Back to resultsWB-EMS and Nutrition in Patients With Hematological Malignancies
Primary Purpose
Hematologic Diseases, Cachexia; Cancer, Leukemia
Status
Unknown status
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
whole-body electromyostimulation
Sponsored by
About this trial
This is an interventional supportive care trial for Hematologic Diseases focused on measuring hematological malignancies, leukemia, myeloma, lymphoma, exercise, nutrition, protein, WB-EMS, whole-body electromyostimulation
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
- 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
Sites / Locations
- Department of Medicine 1, Hector Center for Nutrition, Exercise and Sports, Friedrich-Alexander-University Erlangen-NurembergRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
No Intervention
Experimental
Arm Label
Control group
WB-EMS group
Arm Description
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
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
Outcomes
Primary Outcome Measures
Skeletal muscle mass
Skeletal muscle mass assessed by bioelectrical impedance analysis (in kg)
Secondary Outcome Measures
Physical function - Isometric muscle strength
Hand grip strength assessed by hand dynamometer (in kg)
Cardiorespiratory Fitness
VO2max assessed by spirometry
Patient-reported Quality of Life (QoL)
EORTC QLQ - C30 questionnaire
Patient-reported Fatigue
FACIT-Fatigue scale
Depression/Anxiety
Hospital Anxiety and Depression Scale
Inflammatory blood markers
Blood collection and analysis (Albumin, CRP, Cytokines)
Full Information
NCT ID
NCT03556748
First Posted
June 4, 2018
Last Updated
June 4, 2018
Sponsor
University of Erlangen-Nürnberg Medical School
1. Study Identification
Unique Protocol Identification Number
NCT03556748
Brief Title
WB-EMS and Nutrition in Patients With Hematological Malignancies
Official Title
Effect of Whole-body Electromyostimulation Combined With Individualized Nutritional Support on Patients With Hematological Malignancies
Study Type
Interventional
2. Study Status
Record Verification Date
June 2018
Overall Recruitment Status
Unknown status
Study Start Date
November 1, 2017 (Actual)
Primary Completion Date
October 31, 2019 (Anticipated)
Study Completion Date
October 31, 2019 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Erlangen-Nürnberg Medical School
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hematologic Diseases, Cachexia; Cancer, Leukemia, Myeloma, Lymphoma, Cancer
Keywords
hematological malignancies, leukemia, myeloma, lymphoma, exercise, nutrition, protein, WB-EMS, whole-body electromyostimulation
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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)
Allocation
Non-Randomized
Enrollment
40 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Control group
Arm Type
No Intervention
Arm Description
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
Arm Title
WB-EMS group
Arm Type
Experimental
Arm Description
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
Intervention Type
Other
Intervention Name(s)
whole-body electromyostimulation
Intervention Description
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
Primary Outcome Measure Information:
Title
Skeletal muscle mass
Description
Skeletal muscle mass assessed by bioelectrical impedance analysis (in kg)
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
Physical function - Isometric muscle strength
Description
Hand grip strength assessed by hand dynamometer (in kg)
Time Frame
12 weeks
Title
Cardiorespiratory Fitness
Description
VO2max assessed by spirometry
Time Frame
12 weeks
Title
Patient-reported Quality of Life (QoL)
Description
EORTC QLQ - C30 questionnaire
Time Frame
12 weeks
Title
Patient-reported Fatigue
Description
FACIT-Fatigue scale
Time Frame
12 weeks
Title
Depression/Anxiety
Description
Hospital Anxiety and Depression Scale
Time Frame
12 weeks
Title
Inflammatory blood markers
Description
Blood collection and analysis (Albumin, CRP, Cytokines)
Time Frame
12 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
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
Facility Information:
Facility Name
Department of Medicine 1, Hector Center for Nutrition, Exercise and Sports, Friedrich-Alexander-University Erlangen-Nuremberg
City
Erlangen
ZIP/Postal Code
91052
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yurdaguel Zopf, Prof. Dr. med.
Phone
+49 9131 85-45218
Email
yurdaguel.zopf@uk-erlangen.de
First Name & Middle Initial & Last Name & Degree
Hans Joachim Herrmann, Dr. oec. troph.
Phone
+49 9131 85-45017
Email
hans.herrmann@uk-erlangen.de
12. IPD Sharing Statement
Learn more about this trial
WB-EMS and Nutrition in Patients With Hematological Malignancies
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