Ignite Creation Date:
2024-05-19 @ 5:34 PM
Last Modification Date:
2024-10-26 @ 3:29 PM
Study NCT ID:
NCT06414122
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-07-12
First Post:
2024-05-10
Brief Title:
Modulated Mid-frequency Whole-body Electromyostimulation and Nutritional Therapy in Gastrointestinal Cancer Patients
Sponsor:
University of Cologne
Organization:
University of Cologne
Study Overview
Official Title:
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
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
MOMENT
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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None