- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06036953
Electrical Muscle Stimulation on Muscle Mass, Strength, and Body Composition
September 7, 2023 updated by: Chi-Chang Huang, National Taiwan Sport University
Effect of 8-week Frequency-specific Electrical Muscle Stimulation Combined With Resistance Exercise Training on Muscle Mass, Strength, and Body Composition in Men and Women: A Feasibility and Safety Study
In recent years, electrical muscle stimulation (EMS) devices have been developed as a complementary training technique that is novel, attractive, and time-saving for physical fitness and rehabilitation.
While it is known that EMS training can improve muscle mass and strength, most studies have focused on the elderly or specific patient populations.
The aim of this study was to investigate the effects of frequency-specific EMS combined with resistance exercise training for 8 weeks on muscle mass, strength, power, body composition, and parameters related to exercise fatigue.
Additionally, we aimed to evaluate the feasibility and safety of EMS as an exercise aid to improve body composition.
We recruited 14 male and 14 female subjects who were randomly assigned to two groups with gender parity (7 male and 7 female/group): (1) no EMS group and (2) daily EMS group.
Blood biochemical routine analysis was performed every 4 weeks from pre-intervention to post-intervention, and body composition, muscle strength, and explosive power were evaluated 8 weeks before and after the intervention.
We also performed an exercise challenge analysis of fatigue biochemical indicators after 8 weeks of intervention.
Study Overview
Status
Completed
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
28
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Taoyuan, Taiwan, 33301
- Graduate Institute of Sports Science, National Taiwan Sport University
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Yes
Description
Inclusion Criteria:
- healthy
Exclusion Criteria:
- smoking or drinking habits
- cardiovascular disease
- neuromuscular disease
- metabolic disease
- asthma
- pregnancy
- body mass index (BMI) over 27
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
No Intervention: No EMS
|
|
Experimental: EMS
|
The electric muscle stimulator (EMS) used in this study was from Funcare (Funcare Co., Ltd, Taichung, Taiwan).
EMS electrodes were attached to the biceps of both hands, the abdomen, and the quadriceps of both legs sequentially.
Each part was stimulated once a day for 30 minutes.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
VO2max
Time Frame: After 8 weeks of EMS
|
To evaluate the maximum oxygen consumption and exercise performance, we used a treadmill (Pulsar, h/p/cosmos, Nussdorf-Traunstein, Germany) and an automatic breathing analyzer (Vmax 29c, Sensor Medics, Yorba Linda, CA, USA).
In addition, a polar heart rate device was used to monitor the heart rate (HR).
The speed range of the treadmill was set to 7.2 km/h and increased by 1.8 km/h every 2 min until fatigue, according to Bruce's protocol.
When the breathing exchange rate (the volume ratio of carbon dioxide produced to oxygen consumed, VCO2/VO2) was higher than 1.10 and reached the maximum heart rate (maximum heart rate = 220 - age), oxygen consumption was considered to be maximum.
The three highest VO2max peak were averaged to obtain the VO2max values of the individual volunteers.
|
After 8 weeks of EMS
|
Body composition_body fat
Time Frame: up to 8 weeks
|
The multi-frequency principle was applied to measure body composition by using a bioelectrical impedance analyzer (BIA) on an InBody 570 device (In-body, Seoul, South Korea).
To perform the measurements, after the subjects' palms and soles were removed from the sensors, the subjects stood on the footing electrodes and held the sensing handles with two hands.
During the measurements, the subjects kept their arms open and left their bodies at an angle of 30° without speaking or moving.
The subjects also fasted for at least 8 h before the test.
The body fat were meansure
|
up to 8 weeks
|
Body composition_muscle mass
Time Frame: up to 8 weeks
|
The multi-frequency principle was applied to measure body composition by using a bioelectrical impedance analyzer (BIA) on an InBody 570 device (In-body, Seoul, South Korea).
To perform the measurements, after the subjects' palms and soles were removed from the sensors, the subjects stood on the footing electrodes and held the sensing handles with two hands.
During the measurements, the subjects kept their arms open and left their bodies at an angle of 30° without speaking or moving.
The subjects also fasted for at least 8 h before the test.
The muscle mass were meansure
|
up to 8 weeks
|
Grip strength
Time Frame: up to 8 weeks
|
Use the armed grip machine (T.K.K.5401, Takei Scientific Instruments Co.,Ltd, Niigata, Japan) to measure, hold each of the left and right hands three times until they are weak, and record the maximum value
|
up to 8 weeks
|
The Countermovement Jump (CMJ) Test
Time Frame: up to 8 weeks
|
The CMJ test is a practical, effective, reliable, and simple method of measuring lower limb strength, which is related to the maximum speed, strength and explosive force of the lower limbs.
For this test, participants stood on the Kistler force measurement platform (9260AA, Kistler Co., Ltd., Switzerland) on both feet and performed to inspection.
During the test, they were asked to put their hands on their hips and remain on the platform.
After that, they were asked to squat down until the knees bent 90 degrees and then to immediately jump as high as possible.
The average power (MF), were recorded during the jump.
Each participant repeated the test 3 times, and CMJ data were obtained at the designated points.
The instrument was calibrated for each individual's weight.
|
up to 8 weeks
|
Clinical Biochemistry of lactate level
Time Frame: After 8 weeks of EMS
|
For assessment of fatigue-related indices, volunteers fasted for at least 8 h before the 60% VO2max fixed intensity exercise challenge.
Blood samples were collected with an arm venous catheter at indicated time points during exercise and recovery periods, including baseline (0), 30 (E30) min during the exercise phase, and 60 (R60) min in the recovery phase.
Serum lactate (mmol/L), were assessed for monitoring physiological adaptation.
All biochemical indices were assessed using an autoanalyzer (Hitachi 7060, Tokyo, Japan).
|
After 8 weeks of EMS
|
Clinical Biochemistry of ammonia level
Time Frame: After 8 weeks of EMS
|
For assessment of fatigue-related indices, volunteers fasted for at least 8 h before the 60% VO2max fixed intensity exercise challenge.
Blood samples were collected with an arm venous catheter at indicated time points during exercise and recovery periods, including baseline (0), 30 (E30) min during the exercise phase, and 60 (R60) min in the recovery phase.
Serum ammonia (umol/L), were assessed for monitoring physiological adaptation.
All biochemical indices were assessed using an autoanalyzer (Hitachi 7060, Tokyo, Japan).
|
After 8 weeks of EMS
|
Clinical Biochemistry of glucose level
Time Frame: After 8 weeks of EMS
|
For assessment of fatigue-related indices, volunteers fasted for at least 8 h before the 60% VO2max fixed intensity exercise challenge.
Blood samples were collected with an arm venous catheter at indicated time points during exercise and recovery periods, including baseline (0), 30 (E30) min during the exercise phase, and 60 (R60) min in the recovery phase.
Serum glucose (mg/dL), were assessed for monitoring physiological adaptation.
All biochemical indices were assessed using an autoanalyzer (Hitachi 7060, Tokyo, Japan).
|
After 8 weeks of EMS
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Safety assessment - AST
Time Frame: baseline, 4 week and 8 week
|
Safety is assessed function of liver such as AST (8-38 IU/L).
|
baseline, 4 week and 8 week
|
Safety assessment - ALT
Time Frame: baseline, 4 week and 8 week
|
Safety is assessed function of liver such as ALT (4-44 IU/L).
|
baseline, 4 week and 8 week
|
Safety assessment - BUN
Time Frame: baseline, 4 week and 8 week
|
Safety is assessed function of kidney such as Bun (6-20 mg/dl)
|
baseline, 4 week and 8 week
|
Safety assessment - Creatinine
Time Frame: baseline, 4 week and 8 week
|
Safety is assessed function of kidney such as Creatinine (0.6-1.3 mg/dl)
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baseline, 4 week and 8 week
|
Safety assessment - Uric Acid
Time Frame: baseline, 4 week and 8 week
|
Safety is assessed function of kidney such as Uric Acid (3.4-7.6 mg/dl)
|
baseline, 4 week and 8 week
|
Safety assessment - total protein
Time Frame: baseline, 4 week and 8 week
|
Safety is assessed function of kidney such as total protein (6.4-8.9 g/dl)
|
baseline, 4 week and 8 week
|
Safety assessment - free fatty acid
Time Frame: baseline, 4 week and 8 week
|
Safety is assessed function of lipid metabolism such as free fatty acid (0.1-0.9 mmol/L)
|
baseline, 4 week and 8 week
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
November 15, 2021
Primary Completion (Actual)
January 14, 2022
Study Completion (Actual)
November 23, 2022
Study Registration Dates
First Submitted
September 7, 2023
First Submitted That Met QC Criteria
September 7, 2023
First Posted (Actual)
September 14, 2023
Study Record Updates
Last Update Posted (Actual)
September 14, 2023
Last Update Submitted That Met QC Criteria
September 7, 2023
Last Verified
September 1, 2023
More Information
Terms related to this study
Other Study ID Numbers
- 21-034-A2
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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