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临床试验/NCT03306056
NCT03306056Unknown不适用

Comparison of the Effects of Whole-body Electromyostimulation Versus Conventional Low-volume Strength Training in Overweight Individuals at Increased Cardiometabolic Risk

University of Erlangen-Nürnberg Medical School2 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2017年11月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
发起方
入组人数
100
试验地点
2
主要终点
Metabolic Syndrome Z-Score (MetS-Z-Score)

研究概览

简要总结

The main purpose of this study is to compare the effects of whole-body electromyostimulation versus a conventional low-volume strength-training program, each combined with an individualized, weight-reducing diet, on the cardiometabolic risk profile, muscle strength, body composition, inflammatory markers and subjective health outcomes in overweight individuals at increased cardiometabolic risk.

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

Outcome Assessors involved in data analysis will not be aware of the arm to which the participants were allocated (single-blinded masking).

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Body Mass Index >25
  • presence of at least 2 cardiometabolic risk factors

排除标准

  • Healthy persons or patients under age
  • Overweight persons without any additional cardiometabolic risk factors
  • Pregnancy, Lactation
  • Psychological disorders, epilepsy, sever neurological disorders
  • Participation in other exercise- or nutrition studies within the last 6 months
  • acute cardiovascular disease
  • malignant disease
  • Intake of anabolic drugs,
  • Skin injuries in the area of electrode placements
  • Electronic implants (defibrillator, pacemaker)
  • Persons in mental hospitals by order of authorities or jurisdiction

研究组 & 干预措施

Control

Experimental

Nutritional therapy / no exercise

干预措施: Control (Other)

Standard Strength Training

Experimental

Nutritional therapy combined with a Standard Strength Training program

干预措施: Standard Strength Training (Other)

Low-volume Strength Training

Experimental

Nutritional therapy combined with a low-volume Strength Training program

干预措施: Low-volume Strength Training (Other)

Whole-body Electromyostimulation

Experimental

Nutritional therapy combined with Whole-Body Electromyostimulation

干预措施: Whole-Body Electromyostimulation (WB-EMS) (Other)

结局指标

主要结局

Metabolic Syndrome Z-Score (MetS-Z-Score)

时间窗: 12 weeks (baseline to 12 week follow-up assessment)

MetS-Z-Score will be calculated from each individual's measures of waist circumference, mean arterial blood pressure, triglycerides, and HDL-cholesterol, based on equations specific to sex.

次要结局

  • Muscle strength(12 weeks (baseline to 12 week follow-up assessment))
  • Body Composition(12 weeks (baseline to 12 week follow-up assessment))
  • Cardiorespiratory Fitness (CRF)(12 weeks (baseline to 12 week follow-up assessment))
  • Inflammation status(12 weeks (baseline to 12 week follow-up assessment))
  • Health-related quality of life(12 weeks (baseline to 12 week follow-up assessment))
  • Pain scores(12 weeks (baseline to 12 week follow-up assessment))
  • Perceived stress(12 weeks (baseline to 12 week follow-up assessment))
  • Subjective work ability(12 weeks (baseline to 12 week follow-up assessment))

研究者

发起方
University of Erlangen-Nürnberg Medical School
申办方类型
Other
责任方
Sponsor

研究点 (2)

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