WB-EMS and Nutrition in Patients With Hematological Malignancies

Not Applicable

• Conditions: Cachexia; Cancer; Lymphoma; Hematologic Diseases; Myeloma; Leukemia; Cancer
• Interventions: Other: whole-body electromyostimulation

• Registration Number: NCT03556748
• Lead Sponsor: University of Erlangen-Nürnberg Medical School

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2017-11-01
• Status Verified: 2018-06
• Study First Submitted: 2018-06-04
• Study First Submitted QC: 2018-06-04
• Last Update Submitted: 2018-06-04
• Study First Posted: 2018-06-14
• Last Update Posted: 2018-06-14
• Primary Completion: 2019-10-31
• Study Completion: 2019-10-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 40

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
WB-EMS group	whole-body electromyostimulation	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

Primary Outcome Measures

Name	Time	Method
Skeletal muscle mass	12 weeks	Skeletal muscle mass assessed by bioelectrical impedance analysis (in kg)

Secondary Outcome Measures

Name	Time	Method
Depression/Anxiety	12 weeks	Hospital Anxiety and Depression Scale
Inflammatory blood markers	12 weeks	Blood collection and analysis (Albumin, CRP, Cytokines)
Physical function - Isometric muscle strength	12 weeks	Hand grip strength assessed by hand dynamometer (in kg)
Cardiorespiratory Fitness	12 weeks	VO2max assessed by spirometry
Patient-reported Quality of Life (QoL)	12 weeks	EORTC QLQ - C30 questionnaire
Patient-reported Fatigue	12 weeks	FACIT-Fatigue scale

Trial Locations

Locations (1)

Department of Medicine 1, Hector Center for Nutrition, Exercise and Sports, Friedrich-Alexander-University Erlangen-Nuremberg; 🇩🇪 Erlangen, Germany