The aim of the researcher is to determine the effect of 12 weeks of combined training with high energy expenditure and standard energy on the values and sensitivity of fibroblast growth 21 and glycemic indices of overweight women.
Design
The current clinical trial has 3 groups : standard and high energy groups and a control with a simple random method without a blind spot, which was used for randomization using the random number table method on 30 samples.
Settings and conduct
The present clinical trial was conducted in the laboratory of Tabriz University, which has been studied regarding the measurement of sports activity, the energy consumption of exercise and its effect on the metabolic factors of the body.
Participants/Inclusion and exclusion criteria
Being at least 35 years old and at most 55 years old, overweight women of Tabriz city and without any underlying disease
Intervention groups
High energy expenditure group (exercises with high volume 5 days a week) standard energy group (exercises with standard volume) control group without training
Main outcome variables
metabolic and sugar indicators
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20220202053916N1
Registration date:2024-03-08, 1402/12/18
Registration timing:retrospective
Last update:2024-03-08, 1402/12/18
Update count:0
Registration date
2024-03-08, 1402/12/18
Registrant information
Name
Mitra Abdollahi Diba
Name of organization / entity
Islamic Azad University of Tabriz
Country
Iran (Islamic Republic of)
Phone
+98 41 3387 3045
Email address
diba.mitra321@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-06-09, 1401/03/19
Expected recruitment end date
2022-12-29, 1401/10/08
Actual recruitment start date
2022-06-09, 1401/03/19
Actual recruitment end date
2022-12-29, 1401/10/08
Trial completion date
2023-05-09, 1402/02/19
Scientific title
The effect of 12 weeks combined training with high calorie expenditure, on fibroblast growth 21 serum levels and glycemic index in overweight women
Public title
The effect of 12 weeks of physical activity with high consumption on metabolic and sugar indicators
Purpose
Other
Inclusion/Exclusion criteria
Inclusion criteria:
Being at least 35 years old
Not having an underlying disease such as hormonal and sugar problems
Having a BMI between 25 and 29.9
Not having any injury, illness or surgery in the last 6 months
Exclusion criteria:
Being less than 35 and more than 55
Having a BMI above 30
داشتن بیماری های زمینه ای
Age
From 35 years old to 55 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
30
Actual sample size reached:
30
Randomization (investigator's opinion)
Randomized
Randomization description
A simple random method was used which uses a table of random numbers to place the samples in the intervention or control 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
Ethics committee of Tabriz University of medical Sciences
Street address
No19 ,3. Laleh Alley, 1 Babaei St
City
tabriz
Province
East Azarbaijan
Postal code
5167757594
Approval date
2023-06-26, 1402/04/05
Ethics committee reference number
IR.TABRIZU.REC.1402.026
Health conditions studied
1
Description of health condition studied
The problem of overweight and inactivity
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
amount of fibroblast 21 (metabolic factor) in women
Timepoint
Before the start of the project and after 3 month the end of the project
Method of measurement
through blood sampling and sandwich ELISA measurement.
2
Description
Insulin sensitivity index
Timepoint
in two stages before and after the 3-month period
Method of measurement
The effect of exercise training on insulin sensitivity is through blood sampling and sandwich ELISA measurement
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: first intervention . the High calorie Expenditure, physical activity for 5 days a week, which increases the duration of burning. Each training session is 60 minutes Exercising with aerobic and bearing body weight
Category
Lifestyle
2
Description
Control group: second intervention. standard group .physical activity for 3 days a week, which increases the duration of burning. Each training session is 40 minutes.. Exercising with aerobic and bearing body weight.
Category
Lifestyle
3
Description
Control group: they had no intervention
Category
Lifestyle
Recruitment centers
1
Recruitment center
Name of recruitment center
Tabriz university
Full name of responsible person
Mitra Abdollahi Diba
Street address
No. 19, Babai St. 1 Lale Alley 3
City
Tabriz
Province
East Azarbaijan
Postal code
5167757594
Phone
+98 41 3387 3045
Email
diba.mitra321@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
The University of Tabriz
Full name of responsible person
Mitra abdollahi Diba
Street address
No.19 , Babai St. 1 Lale Alley 3
City
Tabriz
Province
East Azarbaijan
Postal code
5167757594
Phone
+98 41 3387 3045
Email
diba.mitra321@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
university of tabriz
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
Other
Person responsible for general inquiries
Contact
Name of organization / entity
The university of Tabriz
Full name of responsible person
Mitra Abdollahi Diba
Position
Student
Latest degree
Master
Other areas of specialty/work
Exercise physiology
Street address
No. 19, 3 Laleh Alley, 1 Babaei St
City
Tabriz
Province
East Azarbaijan
Postal code
5167757594
Phone
+98 41 3387 3045
Email
diba.mitra321@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
The University of Tabriz
Full name of responsible person
Mitra Abdollahi Diba
Position
Student
Latest degree
Master
Other areas of specialty/work
Exercise physiology
Street address
No. 19, 3 Laleh Alley, 1 Babaei St
City
Tabriz
Province
East Azarbaijan
Postal code
5167757594
Phone
+98 41 3387 3945
Email
Diba.Mitra321@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
The University of Tabriz
Full name of responsible person
Mitra Abdollahi Diba
Position
Student
Latest degree
Master
Other areas of specialty/work
Exercise physiology
Street address
No. 19, 3 Laleh Alley, 1 Babaei St
City
Tabriz
Province
East Azarbaijan
Postal code
5167757594
Phone
0098 41 3387305
Email
diba.mitra321@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
No - There is not a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be 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
Undecided - It is not yet known if there will be a plan to make this available