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Effects of Electrical Muscle Stimulation on Waist Circumference in Adults

Primary Purpose

Abdominal Obesity

Status
Completed
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Electrical Muscle Stimulation
Transcutaneous Electrical Nerve Stimulation
Sponsored by
Pusan National University Yangsan Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Abdominal Obesity

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Pusan National University Yangsan Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Electrical Muscle Stimulation

Transcutaneous Electrical Nerve Stimulation

Arm Description

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 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.

Outcomes

Primary Outcome Measures

Waist Circumference
Waist circumference was measured by a tape

Secondary Outcome Measures

Full Information

First Posted
November 15, 2016
Last Updated
May 28, 2021
Sponsor
Pusan National University Yangsan Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT02970812
Brief Title
Effects of Electrical Muscle Stimulation on Waist Circumference in Adults
Official Title
Effects of Electrical Muscle Stimulation on Waist Circumference in Adults: A Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
May 2021
Overall Recruitment Status
Completed
Study Start Date
January 2015 (undefined)
Primary Completion Date
May 2015 (Actual)
Study Completion Date
September 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Pusan National University Yangsan Hospital

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Abdominal Obesity

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Electrical Muscle Stimulation
Arm Type
Experimental
Arm Description
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.
Arm Title
Transcutaneous Electrical Nerve Stimulation
Arm Type
Placebo Comparator
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Electrical Muscle Stimulation
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
Transcutaneous Electrical Nerve Stimulation
Intervention Description
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 Outcome Measure Information:
Title
Waist Circumference
Description
Waist circumference was measured by a tape
Time Frame
12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sang Yeoup Lee
Organizational Affiliation
Pusan National University Yangsan Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Pusan National University Yangsan Hospital
City
Yangsan
State/Province
Gyeungsangnam-do
ZIP/Postal Code
50612
Country
Korea, Republic of

12. IPD Sharing Statement

Plan to Share IPD
No

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Effects of Electrical Muscle Stimulation on Waist Circumference in Adults

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