WB-EMS and Nutrition in Patients With Hematological Malignancies

June 4, 2018 updated by: University of Erlangen-Nürnberg Medical School

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Erlangen, Germany, 91052
        • Recruiting
        • Department of Medicine 1, Hector Center for Nutrition, Exercise and Sports, Friedrich-Alexander-University Erlangen-Nuremberg

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: SUPPORTIVE_CARE
  • Allocation: NON_RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
NO_INTERVENTION: Control group

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

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
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

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Erlangen-Nürnberg Medical School

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

November 1, 2017

Primary Completion (ANTICIPATED)

October 31, 2019

Study Completion (ANTICIPATED)

October 31, 2019

Study Registration Dates

First Submitted

June 4, 2018

First Submitted That Met QC Criteria

June 4, 2018

First Posted (ACTUAL)

June 14, 2018

Study Record Updates

Last Update Posted (ACTUAL)

June 14, 2018

Last Update Submitted That Met QC Criteria

June 4, 2018

Last Verified

June 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EMS Nutr hemato onko

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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