Trial Outcomes & Findings for The Impact of Training With Whole Body-EMS (NCT NCT04288154)
NCT ID: NCT04288154
Last Updated: 2023-08-28
Results Overview
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.
COMPLETED
NA
78 participants
baseline, 16 weeks
2023-08-28
Participant Flow
Participant milestones
| Measure |
Electro Muscle Stimulation (EMS) Group Experimental
EMS device was turned on during exercise for this group.
EMS Device On: The EMS Device was turned on during exercise as opposed to it being turned off for control group.
|
EMS Group - Control
EMS device was turned off during exercise for this group.
EMS Device Off: The EMS Device was turned off during exercise as opposed to it being turned off for control group.
|
|---|---|---|
|
Overall Study
STARTED
|
46
|
32
|
|
Overall Study
COMPLETED
|
37
|
23
|
|
Overall Study
NOT COMPLETED
|
9
|
9
|
Reasons for withdrawal
| Measure |
Electro Muscle Stimulation (EMS) Group Experimental
EMS device was turned on during exercise for this group.
EMS Device On: The EMS Device was turned on during exercise as opposed to it being turned off for control group.
|
EMS Group - Control
EMS device was turned off during exercise for this group.
EMS Device Off: The EMS Device was turned off during exercise as opposed to it being turned off for control group.
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
9
|
9
|
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
EMS Group - Experimental
n=46 Participants
EMS device was turned on during exercise for this group.
EMS Device On: The EMS Device was turned on during exercise as opposed to it being turned off for control group.
|
EMS Group - Control
n=32 Participants
EMS device was turned off during exercise for this group.
EMS Device Off: The EMS Device was turned off during exercise as opposed to it being turned off for control group.
|
Total
n=78 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
35.7 years
STANDARD_DEVIATION 10.8 • n=46 Participants
|
35.6 years
STANDARD_DEVIATION 9.7 • n=32 Participants
|
35.65 years
STANDARD_DEVIATION 1.0 • n=78 Participants
|
|
Sex: Female, Male
Female
|
28 Participants
n=46 Participants
|
19 Participants
n=32 Participants
|
47 Participants
n=78 Participants
|
|
Sex: Female, Male
Male
|
18 Participants
n=46 Participants
|
13 Participants
n=32 Participants
|
31 Participants
n=78 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
United States
|
46 participants
n=46 Participants
|
32 participants
n=32 Participants
|
78 participants
n=78 Participants
|
PRIMARY outcome
Timeframe: baseline, 16 weeksPopulation: Data was not collected or analyzed for 9 subjects in each arm
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.
Outcome measures
| Measure |
EMS Group - Experimental
n=37 Participants
EMS device was turned on during exercise for this group.
EMS Device On: The EMS Device was turned on during exercise as opposed to it being turned off for control group.
|
EMS Group - Control
n=23 Participants
EMS device was turned off during exercise for this group.
EMS Device Off: The EMS Device was turned off during exercise as opposed to it being turned off for control group.
|
|---|---|---|
|
Mean Change in Reactive Hyperemia Index (RHI)
|
0.02 score on a scale
Standard Deviation 0.1
|
-0.26 score on a scale
Standard Deviation 0.3
|
SECONDARY outcome
Timeframe: baseline,16 weeksPopulation: Data was not collected or analyzed for 9 subjects in each arm
Subject's BMI calculated as weight in kilograms divided by height in meters squared. Uses measurements of height and weight obtained during study (with appropriate metric conversions)
Outcome measures
| Measure |
EMS Group - Experimental
n=46 Participants
EMS device was turned on during exercise for this group.
EMS Device On: The EMS Device was turned on during exercise as opposed to it being turned off for control group.
|
EMS Group - Control
n=32 Participants
EMS device was turned off during exercise for this group.
EMS Device Off: The EMS Device was turned off during exercise as opposed to it being turned off for control group.
|
|---|---|---|
|
Change in BMI
|
0.2 kg/m^2
Standard Deviation 0.9
|
0.06 kg/m^2
Standard Deviation 0.5
|
SECONDARY outcome
Timeframe: baseline, 16 weeksPopulation: Data was not collected or analyzed for 9 subjects in each arm
Total cholesterol is the sum of a person's HDL cholesterol, LDL cholesterol, and 20% of their triglyceride levels. Healthy total cholesterol is less than 200 mg/dL of blood
Outcome measures
| Measure |
EMS Group - Experimental
n=37 Participants
EMS device was turned on during exercise for this group.
EMS Device On: The EMS Device was turned on during exercise as opposed to it being turned off for control group.
|
EMS Group - Control
n=23 Participants
EMS device was turned off during exercise for this group.
EMS Device Off: The EMS Device was turned off during exercise as opposed to it being turned off for control group.
|
|---|---|---|
|
Change in Total Cholesterol
|
-1.7 mg/dL
Standard Deviation 25.1
|
19.2 mg/dL
Standard Deviation 26.5
|
SECONDARY outcome
Timeframe: baseline, 16 weeksPopulation: Data was not collected or analyzed for 9 subjects in each arm
VO2 max, or maximal oxygen consumption, refers to the maximum amount of oxygen that an individual can utilize during intense or maximal exercise. VO2 max is the number of milliliters of oxygen used per kilogram of body weight in one minute (ml/kg/min)
Outcome measures
| Measure |
EMS Group - Experimental
n=37 Participants
EMS device was turned on during exercise for this group.
EMS Device On: The EMS Device was turned on during exercise as opposed to it being turned off for control group.
|
EMS Group - Control
n=23 Participants
EMS device was turned off during exercise for this group.
EMS Device Off: The EMS Device was turned off during exercise as opposed to it being turned off for control group.
|
|---|---|---|
|
Change in Maximal Oxygen Consumption (VO2max)
|
0.3 ml/kg/min
Standard Deviation 3.4
|
1.1 ml/kg/min
Standard Deviation 3.9
|
SECONDARY outcome
Timeframe: baseline, week 16Population: Data was not collected or analyzed for 9 subjects in each arm
The LASA is subject reported ten item quality of life questionnaire. The ten items are scored from 0 -10, 0 being as bad as it can be and 10 being as good as it can be. Total scores range from 0 - 100, lower scores indicate being as bad as it can be, higher scores indicate being as good as it can be.
Outcome measures
| Measure |
EMS Group - Experimental
n=37 Participants
EMS device was turned on during exercise for this group.
EMS Device On: The EMS Device was turned on during exercise as opposed to it being turned off for control group.
|
EMS Group - Control
n=23 Participants
EMS device was turned off during exercise for this group.
EMS Device Off: The EMS Device was turned off during exercise as opposed to it being turned off for control group.
|
|---|---|---|
|
Mean Change in Quality-of-Life Score as Measured by the Longitudinal Amsterdam Aging Study (LASA) Questionnaire:
|
0.04 score on a scale
Standard Deviation 0.9
|
0.3 score on a scale
Standard Deviation 0.5
|
SECONDARY outcome
Timeframe: baseline, 16 weeksPopulation: Data was not collected or analyzed for 9 subjects in each arm
A creatine kinase test may be used to detect inflammation of muscles or muscle damage due to muscle disorders. A person may have muscle injury with few or nonspecific symptoms, such as weakness, fever, and nausea, that may also be seen with a variety of other conditions. A healthcare practitioner may use a CK test to help detect muscle damage in these cases, especially if someone is taking a drug such as a statin. Normal values at rest are usually between 60 and 174 U/L.
Outcome measures
| Measure |
EMS Group - Experimental
n=37 Participants
EMS device was turned on during exercise for this group.
EMS Device On: The EMS Device was turned on during exercise as opposed to it being turned off for control group.
|
EMS Group - Control
n=23 Participants
EMS device was turned off during exercise for this group.
EMS Device Off: The EMS Device was turned off during exercise as opposed to it being turned off for control group.
|
|---|---|---|
|
Change in Creatinine Kinase (CK)
|
417.9 U/L
Standard Deviation 1499
|
-137.2 U/L
Standard Deviation 375.9
|
SECONDARY outcome
Timeframe: baseline, week 16Population: Data was not collected or analyzed for 9 subjects in each arm
The Perceived Stress Scale is a subject reported 10 item stress questionnaire. The 10 items are scored from 0 to 4, with 0 = never, 1 = almost never, 2 = sometimes, 3 = fairly often and 4 = very often. Total scores range from 0 - 40, lower scores indicate lower stress, and higher scores indicate higher stress.
Outcome measures
| Measure |
EMS Group - Experimental
n=37 Participants
EMS device was turned on during exercise for this group.
EMS Device On: The EMS Device was turned on during exercise as opposed to it being turned off for control group.
|
EMS Group - Control
n=23 Participants
EMS device was turned off during exercise for this group.
EMS Device Off: The EMS Device was turned off during exercise as opposed to it being turned off for control group.
|
|---|---|---|
|
Mean Change in Stress Score as Measured by the Perceived Stress Scale
|
-1.0 score on a scale
Standard Deviation 5.5
|
-0.4 score on a scale
Standard Deviation 4.8
|
SECONDARY outcome
Timeframe: baseline, 16 weeksPopulation: Data was not collected or analyzed for 9 subjects in each arm
The PHQ-9 Screens for the presence and severity of depression with 9 questions in a scale of 0-3. Zero=not at all, 1=several days, 2=more than half the days, 3=nearly every day. Total scores range 0 - 27. A total score of 0-4=minimal depression, 5-9=mild depression, 10-14=moderate depression, 15-19=moderately severe depression, 20-27=severe depression
Outcome measures
| Measure |
EMS Group - Experimental
n=37 Participants
EMS device was turned on during exercise for this group.
EMS Device On: The EMS Device was turned on during exercise as opposed to it being turned off for control group.
|
EMS Group - Control
n=23 Participants
EMS device was turned off during exercise for this group.
EMS Device Off: The EMS Device was turned off during exercise as opposed to it being turned off for control group.
|
|---|---|---|
|
Mean Change in Depression Score as Measured by the Patient Health Questionnaire (PHQ-9)
|
-0.3 score on a scale
Standard Deviation 3.2
|
0.05 score on a scale
Standard Deviation 1.2
|
SECONDARY outcome
Timeframe: baseline, 16 weeksPopulation: Data was not collected or analyzed for 9 subjects in each arm
Sugar in the form of glucose in the blood. The concentration of glucose in the blood. A healthy normal range is 70 to 99 mg/dL
Outcome measures
| Measure |
EMS Group - Experimental
n=37 Participants
EMS device was turned on during exercise for this group.
EMS Device On: The EMS Device was turned on during exercise as opposed to it being turned off for control group.
|
EMS Group - Control
n=23 Participants
EMS device was turned off during exercise for this group.
EMS Device Off: The EMS Device was turned off during exercise as opposed to it being turned off for control group.
|
|---|---|---|
|
Change in Blood Glucose
|
0.7 mg/dL
Standard Deviation 10.3
|
-0.8 mg/dL
Standard Deviation 8.8
|
SECONDARY outcome
Timeframe: baseline, 16 weeksHemoglobin is a protein within red blood cells. As glucose enters the bloodstream, it binds to hemoglobin, or glycates. The more glucose that enters the bloodstream, the higher the amount of glycated hemoglobin. An A1C level below 5.7 percent is considered normal. Reported as percentage of glycated hemoglobin
Outcome measures
| Measure |
EMS Group - Experimental
n=37 Participants
EMS device was turned on during exercise for this group.
EMS Device On: The EMS Device was turned on during exercise as opposed to it being turned off for control group.
|
EMS Group - Control
n=23 Participants
EMS device was turned off during exercise for this group.
EMS Device Off: The EMS Device was turned off during exercise as opposed to it being turned off for control group.
|
|---|---|---|
|
Change in HbA1c
|
-0.01 percentage of glycated hemoglobin
Standard Deviation 0.2
|
0 percentage of glycated hemoglobin
Standard Deviation 0.2
|
SECONDARY outcome
Timeframe: baseline, 16 weeksPopulation: Data was not collected or analyzed for 9 subjects in each arm
High sensitivity C-reactive protein is a substance produced by the liver in response to inflammation. Normal CRP levels are below 3.0 mg/L
Outcome measures
| Measure |
EMS Group - Experimental
n=37 Participants
EMS device was turned on during exercise for this group.
EMS Device On: The EMS Device was turned on during exercise as opposed to it being turned off for control group.
|
EMS Group - Control
n=23 Participants
EMS device was turned off during exercise for this group.
EMS Device Off: The EMS Device was turned off during exercise as opposed to it being turned off for control group.
|
|---|---|---|
|
Change in High Sensitivity C- Reactive Protein (CRP)
|
0.06 mg/L
Standard Deviation 0.7
|
0.3 mg/L
Standard Deviation 2.3
|
SECONDARY outcome
Timeframe: baseline, 16 weeksPopulation: Data was not collected or analyzed for 9 subjects in each arm
Uric acid is a heterocyclic compound of carbon, nitrogen, oxygen, and hydrogen. Uric acid is a product of the metabolic breakdown of purine nucleotides. Normal blood values are 1.5 to 6.0 milligrams/deciliter (mg/dL) for women and 2.5 to 7.0 mg/dL for men
Outcome measures
| Measure |
EMS Group - Experimental
n=37 Participants
EMS device was turned on during exercise for this group.
EMS Device On: The EMS Device was turned on during exercise as opposed to it being turned off for control group.
|
EMS Group - Control
n=23 Participants
EMS device was turned off during exercise for this group.
EMS Device Off: The EMS Device was turned off during exercise as opposed to it being turned off for control group.
|
|---|---|---|
|
Change in Uric Acid:
|
0.1 mg/dL
Standard Deviation 0.6
|
0.2 mg/dL
Standard Deviation 0.6
|
SECONDARY outcome
Timeframe: Baseline, 16 weeksPopulation: Data was not collected or analyzed for 9 subjects in each arm
Fibrinogen is a protein produced by the liver. This protein helps stop bleeding by helping blood clots to form. Blood fibrinogen is the amount of fibrinogen in a blood sample. Normal range is 200 to 400 mg/dL
Outcome measures
| Measure |
EMS Group - Experimental
n=37 Participants
EMS device was turned on during exercise for this group.
EMS Device On: The EMS Device was turned on during exercise as opposed to it being turned off for control group.
|
EMS Group - Control
n=23 Participants
EMS device was turned off during exercise for this group.
EMS Device Off: The EMS Device was turned off during exercise as opposed to it being turned off for control group.
|
|---|---|---|
|
Change in Fibrinogen
|
5.4 mg/dL
Standard Deviation 27.3
|
9.0 mg/dL
Standard Deviation 34.8
|
SECONDARY outcome
Timeframe: baseline, 16 weeksPopulation: Data was not collected or analyzed for 9 subjects in each arm
Homocysteine is an amino acid which occurs in the body as an intermediate in the metabolism of methionine and cysteine. Normal range 4 and 15 micromoles/liter (µmol/L)
Outcome measures
| Measure |
EMS Group - Experimental
n=37 Participants
EMS device was turned on during exercise for this group.
EMS Device On: The EMS Device was turned on during exercise as opposed to it being turned off for control group.
|
EMS Group - Control
n=23 Participants
EMS device was turned off during exercise for this group.
EMS Device Off: The EMS Device was turned off during exercise as opposed to it being turned off for control group.
|
|---|---|---|
|
Change in Homocysteine
|
-6.7 µmol/L
Standard Deviation 32.8
|
-0.7 µmol/L
Standard Deviation 32.8
|
SECONDARY outcome
Timeframe: baseline, 16 weeksPopulation: Data was not collected or analyzed for 9 subjects in each arm
Lipoprotein is a type of protein that combine with and transport fat or other lipids in the blood plasma. Normal range is less than 30 mg/dL
Outcome measures
| Measure |
EMS Group - Experimental
n=37 Participants
EMS device was turned on during exercise for this group.
EMS Device On: The EMS Device was turned on during exercise as opposed to it being turned off for control group.
|
EMS Group - Control
n=23 Participants
EMS device was turned off during exercise for this group.
EMS Device Off: The EMS Device was turned off during exercise as opposed to it being turned off for control group.
|
|---|---|---|
|
Change in Lipoprotein
|
5.6 30 mg/dL
Standard Deviation 20.9
|
15.4 30 mg/dL
Standard Deviation 38.0
|
Adverse Events
EMS Group - Experimental
EMS Group - Control
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place