WB-EMS and Individualized Nutritional Support in Gynecological Cancer Patients
NCT ID: NCT03570242
Last Updated: 2018-06-26
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
2017-07-01
2020-06-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
NONE
Study Groups
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Control group (palliative treatment)
"usual care" control group (includes patients undergoing palliative Treatment) receives individualized nutritional support (dietary advices: daily protein intake1,2 - 1,5 g/kg bodyweight)
No interventions assigned to this group
WB-EMS group (palliative treatment)
physical exercise group (includes patients undergoing palliative Treatment) receives regular WB-EMS training (2 EMS trainings per week; each session for 20 min)
\+ individualized nutritional support (dietary advices: daily protein intake 1,2-1,5 g/kg bodyweight)
Whole-Body Electromyostimulation (WB-EMS)
WB-EMS training is performed 2x/week for 12 weeks; Stimulation protocol: Frequency of 85 Hz, pulse duration of 0.35 ms, stimulation period of 6 sec, resting period of 4 sec; supervised by certified training instructors/physiotherapists participants perform simple exercises during the stimulation period following a video tutorial
Control group (curative treatment)
"usual care" control group (includes patients undergoing curative treatment 3-4 weeks before surgery) receives individualized nutritional support (dietary advices: daily protein intake1,2 - 1,5 g/kg bodyweight)
No interventions assigned to this group
WB-EMS group (curative treatment)
physical exercise group (includes patients undergoing adjuvant treatment 3-4 weeks before surgery) receives regular WB-EMS training (2 EMS trainings per week; each session for 20 min)
\+ individualized nutritional support (dietary advices: daily protein intake 1,2-1,5 g/kg bodyweight)
Whole-Body Electromyostimulation (WB-EMS)
WB-EMS training is performed 2x/week for 12 weeks; Stimulation protocol: Frequency of 85 Hz, pulse duration of 0.35 ms, stimulation period of 6 sec, resting period of 4 sec; supervised by certified training instructors/physiotherapists participants perform simple exercises during the stimulation period following a video tutorial
Interventions
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Whole-Body Electromyostimulation (WB-EMS)
WB-EMS training is performed 2x/week for 12 weeks; Stimulation protocol: Frequency of 85 Hz, pulse duration of 0.35 ms, stimulation period of 6 sec, resting period of 4 sec; supervised by certified training instructors/physiotherapists participants perform simple exercises during the stimulation period following a video tutorial
Eligibility Criteria
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Inclusion Criteria
* 18 years and older
* ECOG status \> 2
Exclusion Criteria
* acute cardiovascular events
* use of anabolic medications
* epilepsy
* severe neurological diseases
* skin lesions in the area of electrodes
* energy active metals in body
* pregnancy
* acute vein thrombosis
* rheumatic diseases
* pregnant and nursing women
* psychiatric disorders with doubts about legal and cognitive capacity
18 Years
FEMALE
No
Sponsors
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University of Erlangen-Nürnberg Medical School
OTHER
Responsible Party
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Locations
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Department of Medicine 1, Hector Center for Nutrition, Exercise and Sports, Friedrich-Alexander-University Erlangen-Nuremberg
Erlangen, , Germany
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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Gyn EMS
Identifier Type: -
Identifier Source: org_study_id
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