Effects of Intensive Muscle Training on Cardiometabolic Risk Factors - a Randomised Controlled Study
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 28
- 试验地点
- 2
- 主要终点
- Resting blood pressure
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
盲法说明
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.
入排标准
- 年龄范围
- 50 Years 至 70 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Grade 1 hypertension: systolic 140 and/or diastolic 90 mmHg
- •overweight or obese (body mass index > 25 kg/m2)
排除标准
- •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)
研究组 & 干预措施
Whole-body electromyostimulation
12 weeks of Whole-body electromyostimulation, 1.5x 20min/week
干预措施: WB-EMS (Other)
Control group
12 weeks without additional intervention.
干预措施: Control (Other)
结局指标
主要结局
Resting blood pressure
时间窗: 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
时间窗: At baseline and after 12 weeks of intervention
Changes of the Metabolic Syndrome (MetS) as determined by the MetS-Z-Score
次要结局
- Body fat rate(At baseline and after 12 weeks of intervention)
- Lean body mass(At baseline and after 12 weeks of intervention)
- Maximum muscle strength(At baseline and after 12weeks of intervention)
- Aerobic capacity(At baseline and after 12 weeks of intervention)
- Lower extremity muscle power(At baseline and after 12 weeks of intervention)
- Concentration of inflammatory markers(At baseline and after 12 weeks of intervention)
- Concentration of adipose-tissue derived hormones(At baseline and after 12 weeks of intervention)
- Concentration of muscle-tissue derived hormones(At baseline and after 12 weeks of intervention)
- Bluthochdruck - Fragebogen zur Lebenszufriedenheit [Hypertension - Quality of Life Questionnaire](At baseline and after 12 weeks of intervention)
- Sleep Quality Index (PSQI)(At baseline and after 12 weeks of intervention)
- Adverse effects(From baseline assessment to 12 week control assessment (during the intervention))