HealthyPhase 3EMSvsHITNCT02078986
Effectiveness of WB-EMS Versus HIT-Resistance Training (RT)
A Phase 3 study testing Whole Body Electromyostimulation and High Intensity Resistance Exercise Training in people with Healthy and Sedentary, run by University of Erlangen-Nürnberg Medical School at 1 site in Germany.
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. Read more about this study
- Who is it for?
- Ages 25 to 55 years, men onlyHealthy volunteers can take part
- What is being tested?
- Whole Body Electromyostimulation and High Intensity Resistance Exercise Training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteGermany
- Study dates
- Feb 2014to Mar 2015
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 to 55 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- male, 25 to 55 years old
- sedentary / untrained
- Body Mass Index 20 - 30 kg/m2
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Germany1 site
Institute of Medical Physics, University of Erlangen-Nuremberg
Erlangen, Franconia, 91052
About this study
Official title: 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.
- Being tested
- Whole Body Electromyostimulation, High Intensity Resistance Exercise Training
- Keywords
- Whole-Body-Electromyostimulation, High Intensity Resistance Exercise Training (HIT), Lean Body Mass, Muscle Strength
- Medical subject headings
- Sedentary Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Whole Body ElectromyostimulationOther
Supervised WB-EMS, 3 sessions in 2 weeks (1,5 sessions/week) for 14 weeks
High Intensity Resistance Exercise TrainingOther
Supervised High Intensity Resistance Exercise Training (HIT) 2-3 sessions/week for 14 weeks
| Study group | Role | What they receive |
|---|---|---|
| Whole Body Electromyostimulation | Experimental | Not described Receives: Other: Whole Body Electromyostimulation |
| High Intensity Resistance Exercise Training | Experimental | Supervised High Intensity Resistance Exercise 2-3 session/week/14 weeks Receives: Other: High Intensity Resistance Exercise Training |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 14 weeks (baseline to 14 week follow-up assessment)
Secondary outcomes (1)
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)
Measured: 14 weeks (baseline to 14 week follow-up assessment)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Mar 2014 (estimated)
- Study startFeb 2014
- Primary completionFeb 2015
- Study completionMar 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for HealthyStudies of the same condition, open and under way.
- More trials run by University of Erlangen-Nürnberg Medical SchoolThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Erlangen-Nürnberg Medical School
- Sponsor type
- University, hospital or other
- Collaborators
- Klinikum Nürnberg, Benevital Health Park, Herzogenaurach
- Responsible party
- Principal investigator, Wolfgang Kemmler, University of Erlangen-Nürnberg Medical School
- Investigators
- Wolfgang K Kemmler, PhD, Study chair, Institute of Medical Physics, University of Erlangen-NurembergSimon O von Stengel, PhD, Study director, Institute of Medical, University of Erlangen-NurembergMarc Teschler, MA, Principal investigator, Institute of Medical Physical, University of Erlangen-Nuremberg
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02078986
- Sponsor's protocol ID
- EMSvsHIT
- Other IDs
- IMP_FAU
- Acronym
- EMSvsHIT
- Status last verified
- May 2015
- First submitted
- 3 Mar 2014
- Last updated
- 28 May 2015
- Results posted
- No
- Data monitoring committee
- No
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.
PubMed 24130433Kemmler 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.
PubMed 22500224Kemmler 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.
PubMed 23949160
Study at a glance
From the registry record, last updated by the sponsor on 28 May 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Effect of Whole-Body Electromyostimulation Versus High Intensity Resistance Exercise Training on Body Composition and Strength in Middle Aged Males
- ClinicalTrials.gov ID
- NCT02078986
- Acronym / sponsor ID
- EMSvsHIT / EMSvsHIT
- Keywords
- Whole-Body-Electromyostimulation, High Intensity Resistance Exercise Training (HIT), Lean Body Mass, Muscle Strength
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 50 participants (actual)
- Lead sponsor
- University of Erlangen-Nürnberg Medical SchoolUniversity, hospital or other
- Collaborators
- Klinikum Nürnberg, Benevital Health Park, Herzogenaurach
- Study start
- Feb 2014
- Primary completion
- Feb 2015 (actual)
- Study completion
- Mar 2015 (actual)
- First posted
- 5 Mar 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Whole Body Electromyostimulation | Experimental | Other: Whole Body Electromyostimulation |
| High Intensity Resistance Exercise Training | Experimental | Other: High Intensity Resistance Exercise TrainingSupervised High Intensity Resistance Exercise 2-3 session/week/14 weeks |
Who may qualify
- Ages
- 25 to 55 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- male, 25 to 55 years old
- sedentary / untrained
- Body Mass Index 20 - 30 kg/m2
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Whole Body ElectromyostimulationSupervised WB-EMS, 3 sessions in 2 weeks (1,5 sessions/week) for 14 weeks | Other | Whole Body Electromyostimulation |
| High Intensity Resistance Exercise TrainingSupervised High Intensity Resistance Exercise Training (HIT) 2-3 sessions/week for 14 weeks | Other | High Intensity Resistance Exercise Training |
Primary outcome
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)
1 secondary outcome
Appendicular Skeletal Muscle Mass
Time frame: 14 weeks (baseline to 14 week follow-up assessment)
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 May 2015.
- Background: PubMed 24130433Kemmler 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.
- Background: PubMed 22500224Kemmler 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.
- Background: PubMed 23949160Kemmler 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.
- Related InfoLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Wolfgang K Kemmler, PhD study chair
Institute of Medical Physics, University of Erlangen-Nuremberg
Simon O von Stengel, PhD study director
Institute of Medical, University of Erlangen-Nuremberg
Marc Teschler, MA principal investigator
Institute of Medical Physical, University of Erlangen-Nuremberg
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Whole Body Electromyostimulation and High Intensity Resistance Exercise Training in people with Healthy and Sedentary, run by University of Erlangen-Nürnberg Medical School at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 28 May 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early. Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Lean Body mass (time frame: 14 weeks (baseline to 14 week follow-up assessment)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02078986, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 May 2015.