Protocol summary

Summary
The main objective of this researchComparison the effects of a period of concurrent training on some physical fitness factors, body composition and blood biochemical parameters and glucose homeostasis and leptin,cortisol and testosterone and levels of inflammatory and coagulation markers with normal weight and obese Design: Is a prevention trial. How do 30girls 15-13 years Voluntarily In this study, there will be Which is based on objective In two groups 15 people Normal weigh and Obese Divided. Exclusion criteria: Unwillingness to participate in research Interventions: Subjects For 6 weeks in Schedule At the same time exercise endurance and Pilates Will participate. Changes the primary outcome: Glucose homeostasis, Blood biochemical parameters and leptin,cortisol and testosterone and levels of inflammatory and coagulation markers , Fitness tests Contains : Shuttle run test and Wingate Also Body Composition Will be examined

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2016022222498N7
Registration date: 2016-09-13, 1395/06/23
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2016-09-13, 1395/06/23
Registrant information
Name
Ramin Shabani
Name of organization / entity
Islamic Azad University
Country
Iran (Islamic Republic of)
Phone
+98 13 3375 2715
Email address
shabani@iaurasht.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice Chancelior of Reserch,University of Islamic Azad,RashtBrach
Expected recruitment start date
2015-06-22, 1394/04/01
Expected recruitment end date
2015-07-23, 1394/05/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison the effects of a period of concurrent training on some physical fitness factors, body composition and blood biochemical parameters and glucose homeostasis and leptin,cortisol and testosterone and levels of inflammatory and coagulation markers with normal weight and obese
Public title
Comparison the effects of a period of concurrent training on some physical fitness factors, body composition and blood biochemical parameters and glucose homeostasis and leptin,cortisol and testosterone and levels of inflammatory and coagulation markers with normal weight and obese female students
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: female students aged13to15 years old; and with normal weight and obese Exclusion criteria: Unwillingness to participate.
Age
From 81 years old to 79 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 30
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committee of Islamic Azad University, Rasht, Science and R
Street address
Lakan Gate, Azad University Of Rasht Branch, Guilan
City
Rasht
Postal code
Approval date
2015-08-11, 1394/05/20
Ethics committee reference number
IR.IAU.RASHT.REC.1395.5

Health conditions studied

1

Description of health condition studied
Obesity
ICD-10 code
E66.0
ICD-10 code description
Obesity due to excess calories

Primary outcomes

1

Description
Insulin resistance
Timepoint
Before and after 6 Weekexerciese
Method of measurement
it was measured with HOMA-IR index

2

Description
Insulin
Timepoint
Before and after 6 Weekexerciese
Method of measurement
Accordingmg/dl and Blood samples

3

Description
Fasting blood glu cosse
Timepoint
Before and after 6 Weekexerciese
Method of measurement
Accordingmg/dl and Blood samples

4

Description
Total Cholesterol
Timepoint
Before and after 6 Weekexerciese
Method of measurement
Accordingmg/dl and Blood samples

5

Description
Triglycerides
Timepoint
Before and after 6 Weekexerciese
Method of measurement
Accordingmg/dl and Blood samples

6

Description
High-densityLipoprotein
Timepoint
Before and after 6 Weekexerciese
Method of measurement
Accordingmg/dl and Blood samples

7

Description
Low-densityLipoprotein
Timepoint
Before and after 6 Weekexerciese
Method of measurement
Accordingmg/dl and Blood samples

8

Description
Cortisol
Timepoint
Before and after 6 Weekexerciese
Method of measurement
Specific Kits

9

Description
Testosterone
Timepoint
Before and after 6 Weekexerciese
Method of measurement
Specific Kits

10

Description
Leptin
Timepoint
Before and after 6 Weekexerciese
Method of measurement
Specific Kits

11

Description
Inflammatory markers and coagulation
Timepoint
Before and after 6 Weekexerciese
Method of measurement
Specific Kits

12

Description
Fibrinogen
Timepoint
Before and after 6 Weekexerciese
Method of measurement
Specific Kits

13

Description
Hs-CRP
Timepoint
Before and after 6 Weekexerciese
Method of measurement
Specific Kits

14

Description
CBC
Timepoint
Before and after 6 Weekexerciese
Method of measurement
Specific Kits

Secondary outcomes

1

Description
Fitness Indicators
Timepoint
Befor Exercise Training-6Week after Excercise Training
Method of measurement
Shattel run Test-wingate Test

2

Description
Body composition
Timepoint
Befor Exercise Training-6Week after Excercise Training
Method of measurement
BMI-WHR-BF%

Intervention groups

1

Description
6 weeks endurance and pilates concurrent Exercises
Category
N/A

Recruitment centers

1

Recruitment center
Name of recruitment center
Education
Full name of responsible person
Najmeh Abbaspour
Street address
Lakan, Rasht
City
Rasht

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice chancellor for research, University of Islamic Azad, Science and Research of Rasht branch
Full name of responsible person
Dr Ramin Shabani
Street address
Lakan Gate, Azad University, Rasht Branch
City
Rasht
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for research, University of Islamic Azad, Science and Research of Rasht branch
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty

Person responsible for general inquiries

Contact
Name of organization / entity
Islamic Azad University,Rasht Branch
Full name of responsible person
Faeghe gahangiri
Position
MSC
Other areas of specialty/work
Street address
lakan Gate, Azad University, Rasht Branch, Rasht,Guilan
City
Rasht
Postal code
3516-41335
Phone
+98 13 4224 2676
Fax
Email
faeghejahangiri303@hotmail.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Islamic Azad University,RashtBranch
Full name of responsible person
Dr Ramin Shabani
Position
PhD
Other areas of specialty/work
Street address
lakan Gate, Azad University, Rasht Baranch
City
RASHT
Postal code
3516-41335
Phone
+98 13 3443 0503
Fax
Email
shabani@iaurasht.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Islamic Azad University,RashtBranch
Full name of responsible person
Sakineh Hooshyari
Position
MA
Other areas of specialty/work
Street address
Lakan Gate, Islamic Azad University, Rasht Branch, Guilan
City
Rasht
Postal code
3516-41335
Phone
+98 13 4224 2676
Fax
Email
lllsepide_hooshyari@yahoo.comfaeghejahangiri303@hotmail.com
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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