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The Impact of Training With Whole Body-EMS

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Mayo Clinic

Status

Completed

Conditions

Healthy

Treatments

Device: EMS Device On
Other: EMS Device Off

Study type

Interventional

Funder types

Other

Identifiers

NCT04288154
19-003449

Details and patient eligibility

About

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

Full 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.

Enrollment

78 patients

Sex

All

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

Primary purpose

Other

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

78 participants in 2 patient groups, including a placebo group

EMS Group - Experimental
Experimental group
Description:
EMS device will be turned on during exercise for this group.
Treatment:
Device: EMS Device On
EMS Group - Control
Placebo Comparator group
Description:
EMS device will be turned off during exercise for this group.
Treatment:
Other: EMS Device Off

Trial documents
1

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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