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Effects of WB-EMS in Ulcerative Colitis Patients

Primary Purpose

Ulcerative Colitis

Status
Withdrawn
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
active Whole Body Electromyostimulation
Passive WB-EMS
WB-EMS application
Sponsored by
University of Erlangen-Nürnberg Medical School
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Ulcerative Colitis focused on measuring Whole Body Electromyostimulation, Inflammatory Bowel Disease, Lean Body Mass, Muscle Strength

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Medizinische Klinik 1, University of Erlangen-Nurnberg

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

No Intervention

Arm Label

active WB-EMS

Passive WB-EMS

Inactive Control Group

Arm Description

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

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

sedentary non-training control group

Outcomes

Primary Outcome Measures

Lean Body Mass
Lean Body Mass (LBM) and Appendicular Skeletal Muscle Mass (ASMM) as assessed by Dual-Energy-x-Ray Absorptiometry (DXA)
Isokinetic muscle strength
Isokinetic muscle strength of the leg extensors and - flexors as assessed by a isokinetic leg strength

Secondary Outcome Measures

Quality of Life (QoL)
QoL as assessed by inflammatory bowel disease questionnaire (IBDQ-D) and Depression Scores
Isometric muscle strength
Isometric strength of the trunk flexors.

Full Information

First Posted
May 19, 2014
Last Updated
January 23, 2018
Sponsor
University of Erlangen-Nürnberg Medical School
Collaborators
University of Erlangen-Nürnberg
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1. Study Identification

Unique Protocol Identification Number
NCT02144129
Brief Title
Effects of WB-EMS in Ulcerative Colitis Patients
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
January 2018
Overall Recruitment Status
Withdrawn
Study Start Date
March 2014 (undefined)
Primary Completion Date
January 2018 (Actual)
Study Completion Date
January 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Erlangen-Nürnberg Medical School
Collaborators
University of Erlangen-Nürnberg

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ulcerative Colitis
Keywords
Whole Body Electromyostimulation, Inflammatory Bowel Disease, Lean Body Mass, Muscle Strength

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
active WB-EMS
Arm Type
Experimental
Arm Description
2 sessions/week with 20 min of active WB-EMS application
Arm Title
Passive WB-EMS
Arm Type
Experimental
Arm Description
2 sessions/week with 20 min of passive WB-EMS application in a resting supine position
Arm Title
Inactive Control Group
Arm Type
No Intervention
Arm Description
sedentary non-training control group
Intervention Type
Other
Intervention Name(s)
active Whole Body Electromyostimulation
Intervention Type
Other
Intervention Name(s)
Passive WB-EMS
Intervention Type
Device
Intervention Name(s)
WB-EMS application
Primary Outcome Measure Information:
Title
Lean Body Mass
Description
Lean Body Mass (LBM) and Appendicular Skeletal Muscle Mass (ASMM) as assessed by Dual-Energy-x-Ray Absorptiometry (DXA)
Time Frame
12 weeks, baseline to 12 week follow-up
Title
Isokinetic muscle strength
Description
Isokinetic muscle strength of the leg extensors and - flexors as assessed by a isokinetic leg strength
Time Frame
12 weeks, baseline to 12 week follow-up
Secondary Outcome Measure Information:
Title
Quality of Life (QoL)
Description
QoL as assessed by inflammatory bowel disease questionnaire (IBDQ-D) and Depression Scores
Time Frame
12 weeks, baseline to 12 week follow-up
Title
Isometric muscle strength
Description
Isometric strength of the trunk flexors.
Time Frame
12 weeks, baseline 12 week follow-up
Other Pre-specified Outcome Measures:
Title
Aerobic capacity
Description
Aerobic capacity as assessed by 6 min walking test
Time Frame
12 weeks, baseline to 12 weel follow-up
Title
Inflammatory Markers
Time Frame
12 weeks, baseline to 12 week follow-up

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yurdagül Zopf, MD
Organizational Affiliation
University of Erlangen-Nürnberg
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Wolfgang K Kemmler, PhD
Organizational Affiliation
University of Erlangen-Nürnberg Medical School
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Michael Weineck, MS
Organizational Affiliation
University of Erlangen-Nürnberg
Official's Role
Principal Investigator
Facility Information:
Facility Name
Medizinische Klinik 1, University of Erlangen-Nurnberg
City
Erlangen
State/Province
Franconia
ZIP/Postal Code
91054
Country
Germany

12. IPD Sharing Statement

Citations:
PubMed Identifier
24130433
Citation
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.
Results Reference
background
PubMed Identifier
23949160
Citation
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.
Results Reference
background

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Effects of WB-EMS in Ulcerative Colitis Patients

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