WB-EMS and Nutrition in Patients With Hematological Malignancies

University of Erlangen-Nürnberg Medical School

Status: Unknown

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

Treatments: Other: whole-body electromyostimulation

Study type: Interventional

Funder types: Other

Identifiers

NCT03556748

EMS Nutr hemato onko

Details and patient eligibility

About

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.

Enrollment: 40 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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40 participants in 2 patient groups

Control group

No Intervention group

Description:

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 group

Description:

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

Treatment:

Other: whole-body electromyostimulation