Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| WB-EMS | Experimental | 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 | Active Comparator | Control group receives multimodal therapy with moderate conventional exercise training in a group and conventional nutritional counselling with guidelines and digital nutritional coaching |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| mid-frequency whole-body electromyostimulation (WB-EMS) | Other | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Performance Status |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Helen Schörghofer | Contact | +49221478 | 42646 | helen.schoerghofer@uk-koeln.de |
| Name | Affiliation | Role |
|---|---|---|
| Freerk T Baumann, Univ.-Prof. | Universitätsklinikum Köln | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Universitätsklinikum Köln, Centrum für Integrierte Onkologie (CIO) | Cologne | North Rhine-Westphalia | 50937 | Germany |
All IPD that underlie results in a publication
Not provided
Beginning 6 months and ending 24 months after article publication
IPD will be shared with researchers who provide a methodologically sound proposal to achieve aims in the approved proposal. Proposals should be directed to helen.schoerghofer@uk-koeln.de. To gain access, data requestors will need to sign a data access agreement.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| conventional exercise training | Other | 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 | Other | conventional nutritional counselling with guidelines and digital nutritional coaching |
|
Performance Status, with the help of Karnofsky Index (range 0 - 100, higher = better)
| Baseline and week 12 |
| Endurance capacity | Endurance capacity, using spiroergometry measuring maximal oxygen uptake (VO2 max) (higher = better) | Baseline and week 12 |
| Lower limb performance | Lower limb performance, using 1 minute sit-to-stand test (higher = better) | Baseline and week 12 |
| Upper limb performance | Upper limb performance, using hand grip strength dynamometry (higher = better) | Baseline and week 12 |
| 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 |
| 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 |
| ID | Term |
|---|---|
| D004938 | Esophageal Neoplasms |
| D013274 | Stomach Neoplasms |
| D004379 | Duodenal Neoplasms |
| D015179 | Colorectal Neoplasms |
| ID | Term |
|---|---|
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D006258 | Head and Neck Neoplasms |
| D004066 | Digestive System Diseases |
| D004935 | Esophageal Diseases |
| D005767 | Gastrointestinal Diseases |
| D013272 | Stomach Diseases |
| D007414 | Intestinal Neoplasms |
| D004378 | Duodenal Diseases |
| D007410 | Intestinal Diseases |
| D003108 | Colonic Diseases |
| D012002 | Rectal Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D044623 | Nutrition Therapy |
| ID | Term |
|---|---|
| D013812 | Therapeutics |
Not provided
Not provided