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The effect of endurance, resistance and combined training (resistance-endurance) on the levels of Pentraxin 3, Galectin 3 and some inflammatory mediators in obese women

Protocol summary

Study aim
The effect of endurance, resistance and combination training on the levels of Pentraxin 3, Galactin 3 and some inflammatory mediators in obese women
Design
The study is a randomized, factorial clinical trial. The target population is 48 obese women who are divided into three training groups and a control group. 30 minutes of endurance training with 60% heart rate on the treadmill. Resistance training with intensity of 10 RM and Includes leg presses, forefoot, flat foot, chest press and paddling for 30 minutes. Combined training includes 15 minutes of endurance training and 15 minutes of resistance training.
Settings and conduct
Subjects attend the Top Technique Gymnasium on individual days of the week from 9 to 10 am, and after warming up for 30 minutes, perform their own exercises under the supervision of the relevant instructor, and after cooling off, the session ends. On the first day of fasting, a blood sample is taken before the start of training and 48 hours after the last training session, a blood sample is taken.
Participants/Inclusion and exclusion criteria
Obese women between the ages of 20 and 35 who wish to participate in this study. Do not participate in regular exercise for the past year. Have no history of heart disease or diabetes. Do not use drugs or alcohol. General physical and mental health.
Intervention groups
After filling out the consent form, the subjects are divided into four groups of 12 people. The first group: endurance training, the second group: resistance training, the third group: the combined training, the fourth group: control. Except for the control group, each group undergoes exercise for 12 weeks and 3 sessions per week.
Main outcome variables
Pentraxin 3,Galactin3,Tumor necrosis factor-a (TNF-a) ,Serum Amyloid A (SAA)

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20210626051720N1
Registration date: 2021-07-11, 1400/04/20
Registration timing: registered_while_recruiting

Last update: 2021-07-11, 1400/04/20
Update count: 0
Registration date
2021-07-11, 1400/04/20
Registrant information
Name
Mahrokh Kooti
Name of organization / entity
The University of Tehran
Country
Iran (Islamic Republic of)
Phone
+98 21 2244 1378
Email address
kooti.mahrokh@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-07-01, 1400/04/10
Expected recruitment end date
2021-08-06, 1400/05/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of endurance, resistance and combined training (resistance-endurance) on the levels of Pentraxin 3, Galectin 3 and some inflammatory mediators in obese women
Public title
The effect of endurance, resistance and combination training on some inflammatory mediators in obese women
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Overweight women with a body mass index above 30 No history of regular physical activity in the past year Having a general level of physical and mental health
Exclusion criteria:
Having type 2 diabetes Cardiovascular diseases Drug or alcohol addiction
Age
From 20 years old to 35 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 48
Randomization (investigator's opinion)
Randomized
Randomization description
Using the lottery method The names of the subjects are written on 40 separate pieces of paper and placed in a container. The names of the subjects are then randomly extracted and placed in the intervention or placebo group. The first 30 names are in the intervention group and the rest are in the placebo group.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Factorial
Other design features
This study is a randomized factorial clinical trial. The target population includes 48 obese women in Tehran. People will be divided into four groups of 12 people.

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committee of the Faculty of Physical Education and Sports Sciences, University of Tehran
Street address
Thirteenth floor, Block A, Central headquarters of the Ministry of Health, Qads town
City
Tehran
Province
Tehran
Postal code
3144685543
Approval date
2021-03-14, 1399/12/24
Ethics committee reference number
IR.UT.SPORT.REC.1400.006

Health conditions studied

1

Description of health condition studied
Overweight and obesity
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
Pentraxine 3
Timepoint
First, the end of the study
Method of measurement
Kit Eliza

2

Description
Galactin 3
Timepoint
First, the end of the study
Method of measurement
Kit Eliza

3

Description
Tumor necrosis factor-a (TNF-a)
Timepoint
First, the end of the study
Method of measurement
Kit Eliza

4

Description
Serum Amyloid A (SAA)
Timepoint
First, the end of the study
Method of measurement
Kit Eliza

Secondary outcomes

1

Description
Insulin
Timepoint
First, the end of the study
Method of measurement
Insulin Eliza Kit

2

Description
Glucose
Timepoint
First, the end of the study
Method of measurement
Glucose Assessment Kit

Intervention groups

1

Description
Control group: 12 obese women without regular exercise
Category
Prevention

2

Description
Intervention group: Endurance exercise (performed by 12 obese women for 12 weeks and 3 sessions per week, 30 minutes on a treadmill with 60% heart rate) is performed before and after exercise for 15 minutes, warming up and cooling down, respectively.
Category
Prevention

3

Description
Intervention group: Resistance training (will be performed by 12 obese women for 12 weeks and 3 sessions per week. Each resistance training session will be about 30 minutes, which will include four sets with 8-12 repetitions and 10RM intensity, which includes leg presses, forward leg movements, Sit on the back of the foot, chest press and paddle.) Warm up and cool down for 15 minutes before and after exercise, respectively.10RM is approximately equal to 75% of 1RM.
Category
Prevention

4

Description
Intervention group: Combined exercise (endurance-resistance) :( will be performed by 12 obese women for 12 weeks and 3 sessions per week. The combined exercise program in each session will include 15 minutes of aerobic exercise and 15 minutes of resistance exercise (two sets for each movement) .) Warm up and cool down for 15 minutes before and after training, respectively.
Category
Prevention

Recruitment centers

1

Recruitment center
Name of recruitment center
Medical University Tehran
Full name of responsible person
Kooti Mahrokh
Street address
Medical School,Poursina St, Enghelab St.
City
Tehran
Province
Tehran
Postal code
1411763151
Phone
+98 21 8889 6696
Email
kooti.mahrokh@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
University of Tehran
Full name of responsible person
Rahimian Mohammad
Street address
In front of the university dormitory, Amirabad, Kargarshamali street
City
Tehran
Province
Tehran
Postal code
1417935840
Phone
+98 21 8835 1730
Email
rahimian@ut.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 Tehran
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
The University of Tehran
Full name of responsible person
Kooti Mahrokh
Position
Student
Latest degree
Ph.D.
Other areas of specialty/work
Physiology
Street address
No. 14, Behesh Asa alley, Shariati, Mirdamad
City
Tehran
Province
Tehran
Postal code
1911861021
Phone
+98 21 2211 1449
Email
kooti.mahrokh@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
The University of Tehran
Full name of responsible person
Soori Rahman
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Physiology
Street address
Amirabad Street, in front of the university dormitory
City
Teran
Province
Tehran
Postal code
1417935840
Phone
+98 21 8835 1740
Email
soori@ut.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
The University of Tehran
Full name of responsible person
Kooti Mahrokh
Position
Student
Latest degree
Ph.D.
Other areas of specialty/work
Physiology
Street address
No. 14, Behesh Asa alley, Shariati, Mirdamad
City
Tehran
Province
Tehran
Postal code
1911861021
Phone
+98 21 2211 1449
Email
kooti.mahrokh@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
Undecided - It is not yet known if there will be 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
Not applicable
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