The purpose of this study is to investigate the effect of eight weeks mini-trampoline exercises on lipid profile and anthropometric indexes in 12-15 years old girls.
Design
Pretest-posttest randomized-groups design
Settings and conduct
This study will be performed in Kermanshah city. The participants will be randomly assigned into two groups of mini-trampoline and control.
Participants/Inclusion and exclusion criteria
Twelve to fifteen years old girls with overweight and without any acute or chronic disease
Intervention groups
Mini-trampoline training
Main outcome variables
lipid profile; anthropometric indices
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20170326033146N3
Registration date:2021-02-13, 1399/11/25
Registration timing:prospective
Last update:2021-02-13, 1399/11/25
Update count:0
Registration date
2021-02-13, 1399/11/25
Registrant information
Name
Vahid Tadibi
Name of organization / entity
Razi University
Country
Iran (Islamic Republic of)
Phone
+98 83 3427 9265
Email address
vahidtadibi@razi.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-04-04, 1400/01/15
Expected recruitment end date
2021-04-19, 1400/01/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of a mini trampoline training program on lipid profile and anthropometric indices in 12-15 years old overweight girls
Public title
Effect of mini trampoline on lipid profile
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Overweight based on the BMI for different ages as following: 12-12.5 years old: 21.68 - 26.66 ; 12.5-13 years old: 22.14 - 27.23 ; 13-13.5 years old: 22.58 - 27.75 ; 13.5-14 years old: 22.98 - 28.19 ; 14-14.5 years old: 23.34 - 27.56 ; 14.5-15 years old: 23.66 - 28.86
12-15 years old
Without exercise training experience during 6 months before the study
Exclusion criteria:
Any acute or chronic disease
Age
From 12 years old to 15 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
24
Randomization (investigator's opinion)
Randomized
Randomization description
Permuted block randomization; allocating of subjects will be performed using permuted block randomization with six blocks of four (two for experimental and two for the control group in each block) until reaching two equal groups of 12 in each.
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 Kermanshah Razi University
Street address
Tagh-e-Bostan, University St.
City
Kermanshah
Province
Kermanshah
Postal code
۶۷۱۴۴۱۴۹۷۱
Approval date
2021-01-27, 1399/11/08
Ethics committee reference number
IR.RAZI.REC.1399.060
Health conditions studied
1
Description of health condition studied
Overweight
ICD-10 code
E66.3
ICD-10 code description
Overweight
Primary outcomes
1
Description
Lipid profile
Timepoint
Before and after the intervention
Method of measurement
Blood sampling
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Mini-trampoline exercises will be performed for eight weeks, three non-consecutive days a week. The place of training will be Andisheh Cultural and Sports Complex (Kermanshah city). To prevent possible injuries during exercise, the safety rules recommended by the American Academy of Pediatric will be followed. For exercises, hexagonal mini-trampolines with dimensions of 130 cm and six legs with a length of 30 cm with a weight bearing of up to 130 kg will be used.
Category
Prevention
2
Description
Control group: No intervention will be performed
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Razi university
Full name of responsible person
Mona Amiri Paryan
Street address
No. 38, Ravanbakhsh Ave., Mosadegh Sq.
City
Kermanshah
Province
Kermanshah
Postal code
6713716814
Phone
+98 83 3727 2110
Email
monaparyan6@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Razi University
Full name of responsible person
Farzad Veisi
Street address
Deputy of Research and Technology, Razi University, University St., Tagh-e-Bostan,
City
Kermanshah
Province
Kermanshah
Postal code
6714414971
Phone
+98 83 3427 4515
Email
veysi@razi.ac.ir
Web page address
https://are.razi.ac.ir/%D8%B5%D9%81%D8%AD%D9%87-1
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Razi 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
Razi University
Full name of responsible person
Vahid Tadibi
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Physiology
Street address
School of Sports Sciences, Razi University, University Blvd., Taghe Bostan
City
Kermanshah
Province
Kermanshah
Postal code
6714414971
Phone
+98 83 3427 9265
Fax
Email
vtadibi@yahoo.com
Web page address
https://phe.razi.ac.ir/~vahidtadibi
Person responsible for scientific inquiries
Contact
Name of organization / entity
Razi University
Full name of responsible person
Vahid Tadibi
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Physiology
Street address
School of Sports Sciences, Razi University, University Blvd., Taghe Bostan
City
Kermanshah
Province
Kermanshah
Postal code
6714414971
Phone
+98 83 3427 9265
Email
vtadibi@yahoo.com
Web page address
https://phe.razi.ac.ir/~vahidtadibi
Person responsible for updating data
Contact
Name of organization / entity
Razi University
Full name of responsible person
Vahid Tadibi
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Physiology
Street address
School of Sports Science, Razi University< University Blvd., Taghe Bostan
City
Kermanshah
Province
Kermanshah
Postal code
6714414971
Phone
+98 83 3427 9265
Email
vtadibi@yahoo.com
Web page address
https://phe.razi.ac.ir/~vahidtadibi
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
No more information
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is 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
Not applicable
Analytic Code
Not applicable
Data Dictionary
Not applicable
Title and more details about the data/document
All Data
When the data will become available and for how long
assess ability immediately after publication of the results
To whom data/document is available
Researchers
Under which criteria data/document could be used
For meta analysis
From where data/document is obtainable
Vahid Tadibi
vtadibi@yahoo.com
What processes are involved for a request to access data/document