In general, people with a lower socioeconomic status are more likely to be exposed to risky behaviors such as physical inactivity, poor diet, and not participating in health examinations, as well as psychological stress. One of the causes of inactivity is the lack of targeted sports programs for this group of people.
The purpose of this research is to implement a regular program for this group of people.
Design
Two groups of 40 people each (experimental-control)
Settings and conduct
Islamshahr Imam Khomeini Stadium Shatre
Participants/Inclusion and exclusion criteria
Among the eligible volunteers and based on the desired criteria for entry: marriage, living in Islamshahr and suburbs, at least 30 years old and at most 50 years old, at least a diploma, not having any diseases affecting exercise intervention such as orthopedic diseases, Neuromuscular or cardiovascular diseases and not prohibiting sports activities by a doctor. Exclusion criteria: celibacy, under-diploma education, residence outside of Tehran, lack of regular participation of the subject in training, illness before and during the training protocol.
Intervention groups
The exercise protocol (exercise instructions) will be based on the recommendations of ACSM in the form of three sessions per week and for 60 minutes, which will be designed by a researcher. The exercise protocol will include three stages of warming up the main part of the exercise and cooling down.
Main outcome variables
The effects of a three-month period of sports activity on the levels of inflammatory factors in sedentary women with low socioeconomic status
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20230803059019N1
Registration date:2023-08-20, 1402/05/29
Registration timing:retrospective
Last update:2023-08-20, 1402/05/29
Update count:0
Registration date
2023-08-20, 1402/05/29
Registrant information
Name
Seyed Mohsen Hoseini
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 7730 4261
Email address
mohsentrainer@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-07-15, 1402/04/24
Expected recruitment end date
2023-07-22, 1402/04/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effects of three-months of exercise intervention on the levels of inflammatory factors in women with low socioeconomic status
Public title
The effects of three-months of exercise intervention on the levels of inflammatory factors in women with low socioeconomic status
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Sedentary healthy women
low socioeconomic status
Exclusion criteria:
Diseases affecting exercise intervention such as orthopedic diseases, neuromuscular or cardiovascular diseases
Prohibition of sports activities by the doctor
Age
From 30 years old to 50 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
80
Randomization (investigator's opinion)
Not randomized
Randomization description
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
SHAHED UNIVERSITY
Street address
Shahid University, Shahid Reza Ali Street, Shahid Oliya Blvd., Aftab City, Tehran
City
TEHRAN
Province
Tehran
Postal code
3319118651
Approval date
2023-07-10, 1402/04/19
Ethics committee reference number
IR.SHAHED.REC.1402.044
Health conditions studied
1
Description of health condition studied
Intense physical activity, despite its various benefits for general health, can cause possible damage to various body tissues due to the increase in oxidative stress through the increase in the production of reactive species. How to regulate inflammatory responses in exercise protocols is different in different people. the existing research shows that sports activity can have different results based on the intensity and duration.
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
TNF-alpha: anti-inflammatory cytokines are secreted in response to inflammation and are limiting and reversing the progressive process of inflammation.
Timepoint
In two stages, pre-test and post-test
Method of measurement
Blood sampling and measurement by ELISA device
2
Description
IL-10 : anti-inflammatory cytokines are secreted in response to inflammation and are limiting and reversing the progressive process of inflammation.
Timepoint
In two stages, pre-test and post-test
Method of measurement
Blood sampling and measurement by ELISA device
Secondary outcomes
empty
Intervention groups
1
Description
In this research, we will have two groups of subjects with a pre-test and post-test design, which will include an experimental group and a control group, the experimental group includes 40 healthy sedentary women with low socioeconomic status and the control group includes 20 healthy sedentary women with economic status It is of low social status in Islamshahr city. The exercise protocol (exercise instructions) will be based on ACSM's recommendations in the form of three sessions per week for 60 minutes, which will be designed by a researcher. The exercise protocol will include three stages of warming up the main part of the exercise and cooling down. The first stage 15 1 minute of warm-up (10 minutes of walking with moderate intensity, 5 minutes of stretching and rhythmic movements and movement exercises), the second stage of the main part of the exercise is 30 minutes (including selected exercises to improve cardiorespiratory endurance, muscular endurance, flexibility in a combination with equipment and with weight body) and the final 15-minute third stage (including 10 minutes of group games and entertainment to improve the spirit and collective vitality of the subjects and 5 minutes of light aerobic activity and stretching exercises will be performed.
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
SHAHED UNIVERSITYT
Full name of responsible person
AMIN ISANEJAD
Street address
Shahid University, Shahid Reza Ali Street, Shahid Oliya Blvd., Aftab City, Tehran
City
TEHRAN
Province
Tehran
Postal code
3319118651
Phone
+98 21 5522 8800
Email
ict@shahed.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shahed University
Full name of responsible person
AIMN ISANEJAD
Street address
Shahid University, Shahid Reza Ali Street, Shahid Oliya Blvd., Aftab City, Tehran
City
TEHRAN
Province
Tehran
Postal code
3319118651
Phone
+98 21 5522 8800
Email
ict@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
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
Shahed University
Full name of responsible person
Seyed Mohsen Hoseini
Position
STUDENT
Latest degree
Bachelor
Other areas of specialty/work
Physiology
Street address
Unit 2,Plates 6,ThreeOrchid Alley, Behesht Gharabi St.Hakimiya
City
TEHRAN
Province
Tehran
Postal code
1651875579
Phone
+98 21 7730 4261
Email
mohsentrainer@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahed University
Full name of responsible person
Seyed Mohsen Hoseini
Position
student
Latest degree
Bachelor
Other areas of specialty/work
Exercise Physiology
Street address
Hakimiya, Behesht Gharabi St., Orchid Alley, Three Plates 6, Unit 2
City
tehran
Province
Tehran
Postal code
1651875579
Phone
+98 21 7730 4261
Email
mohsentrainer@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Shahed University
Full name of responsible person
Seyed Mohsen Hoseini
Position
student
Latest degree
Bachelor
Other areas of specialty/work
Exercise Physiology
Street address
Hakimiya, Behesht Gharabi St., Orchid Alley, Three Plates 6, Unit 2
City
tehran
Province
Tehran
Postal code
1651875579
Phone
+98 21 7730 4261
Email
mohsentrainer@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
There is no more information
Study Protocol
No - There is not a plan to make this available
Statistical Analysis Plan
Not applicable
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
All data can be viewed after checking and coding and identifying individual information
When the data will become available and for how long
The start of access is 6 months
To whom data/document is available
Supervisor and internal and external referees of the thesis
Under which criteria data/document could be used
In order to improve the quality of future research
From where data/document is obtainable
To the university library
What processes are involved for a request to access data/document
First, the university archive, then the supervisor or the library