Effects of WB-EMS in Ulcerative Colitis Patients

January 23, 2018 updated by: Wolfgang Kemmler, University of Erlangen-Nürnberg Medical School

Effects of Different Types of Whole Body Electromyostimulation (WB-EMS) Application on Body Composition, Muscle Strength and Quality of Life in Patients With Ulcerative Colitis

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.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Study Type

Interventional

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
    • Franconia
      • Erlangen, Franconia, Germany, 91054
        • Medizinische Klinik 1, University of Erlangen-Nurnberg

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: active WB-EMS
2 sessions/week with 20 min of active WB-EMS application
Other: active Whole Body Electromyostimulation
Device: WB-EMS application
Experimental: Passive WB-EMS
2 sessions/week with 20 min of passive WB-EMS application in a resting supine position
Other: Passive WB-EMS
No Intervention: Inactive Control Group
sedentary non-training control group

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Lean Body Mass
Time Frame: 12 weeks, baseline to 12 week follow-up
Lean Body Mass (LBM) and Appendicular Skeletal Muscle Mass (ASMM) as assessed by Dual-Energy-x-Ray Absorptiometry (DXA)
12 weeks, baseline to 12 week follow-up
Isokinetic muscle strength
Time Frame: 12 weeks, baseline to 12 week follow-up
Isokinetic muscle strength of the leg extensors and - flexors as assessed by a isokinetic leg strength
12 weeks, baseline to 12 week follow-up

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Quality of Life (QoL)
Time Frame: 12 weeks, baseline to 12 week follow-up
QoL as assessed by inflammatory bowel disease questionnaire (IBDQ-D) and Depression Scores
12 weeks, baseline to 12 week follow-up
Isometric muscle strength
Time Frame: 12 weeks, baseline 12 week follow-up
Isometric strength of the trunk flexors.
12 weeks, baseline 12 week follow-up

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Aerobic capacity
Time Frame: 12 weeks, baseline to 12 weel follow-up
Aerobic capacity as assessed by 6 min walking test
12 weeks, baseline to 12 weel follow-up
Inflammatory Markers
Time Frame: 12 weeks, baseline to 12 week follow-up
12 weeks, baseline to 12 week follow-up

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Erlangen-Nürnberg Medical School

Collaborators

University of Erlangen-Nürnberg

Investigators

  • Study Chair: Yurdagül Zopf, MD, University of Erlangen-Nürnberg
  • Study Director: Wolfgang K Kemmler, PhD, University of Erlangen-Nürnberg Medical School
  • Principal Investigator: Michael Weineck, MS, University of Erlangen-Nürnberg

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2014

Primary Completion (Actual)

January 1, 2018

Study Completion (Actual)

January 1, 2018

Study Registration Dates

First Submitted

May 19, 2014

First Submitted That Met QC Criteria

May 20, 2014

First Posted (Estimate)

May 21, 2014

Study Record Updates

Last Update Posted (Actual)

January 25, 2018

Last Update Submitted That Met QC Criteria

January 23, 2018

Last Verified

January 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EMS_COL
  • Substudy 1 (Other Identifier: Medizinische Klinik 1, University of Erlangen-Nurnberg)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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