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Clinical Trials/NCT03556748
NCT03556748
Unknown
N/A

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

University of Erlangen-Nürnberg Medical School1 site in 1 country40 target enrollmentNovember 1, 2017

Overview

Phase
N/A
Intervention
Not specified
Conditions
Hematologic Diseases
Sponsor
University of Erlangen-Nürnberg Medical School
Enrollment
40
Locations
1
Primary Endpoint
Skeletal muscle mass
Last Updated
7 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
November 1, 2017
End Date
October 31, 2019
Last Updated
7 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
University of Erlangen-Nürnberg Medical School
Responsible Party
Sponsor

Eligibility Criteria

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
  • severe neurological diseases
  • skin lesions in the area of electrodes
  • energy active metals in body
  • acute vein thrombosis
  • rheumatic diseases
  • pregnant and nursing women

Outcomes

Primary Outcomes

Skeletal muscle mass

Time Frame: 12 weeks

Skeletal muscle mass assessed by bioelectrical impedance analysis (in kg)

Secondary Outcomes

  • Depression/Anxiety(12 weeks)
  • Inflammatory blood markers(12 weeks)
  • Physical function - Isometric muscle strength(12 weeks)
  • Cardiorespiratory Fitness(12 weeks)
  • Patient-reported Quality of Life (QoL)(12 weeks)
  • Patient-reported Fatigue(12 weeks)

Study Sites (1)

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