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Low-theshold WB-EMS combined with nutritional therapy

WB-EMS using a mobile System combined with nutritional therapy

Flexi band resistance Training combined with nutritional therapy

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 (Sham-intervention)

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

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

Free WB-EMS

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

Flexi band resistance training

Hans Joachim Herrmann, Dr.

Yurdagül Zopf, Prof.

Dejan Reljic, Dr.

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.

Parallel Assignment parallel-group, randomized-controlled study

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

Effects of Flexi Band Resistance Training Versus Different Electromyostimulation Exercise Programs in Patients With the Diagnosis of Malignant Diseases

Muscle strength of the five major muscle groups (chest, upper back, lower back, abdominals, legs) will be assessed by using specific strength-training devices and estimated using the one Repetition Maximum (1-RM, the maximum amount of weight \[kg\] that can be lifted for one repetition)

Muscle mass (kg) will be measured by Bioelectrical Impedance Analysis (BIA)

Fat mass (kg) will be measured by Bioelectrical Impedance Analysis (BIA)

Total body water (L) will be measured by Bioelectrical Impedance Analysis (BIA)

CRF will be assessed by measuring Maximum Oxygen uptake (VO2max)

Inflammation will be assessed by measuring blood levels (mg/L) of c-reactive protein (CRP) and high-sensitivity c-reactive protein (hs-CRP).

Patient-reported performance Status will be assessed using the ECOG Performance Status questionnaire. It describes a patient's level of functioning in terms of their ability to care for themself, daily activity, and physical ability. The score ranges from 0-5 (lower values = better outcome).

Patient-reported performance status-2 will be assessed using the Karnofsky index. It is used methods to assess the functional status of a Patient. The score ranges from 0-100 (higher value = better outcome).

Patient-reported QoL will be assessed using the EORTC QLQ-C30 questionnaire. It contains 30 questions (items), representing various aspects/dimensions of QoL (physical, role, emotional, cognitive and social), and 3 symptom scales (fatigue, pain and nausea).The scales of the different dimensions of QoL (higher values = better outcome) and symptoms (lower values = better outcomes) range from 0-100.

Fatigue will be assessed using the FACIT-Fatigue scale. It contains 13 items (different aspects/dimensions of fatigue) each assessed on a scale of 0-4, with lower values indicating a better outcome).

Patient-reported Physical Activity (PA) will be assessed using the the International Physical Activity Questionnaire (IPAQ). IPAQ records 4 aspects of PA (job-, transportation-, housework-, and leisure-time-related). There are two forms of output from scoring the IPAQ. Results can be reported in categories (low, moderate or high PA levels) or as a continuous variable (MET minutes a week, 1 MET = resting energy expenditure). MET minutes represent the amount of energy expended carrying out physical activity. High PA = at least 1500 MET minutes/week; moderate PA: at least 600 MET minutes/week; low PA: \< 600 MET minutes/week. Higher values represent a better outcome.

Obejective measurement of physical activity will be preformed using Pedometers. Higher values represent a better outcome.

MetS will be calculated MetS-Z-Score will be calculated from each individual's measures of waist circumference (cm), mean arterial blood pressure (mmHg), blood levels of glucose (mg/dL), triglycerides (mg/dL), and HDL-cholesterol (mg/dL), based on equations specific to sex.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Flexi Band Resistance Training Versus EMS Exercise in Patients With the Diagnosis of Malignant Diseases	NCT04067167	Cancer Cancer Cachexia Inflammation Muscular Atroph...	WB-EMS (Sham-in... WB-EMS Free WB-EMS Flexi band resi...	18 Years -	University of Erlangen-Nürnberg Medical School
Flexi Band Resistance Training Versus EMS Exercise in Patients With the Diagnosis of Malignant Diseases	NCT04067167	Cancer Cancer Cachexia Inflammation Muscular Atroph...	WB-EMS (Sham-in... WB-EMS Free WB-EMS Flexi band resi...	18 Years -	University of Erlangen-Nürnberg Medical School

Spots Global Cancer Trial Database for muscular atrophy