WB-EMS and Individualized Nutritional Support in Gynecological Cancer Patients

NCT ID: NCT03570242

Last Updated: 2018-06-26

Study Results

Results pending

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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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

150 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-07-01

Study Completion Date

2020-06-30

Brief Summary

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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, quality of life, fatigue and Inflammatory status on patients with gynecological cancer undergoing palliative anti-cancer Treatment. Furthermore, this study assesses the effect of this combined therapeutic approach within a 3 to 4-week pre-operative study Intervention on the period of hospitalization in gynecological patients undergoing curative anti-cancer Treatment.

Detailed Description

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Conditions

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Gynecologic Cancer Cachexia

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

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)

Group Type NO_INTERVENTION

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)

Group Type EXPERIMENTAL

Whole-Body Electromyostimulation (WB-EMS)

Intervention Type OTHER

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)

Group Type NO_INTERVENTION

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)

Group Type EXPERIMENTAL

Whole-Body Electromyostimulation (WB-EMS)

Intervention Type OTHER

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

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* female patients with gynecological cancer undergoing palliative or curative treatment
* 18 years and older
* ECOG status \> 2

Exclusion Criteria

* simultaneous participation in other nutritional or exercise intervention Trials or in the past 6 months
* 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
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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University of Erlangen-Nürnberg Medical School

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Department of Medicine 1, Hector Center for Nutrition, Exercise and Sports, Friedrich-Alexander-University Erlangen-Nuremberg

Erlangen, , Germany

Site Status RECRUITING

Countries

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Germany

Central Contacts

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Yurdagül Zopf, Prof. Dr. med.

Role: CONTACT

+49 9131 85-45218

Hans Joachim Herrmann, Dr. oec. troph.

Role: CONTACT

+49 9131 85-45017

Facility Contacts

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Yurdaguel Zopf, Prof. Dr. med.

Role: primary

Other Identifiers

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Gyn EMS

Identifier Type: -

Identifier Source: org_study_id

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