HealthyNCT04288154
The Impact of Training With Whole Body-EMS
A study testing EMS Device On and EMS Device Off in people with Healthy, run by Mayo Clinic at 1 site in United States.
Trial summary
Researchers are trying to find out what impact training with whole body-EMS (Electronic muscle stimulation) has on various health outcomes. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- EMS Device On and EMS Device Off
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 78 participants
- Where
- 1 siteUnited States
- Study dates
- 30 Nov 2020to 8 Aug 2022
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy individuals
- Employees at the Mayo Clinic, Rochester, MN
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Researchers are trying to find out what impact training with whole body-EMS (Electronic muscle stimulation) has on various health outcomes.
Read the 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.
- Conditions
- Healthy
- Being tested
- EMS Device On, EMS Device Off
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EMS Device OnDevice
The EMS Device will turned on during exercise as opposed to it being turned off for control group.
EMS Device OffOther
The EMS Device will turned off during exercise as opposed to it being turned off for control group.
| Study group | Role | What they receive |
|---|---|---|
| EMS Group - Experimental | Experimental | EMS device will be turned on during exercise for this group. Receives: Device: EMS Device On |
| EMS Group - Control | Placebo comparator | EMS device will be turned off during exercise for this group. Receives: Other: EMS Device Off |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: baseline, 16 weeks
Secondary outcomes (14)
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)
Measured: baseline,16 weeks
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
Measured: baseline, 16 weeks
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)
Measured: baseline, 16 weeks
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.
Measured: baseline, week 16
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.
Measured: baseline, 16 weeks
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.
Measured: baseline, week 16
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
Measured: baseline, 16 weeks
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
Measured: baseline, 16 weeks
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
Measured: baseline, 16 weeks
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
Measured: baseline, 16 weeks
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
Measured: baseline, 16 weeks
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
Measured: Baseline, 16 weeks
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)
Measured: baseline, 16 weeks
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
Measured: baseline, 16 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Feb 2020
- Study start30 Nov 2020
- Primary completion8 Aug 2022
- Study completion8 Aug 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for HealthyStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 78 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Amir Lerman, Mayo Clinic
- Investigators
- Amir Lerman, MD, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04288154
- Sponsor's protocol ID
- 19-003449
- Status last verified
- Aug 2023
- First submitted
- 24 Jan 2020
- Last updated
- 28 Aug 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Training With Whole Body-EMS
- ClinicalTrials.gov ID
- NCT04288154
- Acronym / sponsor ID
- 19-003449
- Conditions
- Healthy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 78 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- 30 Nov 2020 (actual)
- Primary completion
- 8 Aug 2022 (actual)
- Study completion
- 8 Aug 2022 (actual)
- First posted
- 28 Feb 2020 (actual)
- Results
- Posted 27 Jul 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| EMS Group - Experimental | Experimental | Device: EMS Device OnEMS device will be turned on during exercise for this group. |
| EMS Group - Control | Placebo comparator | Other: EMS Device OffEMS device will be turned off during exercise for this group. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Healthy individuals
- Employees at the Mayo Clinic, Rochester, MN
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EMS Device OnThe EMS Device will turned on during exercise as opposed to it being turned off for control group. | Device | EMS Group - Experimental |
| EMS Device OffThe EMS Device will turned off during exercise as opposed to it being turned off for control group. | Other | EMS Group - Control |
Primary outcome
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.
14 secondary outcomes
Change in BMI
Time frame: baseline,16 weeks
Change in Total Cholesterol
Time frame: baseline, 16 weeks
Change in Maximal Oxygen Consumption (VO2max)
Time frame: 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
Change in Creatinine Kinase (CK)
Time frame: baseline, 16 weeks
Mean Change in Stress Score as Measured by the Perceived Stress Scale
Time frame: baseline, week 16
Mean Change in Depression Score as Measured by the Patient Health Questionnaire (PHQ-9)
Time frame: baseline, 16 weeks
Change in Blood Glucose
Time frame: baseline, 16 weeks
Change in HbA1c
Time frame: baseline, 16 weeks
Change in High Sensitivity C- Reactive Protein (CRP)
Time frame: baseline, 16 weeks
Change in Uric Acid:
Time frame: baseline, 16 weeks
Change in Fibrinogen
Time frame: Baseline, 16 weeks
Change in Homocysteine
Time frame: baseline, 16 weeks
Change in Lipoprotein
Time frame: baseline, 16 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Aug 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Mayo Clinic Clinical TrialsLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Amir Lerman, MD principal investigator
Mayo Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing EMS Device On and EMS Device Off in people with Healthy, run by Mayo Clinic at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 27 Jul 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean Change in Reactive Hyperemia Index (RHI) (time frame: baseline, 16 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Aug 2023.