Clinical trial NCT02144129: 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
Overall status: WITHDRAWN
Phase: NA
Conditions: Ulcerative Colitis
Keywords: Whole Body Electromyostimulation
Inflammatory Bowel Disease
Lean Body Mass
Muscle Strength
Lead sponsor: University of Erlangen-Nürnberg Medical School
Sponsor class: OTHER
Collaborators: name: University of Erlangen-Nürnberg
First posted: 2014-05-21
Enrollment: 0
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Lean Body Mass
timeFrame: 12 weeks, baseline to 12 week follow-up
measure: Isokinetic muscle strength
timeFrame: 12 weeks, baseline to 12 week follow-up
Secondary outcomes:
measure: Quality of Life (QoL)
timeFrame: 12 weeks, baseline to 12 week follow-up
measure: Isometric muscle strength
timeFrame: 12 weeks, baseline 12 week follow-up
Other outcomes:
measure: Aerobic capacity
timeFrame: 12 weeks, baseline to 12 weel follow-up
measure: Inflammatory Markers
timeFrame: 12 weeks, baseline to 12 week follow-up
Locations:
city: Erlangen
country: Germany
facility: Medizinische Klinik 1, University of Erlangen-Nurnberg
state: Franconia
Study officials:
affiliation: University of Erlangen-Nürnberg
name: Yurdagül Zopf, MD
role: STUDY_CHAIR
affiliation: University of Erlangen-Nürnberg Medical School
name: Wolfgang K Kemmler, PhD
role: STUDY_DIRECTOR
affiliation: University of Erlangen-Nürnberg
name: Michael Weineck, MS
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.