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This study evaluates the effects of a 12-week whole-body electromyostimulation (WB-EMS) training combined with individualized nutritional support on body composition, muscle strength and function, quality of life, fatigue and Inflammatory status on patients with gynecological cancer undergoing palliative anti-cancer Treatment. Furthermore, this study assesses the effect of this combined therapeutic approach within a 3 to 4-week pre-operative study Intervention on the period of hospitalization in gynecological patients undergoing curative anti-cancer Treatment.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control group (palliative treatment) | No Intervention | "usual care" control group (includes patients undergoing palliative Treatment) receives individualized nutritional support (dietary advices: daily protein intake1,2 - 1,5 g/kg bodyweight) | |
| WB-EMS group (palliative treatment) | Experimental | physical exercise group (includes patients undergoing palliative Treatment) receives regular WB-EMS training (2 EMS trainings per week; each session for 20 min) + individualized nutritional support (dietary advices: daily protein intake 1,2-1,5 g/kg bodyweight) |
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| Control group (curative treatment) | No Intervention | "usual care" control group (includes patients undergoing curative treatment 3-4 weeks before surgery) receives individualized nutritional support (dietary advices: daily protein intake1,2 - 1,5 g/kg bodyweight) | |
| WB-EMS group (curative treatment) | Experimental | physical exercise group (includes patients undergoing adjuvant treatment 3-4 weeks before surgery) receives regular WB-EMS training (2 EMS trainings per week; each session for 20 min) + individualized nutritional support (dietary advices: daily protein intake 1,2-1,5 g/kg bodyweight) |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Whole-Body Electromyostimulation (WB-EMS) | Other | WB-EMS training is performed 2x/week for 12 weeks; Stimulation protocol: Frequency of 85 Hz, pulse duration of 0.35 ms, stimulation period of 6 sec, resting period of 4 sec; supervised by certified training instructors/physiotherapists participants perform simple exercises during the stimulation period following a video tutorial |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Skeletal muscle mass | Skeletal muscle mass assessed by bioelectrical impedance analysis (in kg) | 12 weeks (palliative treatment), 3-4 weeks (curative treatment) |
| Period of hospitalization | Days of Hospital stay after curative surgery | 3-4 week (curative treatment) |
| Measure | Description | Time Frame |
|---|---|---|
| Physical function - Isometric muscle strength | Hand grip strength assessed by hand dynamometer (in kg) | 12 weeks (palliative treatment), 3-4 weeks (curative treatment) |
| Physical function - Endurance |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Yurdagül Zopf, Prof. Dr. med. | Contact | +49 9131 85-45218 | yurdaguel.zopf@uk-erlangen.de | |
| Hans Joachim Herrmann, Dr. oec. troph. | Contact | +49 9131 85-45017 | hans.herrmann@uk-erlangen.de |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Medicine 1, Hector Center for Nutrition, Exercise and Sports, Friedrich-Alexander-University Erlangen-Nuremberg | Recruiting | Erlangen | 91052 | Germany |
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| ID | Term |
|---|---|
| D002100 | Cachexia |
| D009043 | Motor Activity |
| ID | Term |
|---|---|
| D015431 | Weight Loss |
| D001836 | Body Weight Changes |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
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|
Six-minute-walk test (walking distance in m)
| 12 weeks (palliative treatment), 3-4 weeks (curative treatment) |
| Physical function - Lower limb strength | 30 second sit-to-stand test (number of sit-to-stand cycles) | 12 weeks (palliative treatment), 3-4 weeks (curative treatment) |
| Patient-reported performance status | Karnofsky index | 12 weeks (palliative treatment), 3-4 weeks (curative treatment), Total Score ranges from 0-100 with a higher score indicating better performance status |
| Patient-reported Quality of Life (QoL) | European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ - C30); Total score ranges from 0-100 with a higher score indicating better functioning/Quality of life or higher symptom burden | 12 weeks (palliative treatment), 3-4 weeks (curative treatment) |
| Patient-reported Fatigue | FACIT-Fatigue scale; Total score ranges from 0-52 with a higher score indicating better Quality of life/less fatigue | 12 weeks (palliative treatment), 3-4 weeks (curative treatment) |
| Pain score | Visual Analogue Scale (VAS); Total score ranges from 0-10 with a higher score indicating higher pain | 12 weeks (palliative treatment), 3-4 weeks (curative treatment) |
| Depression score | Beck Depression Inventory (BDI); Total score ranges from 0-63 with higher score indicating higher depression | 12 weeks (palliative treatment), 3-4 weeks (curative treatment) |
| Gastrointestinal toxicity of chemotherapy | Number of participants with treatment-related adverse events of gastrointestinal toxicity as assessed by CTCAE v4.0 | 12 weeks (palliative treatment), 3-4 weeks (curative treatment) |
| Physical activity | International Physical Activity Questionnaire (IPAQ); Higher score indicates higher physical acitivity level | 12 weeks (palliative treatment), 3-4 weeks (curative treatment) |
| Inflammatory status | Analysis of serum C-reactive protein (CRP) and albumin concentrations | 12 weeks (palliative treatment), 3-4 weeks (curative treatment) |
| D013568 |
| Pathological Conditions, Signs and Symptoms |
| D013851 | Thinness |
| D001519 | Behavior |