Effects of WB-EMS and Dietetic Treatment on Cancer Patients

University of Erlangen-Nürnberg Medical School278 enrolled

Overview

This study evaluates the effects of a 12-week whole-body electromyostimulation (WB-EMS) training combined with individualized nutritional support on body composition, muscle strength and function and quality of life of patients with malignant disease undergoing curative or palliative anti-cancer treatment

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

278

Conditions

Cancer Cancer Cachexia Weight Loss Muscle Loss Muscle Weakness

Interventions

Whole-Body Electromyostimulation (WB-EMS)OTHER

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

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * malignant disease (solid or hematological cancer): head and neck cancer, colorectal carcinoma, small intestinal cancer, gastric cancer, oesophageal cancer, pancreas carcinoma, liver cell carcinoma, cholangiocarcinoma,lung cancer, breast cancer, cervix cancer, ovarian cancer, prostate cancer, renal cell carcinoma, malignant melanoma, patients with leukaemia and malignant lymphomas or Graft-versus-Host-Disease after bone marrow transplantation * ongoing or planned curative or palliative anti-cancer therapy Exclusion Criteria: * simultaneous participation in other nutritional or exercise intervention trials * acute cardiovascular events * use of anabolic medications * epilepsy * severe neurological diseases * skin lesions in the area of electrodes * energy active metals in body * pregnancy * acute vein thrombosis

Locations (1)

Medizinische Klinik 1, University of Erlangen-Nürnberg

Erlangen, Bavaria / Franconia, Germany

Outcomes

Primary Outcomes

Skeletal muscle mass

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

Time frame: 12 weeks

Physical function - Gait pattern

Sensor-based gait analysis

Time frame: 12 weeks

Secondary Outcomes

Physical function - Isometric muscle strength

Hand grip strength assessed by hand dynamometer (in kg)

Time frame: 12 weeks

Physical function - Endurance

Six-minute-walk test (walking distance in m)

Time frame: 12 weeks

Physical function - Lower limb strength

30 second sit-to-stand test (number of sit-to-stand cycles)

Time frame: 12 weeks

Patient-reported performance status

ECOG performance status/Karnofsky index

Time frame: 12 weeks

Patient-reported Quality of Life (QoL)

EORTC QLQ - C30 questionnaire

Time frame: 12 weeks

Patient-reported Fatigue

FACIT-Fatigue scale

Time frame: 12 weeks

Inflammatory blood markers

Blood collection and analysis e.g. of C-reactive protein (CRP), Albumin

Data from ClinicalTrials.gov

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