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Completed

NCT Number: NCT02970812

Effects of Electrical Muscle Stimulation on Waist Circumference in Adults

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.

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Pusan National University Yangsan Hospital

Yangsan, Gyeungsangnam-do, 50612, South Korea

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

Electrical muscle stimulation

Device

Participants were under EMS 5 times a week for 12 weeks. Pads were applied on participants' abdomen, rectus abdominis and external oblique abdominal muscle areas without any recent wound, infection, scar, and warts while lie on their back.

Transcutaneous electrical nerve stimulation

Device

Participants were under TENS 5 times a week for 12 weeks. Pads were applied on participants' abdomen, rectus abdominis and external oblique abdominal muscle areas without any recent wound, infection, scar, and warts while lie on their back.

Primary outcomes

  1. Waist Circumference

    Time frame: 12 weeks

    Waist circumference was measured by a tape

Sponsors and collaborators

Lead sponsor

Pusan National University Yangsan Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2015
Study completion
2015
First posted
Nov 22, 2016
Registry last updated
Jun 10, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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