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The effect of eight weeks of high intensity interval and continuous training on galectin 3, GDF15, NT-ProBNP and IL6 in overweight men

Protocol summary

Study aim
The aim of this study was to evaluate the effect of eight weeks of intense and continuous intermittent training on galactin 3, growth differentiating factor 15, NT-proBNP and interleukin 6 in overweight men.
Design
In this study, 36 overweight men participated voluntarily who were randomly divided into three groups of control, continuous training and high intensity interval training.
Settings and conduct
The present study is conducted in Ahar city. Training protocols run for three sessions per week for eight weeks. Blood samples are taken from the subjects in two stages before the test and after the test.
Participants/Inclusion and exclusion criteria
Criteria for selection of individuals, being male, age range between 23 to 28 years and body mass index between 25 to 30, Lack of cardiovascular, liver, kidney and pulmonary disease and serious physical and orthopedic injuries, as well as lack of regular exercise in the year leading to the study.
Intervention groups
High intensity interval training group and continuous training group and control group.The intense interval training group first warmed up on the treadmill for 10 minutes with an intensity of 40-50% of the maximum heart rate, and then the main program, which included 4 repetitions of 4 minutes of activity, was performed. Between each workout was a 3-minute active rest session with an intensity of 50-40 percent of the maximum heart rate. The moderate-intensity continuous training protocol included 4 minutes of warm-up with 40 to 50 percent of maximum heart rate and 40 minutes of running with 60 to 70 percent of heart rate. Finally, 3 minutes of cooling with 50 percent intensity is included. The control group did not have any training during this period.
Main outcome variables
Galectin-3; GDF-15; NT-proBNP, which are predictors of cardiovascular status.

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20201108049299N1
Registration date: 2020-12-06, 1399/09/16
Registration timing: retrospective

Last update: 2020-12-06, 1399/09/16
Update count: 0
Registration date
2020-12-06, 1399/09/16
Registrant information
Name
mohammad moradi
Name of organization / entity
University of tehran
Country
Iran (Islamic Republic of)
Phone
+98 41 4422 9447
Email address
m.moradi13@ut.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-09-24, 1398/07/02
Expected recruitment end date
2019-10-02, 1398/07/10
Actual recruitment start date
2019-09-24, 1398/07/02
Actual recruitment end date
2019-10-02, 1398/07/10
Trial completion date
2019-11-28, 1398/09/07
Scientific title
The effect of eight weeks of high intensity interval and continuous training on galectin 3, GDF15, NT-ProBNP and IL6 in overweight men
Public title
The effect of two types of exercise on some predictors of cardiovascular status in overweight men
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Age range between 23 and 28 BMI between 25 and 30 Male gender
Exclusion criteria:
No history of known cardiovascular, hepatic, renal, pulmonary and diabetic diseases, hypothyroidism No serious physical injury and orthopedics Do not take food and medicine supplements no regular exercise in the year leading up to the study
Age
From 23 years old to 28 years old
Gender
Male
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 36
Actual sample size reached: 36
Randomization (investigator's opinion)
Randomized
Randomization description
Simple Random
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 Tehran University
Street address
No. 25, Yakhchal Ave., Sheikh shahab Blvd.
City
Ahar
Province
East Azarbaijan
Postal code
5451777485
Approval date
2019-07-15, 1398/04/24
Ethics committee reference number
IR.UT.SPORT.REC.1398.031

Health conditions studied

1

Description of health condition studied
Overweight
ICD-10 code
E66.3
ICD-10 code description
Overweight

Primary outcomes

1

Description
Galectin 3
Timepoint
Two days before the start of the study and two days after the end of the study (eight weeks of study)
Method of measurement
Blood draw from arm vein and laboratory kit of galectin 3

2

Description
Interleukin 6
Timepoint
Two days before the start of the study and two days after the end of the study (eight weeks of study)
Method of measurement
Blood draw from arm vein and laboratory kit of Interleukin6

3

Description
NT-ProB-Type Natriuretic Peptide (BNP)
Timepoint
Two days before the start of the study and two days after the end of the study (eight weeks of study)
Method of measurement
Blood draw from arm vein and laboratory kit of NT-ProBNP

4

Description
Growth Differentiation Factor-15 (GDF15)
Timepoint
Two days before the start of the study and two days after the end of the study (eight weeks of study)
Method of measurement
Blood draw from arm vein and laboratory kit of GDF15

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group 1: High intensity interval training with three sessions of interval training protocol each week for eight weeks.
Category
N/A

2

Description
Intervention group 2: Continuous training that performed three sessions of continuous training protocol every eight weeks.
Category
N/A

3

Description
Control group: did not have any exercise activities during the study.
Category
N/A

Recruitment centers

1

Recruitment center
Name of recruitment center
Ahar city
Full name of responsible person
Mohammad Moradi
Street address
Ahar Azad University Sports Gym., Ahar-Tabriz Road
City
Ahar
Province
East Azarbaijan
Postal code
5451116714
Phone
+98 41 4423 9758
Email
m.moradi13@ut.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
The University of Tehran
Full name of responsible person
Ali Akbarnejad
Street address
Faculty of Physical Education and Sport Sciences, Kargar Shomali Ave., Engelab Sq
City
Tehran
Province
Tehran
Postal code
6619-14155
Phone
+98 21 8835 1730
Email
infosport@ut.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
personal expenses
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
Persons

Person responsible for general inquiries

Contact
Name of organization / entity
The University of Tehran
Full name of responsible person
Mohammad Moradi
Position
PHD Student
Latest degree
Master
Other areas of specialty/work
Physical Education
Street address
No. 25 Yakhchal Ave., Sheikh Shahab Blvd
City
Ahar
Province
East Azarbaijan
Postal code
5451777485
Phone
+98 41 4422 9447
Email
m.moradi13@ut.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
The University of Tehran
Full name of responsible person
Mohammad Moradi
Position
PHD Student
Latest degree
Ph.D.
Other areas of specialty/work
Physiology of Exercise
Street address
No. 25, Yakhchal Ave., Sheikh Shahab Blvd., Ahar
City
Ahar
Province
East Azarbaijan
Postal code
5451777485
Phone
+98 41 4422 9447
Fax
Email
m.moradi13@ut.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
University of tehran
Full name of responsible person
Mohammad Moradi
Position
PHD student
Latest degree
Ph.D.
Other areas of specialty/work
Physiology of exercise
Street address
No.25 , Yakhchal Ave., sheikh shahab Blvd. , Ahar
City
Ahar
Province
East Azarbaijan
Postal code
5451777485
Phone
+98 41 4422 9447
Fax
Email
m.moradi13@ut.ac.ir

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Yes - There is 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
Not applicable
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
No - There is not a plan to make this available
Data Dictionary
Not applicable
Title and more details about the data/document
Sample data can be shared on average in a table
When the data will become available and for how long
Access period starts 6 months after the results are published
To whom data/document is available
Researchers working in academic and scientific institutions
Under which criteria data/document could be used
To use data for research work
From where data/document is obtainable
University of Tehran Faculty of Physical Education infosport@ut.ac.ir http://www.sport.ut.ac.ir 02188351730
What processes are involved for a request to access data/document
Refer to the library unit of the Faculty of Physical Education, University of Tehran
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