1
Clinical Trial Protocol
Iranian Registry of Clinical Trials
05 Nov 2022
Comparison of aerobic and Karate training on body composition and physical fitness in obese girls
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
2 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
3 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
4 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
