CancerFREEDOMNCT04067167
Flexi Band Resistance Training Versus EMS Exercise in Patients With the Diagnosis of Malignant Diseases
A study testing WB-EMS, Free WB-EMS and Flexi band resistance training in people with Cancer and Cancer Cachexia, run by University of Erlangen-Nürnberg Medical School at 1 site in Germany.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cancer, Cancer Cachexia, Inflammation
- What is being tested?
- WB-EMS, Free WB-EMS and Flexi band resistance training
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 1 siteGermany
- Study dates
- 1 May 2019to 30 Jun 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 10Show fewer
- skin lesions in the area of electrodes
- energy active metals in body
- pregnancy
- acute vein thrombosis
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Germany1 site, 1 recruiting
- Recruiting
Department of Medicine 1, Hector-Center for Nutrition, Exercise and Sports
Erlangen, 91054
Hans Joachim Herrmann, Dr., +49 9131 8545218, hans.herrmann@uk-erlangen.de
Dejan Reljic, Dr., +49 9131 8545218, dejan.reljic@uk-erlangen.de
About this study
Official title: Effects of Flexi Band Resistance Training Versus Different Electromyostimulation Exercise Programs 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.
- Conditions
- Cancer, Cancer Cachexia, Inflammation, Muscular Atrophy
- Being tested
- WB-EMS (Sham-intervention), WB-EMS, Free WB-EMS, Flexi band resistance training
- Keywords
- Cancer, Cachexia, Muscular strength, Resistance training, Body composition, Muscle mass, Physical exercise, Nutrition, whole-body electromyostimulation
- Medical subject headings
- Neoplasms, Inflammation, Muscular Atrophy, Cachexia, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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-EMSOther
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-EMSOther
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 trainingOther
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 group | Role | What they receive |
|---|---|---|
| WB-EMS (Sham-intervention) | Sham comparator | Low-theshold WB-EMS combined with nutritional therapy Receives: Other: WB-EMS (Sham-intervention) |
| WB-EMS | Experimental | WB-EMS combined with nutritional therapy Receives: Other: WB-EMS |
| Free WB-EMS | Experimental | WB-EMS using a mobile System combined with nutritional therapy Receives: Other: Free WB-EMS |
| Flexi Band Resistance Training | Experimental | Flexi band resistance Training combined with nutritional therapy Receives: Other: Flexi band resistance training |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 12 weeks
Secondary outcomes (12)
Muscle Mass
Muscle mass (kg) will be measured by Bioelectrical Impedance Analysis (BIA)
Measured: 12 weeks
Fat Mass
Fat mass (kg) will be measured by Bioelectrical Impedance Analysis (BIA)
Measured: 12 weeks
Total Body Water
Total body water (L) will be measured by Bioelectrical Impedance Analysis (BIA)
Measured: 12 weeks
Cardiorespiratory Fitness (CRF)
CRF will be assessed by measuring Maximum Oxygen uptake (VO2max)
Measured: 12 weeks
Inflammation status
Inflammation will be assessed by measuring blood levels (mg/L) of c-reactive protein (CRP) and high-sensitivity c-reactive protein (hs-CRP).
Measured: 12 weeks
Patient-reported performance status-1
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).
Measured: 12 weeks
Patient-reported performance status-2
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).
Measured: 12 weeks
Patient-reported Quality of Life (QoL)
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.
Measured: 12 weeks
Patient-reported Fatigue
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).
Measured: 12 weeks
Patient-reported Physical Activity
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.
Measured: 12 weeks
Objective Physical Activity
Obejective measurement of physical activity will be preformed using Pedometers. Higher values represent a better outcome.
Measured: 12 weeks
Cardiometabolic Risk Profile (Metabolic Syndrome Z-Score, MetS)
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.
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Aug 2019
- Study start1 May 2019
- Primary completionJun 2026 (estimated)
- Study completion30 Jun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for CancerStudies of the same condition, open and under way.
- More trials run by University of Erlangen-Nürnberg Medical SchoolThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Parallel Assignment parallel-group, randomized-controlled study
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Erlangen-Nürnberg Medical School
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Dejan Reljic, Dr., Principal investigator, University Erlangen Nuremberg Medical SchoolYurdagül Zopf, Prof., Principal investigator, University Erlangen Nuremberg Medical School
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04067167
- Sponsor's protocol ID
- FREEDOM-Study
- Acronym
- FREEDOM
- Status last verified
- Jan 2025
- First submitted
- 15 May 2019
- Last updated
- 20 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Ernst M, Wagner C, Oeser A, Messer S, Wender A, Cryns N, Brockelmann PJ, Holtkamp U, Baumann FT, Wiskemann J, Monsef I, Scherer RW, Mishra SI, Skoetz N. Resistance training for fatigue in people with cancer. Cochrane Database Syst Rev. 2024 Nov 28;11(11):CD015518. doi: 10.1002/14651858.CD015518.
PubMed 39606939
Study at a glance
From the registry record, last updated by the sponsor on 20 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Flexi Band Resistance Training Versus Different Electromyostimulation Exercise Programs in Patients With the Diagnosis of Malignant Diseases
- ClinicalTrials.gov ID
- NCT04067167
- Acronym / sponsor ID
- FREEDOM / FREEDOM-Study
- Conditions
- Cancer, Cancer Cachexia, Inflammation, Muscular Atrophy
- Keywords
- Cancer, Cachexia, Muscular strength, Resistance training, Body composition, Muscle mass, Physical exercise, Nutrition
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- University of Erlangen-Nürnberg Medical SchoolUniversity, hospital or other
- Study start
- 1 May 2019 (actual)
- Primary completion
- Jun 2026 (estimated)
- Study completion
- 30 Jun 2026 (estimated)
- First posted
- 26 Aug 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
- Model description
- Parallel Assignment parallel-group, randomized-controlled study
| Arm | Type | Receives |
|---|---|---|
| WB-EMS (Sham-intervention) | Sham comparator | Other: WB-EMS (Sham-intervention)Low-theshold WB-EMS combined with nutritional therapy |
| WB-EMS | Experimental | Other: WB-EMSWB-EMS combined with nutritional therapy |
| Free WB-EMS | Experimental | Other: Free WB-EMSWB-EMS using a mobile System combined with nutritional therapy |
| Flexi Band Resistance Training | Experimental | Other: Flexi band resistance trainingFlexi band resistance Training combined with nutritional therapy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (10 listed)
- simultaneous participation in other nutritional or exercise intervention Trials
- bone metastases with high fracture risk
- cardiovascular disease
- use of anabolic medications
- epilepsy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 | Other | WB-EMS (Sham-intervention) |
| WB-EMSWhole-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 | Other | WB-EMS |
| Free WB-EMSWhole-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 | Other | Free WB-EMS |
| Flexi band resistance trainingFlexi 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 | Other | Flexi Band Resistance Training |
Primary outcome
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)
12 secondary outcomes
Muscle Mass
Time frame: 12 weeks
Fat Mass
Time frame: 12 weeks
Total Body Water
Time frame: 12 weeks
Cardiorespiratory Fitness (CRF)
Time frame: 12 weeks
Inflammation status
Time frame: 12 weeks
Patient-reported performance status-1
Time frame: 12 weeks
Patient-reported performance status-2
Time frame: 12 weeks
Patient-reported Quality of Life (QoL)
Time frame: 12 weeks
Patient-reported Fatigue
Time frame: 12 weeks
Patient-reported Physical Activity
Time frame: 12 weeks
Objective Physical Activity
Time frame: 12 weeks
Cardiometabolic Risk Profile (Metabolic Syndrome Z-Score, MetS)
Time frame: 12 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jan 2026.
- Derived from this study: PubMed 39606939Ernst M, Wagner C, Oeser A, Messer S, Wender A, Cryns N, Brockelmann PJ, Holtkamp U, Baumann FT, Wiskemann J, Monsef I, Scherer RW, Mishra SI, Skoetz N. Resistance training for fatigue in people with cancer. Cochrane Database Syst Rev. 2024 Nov 28;11(11):CD015518. doi: 10.1002/14651858.CD015518.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Dejan Reljic, Dr. principal investigator
University Erlangen Nuremberg Medical School
Yurdagül Zopf, Prof. principal investigator
University Erlangen Nuremberg Medical School
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing WB-EMS, Free WB-EMS and Flexi band resistance training in people with Cancer and Cancer Cachexia, run by University of Erlangen-Nürnberg Medical School at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 20 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Hans Joachim Herrmann, Dr. (+49 9131 8545218, hans.herrmann@uk-erlangen.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Muscle strength (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04067167, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jan 2026.