The Impact of Training With Whole Body-EMS

NCT ID: NCT04288154

Last Updated: 2023-08-28

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

78 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-11-30

Study Completion Date

2022-08-08

Brief Summary

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

Detailed Description

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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

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Healthy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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EMS Group - Experimental

EMS device will be turned on during exercise for this group.

Group Type EXPERIMENTAL

EMS Device On

Intervention Type DEVICE

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

EMS Group - Control

EMS device will be turned off during exercise for this group.

Group Type PLACEBO_COMPARATOR

EMS Device Off

Intervention Type OTHER

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

Interventions

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EMS Device On

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

Intervention Type DEVICE

EMS Device Off

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

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Mayo Clinic

OTHER

Sponsor Role lead

Responsible Party

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Amir Lerman

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Amir Lerman, MD

Role: PRINCIPAL_INVESTIGATOR

Mayo Clinic

Locations

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Mayo Clinic

Rochester, Minnesota, United States

Site Status

Countries

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United States

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Related Links

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Other Identifiers

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19-003449

Identifier Type: -

Identifier Source: org_study_id

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