Hypercholesterolemia, Hypertension, Hypertriglyceridemia, Metabolic Syndrome, Overweight and Obesity
Conditions
Brief 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. 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.
Interventions
OTHERWB-EMS
12 weeks of WB-EMS, 1.5x20 min/week
OTHERControl
12 weeks without additional intervention and without life style changes
Sponsors
University of Erlangen-Nürnberg Medical School
Universität Tübingen
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Masking description
The study is blinded exclusively for the measurement assistants, who do not know the status of the participant and are not permitted to ask about it.
Intervention model description
Randomized controlled study with two study arms
Eligibility
Sex/Gender
MALE
Age
50 Years to 70 Years
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Resting blood pressure | 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 | At baseline and after 12 weeks of intervention | Changes of the Metabolic Syndrome (MetS) as determined by the MetS-Z-Score |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Body fat rate | At baseline and after 12 weeks of intervention | Changes of body fat rate as determined by Bio Impedance Analysis (BIA) |
| Lean body mass | At baseline and after 12 weeks of intervention | Changes of lean body mass as determined by Bio Impedance Analysis (BIA) |
| Maximum muscle strength | At baseline and after 12weeks of intervention | Changes of maximum hip-/leg extension strength as determined by a leg press |
| Aerobic capacity | At baseline and after 12 weeks of intervention | Changes of aerobic capacity as determined by a stepwise crosstrainer test to submaximum exertion |
| Lower extremity muscle power | At baseline and after 12 weeks of intervention | Changes of lower extremity muscle power as determined by a 5times sit to stand test |
| Concentration of inflammatory markers | At baseline and after 12 weeks of intervention | Changes of inflammatory markers as determined by cytokines |
| Concentration of adipose-tissue derived hormones | At baseline and after 12 weeks of intervention | Changes of adipose tissue-derived hormones as determined by adipokines |
| Concentration of muscle-tissue derived hormones | At baseline and after 12 weeks of intervention | Changes of muscle-tissue derived hormones as determined by myokines |
| Bluthochdruck - Fragebogen zur Lebenszufriedenheit [Hypertension - Quality of Life Questionnaire] | 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 |
| Sleep Quality Index (PSQI) | At baseline and after 12 weeks of intervention | 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. |
| Adverse effects | From baseline assessment to 12 week control assessment (during the intervention) | All categories of adverse effects as determined by structured monthly telephone interview |
Countries
Germany
Contacts
PRINCIPAL_INVESTIGATORWolfgang Kemmler, PhD
Institute of Radiology, University Hospital Erlangen, Germany
Outcome results
None listed