- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07406191
WB-EMS Effects on Cardiometabolic Risk Factors
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.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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-
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Erlangen, Germany, 91052
- Faculty of Medicine, University of Tuebingen
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Erlangen, Germany, 91054
- Institute of Radiology, University Hospital Erlangen
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Grade 1 hypertension: systolic 140 and/or diastolic 90 mmHg
- overweight or obese (body mass index > 25 kg/m2)
Exclusion Criteria:
- 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
- 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)
Study Plan
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 |
|---|---|
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Experimental: Whole-body electromyostimulation
12 weeks of Whole-body electromyostimulation, 1.5x 20min/week
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12 weeks of WB-EMS, 1.5x20 min/week
Other Names:
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Other: Control group
12 weeks without additional intervention.
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12 weeks without additional intervention and without life style changes
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Resting blood pressure
Time Frame: At baseline and after 12 weeks of intervention
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Changes of mean arterial blood pressure after 10 min of rest in a sitting position as assessed by an automatic sphygmomanometer
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At baseline and after 12 weeks of intervention
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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
|
At baseline and after 12 weeks of intervention
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Body fat rate
Time Frame: At baseline and after 12 weeks of intervention
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Changes of body fat rate as determined by Bio Impedance Analysis (BIA)
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At baseline and after 12 weeks of intervention
|
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Lean body mass
Time Frame: At baseline and after 12 weeks of intervention
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Changes of lean body mass as determined by Bio Impedance Analysis (BIA)
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At baseline and after 12 weeks of intervention
|
|
Maximum muscle strength
Time Frame: At baseline and after 12weeks of intervention
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Changes of maximum hip-/leg extension strength as determined by a leg press
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At baseline and after 12weeks of intervention
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Aerobic capacity
Time Frame: At baseline and after 12 weeks of intervention
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Changes of aerobic capacity as determined by a stepwise crosstrainer test to submaximum exertion
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At baseline and after 12 weeks of intervention
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Lower extremity muscle power
Time Frame: At baseline and after 12 weeks of intervention
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Changes of lower extremity muscle power as determined by a 5times sit to stand test
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At baseline and after 12 weeks of intervention
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Adverse effects
Time Frame: From baseline assessment to 12 week control assessment (during the intervention)
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All categories of adverse effects as determined by structured monthly telephone interview
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From baseline assessment to 12 week control assessment (during the intervention)
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Concentration of inflammatory markers
Time Frame: At baseline and after 12 weeks of intervention
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Changes of inflammatory markers as determined by cytokines
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At baseline and after 12 weeks of intervention
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Concentration of adipose-tissue derived hormones
Time Frame: At baseline and after 12 weeks of intervention
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Changes of adipose tissue-derived hormones as determined by adipokines
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At baseline and after 12 weeks of intervention
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Concentration of muscle-tissue derived hormones
Time Frame: At baseline and after 12 weeks of intervention
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Changes of muscle-tissue derived hormones as determined by myokines
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At baseline and after 12 weeks of intervention
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Bluthochdruck - Fragebogen zur Lebenszufriedenheit [Hypertension - Quality of Life Questionnaire]
Time Frame: At baseline and after 12 weeks of intervention
|
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
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At baseline and after 12 weeks of intervention
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Sleep Quality Index (PSQI)
Time Frame: At baseline and after 12 weeks of intervention
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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.
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At baseline and after 12 weeks of intervention
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Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Wolfgang Kemmler, PhD, Institute of Radiology, University Hospital Erlangen, Germany
Publications and helpful links
General Publications
- Buysse 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.
- 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.
- Johnson 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.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Vascular Diseases
- Cardiovascular Diseases
- Nutrition Disorders
- Metabolic Diseases
- Overnutrition
- Body Weight
- Glucose Metabolism Disorders
- Insulin Resistance
- Hyperinsulinism
- Hyperlipidemias
- Dyslipidemias
- Lipid Metabolism Disorders
- Pathological Conditions, Signs and Symptoms
- Nutritional and Metabolic Diseases
- Signs and Symptoms
- Overweight
- Obesity
- Hypertension
- Metabolic Syndrome
- Hypercholesterolemia
- Hypertriglyceridemia
Other Study ID Numbers
- EMS-KHK
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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