Protocol summary

Study aim
Comparison between the effect of Total-Body Resistant Exercise and Pilates exercises on body muscle strength and resistance and dynamic balance in 13-15 years old girls in Gorgan district in 2021
Design
A controlled clinical trial, with parallel groups, one-way blinded, randomized, on 69 female adolescents. The web https://www.graphpad.com/quickcalcs/randomize1/ was used for randomization.
Settings and conduct
This study was conducted on secondary schools. Each 3 groups conducted 8 weeks exercises with the help of researcher assistance in the gym. The lead researcher does not inform a bout randomization assignment.
Participants/Inclusion and exclusion criteria
inclusion criteria and non inclusion:Girl ؛Age range 13 to 15 years ؛Obtaining informed consent from the parents of the subject and verbal satisfaction of the adolescents ؛Do not suffer from cardiovascular diseases, type 1 diabetes and neurological diseases ؛Not doing regular physical exercises during the last 6 months and during the study ؛Do not use booster supplements in the last 6 months and during the study
Intervention groups
Group 1: A group that performs Total Body Resistance Exercises with the help of a sports coach. Group 2: A group that does Pilates aerobic exercise with the help of a sports coach. Group 3: The group that does the usual school exercise.
Main outcome variables
Resistance؛ Body Muscles strength؛ Dynamic balance

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20211212053363N1
Registration date: 2022-05-09, 1401/02/19
Registration timing: retrospective

Last update: 2022-05-09, 1401/02/19
Update count: 0
Registration date
2022-05-09, 1401/02/19
Registrant information
Name
Fatemeh Jafari
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 17 3253 5630
Email address
oneid33@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-01-04, 1400/10/14
Expected recruitment end date
2022-04-03, 1401/01/14
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison between Total-Body Resistant Exercise and Pilates exercises on body mascular strength and resistance and dynamic balance in Adolescent girls
Public title
Comparison between TRX and Pilates exercises on body mascular strength and resistance and dynamic balance
Purpose
Health service research
Inclusion/Exclusion criteria
Inclusion criteria:
Girl Age range 13 to 15 Obtaining informed consent from parents and verbal satisfaction of adolescents
Exclusion criteria:
Musculoskeletal Disorders cardiovascular disease, type 1 diabetes and neurological diseases regular physical exercise in 6 months time and during the study use booster supplements in 6 months time and during the study
Age
From 13 years old to 15 years old
Gender
Female
Phase
N/A
Groups that have been masked
  • Investigator
Sample size
Target sample size: 69
Randomization (investigator's opinion)
Randomized
Randomization description
Sample of this study will be chosen by probability clustered sampling. At first, first secondary schools of governmental and non-governmental for girls from different parts of Gorgan are determined by cluster sampling and we prepare a list of students whose age is between 13 to 15 years. Each school is considered as a sample. In the next step, schools are randomly assigned to one of three groups of training with TRX movements, the training group with Pilates and the control group as blocked method by https://www.sealedenvelope.com. Allocation concealment is done by prepared sealed letters though written X (control group), T (TRX group) and P (Pilates group) give to the representative of each school. Researcher assistance will select students from each school according to the inclusion criteria.
Blinding (investigator's opinion)
Single blinded
Blinding description
In this one-blinded study, the protocol was written by the lead researcher. the lead investigator blind to the treatment allocation.The lead researcher provides the proposal and the method of protocol gives to the researcher assistance (sports coach) and provides the necessary training. The process of random assignment and performing sports exercises is the responsibility of the researcher assistance that not involved in the part of the study. Finally, the results are given to the researcher and statistical consultant for analysis.
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- Chalus Branch
Street address
17 shahrivar Ave.
City
Chalus
Province
Mazandaran
Postal code
46615/397
Approval date
2021-12-05, 1400/09/14
Ethics committee reference number
IR.IAU.CHALUS.REC.1400.057

Health conditions studied

1

Description of health condition studied
adolescents
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
Power is measured based on McGill performance tests.
Timepoint
Power measurement conducted at first day of study and the last day of study.
Method of measurement
McGill test

2

Description
Muscles Strength
Timepoint
Muscles Strength measurement conducted at first day of study and the last day of study.
Method of measurement
McGill Test

3

Description
Dynamic equilibrium measurement is assessed by Y balance test.
Timepoint
Balanced equilibrum measurement conducted at first day of study and the last day of study.
Method of measurement
Y balance test

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: The duration of training period in the TRX group is for 8 weeks. training sessions conducted three times a week that each session take along one hour including 10 exercises movement.
Category
Lifestyle

2

Description
Intervention group: The duration of training period in the pilates group is for 8 weeks. training sessions conducted three times a week that each session take along one hour including Three warm-up movement, main movement and cooling exercises.
Category
Lifestyle

3

Description
Control group: Conducted ordinal exercise excluding power and resistance strength Such as weights working or doing suspension movements
Category
Lifestyle

Recruitment centers

1

Recruitment center
Name of recruitment center
Gorgans Schools
Full name of responsible person
Fatemeh Jafari
Street address
Pasdaran Street
City
Gorgan
Province
Golestan
Postal code
4913858188
Phone
+98 17 3262 4995
Email
oneid33@yahoo.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Islamic Azad University
Full name of responsible person
Seyed Hasan Seyed Rezayi
Street address
Daneshgah Blvd
City
Aliabad katul
Province
Golestan
Postal code
93451-49417
Phone
+98 17 3422 2300
Email
info@aliabadiau.ac.ir
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
Fatemeh Jafari
Position
Master of science student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Daneshgah Blvd
City
Aliabad katul
Province
Golestan
Postal code
93451-49417
Phone
+98 17 3422 2300
Email
info@aliabadiau.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Nafiseh Hekmati pour
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Daneshgah Blvd
City
Aliabad katul
Province
Golestan
Postal code
93451-49417
Phone
+98 17 3422 2300
Email
n_hekmati68@yahoo.com

Person responsible for updating data

Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Fatemeh Jafari
Position
Master of Science
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Daneshgah Blvd
City
Aliabad katul
Province
Golestan
Postal code
93451-49417
Phone
+98 17 3422 2300
Email
oneid33@yahoo.com

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
"There is no more information."
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
No - There is not a plan to make this available
Informed Consent Form
No - There is not a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
No - There is not a plan to make this available
Data Dictionary
No - There is not a plan to make this available
Title and more details about the data/document
Some personal data, such as information about the main outcome, can be shared.
When the data will become available and for how long
2022
To whom data/document is available
Researchers
Under which criteria data/document could be used
Researchers if they want to use the available data with the permission of the original researchers.
From where data/document is obtainable
Aliabad Azad University, Nafiseh Hekmati pour, 01734237933
What processes are involved for a request to access data/document
Permission of Research president of Islamic Azad University Branch Aliabad katul
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