Abdominal Obesity
Conditions
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.
Interventions
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.
DEVICETranscutaneous 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.
Sponsors
Pusan National University Yangsan Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Waist Circumference | 12 weeks | Waist circumference was measured by a tape |
Countries
South Korea
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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.
EMS: 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. | 30 |
| 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.
TENS: 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. | 30 |
| Total | 60 |
Baseline characteristics
| Characteristic | Electrical Nerve Stimulation | Total | Electrical Muscle Stimulation |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 30 Participants | 60 Participants | 30 Participants |
| Age, Continuous | 38.5 years STANDARD_DEVIATION 10.6 | 39 years STANDARD_DEVIATION 11 | 40 years STANDARD_DEVIATION 12.9 |
| CT visceral fat | 91.0 cm^2 STANDARD_DEVIATION 48.3 | 95.2 cm^2 STANDARD_DEVIATION 58.1 | 105.7 cm^2 STANDARD_DEVIATION 66.3 |
| Region of Enrollment South Korea | 30 participants | 60 participants | 30 participants |
| Sex: Female, Male Female | 21 Participants | 46 Participants | 25 Participants |
| Sex: Female, Male Male | 9 Participants | 14 Participants | 5 Participants |
| Waist circumference | 92.3 cm STANDARD_DEVIATION 7.2 | 92.2 cm STANDARD_DEVIATION 9.6 | 92.2 cm STANDARD_DEVIATION 11.6 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 30 | 0 / 30 |
| other Total, other adverse events | 0 / 30 | 0 / 30 |
| serious Total, serious adverse events | 0 / 30 | 0 / 30 |
Outcome results
Primary
Waist Circumference
Waist circumference was measured by a tape
Time frame: 12 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Electrical Muscle Stimulation | Waist Circumference | 87.0 cm | Standard Deviation 12.4 |
| Electrical Nerve Stimulation | Waist Circumference | 89.4 cm | Standard Deviation 9.5 |