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
This study evaluates the effects of a whole-body electromyostimulation (WB-EMS) training combined with individualized nutritional support on skeletal muscle mass, body composition, muscle strength/function, quality of life, fatigue, pain and gastrointestinal symptoms in patients with hematological malignancies 4-6 weeks before and 4-6 weeks after undergoing stem cell Transplantation. Within this context, this study also investigates the effect of the nutrition and exercise intervention on the period of hospitalization, period of White blood cell recovery and frequency and severity of complications (mucositis, Graft-versus-Host-Disease, infections) after stem cell Transplantation as consequences of the therapeutic immune Suppression.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control group | No Intervention | usual care" control group receives individualized nutritional support (dietary advices: daily protein intake 1.2-1.5 g/kg bodyweight), active exercise therapy is optionally provided (bicycle ergometers at room) during the in-Patient stay | |
| WB-EMS group | Experimental | physical exercise group 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) active exercise therapy is optionally provided (bicycle ergometers at room) during the in-Patient stay |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| whole-body electromyostimulation | Other | WB-EMS training is performed 2x/week for a total of 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 |
|---|---|---|
| Skeletal muscle mass | Skeletal muscle mass assessed by bioelectrical impedance analysis (in kg) | 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Physical function - Isometric muscle strength | Hand grip strength assessed by hand dynamometer (in kg) | 12 weeks |
| Cardiorespiratory Fitness | VO2max assessed by spirometry |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| 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 |
Not provided
| ID | Term |
|---|---|
| D006402 | Hematologic Diseases |
| D002100 | Cachexia |
| D009369 | Neoplasms |
| D007938 | Leukemia |
| D054219 | Neoplasms, Plasma Cell |
| D008223 | Lymphoma |
| D019337 | Hematologic Neoplasms |
| D009043 | Motor Activity |
| ID | Term |
|---|---|
| D006425 | Hemic and Lymphatic Diseases |
| D015431 | Weight Loss |
| D001836 | Body Weight Changes |
| D001835 | Body Weight |
Not provided
Not provided
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
Not provided
Not provided
Not provided
Not provided
|
| 12 weeks |
| Patient-reported Quality of Life (QoL) | EORTC QLQ - C30 questionnaire | 12 weeks |
| Patient-reported Fatigue | FACIT-Fatigue scale | 12 weeks |
| Depression/Anxiety | Hospital Anxiety and Depression Scale | 12 weeks |
| Inflammatory blood markers | Blood collection and analysis (Albumin, CRP, Cytokines) | 12 weeks |
| D012816 |
| Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D013851 | Thinness |
| D009370 | Neoplasms by Histologic Type |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
| D009371 | Neoplasms by Site |
| D001519 | Behavior |