WB-EMS and Nutrition in Patients With Hematological Malignancies

NCT ID: NCT03556748

Last Updated: 2018-06-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-11-01

Study Completion Date

2019-10-31

Brief Summary

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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

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Conditions

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Hematologic Diseases Cachexia; Cancer Leukemia Myeloma Lymphoma Cancer

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

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
Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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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

Group Type NO_INTERVENTION

No interventions assigned to this group

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

Group Type EXPERIMENTAL

whole-body electromyostimulation

Intervention Type OTHER

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

Interventions

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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

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Erlangen-Nürnberg Medical School

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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

Erlangen, , Germany

Site Status RECRUITING

Countries

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Germany

Facility Contacts

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Yurdaguel Zopf, Prof. Dr. med.

Role: primary

+49 9131 85-45218

Hans Joachim Herrmann, Dr. oec. troph.

Role: backup

+49 9131 85-45017

Other Identifiers

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EMS Nutr hemato onko

Identifier Type: -

Identifier Source: org_study_id

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