Effects of WB-EMS in Ulcerative Colitis Patients

Not Applicable

Withdrawn

• Conditions: Ulcerative Colitis
• Interventions: Other: Passive WB-EMS; Other: active Whole Body Electromyostimulation; Device: WB-EMS application

• Registration Number: NCT02144129
• Lead Sponsor: University of Erlangen-Nürnberg Medical School

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-03
• Study First Submitted: 2014-05-19
• Study First Submitted QC: 2014-05-20
• Study First Posted: 2014-05-21
• Status Verified: 2018-01
• Primary Completion: 2018-01
• Study Completion: 2018-01
• Last Update Submitted: 2018-01-23
• Last Update Posted: 2018-01-25

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
active WB-EMS	WB-EMS application	2 sessions/week with 20 min of active WB-EMS application
Passive WB-EMS	Passive WB-EMS	2 sessions/week with 20 min of passive WB-EMS application in a resting supine position
active WB-EMS	active Whole Body Electromyostimulation	2 sessions/week with 20 min of active WB-EMS application

Primary Outcome Measures

Name	Time	Method
Lean Body Mass	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)
Isokinetic muscle strength	12 weeks, baseline to 12 week follow-up	Isokinetic muscle strength of the leg extensors and - flexors as assessed by a isokinetic leg strength

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Medizinische Klinik 1, University of Erlangen-Nurnberg; 🇩🇪 Erlangen, Franconia, Germany