscle mass, fat free mass, fat mass, total body water, body cell mass and extracellular mass, using bioimpedance analysis (BIA) (Nutriguard-MS)
Lower limb performance Baseline and week 12 Lower limb performance, using 1 minute sit-to-stand test (higher = better)
health-related Quality of life Baseline and week 12 Quality of life, using the EORTC QLG Core Questionnaire (EORTC QLQ-C30). The EORTC QLQ-C30 is a 30-item instrument meant to assess some of the different aspects that define the quality of life of cancer patients. Score range 0-100 (higher = better)
Performance Status Baseline and week 12 Performance Status, with the help of Karnofsky Index (range 0 - 100, higher = better)
Upper limb performance Baseline and week 12 Upper limb performance, using hand grip strength dynamometry (higher = better)
Endurance capacity Baseline and week 12 Endurance capacity, using spiroergometry measuring maximal oxygen uptake (VO2 max) (higher = better)
Trial Locations
- Locations (1)
Universitätsklinikum Köln, Centrum für Integrierte Onkologie (CIO)
🇩🇪Cologne, NRW, Germany