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The Effectiveness of Body Percussion Rhythmic Exercises on the balance and cognitive flexibility of the elderly

Protocol summary

Study aim
The main goal: to determine the influence of a course of body percussion rhythmic exercises on the balance and cognitive flexibility of the elderly.
Design
Clinical experiment with control group(30 persons)and intervention group(30persons)by simple random sampling,based on 60 elderly people for simple random and based on single sequence from random designations and random numbers table.
Settings and conduct
The intended experiment in Kashmer city as the influence of a course of body percussion rhythmic exercises on the balance and cognitive flexibility of 60 elderly people is evelnated by measurement tools of cognitive flaxibility,classification test,whiskansin card,and measurment tools of equilibrinm.
Participants/Inclusion and exclusion criteria
The criteria for entering the research includes: the ability for seeing and hearing perfectly, to be over 65 years old, to have asthma and respiratory and heart disease,movement problems and main and using crutches and wheelchaivs, antecedent of heart attacle,antecedent of anesthcsia,skull scriors injury,to have movement disorder and a basic level of physical activity and exercisa habits and similiar backfall proportion.
Intervention groups
60 elderly people have been randomly selected as research sample and will be devided to two group of intervention (30) and control(30).the intervention group, who will perform rhythmic body percussion exercises for 45 minutes, 3 days a week for 12 weeks.but,the control group will not recieveary exercise program during this period.
Main outcome variables
Static equilibrium,dinamic equilibrium ,cognitive flexibility.

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20220704055369N1
Registration date: 2022-10-16, 1401/07/24
Registration timing: prospective

Last update: 2022-10-16, 1401/07/24
Update count: 0
Registration date
2022-10-16, 1401/07/24
Registrant information
Name
Najmeh Khakshormoogadam
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 5522 1725
Email address
najmehkhakshormoogadam@semnan.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-10-22, 1401/07/30
Expected recruitment end date
2023-01-20, 1401/10/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Effectiveness of Body Percussion Rhythmic Exercises on the balance and cognitive flexibility of the elderly
Public title
The Effectiveness of Body Percussion Rhythmic Exercises on the balance and cognitive flexibility of the elderly
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
The ability for seeing and hearing perfectly To be over 65 years old
Exclusion criteria:
To Have asthma and respiratory and heart diseases Movement problems and maim and using crutches and wheelchairs Antecedent of heart attack Antecedent of anesthesia Skull Serious injury To be blind and deaf
Age
From 65 years old to 75 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 60
Randomization (investigator's opinion)
Randomized
Randomization description
60 elderly who have research accomplishment qualifications will be chosen based on research area ,then by simple random sampling will be devided to two groups of intervention 30 persons and contvol 30 persons,while there is equal chance for every one to choose and its based on songle sequence from random designations and random numbers toble.(random numbers table is a large set of numbers that are produced random withovt specific discipline and are shaped as a table).at first,the researcher determine the numbers of table(for example,up,down,left or right)table and then, the researcher take into account the numbers for different gronps(for example,couple numbers for intervention(A)and singular numbers for in terven tion(B).in this method,probably,there is non-equality of persons to each groups.especially,when contant of the sample is low ,while content of the sample of this ineqnality will be decreased.
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 Semnan University of Medical Sciences
Street address
University of Medical Sciences and Healthcare Services,Basij St.
City
Semnan
Province
Semnan
Postal code
35147-99442
Approval date
2022-06-27, 1401/04/06
Ethics committee reference number
IR.SEMUMS.REC.1401.074

Health conditions studied

1

Description of health condition studied
Balance disorders
ICD-10 code
E87.8
ICD-10 code description
Other disorders of electrolyte and fluid balance, not elsewhere classified

Primary outcomes

1

Description
Cognitive flexibility
Timepoint
90day
Method of measurement
Cognitive flexibility measurement tool of the Wisconsin Card Sorting Test

Secondary outcomes

1

Description
Balance
Timepoint
90day
Method of measurement
Measuring balance with Johnson's stork balance tool

Intervention groups

1

Description
Intervention group;60 elderly people who have been selected for this research(betwreen 150 elderly).around 30 persons at intervention group who will perform rhythmic body percussion exercises for 12 weeks,3days a week for 45 minutes .these exercises will be performed as synthetic at each session that includes 7 repetitive movements:stroke to chest,stroke to chest,clap,stroke to chest,stroke to chest,stroke to chest and clap,it will be all,cated to heat and unlimber the elderly 10frist minutes and it 10, will be all.ocafed to refrigerate them 5 last minute.it is necessary to say that these body exercises will be performed by expert coach and will be requested from participants to look at the coach and implement his/her movements,and then will be requested to perform the activity based on rhythme.
Category
Other

2

Description
Control group:they are 30persons and dont reciveve any program at in tervention period .
Category
Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Imam Khomeini (RA) Kashmir Relief Committee
Full name of responsible person
Fatemeh Rezaei
Street address
No. 237, 16 Arghvan Alley, Laden Street, Golestan St
City
Semnan
Province
Semnan
Postal code
۳۵۱۹۸۶۸۷۸۴
Phone
Email
Frezaee39@gmail.com
Web page address

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Semnan University of Medical Sciences
Full name of responsible person
Fatemeh Rezaei
Street address
No. 237, 16 Arghvan Alley, Laden Street, Golestan St
City
Semnan
Province
Semnan
Postal code
۳۵۱۹۸۶۸۷۸۴
Phone
Email
Frezaee39@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Semnan University of Medical Sciences
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
Semnan University of Medical Sciences
Full name of responsible person
Najmeh Khakshor Mooghadam
Position
University Student
Latest degree
Bachelor
Other areas of specialty/work
Others
Street address
No. 5, Shahid Abolqasem Modaresi Alley, 17 Shahrivar St.
City
Kashmar
Province
Razavi Khorasan
Postal code
9671935588
Phone
+98 51 5522 1725
Email
N.khakshor7073@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Semnan University of Medical Sciences
Full name of responsible person
Najmeh Khakshor Mooghadam
Position
University Student
Latest degree
Bachelor
Other areas of specialty/work
Others
Street address
No. 5, Shahid Abolqasem Modaresi Alley, 17 Shahrivar St.
City
Kashmar
Province
Razavi Khorasan
Postal code
9671935588
Phone
+98 51 5522 1725
Email
N.khakshor7073@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Semnan University of Medical Sciences
Full name of responsible person
Najmeh Khakshor Mooghadam
Position
University Student
Latest degree
Bachelor
Other areas of specialty/work
Others
Street address
No. 5, Shahid Abolqasem Modaresi Alley, 17 Shahrivar St.
City
Kashmar
Province
Razavi Khorasan
Postal code
9671935588
Phone
+98 51 5522 1725
Email
Nkhakshor7073@gmail.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
No - There is not a plan to make this available
Statistical Analysis Plan
No - There is not a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
No - There is not 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
The influence of a course of body percussion rhythmic exercises on the balance and cognitive flexibility of the elderly, the results of the research and participants at the research without people identity and the equilibrium basic results and cognitive flexibility of the elderly will be shared.
When the data will become available and for how long
Start of access period 6 months after publishment of results.
To whom data/document is available
It will be available for researchers who work in academic and scientific institutions.
Under which criteria data/document could be used
It is free to study the documents and to use the questionnaire and also data of research.wecan help to elderly and reserchers who are intvested to these studies.
From where data/document is obtainable
The e-mail address of the liable person in n.khakshor7073@gmail.com with the postal address 9671935588 and the phone number 09106798672 with the fax number 05155221725 as najmeh khakshor moghadam,i am ready to answer.
What processes are involved for a request to access data/document
People who are studying in the scientific evedible universities of country are allowed to receive the necessary documents after 6 months of results registration.
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