NCT02144129

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.

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Mar 2014

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2014

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

May 19, 2014

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 21, 2014

Completed
3.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2018

Completed
Last Updated

January 25, 2018

Status Verified

January 1, 2018

Enrollment Period

3.8 years

First QC Date

May 19, 2014

Last Update Submit

January 23, 2018

Conditions

Ulcerative Colitis

Keywords

Whole Body ElectromyostimulationInflammatory Bowel DiseaseLean Body MassMuscle Strength

Outcome Measures

Primary Outcomes (2)

  • 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

  • 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 Outcomes (2)

  • Quality of Life (QoL)

    12 weeks, baseline to 12 week follow-up

  • Isometric muscle strength

    12 weeks, baseline 12 week follow-up

Other Outcomes (2)

  • Aerobic capacity

    12 weeks, baseline to 12 weel follow-up

  • Inflammatory Markers

    12 weeks, baseline to 12 week follow-up

Study Arms (3)

active WB-EMS

EXPERIMENTAL

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

Other: active Whole Body ElectromyostimulationDevice: WB-EMS application

Passive WB-EMS

EXPERIMENTAL

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

Other: Passive WB-EMS

Inactive Control Group

NO INTERVENTION

sedentary non-training control group

Interventions

active Whole Body ElectromyostimulationOTHER
active WB-EMS
Passive WB-EMSOTHER
Passive WB-EMS
WB-EMS applicationDEVICE
active WB-EMS

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • ulcerative colitis
  • ambulatory subjects

You may not qualify if:

  • variables that conflicts with WB-EMS application (e.g. cardiac pacemakers)
  • absence of more than two weeks during the interventional period.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Medizinische Klinik 1, University of Erlangen-Nurnberg

Erlangen, Franconia, 91054, Germany

Location

Related Publications (2)

  • 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.

    PMID: 24130433BACKGROUND

  • 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.

    PMID: 23949160BACKGROUND

MeSH Terms

Conditions

Colitis, UlcerativeInflammatory Bowel Diseases

Condition Hierarchy (Ancestors)

ColitisGastroenteritisGastrointestinal DiseasesDigestive System DiseasesColonic DiseasesIntestinal Diseases

Study Officials

  • Yurdagül Zopf, MD

    University of Erlangen-Nürnberg

    STUDY CHAIR

  • Wolfgang K Kemmler, PhD

    University of Erlangen-Nürnberg Medical School

    STUDY DIRECTOR

  • Michael Weineck, MS

    University of Erlangen-Nürnberg

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor Dr.

Study Record Dates

First Submitted

May 19, 2014

First Posted

May 21, 2014

Study Start

March 1, 2014

Primary Completion

January 1, 2018

Study Completion

January 1, 2018

Last Updated

January 25, 2018

Record last verified: 2018-01

Locations

DE(1)