Effects of Electrical Muscle Stimulation on Waist Circumference in Adults

NCT02970812 | Completed Results DMC

• 1 other identifier: 2003011
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Abdominal Obesity

Outcome Measures

Primary Outcomes (1)

• Waist Circumference

  Waist circumference was measured by a tape

  12 weeks

Study Arms (2)

Electrical Muscle Stimulation

EXPERIMENTAL

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

Transcutaneous Electrical Nerve Stimulation

PLACEBO COMPARATOR

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

Interventions

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.

Electrical Muscle Stimulation

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.

Transcutaneous Electrical Nerve Stimulation

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Pusan National University Yangsan Hospital: lead

Study Sites (1)

Pusan National University Yangsan Hospital

Yangsan, Gyeungsangnam-do, 50612, South Korea

Location

MeSH Terms

Conditions

Obesity, Abdominal

Interventions

Transcutaneous Electric Nerve Stimulation

Condition Hierarchy (Ancestors)

Obesity; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Electric Stimulation Therapy; Therapeutics; Physical Therapy Modalities; Rehabilitation; Analgesia; Anesthesia and Analgesia

Results Point of Contact

• Title: Sang Yeoup Lee
• Organization: Family Medicine Clinic, Pusan National University Yangsan Hospital

saylee@pnu.edu

3601442

Study Officials

• Sang Yeoup Lee

  Pusan National University Yangsan Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: November 15, 2016
• First Posted: November 22, 2016
• Study Start: January 1, 2015
• Primary Completion: May 1, 2015
• Study Completion: September 1, 2015
• Last Updated: June 10, 2021
• Results First Posted: December 4, 2018

Record last verified: 2021-05

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)