Effects of Electrical Muscle Stimulation on Waist Circumference in Adults

Not Applicable

Completed

• Conditions: Abdominal Obesity
• Interventions: Device: Electrical Muscle Stimulation; Device: Transcutaneous Electrical Nerve Stimulation

• Registration Number: NCT02970812
• Lead Sponsor: Pusan National University Yangsan Hospital

Brief Summary

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.

Detailed Description

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.

Study Timeline

• Study Start: 2015-01
• Primary Completion: 2015-05
• Study Completion: 2015-09
• Study First Submitted: 2016-11-15
• Study First Submitted QC: 2016-11-18
• Study First Posted: 2016-11-22
• Results First Submitted: 2018-10-10
• Results First Submitted QC: 2018-11-06
• Results First Posted: 2018-12-04
• Status Verified: 2021-05
• Last Update Submitted: 2021-05-28
• Last Update Posted: 2021-06-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Electrical Muscle Stimulation	Electrical Muscle Stimulation	Electrical Muscle Stimulation (EMS) program was consisted of warm-up, warm-down, contraction and relaxation. It was programed to be resemble to actual muscle action of voluntary exercise. To increase energy consumption as high intensity exercise, tripled the contraction duration. EMS group used Program 3 and regulated intensity though channel from 1 to 4.
Transcutaneous Electrical Nerve Stimulation	Transcutaneous Electrical Nerve Stimulation	Transcutaneous group used Transcutaneous Electrical Nerve Stimulation (TENS) which is the use of electric current produced to stimulate the sensory nerves to block pain signal. It is programed to applied currents regularly, once a second with a frequency of 1 Hz.

Primary Outcome Measures

Name	Time	Method
Waist Circumference	12 weeks	Waist circumference was measured by a tape

Trial Locations

Locations (1)

Pusan National University Yangsan Hospital; 🇰🇷 Yangsan, Gyeungsangnam-do, Korea, Republic of