Determining the effect of high-intensity functional training on the expression of miR-637, CRP, RBP HuR and lipid profile levels in overweight/obese women
Design
The clinical trial will consist of two groups. Twenty-four overweight and obese women aged 35 to 45 years (voluntarily) will be divided into two groups of intervention (Functional training) and control (without intervention) with random arrangement (simple randomization). The present design will be a semi-experimental and single blind.
Settings and conduct
In a quasi-experimental research project, 24 overweight and obese women aged 35 to 45 years were considered as a research sample. Subjects will be randomly divided into 2 groups of 12: control and High Intensity Functional Training (HIFT). The training protocol is performed 3-4 days a week for eight weeks. Blood samples are taken at rest 48 hours before the start of training and 48 hours after the last training session. All measurements and exercises will be measured in the Tabriz Technical and Vocational University.
Participants/Inclusion and exclusion criteria
inclusion criteria: overweight and obese women aged 35 to 45 years, without cardiorespiratory problems, body mass index (BMI) 25 to 35, inactive (less than 90 minutes of regular exercise per week), without blood pressure ; The non-use of drugs and anabolic, anti-inflammatory and antioxidant supplements. exclusion criteria: Chronic diseases (such as cardiovascular disease, cancer or respiratory diseases), smoking and BMI<25.
Intervention groups
Two groups: 1- High Intensity Interval Functional (HIFT) and 2- Control Group (will do nothing)
Main outcome variables
miR-637، C-reactive protein (CRP)، Lipid profile
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20220128053844N2
Registration date:2023-05-31, 1402/03/10
Registration timing:retrospective
Last update:2023-05-31, 1402/03/10
Update count:0
Registration date
2023-05-31, 1402/03/10
Registrant information
Name
hamid reza zolfi
Name of organization / entity
Technical and vocational university
Country
Iran (Islamic Republic of)
Phone
+98 41 3477 9011
Email address
hzolfi@tabrizu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-04-19, 1402/01/30
Expected recruitment end date
2023-05-13, 1402/02/23
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of high-intensity functional training on the expression of miR-637, CRP and lipid profile levels in overweight/obese women
Public title
Effect of exercise training on obese women
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Age range 35 to 45 years
Body mass index 25 to 35
Exclusion criteria:
Smoking
Taking certain medications to control body weight and blood pressure during the last three months
Diastolic and systolic pressures greater than 100 and 140 mm Hg, respectively
having neuromuscular diseases as well as cardio-respiratory diseases.
Having cardiorespiratory diseases
Age
From 35 years old to 45 years old
Gender
Female
Phase
N/A
Groups that have been masked
Participant
Sample size
Target sample size:
24
Randomization (investigator's opinion)
Randomized
Randomization description
Assigning samples using simple random-lottery method. In this method, first the list of names of all members is obtained. It is then assigned a number to each. It is placed inside the box. The papers are then selected and removed individually until the desired sample size is complete.
Blinding (investigator's opinion)
Single blinded
Blinding description
The present study is performed in a single blind manner and the only researchers knows how to assign individuals to different groups.In general, all participants in this project are unaware of what kind of sports group they are said to be, and the researchers will individually give the exercise to individuals and will not be explained to people about the type and name of the exercise. Also, the data analyst, clinical caregiver, outcome assessor, as well as the safety committee and data monitoring will not know how to assign exercise.
Placebo
Not used
Assignment
Parallel
Other design features
In the present study, participants were randomly assigned to two training and control groups. The control group does not receive any intervention (exercise or supplement). Blood samples are taken from the control group only in two time periods.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Research Institute of Movement Sciences
Street address
KhU, No. 43. South Mofatteh Ave., Tehran.
City
Tehran
Province
Tehran
Postal code
1571914911
Approval date
2023-05-02, 1402/02/12
Ethics committee reference number
IR-KHU.KRC.1000.160
Health conditions studied
1
Description of health condition studied
Obesity
ICD-10 code
E66.0
ICD-10 code description
Obesity due to excess calories
Primary outcomes
1
Description
The level of micro RNA 637 (miR-637)
Timepoint
Before and after starting eight weeks of HIFT training
Method of measurement
Real-Time PCR and using PCR mic
2
Description
The level of C-Reactive Protein (CRP)
Timepoint
Before and after starting eight weeks of HIFT training
Method of measurement
It will be measured by Elisa Reader method with high sensitivity.
Secondary outcomes
1
Description
Lipid profile
Timepoint
Before and after the start of research
Method of measurement
Using the kit of Pars Azmoun company and with the sensitivity of the kit, 5 mg/dl will be measured.
Intervention groups
1
Description
Intervention group: Eight weeks of high-intensity interval training (HIFT). Subjects will participate in high-intensity functional training (HIFT) 3-4 days a week for 8 weeks. Blood samples are taken at rest 48 hours before the start of training and 48 hours after the last training session. The duration of the study period will be 2 months (equal to 8 weeks).
Category
Prevention
2
Description
Control group: Control group: In this group, we will not have any exercise or drug intervention. Blood samples will be taken from the subjects in two stages (48 hours before the start of the research study and 48 hours after the last day of the research period). The duration of the study period will be 2 months (equal to 8 weeks).
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Technical and vocational university
Full name of responsible person
Hamidreza Zolfi
Street address
Manzariyeh Ave
City
Tabriz
Province
East Azarbaijan
Postal code
51749-13136
Phone
+98 41 3477 9011
Fax
+98 41 3477 9065
Email
Hamidreza.zolfi@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice-Chancellor for Research and Technology, Technical and Vocational University
Full name of responsible person
Javad Saghaei Saeidi
Street address
Manzariyeh Ave
City
Tabriz
Province
East Azarbaijan
Postal code
51749-13136
Phone
+98 41 3477 9011
Fax
+98 41 3477 9065
Email
javadsaidi_2007@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Technical and Vocational University
Proportion provided by this source
5
Public or private sector
Public
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
East Azarbaijan Technical and Vocational University
Full name of responsible person
Hamidreza zolfi
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Exercise Physiology
Street address
Technical and Vocational University. Manzariyeh,Tabriz,East Azerbaijan Province.
City
Tabriz
Province
East Azarbaijan
Postal code
۵۱۷۴۹۱۳۱۳۶
Phone
+98 41 3477 9011
Fax
+98 41 3477 9065
Email
Hamidreza.zolfi@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Technical and Vocational University
Full name of responsible person
Hamid Reza Zolfi
Position
Assistant Professor of Exercise Physiology
Latest degree
Ph.D.
Other areas of specialty/work
Exercise Physiology
Street address
Technical and Vocational University of East Azarbaijan, Manzariyeh, Tabriz, East Azarbaijan
City
Tabriz
Province
East Azarbaijan
Postal code
۵۱۷۴۹۱۳۱۳۶
Phone
+98 41 3477 9011
Fax
Email
hzolfi@tabrizu.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
East Azarbaijan Technical and Vocational University.
Full name of responsible person
Hamid Reza Zolfi
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Exercise Physiology
Street address
Technical and Vocational University. Manzariyeh,Tabriz, East Azerbaijan Province.
City
Tabriz
Province
East Azarbaijan
Postal code
۵۱۷۴۹۱۳۱۳۶
Phone
041 - ۳۴۷۷۹۰۱۱ -12- داخلی 291
Email
Hamidreza.zolfi@yahoo.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
Undecided - It is not yet known if there will be 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
In the meetings that will be held with the participants before and after the study, all the data and their analysis, consent and trial and study protocol will be explained to them.
When the data will become available and for how long
Depending on the variable, the data of some variables will be accessed before the start of the research and others after the end of the research.
To whom data/document is available
Project participants, researchers and university professors
Under which criteria data/document could be used
Other researchers will be allowed to access the data in order to use and assist other researchers and to commit not to misuse the data.
From where data/document is obtainable
Email - In-person visit
What processes are involved for a request to access data/document
Provide identification documents and research resume and provide commitment in order not to misuse the data