The Impact of Training With Whole Body-EMS

August 14, 2023 updated by: Amir Lerman, Mayo Clinic
Researchers are trying to find out what impact training with whole body-EMS (Electronic muscle stimulation) has on various health outcomes.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
78

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

  • United States
    • Minnesota
      • Rochester, Minnesota, United States, 55905
        • Mayo Clinic

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

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

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: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: EMS Group - Experimental
EMS device will be turned on during exercise for this group.
Device: EMS Device On
The EMS Device will turned on during exercise as opposed to it being turned off for control group.
Placebo Comparator: EMS Group - Control
EMS device will be turned off during exercise for this group.
Other: EMS Device Off
The EMS Device will turned off during exercise as opposed to it being turned off for control group.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Mean Change in Reactive Hyperemia Index (RHI)
Time Frame: baseline, 16 weeks
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.
baseline, 16 weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change in BMI
Time Frame: baseline,16 weeks
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)
baseline,16 weeks
Change in Total Cholesterol
Time Frame: baseline, 16 weeks
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
baseline, 16 weeks
Change in Maximal Oxygen Consumption (VO2max)
Time Frame: baseline, 16 weeks
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)
baseline, 16 weeks
Mean Change in Quality-of-Life Score as Measured by the Longitudinal Amsterdam Aging Study (LASA) Questionnaire:
Time Frame: baseline, week 16
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.
baseline, week 16
Change in Creatinine Kinase (CK)
Time Frame: baseline, 16 weeks
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.
baseline, 16 weeks
Mean Change in Stress Score as Measured by the Perceived Stress Scale
Time Frame: baseline, week 16
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.
baseline, week 16
Mean Change in Depression Score as Measured by the Patient Health Questionnaire (PHQ-9)
Time Frame: baseline, 16 weeks
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
baseline, 16 weeks
Change in Blood Glucose
Time Frame: baseline, 16 weeks
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
baseline, 16 weeks
Change in HbA1c
Time Frame: baseline, 16 weeks
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
baseline, 16 weeks
Change in High Sensitivity C- Reactive Protein (CRP)
Time Frame: baseline, 16 weeks
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
baseline, 16 weeks
Change in Uric Acid:
Time Frame: baseline, 16 weeks
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
baseline, 16 weeks
Change in Fibrinogen
Time Frame: Baseline, 16 weeks
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
Baseline, 16 weeks
Change in Homocysteine
Time Frame: baseline, 16 weeks
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)
baseline, 16 weeks
Change in Lipoprotein
Time Frame: baseline, 16 weeks
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
baseline, 16 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Mayo Clinic

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Amir Lerman, MD, Mayo Clinic

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 30, 2020

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 8, 2022

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 8, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 24, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 25, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 28, 2020

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 28, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 14, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2023

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 19-003449

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

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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