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

NCT04067167 | Recruiting

• 1 other identifier: FREEDOM-Study
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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 subjective outcomes (e.g. quality of life, fatigue, performance status) in patients with malignant disease undergoing curative or palliative anti-cancer treatment.

Conditions

Cancer Cachexia; Inflammation; Muscular Atrophy; Cancer

Keywords

Cancer; Cachexia; Muscular strength; Resistance training; Body composition; Muscle mass; Physical exercise; Nutrition; whole-body electromyostimulation

Outcome Measures

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)

  12 weeks

Secondary Outcomes (12)

• Muscle Mass

  12 weeks

• Fat Mass

  12 weeks

• Total Body Water

  12 weeks

• Cardiorespiratory Fitness (CRF)

  12 weeks

• Inflammation status

  12 weeks

Study Arms (4)

WB-EMS (Sham-intervention)

SHAM COMPARATOR

Low-theshold WB-EMS combined with nutritional therapy

Other: WB-EMS (Sham-intervention)

WB-EMS

EXPERIMENTAL

WB-EMS combined with nutritional therapy

Other: WB-EMS

Free WB-EMS

EXPERIMENTAL

WB-EMS using a mobile System combined with nutritional therapy

Other: Free WB-EMS

Flexi Band Resistance Training

EXPERIMENTAL

Flexi band resistance Training combined with nutritional therapy

Other: Flexi band resistance training

Interventions

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 (Sham-intervention)

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

WB-EMS

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

Free WB-EMS

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

Flexi Band Resistance Training

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Erlangen-Nürnberg Medical School: lead

Study Sites (1)

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

Erlangen, 91054, Germany

RECRUITING

Related Publications (1)

• 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.

  PMID: 39606939 DERIVED

MeSH Terms

Conditions

Neoplasms; Inflammation; Muscular Atrophy; Cachexia; Motor Activity

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms; Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Atrophy; Pathological Conditions, Anatomical; Signs and Symptoms; Weight Loss; Body Weight Changes; Body Weight; Thinness; Behavior

Study Officials

• Dejan Reljic, Dr.

  University Erlangen Nuremberg Medical School

  PRINCIPAL INVESTIGATOR

• Yurdagül Zopf, Prof.

  University Erlangen Nuremberg Medical School

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Hans Joachim Herrmann, Dr.

CONTACT

+49 9131 8545218; hans.herrmann@uk-erlangen.de

Yurdagül Zopf, Prof.

CONTACT

+49 9131 8545218; yurdaguel.zopf@uk-erlangen.de

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Parallel Assignment parallel-group, randomized-controlled study

Study Record Dates

• First Submitted: May 15, 2019
• First Posted: August 26, 2019
• Study Start: May 1, 2019
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): June 30, 2026
• Last Updated: January 20, 2026

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)