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

University of Erlangen-Nürnberg Medical School

Status: Unknown

Conditions: Inflammation; Cancer Cachexia; Cancer; Muscular Atrophy

Treatments: Other: Free WB-EMS; Other: WB-EMS (Sham-intervention); Other: WB-EMS; Other: Flexi band resistance training

Study type: Interventional

Funder types: Other

Identifiers

NCT04067167

FREEDOM-Study

Details and patient eligibility

About

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.

Enrollment: 100 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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100 participants in 4 patient groups

WB-EMS (Sham-intervention)

Sham Comparator group

Description:

Low-theshold WB-EMS combined with nutritional therapy

Treatment:

Other: WB-EMS (Sham-intervention)

WB-EMS

Experimental group

Description:

WB-EMS combined with nutritional therapy

Treatment:

Other: WB-EMS

Free WB-EMS

Experimental group

Description:

WB-EMS using a mobile System combined with nutritional therapy

Treatment:

Other: Free WB-EMS

Flexi Band Resistance Training

Experimental group

Description:

Flexi band resistance Training combined with nutritional therapy

Treatment:

Other: Flexi band resistance training