Effects of WB-EMS in Ulcerative Colitis Patients

NCT ID: NCT02144129

Last Updated: 2018-01-25

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

WITHDRAWN

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Study Start Date

2014-03-31

Study Completion Date

2018-01-31

Brief Summary

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The purpose of this study is to determine the effect of 12 weeks of WB-EMS either applicated passive in a supine resting position or active during slight movements compared with a non-training control group on body composition, muscle strength and QoL in patients with ulcerative colitis.

Our main hypothesis is that active WB-EMS application is significantly more favorable to address our primary endpoints compared with passive application.

Our secondary hypothesis is that passive WB-EMS application is significantly more favorable to address our primary endpoints compared with non-training control.

Detailed Description

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Conditions

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Ulcerative Colitis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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active WB-EMS

2 sessions/week with 20 min of active WB-EMS application

Group Type EXPERIMENTAL

active Whole Body Electromyostimulation

Intervention Type OTHER

WB-EMS application

Intervention Type DEVICE

Passive WB-EMS

2 sessions/week with 20 min of passive WB-EMS application in a resting supine position

Group Type EXPERIMENTAL

Passive WB-EMS

Intervention Type OTHER

Inactive Control Group

sedentary non-training control group

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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active Whole Body Electromyostimulation

Intervention Type OTHER

Passive WB-EMS

Intervention Type OTHER

WB-EMS application

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* ulcerative colitis
* ambulatory subjects

Exclusion Criteria

* variables that conflicts with WB-EMS application (e.g. cardiac pacemakers)
* absence of more than two weeks during the interventional period.
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Erlangen-Nürnberg

OTHER

Sponsor Role collaborator

University of Erlangen-Nürnberg Medical School

OTHER

Sponsor Role lead

Responsible Party

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Wolfgang Kemmler

Professor Dr.

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Yurdagül Zopf, MD

Role: STUDY_CHAIR

University of Erlangen-Nürnberg

Wolfgang K Kemmler, PhD

Role: STUDY_DIRECTOR

University of Erlangen-Nürnberg Medical School

Michael Weineck, MS

Role: PRINCIPAL_INVESTIGATOR

University of Erlangen-Nürnberg

Locations

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Medizinische Klinik 1, University of Erlangen-Nurnberg

Erlangen, Franconia, Germany

Site Status

Countries

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Germany

References

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Kemmler W, von Stengel S. Whole-body electromyostimulation as a means to impact muscle mass and abdominal body fat in lean, sedentary, older female adults: subanalysis of the TEST-III trial. Clin Interv Aging. 2013;8:1353-64. doi: 10.2147/CIA.S52337. Epub 2013 Oct 7.

Reference Type BACKGROUND
PMID: 24130433 (View on PubMed)

Kemmler W, Bebenek M, Engelke K, von Stengel S. Impact of whole-body electromyostimulation on body composition in elderly women at risk for sarcopenia: the Training and ElectroStimulation Trial (TEST-III). Age (Dordr). 2014 Feb;36(1):395-406. doi: 10.1007/s11357-013-9575-2. Epub 2013 Aug 16.

Reference Type BACKGROUND
PMID: 23949160 (View on PubMed)

Other Identifiers

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Substudy 1

Identifier Type: OTHER

Identifier Source: secondary_id

EMS_COL

Identifier Type: -

Identifier Source: org_study_id

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