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The Impact of Training With Whole Body-EMS

The Impact of Training With Whole Body-EMS

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04288154
Enrollment
78
Registered
2020-02-28
Start date
2020-11-30
Completion date
2022-08-08
Last updated
2023-08-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy

Brief summary

Researchers are trying to find out what impact training with whole body-EMS (Electronic muscle stimulation) has on various health outcomes.

Detailed description

All subjects in both groups who enroll into this study will undergo an assessment of peripheral endothelial function with reactive hyperemia-peripheral arterial tonometry (RH-PAT) testing using EndoPAT; an assessment of vital signs including heart rate, blood pressure, weight, height and body mass index; laboratory blood work; cardiorespiratory testing using treadmill testing to determine VO2 max and maximal tolerated heart rate; maximal strength and maximal power testing on chest press and leg press testing; and percent body fat and fat distribution testing at baseline, and at 16-weeks follow-up (immediately after completing a 16-week training program using whole body-EMS). Baseline cardiovascular risk factors will be assessed by subject questionnaire and verified by chart review. In addition, subjects will complete an angina/chest pain symptom questionnaire (Rose Questionnaire), quality of life questionnaire (LASA Questionnaire), depression questionnaire (Patient Health Questionaire-9) and perceived stress questionnaire (Perceived Stress Scale) to assess for psychosocial wellness at each point in the study.

Interventions

DEVICEEMS Device On

The EMS Device will turned on during exercise as opposed to it being turned off for control group.

OTHEREMS Device Off

The EMS Device will turned off during exercise as opposed to it being turned off for control group.

Sponsors

Mayo Clinic
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

Inclusion criteria

* Healthy individuals * Employees at the Mayo Clinic, Rochester, MN

Exclusion criteria

* Subjects under the age of 18 * Pregnant women * Subjects with a history of liver or kidney disease, acute illness, taking medications (such as glucocorticoids) * Subjects who have conditions (such as chronic inflammatory muscular diseases or Cushing's syndrome) that affect muscle mass * Individuals with pacemakers and implantable cardiac defibrillators * Individuals who conduct any other type of resistance training (\> 45 minutes/week) * Individuals who have regular high alcohol consumption (\> 80g/day on 5 days a week) * Subjects unable to consent to or participate in the 16-week EMS intervention or be available for follow up

Design outcomes

Primary

MeasureTime frameDescription
Mean Change in Reactive Hyperemia Index (RHI)baseline, 16 weeksMean change in RHI. RHI measured by noninvasive endothelial peripheral arterial tomography (EndoPat) test. The EndoPAT involves probes on the index fingers of both hands & evaluating the blood flow to one hand before & after inflating a blood pressure (BP) cuff on one arm, temporarily reducing blood flow to the fingers. The finger sensor on the affected arm will show no blood flow, the sensor on the opposite index finger will display normal blood flow level. After several minutes, the BP cuff is released, allowing blood to flow back into the affected lower arm. If the finger sensor on the affected arm shows a rush of blood, the blood vessels are functioning normally. If the blood flow return is sluggish, the blood vessels are unhealthy. EndoPAT results are reported as the Endoscore (range 0-3); a score of 1.67 and lower indicates the need for immediate medical attention; a score between 1.68 and 2 indicates a need to reduce risk factors; a score above 2.1 indicates a healthy heart.

Secondary

MeasureTime frameDescription
Change in Total Cholesterolbaseline, 16 weeksTotal cholesterol is the sum of a person's HDL cholesterol, LDL cholesterol, and 20% of their triglyceride levels. Healthy total cholesterol is less than 200 mg/dL of blood
Change in Maximal Oxygen Consumption (VO2max)baseline, 16 weeksVO2 max, or maximal oxygen consumption, refers to the maximum amount of oxygen that an individual can utilize during intense or maximal exercise. VO2 max is the number of milliliters of oxygen used per kilogram of body weight in one minute (ml/kg/min)
Mean Change in Quality-of-Life Score as Measured by the Longitudinal Amsterdam Aging Study (LASA) Questionnaire:baseline, week 16The LASA is subject reported ten item quality of life questionnaire. The ten items are scored from 0 -10, 0 being as bad as it can be and 10 being as good as it can be. Total scores range from 0 - 100, lower scores indicate being as bad as it can be, higher scores indicate being as good as it can be.
Change in Creatinine Kinase (CK)baseline, 16 weeksA creatine kinase test may be used to detect inflammation of muscles or muscle damage due to muscle disorders. A person may have muscle injury with few or nonspecific symptoms, such as weakness, fever, and nausea, that may also be seen with a variety of other conditions. A healthcare practitioner may use a CK test to help detect muscle damage in these cases, especially if someone is taking a drug such as a statin. Normal values at rest are usually between 60 and 174 U/L.
Mean Change in Stress Score as Measured by the Perceived Stress Scalebaseline, week 16The Perceived Stress Scale is a subject reported 10 item stress questionnaire. The 10 items are scored from 0 to 4, with 0 = never, 1 = almost never, 2 = sometimes, 3 = fairly often and 4 = very often. Total scores range from 0 - 40, lower scores indicate lower stress, and higher scores indicate higher stress.
Mean Change in Depression Score as Measured by the Patient Health Questionnaire (PHQ-9)baseline, 16 weeksThe PHQ-9 Screens for the presence and severity of depression with 9 questions in a scale of 0-3. Zero=not at all, 1=several days, 2=more than half the days, 3=nearly every day. Total scores range 0 - 27. A total score of 0-4=minimal depression, 5-9=mild depression, 10-14=moderate depression, 15-19=moderately severe depression, 20-27=severe depression
Change in BMIbaseline,16 weeksSubject's BMI calculated as weight in kilograms divided by height in meters squared. Uses measurements of height and weight obtained during study (with appropriate metric conversions)
Change in HbA1cbaseline, 16 weeksHemoglobin is a protein within red blood cells. As glucose enters the bloodstream, it binds to hemoglobin, or glycates. The more glucose that enters the bloodstream, the higher the amount of glycated hemoglobin. An A1C level below 5.7 percent is considered normal. Reported as percentage of glycated hemoglobin
Change in High Sensitivity C- Reactive Protein (CRP)baseline, 16 weeksHigh sensitivity C-reactive protein is a substance produced by the liver in response to inflammation. Normal CRP levels are below 3.0 mg/L
Change in Uric Acid:baseline, 16 weeksUric acid is a heterocyclic compound of carbon, nitrogen, oxygen, and hydrogen. Uric acid is a product of the metabolic breakdown of purine nucleotides. Normal blood values are 1.5 to 6.0 milligrams/deciliter (mg/dL) for women and 2.5 to 7.0 mg/dL for men
Change in FibrinogenBaseline, 16 weeksFibrinogen is a protein produced by the liver. This protein helps stop bleeding by helping blood clots to form. Blood fibrinogen is the amount of fibrinogen in a blood sample. Normal range is 200 to 400 mg/dL
Change in Homocysteinebaseline, 16 weeksHomocysteine is an amino acid which occurs in the body as an intermediate in the metabolism of methionine and cysteine. Normal range 4 and 15 micromoles/liter (µmol/L)
Change in Lipoproteinbaseline, 16 weeksLipoprotein is a type of protein that combine with and transport fat or other lipids in the blood plasma. Normal range is less than 30 mg/dL
Change in Blood Glucosebaseline, 16 weeksSugar in the form of glucose in the blood. The concentration of glucose in the blood. A healthy normal range is 70 to 99 mg/dL

Countries

United States

Participant flow

Participants by arm

ArmCount
EMS Group - Experimental
EMS device was turned on during exercise for this group. EMS Device On: The EMS Device was turned on during exercise as opposed to it being turned off for control group.
46
EMS Group - Control
EMS device was turned off during exercise for this group. EMS Device Off: The EMS Device was turned off during exercise as opposed to it being turned off for control group.
32
Total78

Withdrawals & dropouts

PeriodReasonFG000FG001
Overall StudyWithdrawal by Subject99

Baseline characteristics

CharacteristicEMS Group - ControlTotalEMS Group - Experimental
Age, Continuous35.6 years
STANDARD_DEVIATION 9.7
35.65 years
STANDARD_DEVIATION 1
35.7 years
STANDARD_DEVIATION 10.8
Race and Ethnicity Not Collected0 Participants
Region of Enrollment
United States
32 participants78 participants46 participants
Sex: Female, Male
Female
19 Participants47 Participants28 Participants
Sex: Female, Male
Male
13 Participants31 Participants18 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
0 / 460 / 32
other
Total, other adverse events
0 / 460 / 32
serious
Total, serious adverse events
0 / 460 / 32

Outcome results

Primary

Mean Change in Reactive Hyperemia Index (RHI)

Mean change in RHI. RHI measured by noninvasive endothelial peripheral arterial tomography (EndoPat) test. The EndoPAT involves probes on the index fingers of both hands & evaluating the blood flow to one hand before & after inflating a blood pressure (BP) cuff on one arm, temporarily reducing blood flow to the fingers. The finger sensor on the affected arm will show no blood flow, the sensor on the opposite index finger will display normal blood flow level. After several minutes, the BP cuff is released, allowing blood to flow back into the affected lower arm. If the finger sensor on the affected arm shows a rush of blood, the blood vessels are functioning normally. If the blood flow return is sluggish, the blood vessels are unhealthy. EndoPAT results are reported as the Endoscore (range 0-3); a score of 1.67 and lower indicates the need for immediate medical attention; a score between 1.68 and 2 indicates a need to reduce risk factors; a score above 2.1 indicates a healthy heart.

Time frame: baseline, 16 weeks

Population: Data was not collected or analyzed for 9 subjects in each arm

ArmMeasureValue (MEAN)Dispersion
EMS Group - ExperimentalMean Change in Reactive Hyperemia Index (RHI)0.02 score on a scaleStandard Deviation 0.1
EMS Group - ControlMean Change in Reactive Hyperemia Index (RHI)-0.26 score on a scaleStandard Deviation 0.3
Secondary

Change in Blood Glucose

Sugar in the form of glucose in the blood. The concentration of glucose in the blood. A healthy normal range is 70 to 99 mg/dL

Time frame: baseline, 16 weeks

Population: Data was not collected or analyzed for 9 subjects in each arm

ArmMeasureValue (MEAN)Dispersion
EMS Group - ExperimentalChange in Blood Glucose0.7 mg/dLStandard Deviation 10.3
EMS Group - ControlChange in Blood Glucose-0.8 mg/dLStandard Deviation 8.8
Secondary

Change in BMI

Subject's BMI calculated as weight in kilograms divided by height in meters squared. Uses measurements of height and weight obtained during study (with appropriate metric conversions)

Time frame: baseline,16 weeks

Population: Data was not collected or analyzed for 9 subjects in each arm

ArmMeasureValue (MEAN)Dispersion
EMS Group - ExperimentalChange in BMI0.2 kg/m^2Standard Deviation 0.9
EMS Group - ControlChange in BMI0.06 kg/m^2Standard Deviation 0.5
Secondary

Change in Creatinine Kinase (CK)

A creatine kinase test may be used to detect inflammation of muscles or muscle damage due to muscle disorders. A person may have muscle injury with few or nonspecific symptoms, such as weakness, fever, and nausea, that may also be seen with a variety of other conditions. A healthcare practitioner may use a CK test to help detect muscle damage in these cases, especially if someone is taking a drug such as a statin. Normal values at rest are usually between 60 and 174 U/L.

Time frame: baseline, 16 weeks

Population: Data was not collected or analyzed for 9 subjects in each arm

ArmMeasureValue (MEAN)Dispersion
EMS Group - ExperimentalChange in Creatinine Kinase (CK)417.9 U/LStandard Deviation 1499
EMS Group - ControlChange in Creatinine Kinase (CK)-137.2 U/LStandard Deviation 375.9
Secondary

Change in Fibrinogen

Fibrinogen is a protein produced by the liver. This protein helps stop bleeding by helping blood clots to form. Blood fibrinogen is the amount of fibrinogen in a blood sample. Normal range is 200 to 400 mg/dL

Time frame: Baseline, 16 weeks

Population: Data was not collected or analyzed for 9 subjects in each arm

ArmMeasureValue (MEAN)Dispersion
EMS Group - ExperimentalChange in Fibrinogen5.4 mg/dLStandard Deviation 27.3
EMS Group - ControlChange in Fibrinogen9.0 mg/dLStandard Deviation 34.8
Secondary

Change in HbA1c

Hemoglobin is a protein within red blood cells. As glucose enters the bloodstream, it binds to hemoglobin, or glycates. The more glucose that enters the bloodstream, the higher the amount of glycated hemoglobin. An A1C level below 5.7 percent is considered normal. Reported as percentage of glycated hemoglobin

Time frame: baseline, 16 weeks

ArmMeasureValue (MEAN)Dispersion
EMS Group - ExperimentalChange in HbA1c-0.01 percentage of glycated hemoglobinStandard Deviation 0.2
EMS Group - ControlChange in HbA1c0 percentage of glycated hemoglobinStandard Deviation 0.2
Secondary

Change in High Sensitivity C- Reactive Protein (CRP)

High sensitivity C-reactive protein is a substance produced by the liver in response to inflammation. Normal CRP levels are below 3.0 mg/L

Time frame: baseline, 16 weeks

Population: Data was not collected or analyzed for 9 subjects in each arm

ArmMeasureValue (MEAN)Dispersion
EMS Group - ExperimentalChange in High Sensitivity C- Reactive Protein (CRP)0.06 mg/LStandard Deviation 0.7
EMS Group - ControlChange in High Sensitivity C- Reactive Protein (CRP)0.3 mg/LStandard Deviation 2.3
Secondary

Change in Homocysteine

Homocysteine is an amino acid which occurs in the body as an intermediate in the metabolism of methionine and cysteine. Normal range 4 and 15 micromoles/liter (µmol/L)

Time frame: baseline, 16 weeks

Population: Data was not collected or analyzed for 9 subjects in each arm

ArmMeasureValue (MEAN)Dispersion
EMS Group - ExperimentalChange in Homocysteine-6.7 µmol/LStandard Deviation 32.8
EMS Group - ControlChange in Homocysteine-0.7 µmol/LStandard Deviation 32.8
Secondary

Change in Lipoprotein

Lipoprotein is a type of protein that combine with and transport fat or other lipids in the blood plasma. Normal range is less than 30 mg/dL

Time frame: baseline, 16 weeks

Population: Data was not collected or analyzed for 9 subjects in each arm

ArmMeasureValue (MEAN)Dispersion
EMS Group - ExperimentalChange in Lipoprotein5.6 30 mg/dLStandard Deviation 20.9
EMS Group - ControlChange in Lipoprotein15.4 30 mg/dLStandard Deviation 38
Secondary

Change in Maximal Oxygen Consumption (VO2max)

VO2 max, or maximal oxygen consumption, refers to the maximum amount of oxygen that an individual can utilize during intense or maximal exercise. VO2 max is the number of milliliters of oxygen used per kilogram of body weight in one minute (ml/kg/min)

Time frame: baseline, 16 weeks

Population: Data was not collected or analyzed for 9 subjects in each arm

ArmMeasureValue (MEAN)Dispersion
EMS Group - ExperimentalChange in Maximal Oxygen Consumption (VO2max)0.3 ml/kg/minStandard Deviation 3.4
EMS Group - ControlChange in Maximal Oxygen Consumption (VO2max)1.1 ml/kg/minStandard Deviation 3.9
Secondary

Change in Total Cholesterol

Total cholesterol is the sum of a person's HDL cholesterol, LDL cholesterol, and 20% of their triglyceride levels. Healthy total cholesterol is less than 200 mg/dL of blood

Time frame: baseline, 16 weeks

Population: Data was not collected or analyzed for 9 subjects in each arm

ArmMeasureValue (MEAN)Dispersion
EMS Group - ExperimentalChange in Total Cholesterol-1.7 mg/dLStandard Deviation 25.1
EMS Group - ControlChange in Total Cholesterol19.2 mg/dLStandard Deviation 26.5
Secondary

Change in Uric Acid:

Uric acid is a heterocyclic compound of carbon, nitrogen, oxygen, and hydrogen. Uric acid is a product of the metabolic breakdown of purine nucleotides. Normal blood values are 1.5 to 6.0 milligrams/deciliter (mg/dL) for women and 2.5 to 7.0 mg/dL for men

Time frame: baseline, 16 weeks

Population: Data was not collected or analyzed for 9 subjects in each arm

ArmMeasureValue (MEAN)Dispersion
EMS Group - ExperimentalChange in Uric Acid:0.1 mg/dLStandard Deviation 0.6
EMS Group - ControlChange in Uric Acid:0.2 mg/dLStandard Deviation 0.6
Secondary

Mean Change in Depression Score as Measured by the Patient Health Questionnaire (PHQ-9)

The PHQ-9 Screens for the presence and severity of depression with 9 questions in a scale of 0-3. Zero=not at all, 1=several days, 2=more than half the days, 3=nearly every day. Total scores range 0 - 27. A total score of 0-4=minimal depression, 5-9=mild depression, 10-14=moderate depression, 15-19=moderately severe depression, 20-27=severe depression

Time frame: baseline, 16 weeks

Population: Data was not collected or analyzed for 9 subjects in each arm

ArmMeasureValue (MEAN)Dispersion
EMS Group - ExperimentalMean Change in Depression Score as Measured by the Patient Health Questionnaire (PHQ-9)-0.3 score on a scaleStandard Deviation 3.2
EMS Group - ControlMean Change in Depression Score as Measured by the Patient Health Questionnaire (PHQ-9)0.05 score on a scaleStandard Deviation 1.2
Secondary

Mean Change in Quality-of-Life Score as Measured by the Longitudinal Amsterdam Aging Study (LASA) Questionnaire:

The LASA is subject reported ten item quality of life questionnaire. The ten items are scored from 0 -10, 0 being as bad as it can be and 10 being as good as it can be. Total scores range from 0 - 100, lower scores indicate being as bad as it can be, higher scores indicate being as good as it can be.

Time frame: baseline, week 16

Population: Data was not collected or analyzed for 9 subjects in each arm

ArmMeasureValue (MEAN)Dispersion
EMS Group - ExperimentalMean Change in Quality-of-Life Score as Measured by the Longitudinal Amsterdam Aging Study (LASA) Questionnaire:0.04 score on a scaleStandard Deviation 0.9
EMS Group - ControlMean Change in Quality-of-Life Score as Measured by the Longitudinal Amsterdam Aging Study (LASA) Questionnaire:0.3 score on a scaleStandard Deviation 0.5
Secondary

Mean Change in Stress Score as Measured by the Perceived Stress Scale

The Perceived Stress Scale is a subject reported 10 item stress questionnaire. The 10 items are scored from 0 to 4, with 0 = never, 1 = almost never, 2 = sometimes, 3 = fairly often and 4 = very often. Total scores range from 0 - 40, lower scores indicate lower stress, and higher scores indicate higher stress.

Time frame: baseline, week 16

Population: Data was not collected or analyzed for 9 subjects in each arm

ArmMeasureValue (MEAN)Dispersion
EMS Group - ExperimentalMean Change in Stress Score as Measured by the Perceived Stress Scale-1.0 score on a scaleStandard Deviation 5.5
EMS Group - ControlMean Change in Stress Score as Measured by the Perceived Stress Scale-0.4 score on a scaleStandard Deviation 4.8

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026