Cachexia; Cancer, Cancer, Hematologic Diseases, Leukemia, Lymphoma, Myeloma
Conditions
Keywords
hematological malignancies, leukemia, myeloma, lymphoma, exercise, nutrition, protein, WB-EMS, whole-body electromyostimulation
Brief summary
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.
Interventions
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
Sponsors
University of Erlangen-Nürnberg Medical School
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Intervention model description
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
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* adult patients diagnosed with hematological malignancies with an indication for stem cell Transplantation * Interval until Transplantation: 6 weeks * ECOG Status 0-2
Exclusion criteria
* patients with serious osteolytic lesions and increased risk of fall * simultaneous participation in other nutritional or exercise intervention Trials or in the past 6 months * acute cardiovascular events * use of anabolic medications * epilepsy * severe neurological diseases * skin lesions in the area of electrodes * energy active metals in body * acute vein thrombosis * rheumatic diseases * pregnant and nursing women * psychiatric disorders with doubts about legal and cognitive capacity
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Skeletal muscle mass | 12 weeks | Skeletal muscle mass assessed by bioelectrical impedance analysis (in kg) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Cardiorespiratory Fitness | 12 weeks | VO2max assessed by spirometry |
| Patient-reported Quality of Life (QoL) | 12 weeks | EORTC QLQ - C30 questionnaire |
| Physical function - Isometric muscle strength | 12 weeks | Hand grip strength assessed by hand dynamometer (in kg) |
| Depression/Anxiety | 12 weeks | Hospital Anxiety and Depression Scale |
| Inflammatory blood markers | 12 weeks | Blood collection and analysis (Albumin, CRP, Cytokines) |
| Patient-reported Fatigue | 12 weeks | FACIT-Fatigue scale |
Countries
Germany
Outcome results
None listed