Protocol summary

Study aim
Comparison of the effects of inverted pendulum exercises, TRX and conventional stability on selected muscles activity, Centre of pressure deviation and functional movements in healthy non-athlete males
Design
The number of samples is 45 eligible subjects who are selected based on inclusion and exclusion criteria. The samples are divided into three training groups. Variables of selected muscles activity, Centre of pressure deviation and functional movements are measured before and after exercise.
Settings and conduct
The present study is a quasi-experimental research with a pre-test-post-test design with three experimental groups. The number of samples is 45 eligible subjects who are selected based on the inclusion and exclusion criteria of the study and will be randomly placed in one of the experimental groups. The study is one-sided blind, so that the subjects will not be aware of the intervention of other groups. Variables of selected muscle activity, center of pressure fluctuations, and functional movements are measured before and after exercise.
Participants/Inclusion and exclusion criteria
Healthy non-athlete males in the age group of 20 to 30 years
Intervention groups
inverted pendulum exercises, TRX exercises and conventional stability exercises
Main outcome variables
selected muscles activity; Centre of pressure deviation ; functional movements

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20211009052705N1
Registration date: 2021-11-03, 1400/08/12
Registration timing: prospective

Last update: 2021-11-03, 1400/08/12
Update count: 0
Registration date
2021-11-03, 1400/08/12
Registrant information
Name
Mehrdad Bastani
Name of organization / entity
The university of Esfahan
Country
Iran (Islamic Republic of)
Phone
+98 31 4263 7377
Email address
mehr.bastani@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-11-05, 1400/08/14
Expected recruitment end date
2022-01-04, 1400/10/14
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effects of inverted pendulum exercises, TRX and conventional stability on selected muscles activity, Centre of pressure deviation and functional movements in healthy non-athlete males
Public title
Comparison of the effect of three different exercises methods on the quality of neuromuscular adaptation, balance and motor function of healthy males
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Enjoy public health Fill in the consent form consciously Men in the age range of 20 to 30 years Not participating in regular sports activities
Exclusion criteria:
History of severe musculoskeletal and neurological injuriesHistory of trunk or lower limb surgery over the past year
Age
From 20 years old to 30 years old
Gender
Male
Phase
N/A
Groups that have been masked
  • Participant
  • Outcome assessor
  • Data analyser
  • Data and Safety Monitoring Board
Sample size
Target sample size: 50
Randomization (investigator's opinion)
Randomized
Randomization description
A simple randomization method will be used to assign participants to three groups. Random allocation software will be used to create random sequences. The central randomization method will also be used to hide the allocation concealment.
Blinding (investigator's opinion)
Single blinded
Blinding description
The subjects will be randomly assigned to one of the three intervention groups to improve their posture. The subjects will not be aware of the type of intervention of other groups.
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Research Ethics committee of Esfahan University
Street address
Azadi Square, University of Isfahan, Faculty of Sports Sciences
City
Esfahan
Province
Isfehan
Postal code
8174673441
Approval date
2021-09-16, 1400/06/25
Ethics committee reference number
IR.UI.REC.1400.055

Health conditions studied

1

Description of health condition studied
fall
ICD-10 code
R29.6
ICD-10 code description
Repeated falls

Primary outcomes

1

Description
muscles activity
Timepoint
At the beginning of the study (before the start of the intervention) and after 8 weeks of intervention
Method of measurement
16-channel biomonitor MB 6000-T16

2

Description
Balance
Timepoint
At the beginning of the study (before the start of the intervention) and after 8 weeks of intervention
Method of measurement
Force plate machine

3

Description
functional movements
Timepoint
At the beginning of the study (before the start of the intervention) and after 8 weeks of intervention
Method of measurement
FMS

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: inverted pendulum exercises
Category
Prevention

2

Description
Intervention group: TRX exercises
Category
Prevention

3

Description
Intervention group: conventional stability exercises
Category
Prevention

Recruitment centers

1

Recruitment center
Name of recruitment center
آزمایشگاه دانشکده تربیت بدنی دانشگاه اصفهان
Full name of responsible person
مهرداد باستانی
Street address
No. 14, Bastani Alley., Emam Street
City
Najafabad
Province
Isfehan
Postal code
85186-83911
Phone
+98 31 4263 7377
Email
mehr.bastani@yahoo.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
University of Esfahan
Full name of responsible person
Dr. Gholam Ali Ghasemi
Street address
Azadi Square, University of Isfahan, Faculty of Sports Sciences
City
Esfahan
Province
Isfehan
Postal code
8174673441
Phone
+98 31 3793 2128
Email
Gh.ghasemi@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
University of Esfahan
Proportion provided by this source
10
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
Other

Person responsible for general inquiries

Contact
Name of organization / entity
University of Isfahan
Full name of responsible person
Mehrdad Bastani
Position
Researcher
Latest degree
Master
Other areas of specialty/work
Sport Medicine
Street address
No. 14, Bastani Alley., Emam Street
City
Najafabad
Province
Isfehan
Postal code
85186-83911
Phone
+98 31 4263 7377
Email
mehr.bastani@yahoo.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
University of Isfahan
Full name of responsible person
Mehrdad Bastani
Position
Researcher
Latest degree
Master
Other areas of specialty/work
Sport Medicine
Street address
No. 14, Bastani Alley., Emam Street
City
Najafabad
Province
Isfehan
Postal code
85186-83911
Phone
+98 31 4263 7377
Email
mehr.Bastani@yahoo.com

Person responsible for updating data

Contact
Name of organization / entity
University of Isfahan
Full name of responsible person
Mehrdad Bastani
Position
Researcher
Latest degree
Master
Other areas of specialty/work
Sport Medicine
Street address
No. 14, Bastani Alley., Emam Street
City
Najafanad
Province
Isfehan
Postal code
85186-83911
Phone
+98 31 4263 7377
Email
Mehr.bastani@yahoo.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
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
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
All Potential Data Can be Shared After People have not been Identified
When the data will become available and for how long
Start the Access Period one Year After Printing the Results
To whom data/document is available
Data will be Available to Academic and Scientific Researchers
Under which criteria data/document could be used
Any Kind of Functional Analysis on the Submitted Data is Allowed
From where data/document is obtainable
By Email
What processes are involved for a request to access data/document
By Email
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