WB-EMS and Nutrition in Patients With Hematological Malignancies

NCT03556748 | Unknown

• 1 other identifier: EMS Nutr hemato onko
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Hematologic Diseases; Cachexia; Cancer; Leukemia; Myeloma; Lymphoma; Cancer

Keywords

hematological malignancies; leukemia; myeloma; lymphoma; exercise; nutrition; protein; WB-EMS; whole-body electromyostimulation

Outcome Measures

Primary Outcomes (1)

• Skeletal muscle mass

  Skeletal muscle mass assessed by bioelectrical impedance analysis (in kg)

  12 weeks

Secondary Outcomes (6)

• Physical function - Isometric muscle strength

  12 weeks

• Cardiorespiratory Fitness

  12 weeks

• Patient-reported Quality of Life (QoL)

  12 weeks

• Patient-reported Fatigue

  12 weeks

• Depression/Anxiety

  12 weeks

Study Arms (2)

Control group

NO INTERVENTION

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

WB-EMS group

EXPERIMENTAL

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

Interventions

whole-body electromyostimulation 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

WB-EMS group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• adult patients diagnosed with hematological malignancies with an indication for stem cell Transplantation
• Interval until Transplantation: 6 weeks
• ECOG Status 0-2

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Erlangen-Nürnberg Medical School: lead

Study Sites (1)

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

Erlangen, 91052, Germany

RECRUITING

MeSH Terms

Conditions

Hematologic Diseases; Cachexia; Neoplasms; Leukemia; Neoplasms, Plasma Cell; Lymphoma; Hematologic Neoplasms; Motor Activity

Condition Hierarchy (Ancestors)

Hemic and Lymphatic Diseases; Weight Loss; Body Weight Changes; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Thinness; Neoplasms by Histologic Type; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Neoplasms by Site; Behavior

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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

Study Record Dates

• First Submitted: June 4, 2018
• First Posted: June 14, 2018
• Study Start: November 1, 2017
• Primary Completion: October 31, 2019
• Study Completion: October 31, 2019
• Last Updated: June 14, 2018

Record last verified: 2018-06

Locations

DE (1)