Effects of WB-EMS in Ulcerative Colitis Patients

Ulcerative Colitis Clinical Trial

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT02144129
• Other study ID #: EMS_COL
• Secondary ID: Substudy 1
• Status: Withdrawn
• Phase: N/A
• First received: May 19, 2014
• Last updated: January 23, 2018
• Start date: March 2014
• Est. completion date: January 2018

Study information

• Verified date: January 2018
• Source: University of Erlangen-Nürnberg Medical School
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: January 2018
• Est. primary completion date: January 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Colitis
• Colitis, Ulcerative
• Ulcer
• Ulcerative Colitis

Intervention

Other:
• active Whole Body Electromyostimulation

• Passive WB-EMS

Device:
• WB-EMS application

Locations

Country	Name	City	State
Germany	Medizinische Klinik 1, University of Erlangen-Nurnberg	Erlangen	Franconia

Sponsors (2)

Lead Sponsor	Collaborator
University of Erlangen-Nürnberg Medical School	University of Erlangen-Nürnberg

Country where clinical trial is conducted

Germany, 

References & Publications (2)

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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Aerobic capacity	Aerobic capacity as assessed by 6 min walking test	12 weeks, baseline to 12 weel follow-up
Other	Inflammatory Markers		12 weeks, baseline to 12 week follow-up
Primary	Lean Body Mass	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
Primary	Isokinetic muscle strength	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	Quality of Life (QoL)	QoL as assessed by inflammatory bowel disease questionnaire (IBDQ-D) and Depression Scores	12 weeks, baseline to 12 week follow-up
Secondary	Isometric muscle strength	Isometric strength of the trunk flexors.	12 weeks, baseline 12 week follow-up