NCT04288154

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
78

participants targeted

Target at P75+ for not_applicable healthy

Timeline
Completed

Started Nov 2020

Typical duration for not_applicable healthy

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 24, 2020

Completed
1 month until next milestone

First Posted

Study publicly available on registry

February 28, 2020

Completed
9 months until next milestone

Study Start

First participant enrolled

November 30, 2020

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 8, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 8, 2022

Completed
12 months until next milestone

Results Posted

Study results publicly available

July 27, 2023

Completed
Last Updated

August 28, 2023

Status Verified

August 1, 2023

Enrollment Period

1.7 years

First QC Date

January 24, 2020

Results QC Date

July 3, 2023

Last Update Submit

August 14, 2023

Conditions

Healthy

Outcome Measures

Primary Outcomes (1)

  • 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.

    baseline, 16 weeks

Secondary Outcomes (14)

  • Change in BMI

    baseline,16 weeks

  • Change in Total Cholesterol

    baseline, 16 weeks

  • Change in Maximal Oxygen Consumption (VO2max)

    baseline, 16 weeks

  • Mean Change in Quality-of-Life Score as Measured by the Longitudinal Amsterdam Aging Study (LASA) Questionnaire:

    baseline, week 16

  • Change in Creatinine Kinase (CK)

    baseline, 16 weeks

  • +9 more secondary outcomes

Study Arms (2)

EMS Group - Experimental

EXPERIMENTAL

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

Device: EMS Device On

EMS Group - Control

PLACEBO COMPARATOR

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

Other: EMS Device Off

Interventions

EMS Device OnDEVICE

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

EMS Group - Experimental
EMS Device OffOTHER

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

EMS Group - Control

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Healthy individuals
  • Employees at the Mayo Clinic, Rochester, MN

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

Related Links

Results Point of Contact

Title
Amir Lerman, M.D.
Organization
Mayo Clinic
lerman.amir@mayo.edu
507-255-2398

Study Officials

  • Amir Lerman, MD

    Mayo Clinic

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

January 24, 2020

First Posted

February 28, 2020

Study Start

November 30, 2020

Primary Completion

August 8, 2022

Study Completion

August 8, 2022

Last Updated

August 28, 2023

Results First Posted

July 27, 2023

Record last verified: 2023-08

Data Sharing

IPD Sharing
Will not share

Locations

US(1)