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WB-EMS and Nutrition in Patients With Hematological Malignancies

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03556748
Recruitment Status : Unknown
Verified June 2018 by University of Erlangen-Nürnberg Medical School.
Recruitment status was:  Recruiting
First Posted : June 14, 2018
Last Update Posted : June 14, 2018
Sponsor:
Information provided by (Responsible Party):
University of Erlangen-Nürnberg Medical School

Study Description
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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.

Condition or disease Intervention/treatment Phase
Hematologic Diseases Cachexia; Cancer Leukemia Myeloma Lymphoma Cancer Other: whole-body electromyostimulation Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Intervention 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)
Primary Purpose: Supportive Care
Official Title: Effect of Whole-body Electromyostimulation Combined With Individualized Nutritional Support on Patients With Hematological Malignancies
Actual Study Start Date : November 1, 2017
Estimated Primary Completion Date : October 31, 2019
Estimated Study Completion Date : October 31, 2019

Resource links provided by the National Library of Medicine


Arms and Interventions
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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


Outcome Measures
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Primary Outcome Measures :
  1. Skeletal muscle mass [ Time Frame: 12 weeks ]
    Skeletal muscle mass assessed by bioelectrical impedance analysis (in kg)


Secondary Outcome Measures :
  1. Physical function - Isometric muscle strength [ Time Frame: 12 weeks ]
    Hand grip strength assessed by hand dynamometer (in kg)

  2. Cardiorespiratory Fitness [ Time Frame: 12 weeks ]
    VO2max assessed by spirometry

  3. Patient-reported Quality of Life (QoL) [ Time Frame: 12 weeks ]
    EORTC QLQ - C30 questionnaire

  4. Patient-reported Fatigue [ Time Frame: 12 weeks ]
    FACIT-Fatigue scale

  5. Depression/Anxiety [ Time Frame: 12 weeks ]
    Hospital Anxiety and Depression Scale

  6. Inflammatory blood markers [ Time Frame: 12 weeks ]
    Blood collection and analysis (Albumin, CRP, Cytokines)


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  • 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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03556748


Locations
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Germany
Department of Medicine 1, Hector Center for Nutrition, Exercise and Sports, Friedrich-Alexander-University Erlangen-Nuremberg Recruiting
Erlangen, Germany, 91052
Contact: Yurdaguel Zopf, Prof. Dr. med.    +49 9131 85-45218    yurdaguel.zopf@uk-erlangen.de   
Contact: Hans Joachim Herrmann, Dr. oec. troph.    +49 9131 85-45017    hans.herrmann@uk-erlangen.de   
Sponsors and Collaborators
University of Erlangen-Nürnberg Medical School
More Information
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Responsible Party: University of Erlangen-Nürnberg Medical School
ClinicalTrials.gov Identifier: NCT03556748    
Other Study ID Numbers: EMS Nutr hemato onko
First Posted: June 14, 2018    Key Record Dates
Last Update Posted: June 14, 2018
Last Verified: June 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University of Erlangen-Nürnberg Medical School:
hematological malignancies
leukemia
myeloma
lymphoma
exercise
 nutrition
protein
WB-EMS
whole-body electromyostimulation
Additional relevant MeSH terms:
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Neoplasms
Hematologic Neoplasms
Hematologic Diseases
Cachexia
Neoplasms by Site
 Emaciation
Weight Loss
Body Weight Changes
Body Weight