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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT06414122
Other study ID # 22-1294
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date July 2024
Est. completion date September 2026

Study information

Verified date May 2024
Source University of Cologne
Contact Helen Schörghofer
Phone +49221478
Email helen.schoerghofer@uk-koeln.de
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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 information / eligibility

Status Not yet recruiting
Enrollment 88
Est. completion date September 2026
Est. primary completion date September 2026
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - 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 Exclusion Criteria: - 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


Intervention

Other:
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

Locations

Country Name City State
Germany Universitätsklinikum Köln, Centrum für Integrierte Onkologie (CIO) Cologne NRW

Sponsors (1)

Lead Sponsor Collaborator
University of Cologne

Country where clinical trial is conducted

Germany, 

Outcome

Type Measure Description Time frame Safety issue
Primary Muscle mass of the quadriceps muscle 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. Baseline and week 12
Secondary Body composition 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) Baseline and week 12
Secondary Performance Status Performance Status, with the help of Karnofsky Index (range 0 - 100, higher = better) Baseline and week 12
Secondary Endurance capacity Endurance capacity, using spiroergometry measuring maximal oxygen uptake (VO2 max) (higher = better) Baseline and week 12
Secondary Lower limb performance Lower limb performance, using 1 minute sit-to-stand test (higher = better) Baseline and week 12
Secondary Upper limb performance Upper limb performance, using hand grip strength dynamometry (higher = better) Baseline and week 12
Secondary Fatigue 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) Baseline and week 12
Secondary health-related Quality of life 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) Baseline and week 12
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