Modulated Mid-frequency Whole-body Electromyostimulation and Nutritional Therapy in Gastrointestinal Cancer Patients
NCT ID: NCT06414122
Last Updated: 2025-03-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
NA
88 participants
INTERVENTIONAL
2025-06-30
2026-09-30
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
NONE
Study Groups
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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
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
nutritional therapy
conventional nutritional counselling with guidelines and digital nutritional coaching
CONTROL
Control group receives multimodal therapy with moderate conventional exercise training in a group and conventional nutritional counselling with guidelines and digital nutritional coaching
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
nutritional therapy
conventional nutritional counselling with guidelines and digital nutritional coaching
Interventions
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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
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
nutritional therapy
conventional nutritional counselling with guidelines and digital nutritional coaching
Eligibility Criteria
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Inclusion Criteria
* medical clearance for exercise training
* written declaration of consent from the study participant
Exclusion Criteria
* 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)
18 Years
ALL
No
Sponsors
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University of Cologne
OTHER
Responsible Party
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Helen Schörghofer
Helen Schörghofer
Principal Investigators
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Freerk T Baumann, Univ.-Prof.
Role: PRINCIPAL_INVESTIGATOR
Universitätsklinikum Köln
Locations
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Universitätsklinikum Köln, Centrum für Integrierte Onkologie (CIO)
Cologne, North Rhine-Westphalia, Germany
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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22-1294
Identifier Type: -
Identifier Source: org_study_id
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