NCT02293239
Completed
N/A
Effects of Whole-Body Electromyostimulation (WB-EMS) Combined With Individualized Nutritional Support on Patients With Malignant Disease Undergoing Curative or Palliative Anti-cancer Treatment
University of Erlangen-Nürnberg Medical School1 site in 1 country278 target enrollmentAugust 2013
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Cancer
- Sponsor
- University of Erlangen-Nürnberg Medical School
- Enrollment
- 278
- Locations
- 1
- Primary Endpoint
- Physical function - Gait pattern
- Status
- Completed
- Last Updated
- 7 years ago
Overview
Brief Summary
This study evaluates the effects of a 12-week whole-body electromyostimulation (WB-EMS) training combined with individualized nutritional support on body composition, muscle strength and function and quality of life of patients with malignant disease undergoing curative or palliative anti-cancer treatment
Investigators
Eligibility Criteria
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
Exclusion Criteria
- •simultaneous participation in other nutritional or exercise intervention trials
- •acute cardiovascular events
- •use of anabolic medications
- •severe neurological diseases
- •skin lesions in the area of electrodes
- •energy active metals in body
- •pregnancy
- •acute vein thrombosis
Outcomes
Primary Outcomes
Physical function - Gait pattern
Time Frame: 12 weeks
Sensor-based gait analysis
Skeletal muscle mass
Time Frame: 12 weeks
Skeletal muscle mass assessed by bioelectrical impedance analysis (in kg)
Secondary Outcomes
- Patient-reported performance status(12 weeks)
- Patient-reported Fatigue(12 weeks)
- Patient-reported Quality of Life (QoL)(12 weeks)
- Physical function - Endurance(12 weeks)
- Physical function - Isometric muscle strength(12 weeks)
- Physical function - Lower limb strength(12 weeks)
- Inflammatory blood markers(12 weeks)
Study Sites (1)
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