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Clinical Trials in Germany / NCT04067167
Recruiting Not applicable

Flexi Band Resistance Training Versus EMS Exercise in Patients With the Diagnosis of Malignant Diseases

NCT04067167 · tracked via the Priya Life Science Germany tracker
Phase
Not applicable
Started
2019-05-01
Last updated
2026-01-20

Condition(s) studied

CancerCancer CachexiaInflammationMuscular Atrophy

Investigational drug(s) / intervention(s)

WB-EMS (Sham-intervention)WB-EMSFree WB-EMSFlexi band resistance training

WB-EMS (Sham-intervention): Whole-Body Electromyostimulation (WB-EMS): WB-EMS with low-threshold stimulation during a study period of 12 weeks combined with standard nutritional therapy (individualized, protein-rich nutritional therapy and counseling; targeted Protein intake/day: 1.2 - 1.5 g per kg bodyweight) * patients perform simple exercises during the stimulation period following a video tutorial * time-effort per session: \~20 min * 2 training sessions per week

WB-EMS: Whole-Body Electromyostimulation (WB-EMS): WB-EMS during study period of 12 weeks combined with standard nutritional therapy (individualized, protein-rich nutritional therapy and counseling; targeted Protein intake/day: 1.2 - 1.5 g per kg bodyweight) * WB-EMS stimulation protocol: Frequency of 85 Hz, pulse duration of 0.35 ms, stimulation period of 6 sec, resting period of 4 sec; * patients perform simple exercises during the stimulation period following a video tutorial * time-effort per session: \~20 min * 2 training sessions per week

Free WB-EMS: Whole-Body Electromyostimulation (WB-EMS) using a mobile system: WB-EMS during study period of 12 weeks combined with standard nutritional therapy (individualized, protein-rich nutritional therapy and counseling; targeted Protein intake/day: 1.2 - 1.5 g per kg bodyweight) * WB-EMS stimulation protocol: Frequency of 85 Hz, pulse duration of 0.35 ms, stimulation period of 6 sec, resting period of 4 sec; * patients perform simple exercises during the stimulation period following a video tutorial * time-effort per session: \~20 min * 2 training sessions per week

Flexi band resistance training: Flexi band resistance Training: Training during study period of 12 weeks combined with standard nutritional therapy (individualized, protein-rich nutritional therapy and counseling; targeted Protein intake/day: 1.2 - 1.5 g per kg bodyweight) * patients perform resistance exercises using flexi bands * flexi band exercises are conceptualized to activate similar muscle groups as EMS exercise * time-effort per session: \~20 min * 2 training sessions per week

Study summary

The purpose of this study is to investigate the effects of a 12-week flexi band resistance training program compared to different whole-body electromyostimulation (WB-EMS) exercise programs on muscle strength, body composition (in particular muscle mass), cardiorespiratory fitness, inflammation, and patient-reported subjective outcomes (e.g. quality of life, fatigue, performance status) in patients with malignant disease undergoing curative or palliative anti-cancer treatment.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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 * ECOG-Status 0-2 Exclusion Criteria: * simultaneous participation in other nutritional or exercise intervention Trials * bone metastases with high fracture risk * cardiovascular disease * use of anabolic medications * epilepsy * severe neurological or rheumatic diseases * skin lesions in the area of electrodes * energy active metals in body * pregnancy * acute vein thrombosis

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
Department of Medicine 1, Hector-Center for Nutrition, Exercise and Sports Erlangen Germany Recruiting

More University of Erlangen-Nürnberg Medical School trials in Germany

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT04067167 on ClinicalTrials.gov ↗ ← All trials in Germany