The effects of three months of exercise training intervention on physical activity levels, quality of life, cardiovascular disease risk factors and some inflammatory indices in women with low socioeconomic status
The main objective: the effect of a physical activity intervention course on the level of physical activity, health indicators and quality of life
Design
We will have a semi-experimental research with two pre-test and post-test groups, which will include an experimental group and a control group. In this research, 80 women with low socio-economic status and low mobility will be included. The experimental group includes 40 sedentary healthy women with low socioeconomic status and the control group includes 40 healthy sedentary women with low socioeconomic status in Islamshahr city (inclusion criteria). All statistical operations are performed in spss and the differences between groups, their significance and the difference between pre-test and post-test are calculated.
Settings and conduct
The experimental group will perform physical activity with body weight in Imam Khomeini Stadium in Islamshahr, and the control group will continue their normal life.
Participants/Inclusion and exclusion criteria
Conditions for the entry of healthy middle-aged women with low socio-economic status/conditions for the non-entry of women with chronic diseases and high economic status
Intervention groups
sports activity
Main outcome variables
- Physical activity 2 - Quality of life 3 - Risk factors for vascular diseases 4 - Inflammatory indices (IL-6, CRP) 5 - Body composition 6 - Fasting blood sugar 7 - Lipid profile
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20230804059023N1
Registration date:2023-08-10, 1402/05/19
Registration timing:registered_while_recruiting
Last update:2023-08-10, 1402/05/19
Update count:0
Registration date
2023-08-10, 1402/05/19
Registrant information
Name
Bita Ranjbar
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 5121 5080
Email address
bitaranjbar1278@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-08-06, 1402/05/15
Expected recruitment end date
2023-11-06, 1402/08/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effects of three months of exercise training intervention on physical activity levels, quality of life, cardiovascular disease risk factors and some inflammatory indices in women with low socioeconomic status
Public title
The effects of three months of exercise training intervention on physical activity levels, quality of life, cardiovascular disease risk factors and some inflammatory indices in women with low socioeconomic status
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
The desired criteria for the entry and selection of subjects are selected for the study of healthy women
The criteria for their entry is that they have a low socioeconomic status
Exclusion criteria:
Women should not have an acute disease such as cardiovascular disease, metabolic disease, etc
These women do not have a high economic status
Age
No age limit
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
80
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Shahed university
Street address
Block A, Floor 13.Medical Treatment and EducationShahrak Qods, Simai St. of Iran, Central Headquarters of the Ministry of Health,,Tehran,
City
Theran
Province
Tehran
Postal code
3319118651
Approval date
2023-07-10, 1402/04/19
Ethics committee reference number
IR.SHAHED.REC.1402.046
Health conditions studied
1
Description of health condition studied
Sports activity
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Sports intervention
Timepoint
Investigating the effects of a three-month period of sports intervention on the amount of physical activity, quality of life, risk factors of cardiovascular diseases and some inflammatory indicators in women with low socioeconomic status
Method of measurement
International Physical Activity Questionnaire
Secondary outcomes
1
Description
Quality of Life
Timepoint
The effects of three months of exercise training intervention on physical activity levels, quality of life, cardiovascular disease risk factors and some inflammatory indices in women with low socioeconomic status.
Method of measurement
World Health Organization Quality of Life Questionnaire
2
Description
Inflammatory indices (IL-6, CRP)
Timepoint
The effects of three months of exercise training intervention on physical activity levels, quality of life, cardiovascular disease risk factors and some inflammatory indices in women with low socioeconomic status.
Method of measurement
Laboratory kits
Intervention groups
1
Description
Intervention group: exercise exercises will be performed on people, they will fill in quality of life questionnaires, physical activity level, household status information, barriers to sports participation. A checkup test is performed. The training time is 3 months (12 weeks) and the number of training sessions per week is 3 sessions and the class time is one hour, the exercises are done with body weight, the groups are randomly selected
Category
Other
2
Description
Control group: The control group does not receive any intervention
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Shahed University
Full name of responsible person
Amin Esanezhad
Street address
Persian Gulf Highway, Shahed University
City
Tehran
Province
Tehran
Postal code
3319118651
Phone
+98 21 5121 5030
Email
A.isanezhad@shahed.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shahed University
Full name of responsible person
Shahriyar Birjani
Street address
Persian Gulf Highway, Shahed University
City
Tehran
Province
Tehran
Postal code
3319118651
Phone
+98 21 5121 5030
Email
A.isanezhad@shahed.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahed University
Proportion provided by this source
100
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
Shahed University
Full name of responsible person
Bita Ranjbar
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Others
Street address
4 Yas Alley.Phase 2, Star Street.Parand
City
parand
Province
Tehran
Postal code
3761349568
Phone
000982151215030
Email
Bitaranjbar1278@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahed University
Full name of responsible person
Amin Esanezhad
Position
profossor
Latest degree
Ph.D.
Other areas of specialty/work
Others
Street address
Shahed university
City
Tehran
Province
Tehran
Postal code
3319118651
Phone
+98 21 5121 5030
Email
A.isanezhad@shahed.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Shahed University
Full name of responsible person
Bita Ranjbar
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Others
Street address
Persian Gulf Highway.Shahed University
City
Tehran
Province
Tehran
Postal code
3319118651
Phone
+98 21 5121 5030
Email
Bitaranjbar1278@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
Not applicable
Analytic Code
Not applicable
Data Dictionary
Not applicable
Title and more details about the data/document
vThe effects of three months of exercise training intervention on physical activity levels, quality of life, cardiovascular disease risk factors and some inflammatory indices in women with low socioeconomic status.
When the data will become available and for how long
Access starts from 1402
To whom data/document is available
Researchers working in academic institutions
Under which criteria data/document could be used
true
From where data/document is obtainable
bitaranjbar1278@gmail.com
What processes are involved for a request to access data/document