Clinical trial NCT04288154: The Impact of Training With Whole Body-EMS
Official title: The Impact of Training With Whole Body-EMS
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2020-02-28
Enrollment: 78
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.

Eligibility criteria: 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

Primary outcomes:
measure: Mean Change in Reactive Hyperemia Index (RHI)
timeFrame: baseline, 16 weeks
Secondary outcomes:
measure: Change in BMI
timeFrame: baseline,16 weeks
measure: Change in Total Cholesterol
timeFrame: baseline, 16 weeks
measure: Change in Maximal Oxygen Consumption (VO2max)
timeFrame: baseline, 16 weeks
measure: Mean Change in Quality-of-Life Score as Measured by the Longitudinal Amsterdam Aging Study (LASA) Questionnaire:
timeFrame: baseline, week 16
measure: Change in Creatinine Kinase (CK)
timeFrame: baseline, 16 weeks
measure: Mean Change in Stress Score as Measured by the Perceived Stress Scale
timeFrame: baseline, week 16
measure: Mean Change in Depression Score as Measured by the Patient Health Questionnaire (PHQ-9)
timeFrame: baseline, 16 weeks
measure: Change in Blood Glucose
timeFrame: baseline, 16 weeks
measure: Change in HbA1c
timeFrame: baseline, 16 weeks
measure: Change in High Sensitivity C- Reactive Protein (CRP)
timeFrame: baseline, 16 weeks
measure: Change in Uric Acid:
timeFrame: baseline, 16 weeks
measure: Change in Fibrinogen
timeFrame: Baseline, 16 weeks
measure: Change in Homocysteine
timeFrame: baseline, 16 weeks
measure: Change in Lipoprotein
timeFrame: baseline, 16 weeks
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
Study officials:
affiliation: Mayo Clinic
name: Amir Lerman, MD
role: PRINCIPAL_INVESTIGATOR
References: