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Effects of Electrical Muscle Stimulation on Waist Circumference in Adults

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ClinicalTrials.gov Identifier: NCT02970812
Recruitment Status : Completed
First Posted : November 22, 2016
Results First Posted : December 4, 2018
Last Update Posted : June 10, 2021
Sponsor:
Information provided by (Responsible Party):
Sang Yeoup Lee, Pusan National University Yangsan Hospital

Study Description
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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.


Condition or disease Intervention/treatment Phase
Abdominal Obesity Device: Electrical Muscle Stimulation Device: Transcutaneous Electrical Nerve Stimulation Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effects of Electrical Muscle Stimulation on Waist Circumference in Adults: A Randomized Controlled Trial
Study Start Date : January 2015
Actual Primary Completion Date : May 2015
Actual Study Completion Date : September 2015
Arms and Interventions
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Arm Intervention/treatment
Experimental: 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.
 Device: Electrical Muscle Stimulation
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.
Placebo Comparator: 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.
 Device: Transcutaneous Electrical Nerve Stimulation
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.


Outcome Measures
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Primary Outcome Measures :
  1. Waist Circumference [ Time Frame: 12 weeks ]
    Waist circumference was measured by a tape


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02970812


Locations
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Korea, Republic of
Pusan National University Yangsan Hospital
Yangsan, Gyeungsangnam-do, Korea, Republic of, 50612
Sponsors and Collaborators
Pusan National University Yangsan Hospital
Investigators
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Principal Investigator: Sang Yeoup Lee Pusan National University Yangsan Hospital
More Information
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Responsible Party: Sang Yeoup Lee, Professor, Pusan National University Yangsan Hospital
ClinicalTrials.gov Identifier: NCT02970812    
Other Study ID Numbers: 2003011
First Posted: November 22, 2016    Key Record Dates
Results First Posted: December 4, 2018
Last Update Posted: June 10, 2021
Last Verified: May 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Obesity, Abdominal
Obesity
Overnutrition
Nutrition Disorders