Protocol summary

Study aim
Comparison of aerobic and Karate training on body composition and physical fitness in obese girls
Design
Randomized clinical trial with control group, non blinded, with parallel groups
Settings and conduct
Among elementary obese girls in one of the selected schools in Rasht, 45 volunteers girl will be selected as the study population and randomly divide into three group: aerobic group, karate group and control group
Participants/Inclusion and exclusion criteria
Inclusion methods: have age ranges 10-12 years old, be obese be girl, not engaged in structured exercise for at least three last months
Intervention groups
Aerobic group: eight weeks of aerobic exercises, 3 sessions per week, aerobic exercise including Aerobic rhythmic movements as well as physical fitness exercises include walking, climbing, Roping and jumping with an intensity of 65 to 75% of maximum heart rate Karate group: Basic techniques include: Cuki-Waza, Geri-Waza, Uke-Waza, Daci- Waza, Set 10 (duplicate) with 1 minute rest between sets and 1 minute and 30 seconds of rest between each technique, 5. Kumite for 5 minutes. Control group: Without any intervention, subjects in this group will continue their normal routine during the 8 week study period
Main outcome variables
Body composition, physical fitness, movement skill and object control, Physical self understanding

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20150531022498N25
Registration date: 2018-08-02, 1397/05/11
Registration timing: retrospective

Last update: 2018-08-02, 1397/05/11
Update count: 0
Registration date
2018-08-02, 1397/05/11
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
Expected recruitment start date
2017-09-22, 1396/06/31
Expected recruitment end date
2017-10-22, 1396/07/30
Actual recruitment start date
2017-09-22, 1396/06/31
Actual recruitment end date
2017-10-22, 1396/07/30
Trial completion date
empty
Scientific title
Comparison of aerobic and Karate training on body composition and physical fitness in obese girls
Public title
Aerobic training and Karate in obese girls
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Have age ranges 10-12 years old Be obese Be girl Not engaged in structured exercise for at least three last months
Exclusion criteria:
Not regular participation in training sessions
Age
From 10 years old to 12 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 45
Actual sample size reached: 45
Randomization (investigator's opinion)
Randomized
Randomization description
Assigning samples using simple random-lottery method
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 Rasht Azad University
Street address
Islamic Azad University Rasht Branch, Taleshan Bridge, Rasht
City
Rasht
Province
Guilan
Postal code
4147654919
Approval date
2017-09-19, 1396/06/28
Ethics committee reference number
IR.IAU.RASHT.REC.1395.86

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
Body composition
Timepoint
Before and after the end of 8 weeks of training
Method of measurement
Using by measurement of weight, body mass index (BMI), fat percent, fat free mass

2

Description
Physical fitness
Timepoint
Before and after the end of 8 weeks of training
Method of measurement
Using by measurement of Right upper and upper left muscle strength, abdominal muscular endurance, flexibility, agility, maximal oxygen consumption (Vo2max)

3

Description
Handling skills and object control
Timepoint
Before and after the end of 8 weeks of training
Method of measurement
Using by Ulrich test

4

Description
Physical self understanding
Timepoint
Before and after the end of 8 weeks of training
Method of measurement
Using by Piers-Harissis children’s self concept scale questionnaire

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: Eight weeks of aerobic exercises, 3 sessions per week, aerobic exercise including Aerobic rhythmic movements as well as physical fitness exercises include walking, climbing, Roping and jumping with an intensity of 65 to 75% of maximum heart rate
Category
Prevention

2

Description
Intervention group: Karate group: Basic techniques include: Cuki-Waza, Geri-Waza, Uke-Waza, Daci- Waza, Set 10 (duplicate) with 1 minute rest between sets and 1 minute and 30 seconds of rest between each technique, 5. Kumite for 5 minutes.
Category
Prevention

3

Description
Control group: Without any intervention, subjects in this group will continue their normal routine during the 8 week study period
Category
Prevention

Recruitment centers

1

Recruitment center
Name of recruitment center
Selected schools in Rasht
Full name of responsible person
Seyedeh Fatemeh Mosavi
Street address
Education city of Rasht, Rasht
City
Rasht
Province
Guilan
Postal code
4147654919
Phone
+98 13 3342 4080
Email
Mousavifatemeh1993@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Islamic Azad University
Full name of responsible person
Ali Delpasand
Street address
Islamic Azad University Rasht Branch, Taleshan Bridge, Rasht
City
Rasht
Province
Guilan
Postal code
4147654919
Phone
+98 13 3336 4861
Email
shabani_msn@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
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
Full name of responsible person
Seyede Fatemeh mousavi
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Physical training
Street address
Islamic Azad University Rasht Branch, Taleshan Bridge, Rasht
City
Rasht
Province
Guilan
Postal code
4167654919
Phone
+1 333423308
Email
Mousavifatemeh1993@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Dr ramin shabani
Position
Associate Professor
Latest degree
Ph.D.
Other areas of specialty/work
Exercise physiology
Street address
Islamic Azad University Rasht Branch, Taleshan Bridge, Rasht
City
Rasht
Province
Guilan
Postal code
4147654919
Phone
+1 333423308
Email
shabani_msn@yahoo.com

Person responsible for updating data

Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Marzieh Nazari
Position
Phd student
Latest degree
Master
Other areas of specialty/work
Exercise physiology
Street address
Islamic Azad University Rasht Branch, Taleshan Bridge, Rasht
City
Rasht
Province
Guilan
Postal code
4147654919
Phone
+1 333422153
Email
marzieh.nazari.v@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
Undecided - It is not yet known if there will be a plan to make this available
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