UMIN-CTR Clinical Trial

Public title

Evaluation of the muscular hypertrophy effects of long-term using electrical muscle stimulation (EMS) devices

Acronym

Evaluation of the muscular hypertrophy effects of long-term using electrical muscle stimulation (EMS) devices

Scientific Title

Evaluation of the muscular hypertrophy effects of long-term using electrical muscle stimulation (EMS) devices: A randomized open-label parallel-group trial

Scientific Title:Acronym

Evaluation of the muscular hypertrophy effects of long-term using electrical muscle stimulation (EMS) devices

Region

Japan

Condition

Healthy subjects

Classification by specialty

Not applicable

Adult

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

To verify the muscular hypertrophy effects of using electrical muscle stimulation (EMS) devices for eight weeks in healthy subjects.

Basic objectives2

Efficacy

Basic objectives -Others

Trial characteristics_1

Confirmatory

Trial characteristics_2

Pragmatic

Developmental phase

Not applicable

Primary outcomes

The measured value and changes of the following items at four, eight and 12 weeks after the start of using the devices:
the muscle cross section of umbilical region and muscle thickness of each part of rectus abdominis muscle, biceps brachii muscle, triceps brachii muscle and quadriceps femoris

Key secondary outcomes

The measured value and changes of the following items at four, eight and 12 weeks after the start of using the devices:
body weight, BMI, body fat percentage, body temperature, fat mass, lean body mass, muscle mass*
*Whole body, trunk, left arm, right arm, left leg and right leg

Study type

Interventional

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Open -no one is blinded

Control

No treatment

Stratification

YES

Dynamic allocation

NO

Institution consideration

Institution is not considered as adjustment factor.

Blocking

NO

Concealment

No need to know

No. of arms

6

Purpose of intervention

Treatment

Type of intervention

Device,equipment

Interventions/Control_1

Duration: eight weeks
Test device: AbsFit1
Administration: Before using, put a jelly-seat on the electrode part of the device. Put the device with the jelly-seat on the abdomen (between under rib and loin) and turn on the power. Then, the subjects set with a controller of the device to the maximum intensity level that they can withstand for the electrical stimulation and lock the device with a dedicated support-belt. The training time is 23 minutes, once per day at any time during the day. After finishing the training, leave the device from the body and store the device on a dedicated mount board. Use the device with resting-state such as sitting style. Exchange batteries and jelly-seats every two weeks.

Interventions/Control_2

Duration: eight weeks
Test device: AbsFit2
Administration: Before using, put a jelly-seat on the electrode part of the device. Put the device with the jelly-seat on the abdomen (between under rib and loin) and turn on the power. Then, the subjects set with a controller of the device to the maximum intensity level that they can withstand for the electrical stimulation and lock the device with a dedicated support-belt. The training time is 23 minutes, once per day at any time during the day. After finishing the training, leave the device from the body and store the device on a dedicated mount board. Use the device with resting-state such as sitting style. Charge the battery every day and exchange jelly-seats every two weeks.

Interventions/Control_3

Duration: eight weeks
Test device: AbsBelt
Administration: Before using, put a jelly-seat on the electrode part of the device. Put the center-part of the device on between under rib and loin, side-part of it on right and left rib and lock the main device with a fixing-band. Then turn on the power, the subjects set with a controller of the device to the maximum intensity level that they can withstand for the electrical stimulation and lock the device with a dedicated support-belt. The training time is 23 minutes, once per day at any time during the day. After finishing the training, leave the device from the body and store the device on a dedicated mount board. Use the device with resting-state such as sitting style. Charge the battery every day and exchange jelly-seats every two weeks.

Interventions/Control_4

Duration: eight weeks
Test device: BodyFit (arm)
Administration: Before using, put a jelly-seat on the electrode part of the device. Place the control unit toward the inside elbow and put on the device like holding inside the upper arm. After turning on the power, the subjects set with a controller of the device to the maximum intensity level that they can withstand for the electrical stimulation and lock the device with a dedicated support-belt. The training time is 23 minutes, once per day at any time during the day. After finishing the training, leave the device from the body and store the device on a dedicated mount board. Use the device with resting-state such as sitting style. Make sure to put BodyFit on the middle between the shoulder and elbow. Use the device with only one decided arm (non-dominant arm). Exchange batteries and jelly-seats every two weeks.

Interventions/Control_5

Duration: eight weeks
Test device: BodyFit (leg)
Administration: Before using, put a jelly-seat on the electrode part of the device. Place the control unit toward the knee and turn a controller down and put on the device like holding the thigh (front side). After turning on the power, the subjects set with a controller of the device to the maximum intensity level that they can withstand for the electrical stimulation and lock the device with a dedicated support-belt. The training time is 23 minutes, once per day at any time during the day. After finishing the training, leave the device from the body and store the device on a dedicated mount board. Use the device with resting-state such as sitting style. Make sure to put BodyFit on the middle between the hip joint and knee. Use the device with only one decided leg (non-dominant leg). Exchange batteries and jelly-seats every two weeks.

Interventions/Control_6

Duration: eight weeks
Test device: None

Interventions/Control_7

Interventions/Control_8

Interventions/Control_9

Interventions/Control_10

Age-lower limit

20

years-old

<=

Age-upper limit

70

years-old

>

Gender

Male and Female

Key inclusion criteria

1. General healthy subjects

2. Subjects who age between 20 or more and less than 70 when they provide written informed consent

3. Subjects who are judged as eligible to participate in the study by the physician

4. Subjects who do not show discomfort and aversion with electrical stimulation by the test devices

5. Subjects between 18.5 and 25 in body mass index (BMI)

6. Within the subjects who met the first to fifth inclusion criteria, six or more male and six or more female are selected from each generation

Key exclusion criteria

1. Subjects who are undergoing medical treatment or have a medical history of malignant tumor, heart failure, or myocardial infarction

2. Subjects who have a cardiac disorder or potential one

3. Subjects who have a pacemaker or an implantable cardioverter defibrillator (ICD)

4. Subjects who have a metal such as a joint prosthesis, clips, and so on.

5. Currently undergoing treatment for any of the following chronic disease: cardiac arrhythmia, liver disorder, kidney disorder, cerebrovascular disorder, rheumatism, diabetes mellitus, dyslipidemia, hypertension, or any other chronic diseases

6. Subjects who have a wound on the skin of the target part

7. Subjects who have been diagnosed with epilepsy

8. Subjects who use or take "Foods for Specified Health Uses", "Foods with Functional Claims", or other functional food/beverage in daily

9. Subjects who are currently taking food and supplements affecting muscular hypertrophy such as protein, amino acids, and 3-Hydroxy 3-MethylButyrate (HMB)

10. Subjects who have exercise habits or muscular workouts more than two times per week

11. Subjects who are required to be placed at rest

12. Subjects who have an acute painful disease such as spine fractures, sprains, and flesh breaks

13. Currently taking medicines (include herbal medicines) and supplements

14. Subjects who have metal allergy

15. Subjects who cannot understand the method of application of test device

16. Subjects who are pregnant, breast-feeding, and planning to become pregnant

17. Subjects who have been enrolled in other clinical trials within the last three months before the agreement to participate in this trial or plan to participate another trial during this trial

18. Subjects who are judged as ineligible to participate in the study by the physician

Target sample size

90

Name of lead principal investigator

1st name	Kazuo
Middle name
Last name	YAMAMOTO

Organization

ORTHOMEDICO Inc.

Division name

CEO

Zip code

112-0002

Address

2F Sumitomo Fudosan Korakuen Bldg., 1-4-1, Koishikawa, Bunkyo-ku, Tokyo, Japan.

TEL

03-3818-0610

Email

kazu@orthomedico.jp

Name of contact person

1st name	Naoko
Middle name
Last name	SUZUKI

Organization

ORTHOMEDICO Inc.

Division name

R&D Department

Zip code

112-0002

Address

2F Sumitomo Fudosan Korakuen Bldg., 1-4-1, Koishikawa, Bunkyo-ku, Tokyo, Japan.

TEL

03-3818-0610

Homepage URL

Email

nao@orthomedico.jp

Institute

ORTHOMEDICO Inc.

Institute

Department

Personal name

Organization

MTG Co., Ltd.

Organization

Division

Category of Funding Organization

Profit organization

Nationality of Funding Organization

Co-sponsor

Medical Corporation Seishinkai, Takara Clinic

Name of secondary funder(s)

Organization

the ethical committee of the Takara Clinic, Medical Corporation Seishinkai

Address

9F Taisei Building, 2-3-2, Higashi-gotanda, Shinagawa-ku, Tokyo, Japan.

Tel

03-5793-3623

Email

info@takara-clinic.com

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

医療法人社団盛心会 タカラクリニック (東京都)
Medical Corporation Seishinkai, Takara Clinic (Tokyo, Japan)

Date of disclosure of the study information

2019

Year

12

Month

25

Day

URL releasing protocol

Publication of results

Unpublished

URL related to results and publications

Number of participants that the trial has enrolled

102

Results

Results date posted

Results Delayed

Results Delay Reason

Date of the first journal publication of results

Baseline Characteristics

Participant flow

Adverse events

Outcome measures

Plan to share IPD

IPD sharing Plan description

Recruitment status

Completed

Date of protocol fixation

2019

Year

12

Month

20

Day

Date of IRB

2019

Year

12

Month

20

Day

Anticipated trial start date

2019

Year

12

Month

26

Day

Last follow-up date

2020

Year

03

Month

21

Day

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Registered date

2019

Year

12

Month

25

Day

Last modified on

2020

Year

06

Month

25

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044456