Clinical trial NCT03556748: 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
Overall status: UNKNOWN
Phase: NA
Conditions: Hematologic Diseases
Cachexia; Cancer
Leukemia
Myeloma
Lymphoma
Cancer
Keywords: hematological malignancies
leukemia
myeloma
lymphoma
exercise
nutrition
protein
WB-EMS
whole-body electromyostimulation
Lead sponsor: University of Erlangen-Nürnberg Medical School
Sponsor class: OTHER
First posted: 2018-06-14
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
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
Primary purpose: SUPPORTIVE_CARE

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.


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

Primary outcomes:
measure: Skeletal muscle mass
timeFrame: 12 weeks
Secondary outcomes:
measure: Physical function - Isometric muscle strength
timeFrame: 12 weeks
measure: Cardiorespiratory Fitness
timeFrame: 12 weeks
measure: Patient-reported Quality of Life (QoL)
timeFrame: 12 weeks
measure: Patient-reported Fatigue
timeFrame: 12 weeks
measure: Depression/Anxiety
timeFrame: 12 weeks
measure: Inflammatory blood markers
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Erlangen
country: Germany
facility: Department of Medicine 1, Hector Center for Nutrition, Exercise and Sports, Friedrich-Alexander-University Erlangen-Nuremberg
Study officials:
References: