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The effectiveness of resistance and aerobic trainings on serum levels of TSH and GH, body composition and cognitive functions indexes in adolescents

Protocol summary

Study aim
The effectiveness of resistance and aerobic trainings on serum levels of TSH and GH, body composition and cognitive functions indexes in adolescents
Design
In the first phase of the study, girls and boys subjects were selected and a relationship was made between the amount of daily physical activity and some of the desired variables. In the second phase of the study, subjects will be randomly divided into 12 groups. The trial did not have a drug intervention and therefore there is no blinding. Stratified randomization will be used for grouping .
Settings and conduct
After the call is published in the first secondary schools of the city and suburbs, subjects will be stratified randomization were selected. Different stages of study will be done in Islamic Azad University of Aliabad Katoul branch.
Participants/Inclusion and exclusion criteria
Entry requirements: - Being between 11 and 15 years old - Studying in one of the first secondary schools of Aliabad city - Consent of the family for their child's participation in the trial - Ability to participate in physical exercises Removal conditions: - Taking a specific drug - Suffering from specific physical or mental diseases - Drug abuse - lack of education
Intervention groups
intervention groups: - Active group (boys and girls) including groups: resistance training, aerobic training, control - Inactive group (boys and girls) including groups: resistance training, aerobic training, control A total of 12 groups
Main outcome variables
Daily physical activity level, TSH and GH hormones, body mass index, body fat, body fat percentage, body fat free mass, body fat free mass percentage, waist circumference, short-term working memory, processing process, reaction time, number of errors

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20180712040448N2
Registration date: 2023-06-01, 1402/03/11
Registration timing: registered_while_recruiting

Last update: 2023-06-01, 1402/03/11
Update count: 0
Registration date
2023-06-01, 1402/03/11
Registrant information
Name
Reza Rezaeshirazi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 17 3323 7714
Email address
Dr.rezaee@aliabadiau.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-05-22, 1402/03/01
Expected recruitment end date
2023-09-21, 1402/06/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effectiveness of resistance and aerobic trainings on serum levels of TSH and GH, body composition and cognitive functions indexes in adolescents
Public title
The effect of physical exercises on TSH, GH, body composition indices and cognitive functions
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Being between 11 and 15 years old Studying in one of the first secondary schools of Aliabad Katul city Consent of the family for their child's participation in the trial Ability to participate in physical exercises
Exclusion criteria:
Taking a specific drug Suffering from specific physical or mental diseases Drug abuse lack of education
Age
From 11 years old to 15 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 600
Randomization (investigator's opinion)
Randomized
Randomization description
Participants were selected by stratified randommization and will be divided into research groups. Randomization Unit: Individual Randomization tool: Table of Morgan random numbers table The participants will be divided into boy and girl groups and then into active and inactive groups. Then they will be placed in the following groups: aerobic exercise, resistance exercise and control.
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 Islamic Azad University, Aliabad Katul Branch
Street address
Aliabad Katul city - University Blvd - 4941793451
City
Aliabad Katul
Province
Golestan
Postal code
4941793451
Approval date
2023-01-08, 1401/10/18
Ethics committee reference number
IR.IAU.AK.REC.1401.003

Health conditions studied

1

Description of health condition studied
Examining changes in TSH hormone
ICD-10 code
E22.9
ICD-10 code description
Hyperfunction of pituitary gland, unspecified

2

Description of health condition studied
Examining changes in GH hormone
ICD-10 code
E22.9
ICD-10 code description
Hyperfunction of pituitary gland, unspecified

3

Description of health condition studied
Examining changes in body composition indices
ICD-10 code
E66.09
ICD-10 code description
Other obesity due to excess calories

4

Description of health condition studied
Examining changes in cognitive function
ICD-10 code
F99
ICD-10 code description
Mental disorder, not otherwise specified

Primary outcomes

1

Description
TSH blood levels
Timepoint
Measurement of TSH blood levels at the beginning of the second phase study (before the start of the intervention) and 16 weeks later
Method of measurement
laboratory kit

2

Description
GH blood levels
Timepoint
Measurement of GH blood levels at the beginning of the second phase study (before the start of the intervention) and 16 weeks later
Method of measurement
laboratory kit

3

Description
BMI
Timepoint
At the beginning of the first phase of the study and its end
Method of measurement
BMI Formula

4

Description
Short term working memory
Timepoint
At the beginning of the first phase of the study, the beginning of the second phase of the study and its end
Method of measurement
digit span forward test

5

Description
Amount of daily physical activity
Timepoint
At the beginning of the first phase of the study
Method of measurement
International Physical Activity Questionnaire (IPAQ) – Long Form

6

Description
Body fat percentage
Timepoint
At the beginning of the first phase of the study and its end
Method of measurement
Jackson-Pollock Formula

7

Description
Lean body mass percentage
Timepoint
At the beginning of the first phase of the study and its end
Method of measurement
Jackson Pollock's complementary formula

8

Description
processing speed
Timepoint
At the beginning of the first phase of the study, the beginning of the second phase of the study and its end
Method of measurement
digit-symbol coding test

9

Description
reaction time
Timepoint
At the beginning of the first phase of the study, the beginning of the second phase of the study and its end
Method of measurement
computer modified Stroop color-word test

10

Description
error number
Timepoint
At the beginning of the first phase of the study, the beginning of the second phase of the study and its end
Method of measurement
computer modified Stroop color-word test

11

Description
Body fat mass
Timepoint
At the beginning of the first phase of the study and its end
Method of measurement
FM formula

12

Description
Fat-free body mass
Timepoint
At the beginning of the first phase of the study and its end
Method of measurement
PFFM formula

13

Description
waist circumference
Timepoint
At the beginning of the first phase of the study and its end
Method of measurement
tape measure

Secondary outcomes

1

Description
lipid profile
Timepoint
At the beginning of the second phase the study (before the start of the intervention) and 16 weeks later
Method of measurement
laboratory kit

2

Description
Glucose
Timepoint
At the beginning of the second phase the study (before the start of the intervention) and 16 weeks later
Method of measurement
laboratory kit

3

Description
height
Timepoint
At the beginning of the first phase of the study, at the beginning of the second phase of the study and its end
Method of measurement
tape measure

4

Description
Weight
Timepoint
At the beginning of the first phase of the study, at the beginning of the second phase of the study and its end
Method of measurement
digital Balance

5

Description
blood pressure
Timepoint
At the beginning of the first phase of the study, at the beginning of the second phase of the study and its end
Method of measurement
Sphygmomanometer

6

Description
Muscle strength
Timepoint
At the beginning of the first phase of the study, at the beginning of the second phase of the study and its end
Method of measurement
1 RM Formula

7

Description
aerobic power
Timepoint
At the beginning of the first phase of the study, at the beginning of the second phase of the study and its end
Method of measurement
submaximal treadmill test

8

Description
Personality measurement
Timepoint
At the beginning of the first phase of the study and its end
Method of measurement
Eysenck Eysenck Personality Questionnaire (JEPQ) Questionnaire (JEPQ)

9

Description
academic motivation
Timepoint
At the beginning of the first phase of the study and its end
Method of measurement
Harter's standard academic motivation questionnaire

10

Description
moods
Timepoint
At the beginning of the first phase of the study and its end
Method of measurement
Brunel Mood Scale Questionnaire

11

Description
General Health
Timepoint
At the beginning of the first phase of the study and its end
Method of measurement
General Health Questionare (GHQ-28)

12

Description
Internet Addiction
Timepoint
At the beginning of the first phase of the study and its end
Method of measurement
Young's Internet Addiction Questionnaire

13

Description
Appetite
Timepoint
At the beginning of the first phase of the study and its end
Method of measurement
Adolescent Food Habits Checklist (Johnson & et al)

14

Description
Complete Blood count (CBC)
Timepoint
At the beginning of the second phase the study (before the start of the intervention) and 16 weeks later
Method of measurement
Fluorescece Flow Cytometry

15

Description
Speed
Timepoint
At the beginning of the first phase of the study, at the beginning of the second phase of the study and its end
Method of measurement
60 yard test

16

Description
legs explosive power
Timepoint
At the beginning of the first phase of the study, at the beginning of the second phase of the study and its end
Method of measurement
Sargent Jump Test

17

Description
Hands explosive power
Timepoint
At the beginning of the first phase of the study, at the beginning of the second phase of the study and its end
Method of measurement
Medicine ball throw

18

Description
agility
Timepoint
At the beginning of the first phase of the study, at the beginning of the second phase of the study and its end
Method of measurement
T test

Intervention groups

1

Description
Intervention group: Resistance training: Each participant’s 6 repetition maximum (6 RM) will use to estimate their 1 RM using the Brzycki formula (%1RM = 102.78–2.78 * repetitions). This will use to determine the load corresponding to the prescribed intensity (% of 1RM) for the first week of training. The resistance training program will inform by accepted guidelines for resistance training in youth and involved a twice a week progressive periodized program including a variety of exercises for all major muscle groups using resistance machine exercises and free weights (bars and dumbbells), medicine balls, Bosu and Swiss balls. Participants perform between 2 and 4 sets of an exercise with between 30–120 seconds rest between sets. Overall, intensity will increase across the 16 weeks such that during weeks 1–5; 16–20 RM with 30 seconds rest between sets, in weeks 6–10; between 8–14 RM, with between 30–120 seconds inter-set rest, and in weeks 11–16; between 6 and 12 RM with 30–120 seconds inter-set rest.
Category
Lifestyle

2

Description
Intervention group: Aerobic training: The intensity of the sessions was progressively will increase from moderate to vigorous across the course of the intervention. In order to determine the HR range which corresponded to the prescribed intensity, we will estimate maximum heart rate according to the Astrand’s formula (HR max = 216.6 –(0.84 x age)). Intensity and duration will progresse across the 16-week program as follows: weeks 1–3; 20 minutes at 65–75% of estimated max HR; weeks 4–6; 30 mins at 65–75%, weeks 7–12; 30 minutes at 70–80%, weeks 13–16; 35 minutes at 70–80%. The principal activities will use in aerobic are variations in straight line and multi directional jogging/running, with obstacles such as cones, hoops and speed ladders. Sessions also include step aerobics and sports orientated sessions incorporating balls.
Category
Lifestyle

3

Description
Control group: They received no intervention without any lifestyle changes.
Category
N/A

Recruitment centers

1

Recruitment center
Name of recruitment center
First Secondary Schools of Aliabad Katoul ity
Full name of responsible person
Reza Rezaeeshirazi
Street address
Islamic Azad University, Aliabad Katul Branch, University Blvd
City
Aliabad Katoul
Province
Golestan
Postal code
93451-49417
Phone
+98 17 3422 3300
Fax
+98 17 3422 5673
Email
Dr.Rezaee@aliabadiau.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Islamic Azad University Aliabad Katoul Branch
Full name of responsible person
Salman Amirkhan
Street address
Islamic Azad University, Aliabad Katul Branch, University Blvd
City
Aliabad Katoul
Province
Golestan
Postal code
93451-49417
Phone
+98 17 3422 3300
Email
salman_amirkhani@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Islamic Azad University Aliabad Katoul Branch
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
Academic

Person responsible for general inquiries

Contact
Name of organization / entity
Islamic Azad University Aliabad Katoul Branch
Full name of responsible person
Reza Rezaeeshirazi
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Sport Physiology
Street address
Aliabad Katul City - University Blvd
City
Aliabad Katoul
Province
Golestan
Postal code
4941793451
Phone
+98 17 3422 2300
Email
Dr.Rezaee@aliabadiau.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Islamic Azad University Aliabad Katoul Branch
Full name of responsible person
Reza Rezaeeshirazi
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Sport Physiology
Street address
Aliabad Katul City - University Blvd
City
Aliabad Katoul
Province
Golestan
Postal code
4941793451
Phone
+98 17 3422 2300
Email
Dr.Rezaee@aliabadiau.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Islamic Azad University Aliabad Katoul Branch
Full name of responsible person
Reza Rezaeeshirazi
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Sport Physiology
Street address
Aliabad Katul City - University Blvd
City
Aliabad Katoul
Province
Golestan
Postal code
4941793451
Phone
+98 17 3422 2300
Email
Dr.Rezaee@aliabadiau.ac.ir

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
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
All information except statistical data; It can be shared after de-identifying the participants.
When the data will become available and for how long
The access period starts 6 months after the results are published
To whom data/document is available
Only for researchers working in academic and scientific institutions
Under which criteria data/document could be used
Teaching how to sample, randomize, implement the protocol and use tools and tests
From where data/document is obtainable
Dr. reza Rezaeeshirazi Dr.Rezaee@aliabadiau.ac.ir
What processes are involved for a request to access data/document
The applicant will receive the desired answer two weeks after submitting her/his application via email.
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