WB-EMS and Nutrition in Patients With Hematological Malignancies

Study Overview
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Brief Summary
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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.

Official Title
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Effect of Whole-body Electromyostimulation Combined With Individualized Nutritional Support on Patients With Hematological Malignancies

Conditions
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Hematologic Diseases, Cachexia; Cancer, Leukemia, Myeloma, Lymphoma, Cancer

Intervention / Treatment
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* Other: whole-body electromyostimulation


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Interventional 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
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Control group<br>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 | |
| Experimental: WB-EMS group<br>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 | Other: whole-body electromyostimulation<br>* 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<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Skeletal muscle mass | Skeletal muscle mass assessed by bioelectrical impedance analysis (in kg) | 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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hematological malignancies, leukemia, myeloma, lymphoma, exercise, nutrition, protein, WB-EMS, whole-body electromyostimulation