Comparison of the effect of 8-week High & Low Frequency Whole-Body Electromyostimulation (WB-EMS) on Some Physiological Variables and miR146a & miR133a Expression in Men with Overweight/Obesity
Comparison of the effect of 8 weeks of high and low frequency electrical muscle stimulation (WB-EMS) exercises on some physiological indicators and the expression of miR146a and miR133a in overweight and obese men.
Design
The clinical trial has 2 intervention groups. After selecting the samples, they are divided into intervention groups in a simple random manner. The possible number of samples will be 30 people (two groups of 15 people).
Settings and conduct
The location of the project will be in Isfahan and in a sports club with a pre-test-post-test plan. After collecting statistical samples with a BMI above 25, 30 of them will participate in this research.For the subjects, 48 hours before the start of training and 48 hours after the last training protocol, a blood sample will be taken, and then the effect of training on the levels of biomarkers will be examined.
Participants/Inclusion and exclusion criteria
Age 25-35
Body mass index 29.5-35 kg/m2
Absence of any disease
Intervention groups
Intervention group: high intensity EMS training group
Intervention group: EMS training group with low intensity
Main outcome variables
Dependent variables in this research will include serum miR146a and miR133a and body fat percentage.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20240205060906N1
Registration date:2024-03-06, 1402/12/16
Registration timing:retrospective
Last update:2024-03-06, 1402/12/16
Update count:0
Registration date
2024-03-06, 1402/12/16
Registrant information
Name
hadi fakhari
Name of organization / entity
The University of isfahan
Country
Iran (Islamic Republic of)
Phone
+98 35 3247 1880
Email address
h.fakhari68@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-02-04, 1402/11/15
Expected recruitment end date
2024-03-05, 1402/12/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effect of 8-week High & Low Frequency Whole-Body Electromyostimulation (WB-EMS) on Some Physiological Variables and miR146a & miR133a Expression in Men with Overweight/Obesity
Public title
Comparison of the effect of 8 weeks of electrical muscle stimulation exercises on some physiological indicators and miRs related to obesity
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Age 25-35
Body mass index 29.5-35 kg/m2
Absence of any disease
Exclusion criteria:
have a specific disease
doctor's prohibition
Problems in the motor organs that prevent movement
Age
From 25 years old to 35 years old
Gender
Male
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
30
Randomization (investigator's opinion)
Randomized
Randomization description
After selection, the samples are divided into intervention groups in a simple random manner (using a lottery for sampling). First, odd numbers are determined for the first group (training group with low EMS frequency) and odd numbers for the second group (training group with high EMS frequency). Numbers 1 to 30 are written on paper and participants will draw their numbers from a basket. Participants who received odd numbers will be in the first training group and participants who received even numbers will be in the second training group.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Research Ethics Committees Certificate Isfahan University
Street address
Isfahan, Azadi Square, Isfahan University
City
isfahan
Province
Yazd
Postal code
۸۱۷۴۶۷۳۴۴۱
Approval date
2023-05-20, 1402/02/30
Ethics committee reference number
ir.ui.rec.1402.134
Health conditions studied
1
Description of health condition studied
Overweight/obesity
ICD-10 code
E66
ICD-10 code description
Overweight and obesity
Primary outcomes
1
Description
Dependent variables1: miR146a
Timepoint
At the beginning and end of the study
Method of measurement
A real-time reverse transcriptase-polymerase chain reaction (RT-PCR) system
2
Description
Dependent variables2: miR133a
Timepoint
At the beginning and end of the study
Method of measurement
A real-time reverse transcriptase-polymerase chain reaction system
3
Description
Dependent variables 3: Body Fat Percentage
Timepoint
At the beginning and end of the study
Method of measurement
Using a valid caliper (Lange skinfold caliper)
4
Description
Dependent variables 3: Peak Muscle Torque
Timepoint
At the beginning and end of the study
Method of measurement
Biodex System 3 Isokinetic Dynamometer
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: EMS training group with low intensity.This group performs certain training for 8 weeks (3 sessions/week) using the designated tools.Initial blood sampling was done 48 hours before the start of the first training session to determine the baseline values of miR146a and miR133a.After 48 hours from the completion of 8 weeks of training, the second sampling of subjects is done.
Category
Prevention
2
Description
Intervention group: high intensity EMS training group.This group performs certain training for 8 weeks (3 sessions/week) using the designated tools.Initial blood sampling was done 48 hours before the start of the first training session to determine the baseline values of miR146a and miR133a.After 48 hours from the completion of 8 weeks of training, the second sampling of subjects is done.
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
University of Isfahan
Full name of responsible person
Vazgen Minasian
Street address
Isfahan, Azadi square, University of Isfahan
City
Isfahan
Province
Isfehan
Postal code
8174673441
Phone
+98 31 3793 2369
Email
vazgenmin@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
University of Isfahan
Full name of responsible person
Vazgen Minasian
Street address
Isfahan, Azadi square, University of Isfahan
City
Isfahan
Province
Isfehan
Postal code
8174673441
Phone
+98 31 3793 2003
Email
v.minasian@spr.ui.ac.ir
Web page address
https://ui.ac.ir/
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
University of Isfahan
Proportion provided by this source
100
Public or private sector
Private
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
The University of Isfahan
Full name of responsible person
Hadi Fakhari
Position
PhD student
Latest degree
Master
Other areas of specialty/work
Physiology
Street address
Isfahan, Azadi Square, University of Isfahan
City
Isfahan
Province
Isfehan
Postal code
۸۱۷۴۶۷۳۴۴۱
Phone
+98 31 3793 2128
Email
h.fakhari68@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
The University of Isfahan
Full name of responsible person
Hadi Fakhari
Position
phd student
Latest degree
Master
Other areas of specialty/work
Physiology
Street address
Isfahan, Azadi Square, University of Isfahan
City
Isfahan
Province
Isfehan
Postal code
۸۱۷۴۶۷۳۴۴۱
Phone
+98 31 3793 2128
Email
h.fakhari68@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
The University of Isfahan
Full name of responsible person
Hadi Fakhari
Position
Phd student
Latest degree
Master
Other areas of specialty/work
Physiology
Street address
Isfahan, Azadi Square, University of Isfahan
City
Isfahan
Province
Yazd
Postal code
۸۱۷۴۶۷۳۴۴۱
Phone
+98 31 3793 2128
Email
h.fakhari68@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
No - There is not a plan to make this available
Data Dictionary
No - There is not a plan to make this available
Title and more details about the data/document
Participants' data will be shared after de-identification.
When the data will become available and for how long
The access period starts 6 months after the results are published
To whom data/document is available
Researchers working in academic and scientific institutions
Under which criteria data/document could be used
If needed to conduct scientific research
From where data/document is obtainable
with the person in charge of research and via email h.fakhari68@gmail.com
What processes are involved for a request to access data/document
Documents that show the applicant's membership in scientific and research centers