HypertensionNCT07406191
WB-EMS Effects on Cardiometabolic Risk Factors
A study testing WB-EMS in people with Hypertension and Metabolic Syndrome, run by University of Erlangen-Nürnberg Medical School at 2 sites in Germany.
Trial summary
From the age of 50 onwards, there is a disproportionate decline in muscle strength, mass and function, which can be prevented or at least delayed by physical training. Unfortunately, many training programmes are very time-consuming and strenuous and are therefore not carried out consistently. Read more about this study
- Who is it for?
- Ages 50 to 70 years, men only
- Conditions the study is for
- Hypertension, Metabolic Syndrome, Hypercholesterolemia
- What is being tested?
- WB-EMS
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 2 sitesGermany
- Study dates
- 15 Feb 2026to 31 Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 50 to 70 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Grade 1 hypertension: systolic 140 and/or diastolic 90 mmHg
- overweight or obese (body mass index > 25 kg/m2)
Who cannot join
- blood pressure-lowering pharmacologic therapy.
- WB-EMS application and regular resistance exercise training
- Conditions and illnesses that preclude intensive physical exertion
- Severe cardiac arrhythmia
- Heart failure
- acute pulmonary embolism
Show all 10Show fewer
- acute myocarditis
- severe hypertension, e.g. blood pressure > 200 mmHg systolic and/or >110 mmHg diastolic
- Contraindications for bioimpedance analysis (e.g. pacemaker)
- Contraindications for WB-EMS application (e.g. acute infections/fever, epilepsy)
Trial locations and contacts
2 sites in 1 country.
Germany2 sites
Faculty of Medicine, University of Tuebingen
Erlangen, 91052
Institute of Radiology, University Hospital Erlangen
Erlangen, 91054
About this study
Official title: Effects of Intensive Muscle Training on Cardiometabolic Risk Factors - a Randomised Controlled Study
From the age of 50 onwards, there is a disproportionate decline in muscle strength, mass and function, which can be prevented or at least delayed by physical training. Unfortunately, many training programmes are very time-consuming and strenuous and are therefore not carried out consistently. Whole-body electromyostimulation (WB-EMS), a technology in which all major muscle groups are stimulated with an adjusted stimulation level, could be a time-effective and joint-friendly alternative.
However, there are some contraindications to the widespread use of this technology, which are particularly common in middle-aged and elderly people. For example, high blood pressure, which affects more than half of men over the age of 50 in Germany, is considered a contraindication for WB-EMS training. However, this assessment is not very reliable; at least, acute WB-EMS application does not lead to an increase in blood pressure. In addition, there are no study results available for long-term WB-EMS application in people with high blood pressure.
The present study particularly investigate whether and to what extent several weeks of WB-EMS training has an effect on resting blood pressure in people with mild blood pressure. Additionally, the effect of WB-EMS on other cardiometabolic risk factors and physical function will be addressed.
- Conditions
- Hypertension, Metabolic Syndrome, Hypercholesterolemia, Hypertriglyceridemia, Overweight and Obesity
- Being tested
- WB-EMS, Control
- Medical subject headings
- Hypertension, Metabolic Syndrome, Hypercholesterolemia, Hypertriglyceridemia, Overweight, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
WB-EMSOther
Also called Electromyostimulation
12 weeks of WB-EMS, 1.5x20 min/week
ControlOther
Also called Non-intervention control group
12 weeks without additional intervention and without life style changes
| Study group | Role | What they receive |
|---|---|---|
| Whole-body electromyostimulation | Experimental | 12 weeks of Whole-body electromyostimulation, 1.5x 20min/week Receives: Other: WB-EMS |
| Control group | Other | 12 weeks without additional intervention. Receives: Other: Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Resting blood pressure
Changes of mean arterial blood pressure after 10 min of rest in a sitting position as assessed by an automatic sphygmomanometer
Measured: At baseline and after 12 weeks of intervention
Metabolic syndrome
Changes of the Metabolic Syndrome (MetS) as determined by the MetS-Z-Score
Measured: At baseline and after 12 weeks of intervention
Secondary outcomes (11)
Body fat rate
Changes of body fat rate as determined by Bio Impedance Analysis (BIA)
Measured: At baseline and after 12 weeks of intervention
Lean body mass
Changes of lean body mass as determined by Bio Impedance Analysis (BIA)
Measured: At baseline and after 12 weeks of intervention
Maximum muscle strength
Changes of maximum hip-/leg extension strength as determined by a leg press
Measured: At baseline and after 12weeks of intervention
Aerobic capacity
Changes of aerobic capacity as determined by a stepwise crosstrainer test to submaximum exertion
Measured: At baseline and after 12 weeks of intervention
Lower extremity muscle power
Changes of lower extremity muscle power as determined by a 5times sit to stand test
Measured: At baseline and after 12 weeks of intervention
Concentration of inflammatory markers
Changes of inflammatory markers as determined by cytokines
Measured: At baseline and after 12 weeks of intervention
Concentration of adipose-tissue derived hormones
Changes of adipose tissue-derived hormones as determined by adipokines
Measured: At baseline and after 12 weeks of intervention
Concentration of muscle-tissue derived hormones
Changes of muscle-tissue derived hormones as determined by myokines
Measured: At baseline and after 12 weeks of intervention
Bluthochdruck - Fragebogen zur Lebenszufriedenheit [Hypertension - Quality of Life Questionnaire]
Changes in QoL in people with hypertension according to a questionnaire from 1 (excellent, completely agree) to 6 (very bad/completely disagree). Lower scores indicate better outcomes
Measured: At baseline and after 12 weeks of intervention
Sleep Quality Index (PSQI)
Changes in sleep quality according to the Pittsburgh Sleep Quality Index questionnaire on a scale from 1 (worst outcome) to 4 (best outcome). Higher scores indicate better sleep quality.
Measured: At baseline and after 12 weeks of intervention
Adverse effects
All categories of adverse effects as determined by structured monthly telephone interview
Measured: From baseline assessment to 12 week control assessment (during the intervention)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Feb 2026
- Study start15 Feb 2026
- Primary completion30 Nov 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
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 HypertensionStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized controlled study with two study arms
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Erlangen-Nürnberg Medical School
- Sponsor type
- University, hospital or other
- Collaborators
- Universität Tübingen
- Responsible party
- Sponsor
- Investigators
- Wolfgang Kemmler, PhD, Principal investigator, Institute of Radiology, University Hospital Erlangen, Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07406191
- Sponsor's protocol ID
- EMS-KHK
- Status last verified
- Jan 2026
- First submitted
- 5 Feb 2026
- Last updated
- 14 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Kemmler W, Kohl M, von Stengel S, Willert S, Kast S, Uder M. Effects of whole-body electromyostimulation with different impulse intensity on blood pressure changes in hyper- and normotensive overweight people. A pilot study. Front Physiol. 2024 Feb 22;15:1349750. doi: 10.3389/fphys.2024.1349750. eCollection 2024.
PubMed 38455842Johnson JL, Slentz CA, Houmard JA, Samsa GP, Duscha BD, Aiken LB, McCartney JS, Tanner CJ, Kraus WE. Exercise training amount and intensity effects on metabolic syndrome (from Studies of a Targeted Risk Reduction Intervention through Defined Exercise). Am J Cardiol. 2007 Dec 15;100(12):1759-66. doi: 10.1016/j.amjcard.2007.07.027. Epub 2007 Oct 29.
PubMed 18082522Buysse DJ, Reynolds CF 3rd, Monk TH, Berman SR, Kupfer DJ. The Pittsburgh Sleep Quality Index: a new instrument for psychiatric practice and research. Psychiatry Res. 1989 May;28(2):193-213. doi: 10.1016/0165-1781(89)90047-4.
PubMed 2748771
Study at a glance
From the registry record, last updated by the sponsor on 14 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Intensive Muscle Training on Cardiometabolic Risk Factors - a Randomised Controlled Study
- ClinicalTrials.gov ID
- NCT07406191
- Acronym / sponsor ID
- EMS-KHK
- Conditions
- Hypertension, Metabolic Syndrome, Hypercholesterolemia, Hypertriglyceridemia, Overweight and Obesity
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 28 participants (actual)
- Lead sponsor
- University of Erlangen-Nürnberg Medical SchoolUniversity, hospital or other
- Collaborators
- Universität Tübingen
- Study start
- 15 Feb 2026 (actual)
- Primary completion
- 30 Nov 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 12 Feb 2026 (actual)
- 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.
From the age of 50 onwards, there is a disproportionate decline in muscle strength, mass and function, which can be prevented or at least delayed by physical training. Unfortunately, many training programmes are very time-consuming and strenuous and are therefore not carried out consistently. Whole-body electromyostimulation (WB-EMS), a technology in which all major muscle groups are stimulated with an adjusted stimulation level, could be a time-effective and joint-friendly alternative.
However, there are some contraindications to the widespread use of this technology, which are particularly common in middle-aged and elderly people. For example, high blood pressure, which affects more than half of men over the age of 50 in Germany, is considered a contraindication for WB-EMS training. However, this assessment is not very reliable; at least, acute WB-EMS application does not lead to an increase in blood pressure. In addition, there are no study results available for long-term WB-EMS application in people with high blood pressure.
The present study particularly investigate whether and to what extent several weeks of WB-EMS training has an effect on resting blood pressure in people with mild blood pressure. Additionally, the effect of WB-EMS on other cardiometabolic risk factors and physical function will be addressed.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Randomized controlled study with two study arms
| Arm | Type | Receives |
|---|---|---|
| Whole-body electromyostimulation | Experimental | Other: WB-EMS12 weeks of Whole-body electromyostimulation, 1.5x 20min/week |
| Control group | Other | Other: Control12 weeks without additional intervention. |
Who may qualify
- Ages
- 50 to 70 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Grade 1 hypertension: systolic 140 and/or diastolic 90 mmHg
- overweight or obese (body mass index > 25 kg/m2)
Key exclusion criteria (10 listed)
- blood pressure-lowering pharmacologic therapy.
- WB-EMS application and regular resistance exercise training
- Conditions and illnesses that preclude intensive physical exertion
- Severe cardiac arrhythmia
- Heart failure
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 |
|---|---|---|
| WB-EMSAlso: Electromyostimulation12 weeks of WB-EMS, 1.5x20 min/week | Other | Whole-body electromyostimulation |
| ControlAlso: Non-intervention control group12 weeks without additional intervention and without life style changes | Other | Control group |
Primary outcome
Resting blood pressure
Time frame: At baseline and after 12 weeks of intervention
Changes of mean arterial blood pressure after 10 min of rest in a sitting position as assessed by an automatic sphygmomanometer
Metabolic syndrome
Time frame: At baseline and after 12 weeks of intervention
Changes of the Metabolic Syndrome (MetS) as determined by the MetS-Z-Score
11 secondary outcomes
Body fat rate
Time frame: At baseline and after 12 weeks of intervention
Lean body mass
Time frame: At baseline and after 12 weeks of intervention
Maximum muscle strength
Time frame: At baseline and after 12weeks of intervention
Aerobic capacity
Time frame: At baseline and after 12 weeks of intervention
Lower extremity muscle power
Time frame: At baseline and after 12 weeks of intervention
Concentration of inflammatory markers
Time frame: At baseline and after 12 weeks of intervention
Concentration of adipose-tissue derived hormones
Time frame: At baseline and after 12 weeks of intervention
Concentration of muscle-tissue derived hormones
Time frame: At baseline and after 12 weeks of intervention
Bluthochdruck - Fragebogen zur Lebenszufriedenheit [Hypertension - Quality of Life Questionnaire]
Time frame: At baseline and after 12 weeks of intervention
Sleep Quality Index (PSQI)
Time frame: At baseline and after 12 weeks of intervention
Adverse effects
Time frame: From baseline assessment to 12 week control assessment (during the intervention)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 May 2026.
- Background: PubMed 38455842Kemmler W, Kohl M, von Stengel S, Willert S, Kast S, Uder M. Effects of whole-body electromyostimulation with different impulse intensity on blood pressure changes in hyper- and normotensive overweight people. A pilot study. Front Physiol. 2024 Feb 22;15:1349750. doi: 10.3389/fphys.2024.1349750. eCollection 2024.
- Background: PubMed 18082522Johnson JL, Slentz CA, Houmard JA, Samsa GP, Duscha BD, Aiken LB, McCartney JS, Tanner CJ, Kraus WE. Exercise training amount and intensity effects on metabolic syndrome (from Studies of a Targeted Risk Reduction Intervention through Defined Exercise). Am J Cardiol. 2007 Dec 15;100(12):1759-66. doi: 10.1016/j.amjcard.2007.07.027. Epub 2007 Oct 29.
- Background: PubMed 2748771Buysse DJ, Reynolds CF 3rd, Monk TH, Berman SR, Kupfer DJ. The Pittsburgh Sleep Quality Index: a new instrument for psychiatric practice and research. Psychiatry Res. 1989 May;28(2):193-213. doi: 10.1016/0165-1781(89)90047-4.
- Individual participant dataSharing planned: No
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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 Kemmler, PhD principal investigator
Institute of Radiology, University Hospital Erlangen, Germany
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing WB-EMS in people with Hypertension and Metabolic Syndrome, run by University of Erlangen-Nürnberg Medical School at 2 sites 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 2 inclusion and 10 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: under way, not looking for participants, as of the sponsor's last update on 14 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
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?
Resting blood pressure (time frame: At baseline and after 12 weeks of intervention). The study lists 2 primary outcomes in all. 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 NCT07406191, 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 14 May 2026.