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NCT Number: NCT04067167

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

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.

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Key information

Conditions

Cancer Atrophy Behavior Body Weight Body Weight Changes Cachexia Cancer Cachexia Inflammation Motor Activity Muscular Atrophy Neoplasms Nervous System Diseases Neurologic Manifestations Neuromuscular Manifestations Pathologic Processes Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Signs and Symptoms Thinness Weight Loss

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

WB-EMS (Sham-intervention)

Other

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

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

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

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

Primary outcomes

  1. Muscle strength

    Time frame: 12 weeks

    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)

Secondary outcomes

  1. Muscle Mass

    Time frame: 12 weeks

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

  2. Fat Mass

    Time frame: 12 weeks

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

  3. Total Body Water

    Time frame: 12 weeks

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

  4. Cardiorespiratory Fitness (CRF)

    Time frame: 12 weeks

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

  5. Inflammation status

    Time frame: 12 weeks

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

  6. Patient-reported performance status-1

    Time frame: 12 weeks

    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).

  7. Patient-reported performance status-2

    Time frame: 12 weeks

    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).

  8. Patient-reported Quality of Life (QoL)

    Time frame: 12 weeks

    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.

  9. Patient-reported Fatigue

    Time frame: 12 weeks

    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).

  10. Patient-reported Physical Activity

    Time frame: 12 weeks

    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.

  11. Objective Physical Activity

    Time frame: 12 weeks

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

  12. Cardiometabolic Risk Profile (Metabolic Syndrome Z-Score, MetS)

    Time frame: 12 weeks

    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 contacts

Contact information is provided by the study sponsor or research team.

Hans Joachim Herrmann, Dr.

CONTACT

[email protected]

+49 9131 8545218

Yurdagül Zopf, Prof.

CONTACT

[email protected]

+49 9131 8545218

Sponsors and collaborators

Lead sponsor

University of Erlangen-Nürnberg Medical School

Other

Registry information

Official study title

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

Acronym: FREEDOM

Important dates

Study start
2019
Primary completion
2026
Study completion
2026
First posted
Aug 26, 2019
Registry last updated
Jan 20, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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