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

NCT ID: NCT04067167

Last Updated: 2026-01-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-05-01

Study Completion Date

2026-06-30

Brief Summary

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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.

Detailed Description

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Conditions

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Cancer Cancer Cachexia Inflammation Muscular Atrophy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Parallel Assignment parallel-group, randomized-controlled study
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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WB-EMS (Sham-intervention)

Low-theshold WB-EMS combined with nutritional therapy

Group Type SHAM_COMPARATOR

WB-EMS (Sham-intervention)

Intervention Type 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

WB-EMS combined with nutritional therapy

Group Type EXPERIMENTAL

WB-EMS

Intervention Type 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

WB-EMS using a mobile System combined with nutritional therapy

Group Type EXPERIMENTAL

Free WB-EMS

Intervention Type 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

Flexi band resistance Training combined with nutritional therapy

Group Type EXPERIMENTAL

Flexi band resistance training

Intervention Type 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

Interventions

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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

Intervention Type OTHER

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

Intervention Type OTHER

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

Intervention Type OTHER

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

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Erlangen-Nürnberg Medical School

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Dejan Reljic, Dr.

Role: PRINCIPAL_INVESTIGATOR

University Erlangen Nuremberg Medical School

Yurdagül Zopf, Prof.

Role: PRINCIPAL_INVESTIGATOR

University Erlangen Nuremberg Medical School

Locations

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Department of Medicine 1, Hector-Center for Nutrition, Exercise and Sports

Erlangen, , Germany

Site Status RECRUITING

Countries

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Germany

Central Contacts

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Hans Joachim Herrmann, Dr.

Role: CONTACT

+49 9131 8545218

Yurdagül Zopf, Prof.

Role: CONTACT

+49 9131 8545218

Facility Contacts

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Hans Joachim Herrmann, Dr.

Role: primary

+49 9131 8545218

Dejan Reljic, Dr.

Role: backup

+49 9131 8545218

References

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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.

Reference Type DERIVED
PMID: 39606939 (View on PubMed)

Other Identifiers

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FREEDOM-Study

Identifier Type: -

Identifier Source: org_study_id

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