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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of Erlangen-Nürnberg Medical School

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

simultaneous participation in other nutritional or exercise intervention Trials

bone metastases with high fracture risk

cardiovascular disease

use of anabolic medications

Trial design

Design model

Parallel

Treatments tested in this trial

  • WB-EMS (Sham-intervention)

    Other 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

    Other 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

  • Free WB-EMS

    Other intervention

    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

    Other intervention

    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

Treatment groups

100 Participants
are divided into 4 treatment groups
Group A: WB-EMS (Sham-intervention)Sham comparator 1 intervention
Group B: WB-EMSExperimental treatment 1 intervention
Group C: Free WB-EMSExperimental treatment 1 intervention
Group D: Flexi Band Resistance TrainingExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Muscle strength

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)

Time frame
12 weeks

Secondary outcomes

1

Muscle Mass

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

Time frame
12 weeks
2

Fat Mass

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

Time frame
12 weeks
3

Total Body Water

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

Time frame
12 weeks
4

Cardiorespiratory Fitness (CRF)

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

Time frame
12 weeks

Other outcomes

Sponsors and contacts

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