The Impact of Training With Whole Body-EMS

Sponsor
Mayo Clinic (Other)
Overall Status
Active, not recruiting
CT.gov ID
NCT04288154
Collaborator
(none)
78
1
2
20.6
3.8

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
  • Device: EMS Device On
  • Other: EMS Device Off
N/A

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

Study Type:
Interventional
Actual Enrollment :
78 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Primary Purpose:
Other
Official Title:
The Impact of Training With Whole Body-EMS
Actual Study Start Date :
Nov 30, 2020
Anticipated Primary Completion Date :
Aug 19, 2022
Anticipated Study Completion Date :
Aug 19, 2022

Arms and Interventions

Arm Intervention/Treatment
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.

Outcome Measures

Primary Outcome Measures

  1. Impact of EMS on EndoPAT [16 weeks]

    To assess the impact of training with whole body-EMS for a 16-week period of time, involving 1.0 x 20 minute training sessions per week, on peripheral endothelial function as measured using EndoPAT.

Secondary Outcome Measures

  1. Impact of EMS on BMI [16 weeks]

    To assess the impact of training with whole body-EMS for a 16-week period of time, involving 1.0 x 20 minute training sessions per week, on:i) Body mass index, waist circumference, percentage body fat and distribution, and blood pressure

  2. Impact of EMS on Serum Lipid Profile [16 weeks]

    To assess the impact of training with whole body-EMS for a 16-week period of time, involving 1.0 x 20 minute training sessions per week to Serum lipid profile

  3. Impact of EMS on VO2 [16 weeks]

    To assess the impact of training with whole body-EMS for a 16-week period of time, involving 1.0 x 20 minute training sessions per week, on:iii) VO2 maximum (Cardiopulmonary exercise testing parameters

  4. Impact of EMS on Maximum Strength & Power in Chest Press and Leg Press [16 weeks]

    To assess the impact of training with whole body-EMS for a 16-week period of time, involving 1.0 x 20 minute training sessions per week, on:iv) Maximum strength and maximum power in chest press and leg press

  5. Impact of EMS on Angina [16 weeks]

    To assess the impact of training with whole body-EMS for a 16-week period of time, involving 1.0 x 20 minute training sessions per week, on:v) Symptoms of angina as measured by the Rose Questionnaire

  6. Impact of EMS to Longitudinal Amsterdam Aging Study Questionnaire [16 weeks]

    To assess the impact of training with whole body-EMS for a 16-week period of time, involving 1.0 x 20 minute training sessions per week, on:vi) Quality of life as measured by the Longitudinal Amsterdam Aging Study Questionnaire, with values of 0-10 (0 being as bad as it can be and 10 being as good as it can be)

  7. Impact of EMS on Creatinine [16 weeks]

    To assess the impact of training with whole body-EMS for a 16-week period of time, involving 1.0 x 20 minute training sessions per week, on:vii) Temporal changes in blood levels of creatinine kinase

  8. Impact of EMS to Perceived Stress Scale [16 weeks]

    To assess the impact of training with whole body-EMS for a 16-week period of time, involving 1.0 x 20 minute training sessions per week, on symptoms of stress as measured on the Perceived Stress Scale with values of 0 to 4, with 0 being never stressed and 4 being very often stressed.

  9. Impact of EMS to Patient Health Questionnaire [16 weeks]

    To assess the impact of training with whole body-EMS for a 16-week period of time, involving 1.0 x 20 minute training sessions per week on Quality of life as measured by the Patient Health Questionnaire with a score of 0-27; 0 being no depression and 27 being severe depression.

  10. Impact of EMS on Blood Glucose [16 weeks]

    To assess the impact of training with whole body-EMS for a 16-week period of time, involving 1.0 x 20 minute training sessions per week on Blood Glucose

  11. Impact of EMS on HbA1c [16 weeks]

    To assess the impact of training with whole body-EMS for a 16-week period of time, involving 1.0 x 20 minute training sessions per week on HbA1c

  12. Impact of EMS on High-Sensitivity CRP [16 weeks]

    To assess the impact of training with whole body-EMS for a 16-week period of time, involving 1.0 x 20 minute training sessions per week on high-sensitivity CRP

  13. Impact of EMS on Uric Acid [16 weeks]

    To assess the impact of training with whole body-EMS for a 16-week period of time, involving 1.0 x 20 minute training sessions per week on uric acid.

  14. Impact of EMS on Fibrinogen [16 weeks]

    To assess the impact of training with whole body-EMS for a 16-week period of time, involving 1.0 x 20 minute training sessions per week on fibrinogen

  15. Impact of EMS on Homocysteine [16 weeks]

    To assess the impact of training with whole body-EMS for a 16-week period of time, involving 1.0 x 20 minute training sessions per week on homocysteine.

  16. Impact of EMS on Lipoprotein [16 weeks]

    To assess the impact of training with whole body-EMS for a 16-week period of time, involving 1.0 x 20 minute training sessions per week on lipoprotein.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Mayo Clinic Rochester Minnesota United States 55905

Sponsors and Collaborators

  • Mayo Clinic

Investigators

  • Principal Investigator: Amir Lerman, MD, Mayo Clinic

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Publications

None provided.
Responsible Party:
Amir Lerman, Principal Investigator, Mayo Clinic
ClinicalTrials.gov Identifier:
NCT04288154
Other Study ID Numbers:
  • 19-003449
First Posted:
Feb 28, 2020
Last Update Posted:
Jun 24, 2022
Last Verified:
Jun 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
Yes

Study Results

No Results Posted as of Jun 24, 2022