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临床试验/NCT02970812
NCT02970812已完成不适用

Effects of Electrical Muscle Stimulation on Waist Circumference in Adults: A Randomized Controlled Trial

Pusan National University Yangsan Hospital2 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2015年1月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
60
试验地点
2
主要终点
Waist Circumference

研究概览

简要总结

This randomized, placebo-controlled, double-blind, controlled study was designed to investigate the efficacy of electrical muscle simulation (EMS) for treatment of waist circumference (WC) reduction in abdominal obese adults.

60 patients with abdominal obese, man with WC > 90 cm and woman with WC > 80 cm, received EMS as experimental group (EG) or transcutaneous electrical nerve stimulation (TENS) as control group (CG) 5 times a week for 12 weeks.

详细描述

Background: This randomized, placebo-controlled, double-blind, controlled study was designed to investigate the efficacy of electrical muscle simulation (EMS) for treatment of waist circumference (WC) reduction in abdominal obese adults.

Methods: 60 patients with abdominal obese, man with WC > 90 cm and woman with WC > 80 cm, received EMS as experimental group (EG) or transcutaneous electrical nerve stimulation (TENS) as control group (CG) 5 times a week for 12 weeks.

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
Double (Participant, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Subject has abdominal obese seventy subjects between the age 18 and 65 years
  • Abdominal obesity was defined as having a waist circumference (WC) >90 cm for men or WC >80 cm for women was defined based on the Asia-Pacific criteria of the International Diabetes Federation.

排除标准

  • pregnant or breastfeeding, had taken any treatment for weight loss or any medication known to affect weight
  • had a weight loss of 3% or more in the preceding 3 months, had undergone any major surgery during the 1 year prior to study commencement
  • had any inserted metallic materials including a pacemaker.
  • aspartate aminotransferase or alanine aminotransferase of 100 mg/dL or more
  • serum creatinine of 1.5 mg/dL or more
  • a history of coronary arterial disease or cerebrovascular disease, impairment of a major organ system, cancer, severe lung diseases, severe cerebral trauma, uncontrolled hypertension and psychiatric diseases including eating disorder, etc.

结局指标

主要结局

Waist Circumference

时间窗: 12 weeks

Waist circumference was measured by a tape

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Sang Yeoup Lee

Professor

Pusan National University Yangsan Hospital

研究点 (2)

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