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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02970812
Other study ID # 2003011
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date January 2015
Est. completion date September 2015

Study information

Verified date May 2021
Source Pusan National University Yangsan Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 60
Est. completion date September 2015
Est. primary completion date May 2015
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 65 Years
Eligibility 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


Related Conditions & MeSH terms


Intervention

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.
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.

Locations

Country Name City State
Korea, Republic of Pusan National University Yangsan Hospital Yangsan Gyeungsangnam-do

Sponsors (1)

Lead Sponsor Collaborator
Pusan National University Yangsan Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type Measure Description Time frame Safety issue
Primary Waist Circumference Waist circumference was measured by a tape 12 weeks
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