Trial Outcomes & Findings for Effects of Electrical Muscle Stimulation on Waist Circumference in Adults (NCT NCT02970812)

NCT ID: NCT02970812

Last Updated: 2021-06-10

Results Overview

Waist circumference was measured by a tape

Recruitment status

COMPLETED

Study phase

Target enrollment

60 participants

Primary outcome timeframe

12 weeks

Results posted on

2021-06-10

Participant Flow

Participant milestones

Participant milestones
Measure	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.	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.
Overall Study STARTED	30	30
Overall Study COMPLETED	22	28
Overall Study NOT COMPLETED	8	2

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Effects of Electrical Muscle Stimulation on Waist Circumference in Adults

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Electrical Muscle Stimulation n=30 Participants 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.	Electrical Nerve Stimulation n=30 Participants 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.	Total n=60 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants
Age, Categorical Between 18 and 65 years	30 Participants n=99 Participants	30 Participants n=107 Participants	60 Participants n=206 Participants
Age, Categorical >=65 years	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants
Age, Continuous	40 years STANDARD_DEVIATION 12.9 • n=99 Participants	38.5 years STANDARD_DEVIATION 10.6 • n=107 Participants	39 years STANDARD_DEVIATION 11 • n=206 Participants
Sex: Female, Male Female	25 Participants n=99 Participants	21 Participants n=107 Participants	46 Participants n=206 Participants
Sex: Female, Male Male	5 Participants n=99 Participants	9 Participants n=107 Participants	14 Participants n=206 Participants
Region of Enrollment South Korea	30 participants n=99 Participants	30 participants n=107 Participants	60 participants n=206 Participants
Waist circumference	92.2 cm STANDARD_DEVIATION 11.6 • n=99 Participants	92.3 cm STANDARD_DEVIATION 7.2 • n=107 Participants	92.2 cm STANDARD_DEVIATION 9.6 • n=206 Participants
CT visceral fat	105.7 cm^2 STANDARD_DEVIATION 66.3 • n=99 Participants	91.0 cm^2 STANDARD_DEVIATION 48.3 • n=107 Participants	95.2 cm^2 STANDARD_DEVIATION 58.1 • n=206 Participants

PRIMARY outcome

Timeframe: 12 weeks

Waist circumference was measured by a tape

Outcome measures

Outcome measures
Measure	Electrical Muscle Stimulation n=30 Participants 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.	Electrical Nerve Stimulation n=30 Participants 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.
Waist Circumference	87.0 cm Standard Deviation 12.4	89.4 cm Standard Deviation 9.5

Adverse Events

Electrical Muscle Stimulation

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Electrical Nerve Stimulation

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Sang Yeoup Lee

Family Medicine Clinic, Pusan National University Yangsan Hospital

Phone: 3601442

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place