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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT02078986
Other study ID # EMSvsHIT
Secondary ID IMP_FAU
Status Terminated
Phase Phase 3
First received March 3, 2014
Last updated May 27, 2015
Start date February 2014
Est. completion date March 2015

Study information

Verified date May 2015
Source University of Erlangen-Nürnberg Medical School
Contact n/a
Is FDA regulated No
Health authority Germany: Federal Ministry of Education and Research
Study type Interventional

Clinical Trial Summary

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.


Recruitment information / eligibility

Status Terminated
Enrollment 50
Est. completion date March 2015
Est. primary completion date February 2015
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Male
Age group 25 Years to 55 Years
Eligibility 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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Other:
Whole Body Electromyostimulation
Supervised WB-EMS, 3 sessions in 2 weeks (1,5 sessions/week) for 14 weeks
High Intensity Resistance Exercise Training
Supervised High Intensity Resistance Exercise Training (HIT) 2-3 sessions/week for 14 weeks

Locations

Country Name City State
Germany Institute of Medical Physics, University of Erlangen-Nuremberg Erlangen Franconia

Sponsors (3)

Lead Sponsor Collaborator
University of Erlangen-Nürnberg Medical School Benevital Gesundheitspark, Herzogenaurach, Klinikum Nürnberg

Country where clinical trial is conducted

Germany, 

References & Publications (3)

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. 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. — 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 Isokinetic Muscle Strength of the leg extensors and -flexors 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) No
Primary Lean Body mass 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) No
Secondary Appendicular Skeletal Muscle Mass 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) No
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