Modulated Mid-frequency Whole-body Electromyostimulation and Nutritional Therapy in Gastrointestinal Cancer Patients

Официальное название

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)

Обзор

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.

Подробное описание

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.

Вмешательства

• Другое mid-frequency whole-body electromyostimulation (WB-EMS)
  supervised group training sessions at least once and optionally twice a week, lasting 11-20 minutes, over 12 weeks, 12-24 training sessions in total
• Другое conventional exercise training
  supervised group training at least once a week, optional additional home-based training once a week, lasting 40 minutes, over 12 weeks, 12-24 training sessions in total
• Другое nutritional therapy
  conventional nutritional counselling with guidelines and digital nutritional coaching

Первичные конечные точки

• Muscle mass of the quadriceps muscle [Срок оценки: Baseline and week 12]

Вторичные конечные точки (7)

• Body composition [Срок оценки: Baseline and week 12]
• Performance Status [Срок оценки: Baseline and week 12]
• Endurance capacity [Срок оценки: Baseline and week 12]
• Lower limb performance [Срок оценки: Baseline and week 12]
• Upper limb performance [Срок оценки: Baseline and week 12]
• Fatigue [Срок оценки: Baseline and week 12]
• health-related Quality of life [Срок оценки: Baseline and week 12]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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)

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Поддерживающая терапия

Центры проведения

Германия · 1 центр

• Universitätsklinikum Köln, Centrum für Integrierte Onkologie (CIO) — Cologne

Идентификаторы

NCT: NCT06414122 · 22-1294

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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