Protocol summary

Study aim
The aim of this study was to determine the effect of eight weeks of bipolar training on Growth Hormone - Insulin-like growth factor-1axis serum indexes of active young men.
Design
Clinical trial with control group, with parallel groups, double-blind, randomized
Settings and conduct
After filling out a special questionnaire to determine the level of physical activity and obtaining consent, they will be selected as subjects. The sample will be selected from the students of Tabriz University. Before and after eight weeks of blood sampling practice, Bruce test and Wingate test will be used to evaluate the performance.
Participants/Inclusion and exclusion criteria
Entry requirements: No metabolic and metabolic diseases Age: 25-18 years Fat percentage between 22-17% Body mass index between 19-25 kg / m2. No entry conditions: smoking Having an underlying disease Age outside the scope of the study Percentage of fat outside the scope of the study Body mass index outside the scope of the study Have a regular workout schedule for the past six months
Intervention groups
1. Medium to Intense Continuous Exercise, 2. Intense Interval Exercise, 3. Bipolar Exercise Volume and 4. Control Group
Main outcome variables
Serum indexes of Growth Hormone - Insulin-like growth factor-1 axis and function of active young men

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20210817052212N1
Registration date: 2021-11-12, 1400/08/21
Registration timing: prospective

Last update: 2021-11-12, 1400/08/21
Update count: 0
Registration date
2021-11-12, 1400/08/21
Registrant information
Name
Behzad Azadi
Name of organization / entity
Mohageg Ardabili University
Country
Iran (Islamic Republic of)
Phone
+98 41 3288 6341
Email address
l_bolboli@uma.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-11-20, 1401/08/29
Expected recruitment end date
2023-01-15, 1401/10/25
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effectiveness of eight weeks of continuous, interval and bipolar training on serum indexes of growth hormone insulin-like growth factor-1axis and performance in active young men
Public title
Effect of eight week continuance, interval and polarized training on serum level indexes of insulin-like growth factor-1 axis and performance in active young men
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Non metabolic disease Age: 25-18 years Fat percentage between 22-17% Body mass index between 19-25 kg / m2
Exclusion criteria:
smoking Age outside the scope of the study Having an underlying disease Have a training program in the last six months
Age
From 18 years old to 25 years old
Gender
Male
Phase
N/A
Groups that have been masked
  • Care provider
  • Data analyser
Sample size
Target sample size: 40
Randomization (investigator's opinion)
Randomized
Randomization description
After selecting the subjects, they were randomly divided into four homogeneous groups(Simple randomization)
Blinding (investigator's opinion)
Double blinded
Blinding description
In this study, educators and data analysts will be kept blind
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
Street address
University of Tabriz., University Square.,Tabriz
City
Tabriz
Province
East Azarbaijan
Postal code
5166616471
Approval date
2020-09-25, 1399/07/04
Ethics committee reference number
IR.TABRIZU.REC.1399.064

Health conditions studied

1

Description of health condition studied
It is not a disease
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
Serum indices of Growth Hormone - Insulin-like growth factor-1 axis
Timepoint
Before the intervention, after the first session and after 8 weeks
Method of measurement
Blood sampling

Secondary outcomes

1

Description
Performance of active young men
Timepoint
Before and after the intervention
Method of measurement
Bruce and Wingate test

Intervention groups

1

Description
Intervention group 1: "Continuous exercise". The subjects of this group will include 10 minutes of warm-up with a variety of stretching, flexibility, walking and running. The main activity of the moderate to intense aerobic exercise group includes 30 to 50 minutes of continuous running with an intensity of 50-70% of the reserve heart rate (pressure perception of 12 to 15) and at the end 5 minutes of cooling down by walking and doing stretching exercises.
Category
N/A

2

Description
Second intervention group: "Periodic exercise". Exercises in this group include 10 minutes of warm-up with a variety of stretching, flexibility, walking and running, and the main activity of the group of subjects in this group includes 3 periods with 4 repetitions and 15-30 seconds of running with an intensity of 85-95% of the reserve heart rate. Pressure perception 16 to 19) in each repetition will be 30-30 seconds of active rest after each repetition and 3 minutes of active rest after each period (active rest in the range of 40-50% of the stored heart rate)
Category
N/A

3

Description
Third intervention group: "Bipolar exercise". The bipolar workout group will perform 80-70% of the main workout volume (30 minutes) with light to moderate intensity (50-60% reserve heart rate) and the remaining 20-30% with 85-95% reserve heart rate intensity, In this way, two periods with 3 repetitions of 15-30 seconds, which will have an active rest of 30-60 seconds after each repetition and an active rest of 3 minutes after each period.
Category
N/A

4

Description
Control group: "No training program".During this eight-week period, they will avoid regular physical activity.
Category
N/A

Recruitment centers

1

Recruitment center
Name of recruitment center
Tabriz University
Full name of responsible person
Behzad Azadi
Street address
University of Tabriz., Imam Khomeini St., 29 Bahman Blvd., Tabriz
City
Tabriz
Province
East Azarbaijan
Postal code
5166616471
Phone
+98 41 3334 0081
Email
behzadazadi2009@gmail.com

2

Recruitment center
Name of recruitment center
Tabriz University
Full name of responsible person
Behzad Azadi
Street address
University of Tabriz., Imam Khomeini St., 29 Bahman Blvd., Tabriz
City
Tabriz
Province
East Azarbaijan
Postal code
5166616471
Phone
+98 41 3334 0081
Email
behzadazadi2009@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Mohaghegh Ardabili University
Full name of responsible person
ِDr Lotfali blboli
Street address
Mohaghegh Ardabil University., End of University Street., Ardabil
City
Ardabil
Province
Ardabil
Postal code
5619913131
Phone
+98 45 3150 5000
Email
info@webenlance.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Mohaghegh Ardabili 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
Mohaghegh Ardabili University
Full name of responsible person
Behzad Azadi
Position
PhD student
Latest degree
Master
Other areas of specialty/work
Exercise physiology
Street address
Mohaghegh Ardabil University., End of University Street., Ardabil
City
Ardabil
Province
Ardabil
Postal code
5619913131
Phone
+98 45 3150 5005
Email
behzadazadi2009@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Mohaghegh Ardabili University
Full name of responsible person
Lotfali Bolboli
Position
Associate Professor
Latest degree
Ph.D.
Other areas of specialty/work
Exercise physiology
Street address
Mohaghegh Ardabil University., End of University Street., Ardabil
City
Adrdabil
Province
Ardabil
Postal code
5619913131
Phone
+98 45 3150 5355
Email
sbolboli@yahoo.com

Person responsible for updating data

Contact
Name of organization / entity
Mohaghegh Ardabili University
Full name of responsible person
Behzad Azadi
Position
PHD Student
Latest degree
Master
Other areas of specialty/work
Exercise physiology
Street address
No. 19, Jashanpour dead end., Akhooni St., Tabriz
City
Tabriz
Province
East Azarbaijan
Postal code
5451638845
Phone
+98 41 3288 6341
Email
behzadazadi2009@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
The need is not seen
Study Protocol
Yes - There is 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
Yes - There is a plan to make this available
Analytic Code
Not applicable
Data Dictionary
Not applicable
Title and more details about the data/document
Primary and secondary consequences will be shared
When the data will become available and for how long
Access since 1401
To whom data/document is available
Researchers working in academic and scientific institutions
Under which criteria data/document could be used
Send via email
From where data/document is obtainable
behzadazadi2009@gmail.com
What processes are involved for a request to access data/document
The request will be sent via registered email within one week
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