- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02078986
Effectiveness of WB-EMS Versus HIT-Resistance Training (RT) (EMSvsHIT)
May 27, 2015 updated by: Wolfgang Kemmler, University of Erlangen-Nürnberg Medical School
Comparison of the Effect of Whole-Body Electromyostimulation Versus High Intensity Resistance Exercise Training on Body Composition and Strength in Middle Aged Males
The main aim of the study is to determine the effects of Whole-Body Electromyostimulation (WB-EMS) on body composition and muscle strength compared with the "golden standard" High Intensity Resistance Exercise Training (HIT) in healthy sedentary middle aged males.
Study Overview
Status
Terminated
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
50
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Franconia
-
Erlangen, Franconia, Germany, 91052
- Institute of Medical Physics, University of Erlangen-Nuremberg
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
25 years to 55 years (Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
Male
Description
Inclusion Criteria:
- male, 25 to 55 years old
- sedentary / untrained
- Body Mass Index 20 - 30 kg/m2
Exclusion Criteria:
- absent ≥ 2 weeks during the interventional period
- medication or diseases with relevant impact on muscle metabolism
- conditions that prevent WB-EMS (e.g. epilepsy, cardiac pacemaker)
- severe neurological diseases
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Whole Body Electromyostimulation
|
Supervised WB-EMS, 3 sessions in 2 weeks (1,5 sessions/week) for 14 weeks
|
Experimental: High Intensity Resistance Exercise Training
Supervised High Intensity Resistance Exercise 2-3 session/week/14 weeks
|
Supervised High Intensity Resistance Exercise Training (HIT) 2-3 sessions/week for 14 weeks
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Lean Body mass
Time Frame: 14 weeks (baseline to 14 week follow-up assessment)
|
Lean Body Mass as assessed by Dual Energy x-Ray Absorptiometry (DXA) was determined twice, at baseline and after 14 weeks of exercise (WB-EMS or HIT)
|
14 weeks (baseline to 14 week follow-up assessment)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Appendicular Skeletal Muscle Mass
Time Frame: 14 weeks (baseline to 14 week follow-up assessment)
|
Appendicular Skeletal Muscle Mass (ASMM) as assessed by DXA was determined at baseline and after 14 weeks of exercise (WB-EMS or HIT)
|
14 weeks (baseline to 14 week follow-up assessment)
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Isokinetic Muscle Strength of the leg extensors and -flexors
Time Frame: 14 weeks (baseline to 14 week follow-up assessment)
|
Isokinetic Muscle Strength leg extensors and -flexors as assessed by a an isokinetic leg press was determined at baseline and after 14 weeks of exercise (WB-EMS or HIT).
|
14 weeks (baseline to 14 week follow-up assessment)
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Study Chair: Wolfgang K Kemmler, PhD, Institute of Medical Physics, University of Erlangen-Nuremberg
- Study Director: Simon O von Stengel, PhD, Institute of Medical, University of Erlangen-Nuremberg
- Principal Investigator: Marc Teschler, MA, Institute of Medical Physical, University of Erlangen-Nuremberg
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- 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.
- 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.
- Kemmler W, von Stengel S. Alternative Exercise Technologies to Fight against Sarcopenia at Old Age: A Series of Studies and Review. J Aging Res. 2012;2012:109013. doi: 10.1155/2012/109013. Epub 2012 Feb 20.
Helpful Links
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
February 1, 2014
Primary Completion (Actual)
February 1, 2015
Study Completion (Actual)
March 1, 2015
Study Registration Dates
First Submitted
March 3, 2014
First Submitted That Met QC Criteria
March 4, 2014
First Posted (Estimate)
March 5, 2014
Study Record Updates
Last Update Posted (Estimate)
May 28, 2015
Last Update Submitted That Met QC Criteria
May 27, 2015
Last Verified
May 1, 2015
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- EMSvsHIT
- IMP_FAU (Other Identifier: Institute of Medical Physics, University of Erlangen-Nuremberg)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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