NCT02078986

Brief 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.

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
50

participants targeted

Target at P25-P50 for phase_3 healthy

Timeline
Completed

Started Feb 2014

Typical duration for phase_3 healthy

Geographic Reach
1 country

1 active site

Status
terminated

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

February 1, 2014

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

March 3, 2014

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 5, 2014

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2015

Completed
28 days until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2015

Completed
Last Updated

May 28, 2015

Status Verified

May 1, 2015

Enrollment Period

1 year

First QC Date

March 3, 2014

Last Update Submit

May 27, 2015

Conditions

HealthySedentaryUntrained

Keywords

Whole-Body-ElectromyostimulationHigh Intensity Resistance Exercise Training (HIT)Lean Body MassMuscle Strength

Outcome Measures

Primary Outcomes (1)

  • 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)

Secondary Outcomes (1)

  • Appendicular Skeletal Muscle Mass

    14 weeks (baseline to 14 week follow-up assessment)

Other Outcomes (1)

  • Isokinetic Muscle Strength of the leg extensors and -flexors

    14 weeks (baseline to 14 week follow-up assessment)

Study Arms (2)

Whole Body Electromyostimulation

EXPERIMENTAL
Other: Whole Body Electromyostimulation

High Intensity Resistance Exercise Training

EXPERIMENTAL

Supervised High Intensity Resistance Exercise 2-3 session/week/14 weeks

Other: High Intensity Resistance Exercise Training

Interventions

Whole Body ElectromyostimulationOTHER

Supervised WB-EMS, 3 sessions in 2 weeks (1,5 sessions/week) for 14 weeks

Whole Body Electromyostimulation
High Intensity Resistance Exercise TrainingOTHER

Supervised High Intensity Resistance Exercise Training (HIT) 2-3 sessions/week for 14 weeks

High Intensity Resistance Exercise Training

Eligibility Criteria

Age25 Years - 55 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • male, 25 to 55 years old
  • sedentary / untrained
  • Body Mass Index 20 - 30 kg/m2

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Institute of Medical Physics, University of Erlangen-Nuremberg

Erlangen, Franconia, 91052, Germany

Location

Related Publications (3)

  • 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, 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.

    PMID: 22500224BACKGROUND

  • 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

Related Links

MeSH Terms

Conditions

Sedentary Behavior

Condition Hierarchy (Ancestors)

Behavior

Study Officials

  • Wolfgang K Kemmler, PhD

    Institute of Medical Physics, University of Erlangen-Nuremberg

    STUDY CHAIR

  • Simon O von Stengel, PhD

    Institute of Medical, University of Erlangen-Nuremberg

    STUDY DIRECTOR

  • Marc Teschler, MA

    Institute of Medical Physical, University of Erlangen-Nuremberg

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor Dr. Wolfgang Kemmler, PhD

Study Record Dates

First Submitted

March 3, 2014

First Posted

March 5, 2014

Study Start

February 1, 2014

Primary Completion

February 1, 2015

Study Completion

March 1, 2015

Last Updated

May 28, 2015

Record last verified: 2015-05

Locations

DE(1)