Whole Body Electromyostimulation and Nutritional Therapy for Patients With Esophageal and Bronchial Carcinoma
NCT ID: NCT03274349
Last Updated: 2018-10-16
Study Results
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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UNKNOWN
NA
150 participants
INTERVENTIONAL
2017-03-17
2021-03-31
Brief Summary
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Detailed Description
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The purpose of this study is to establish an innovative combined therapy involving protein-rich nutritional therapy and highly effective muscle training by personalized whole-body electromyostimulation (WB-EMS) exercise to improve muscle mass, functionality and strength of esophageal and bronchial carcinoma patients in advanced stage. An increase in muscle mass and strength leads to an increase in physical activity, physical capability as well as tolerance to and applicability of tumor therapy. In the course of a 3-months intervention study the efficacy of a combined protein-rich nutritional therapy with an innovative exercise therapy will be documented for patients with esophageal and bronchial carcinoma in advanced or metastatic stage. An effective stopping of the progress of muscle wasting or even increase of muscle mass, strength and function in the patients of the trial would benefit each patient and his family individually, since it could mean a considerable improvement in his quality of life and tolerability of oncological treatment.
Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
SINGLE
Study Groups
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Control
Group of patients receiving individualized protein-rich nutritional therapy without exercise, 12 weeks intervention per patient
protein-rich nutrition therapy
protein-rich nutrition therapy with an objective of reaching 1,2 to 1,5 g protein/kg body weight and day
EMS-group
Group of patients receiving individualized protein-rich nutritional therapy with personalized whole body electromyostimulation exercise, 12 weeks intervention per patient
whole body electromyostimulation exercise
whole body electromyostimulation exercise training twice a week for 20 min each, bipolar, 85 Hz, intermittent pulse/pause, pulse width 350 µsec
protein-rich nutrition therapy
protein-rich nutrition therapy with an objective of reaching 1,2 to 1,5 g protein/kg body weight and day
Interventions
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whole body electromyostimulation exercise
whole body electromyostimulation exercise training twice a week for 20 min each, bipolar, 85 Hz, intermittent pulse/pause, pulse width 350 µsec
protein-rich nutrition therapy
protein-rich nutrition therapy with an objective of reaching 1,2 to 1,5 g protein/kg body weight and day
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* Pregnancy, Lactation
* Psychological disorders, epilepsia, sever neurological disorders
* Participation in other exercise- or nutrition studies within the last 6 months
* Acute cardiovascular disease
* Rheuma
* Intake of anabolic drugs,
* Skin injuries in the area of electrode placements
* Electronic implants (defibrillator, pacemaker)
* Persons in mental hospitals by order of authorities or jurisdiction
18 Years
ALL
No
Sponsors
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University of Erlangen-Nürnberg Medical School
OTHER
Responsible Party
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Principal Investigators
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Yurdaguel Zopf, Prof.
Role: PRINCIPAL_INVESTIGATOR
University Erlangen Nuremberg Medical School
Locations
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University Hospital Erlangen, Department of Medicine 1
Erlangen, Bavaria, Germany
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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EMS Nutr ÖsoBroCA
Identifier Type: -
Identifier Source: org_study_id
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