Designing of a 6-weeks training program with shuttle balance and investigating its effects on postural control, balance, gait speed and the risk of falls in elderly
The overall aim of the present study is to investigate the effect of 6 weeks of balance training on static and dynamic balance, gait speed, postural control and the risk of falls in the elderly.
Design
A randomized controlled clinical trial with parallel non-blinded groups
Settings and conduct
To evaluate the effect of balance exercises on balance, postural control, gait speed and risk of falls in the elderly, a 6-week training program for the elderly who meet the inclusion criteria in the Mehraban elderly home for 3 days a week and 90 days will be done. After the warm-up, the subjects specifically performe exercises with the researcher on the balance shuttle.
Participants/Inclusion and exclusion criteria
Inclusion criteria
Age over 60 years
Ability to move independently
The satisfaction of the patient and the family to participate in the research
make the point 37 to 50 in the balance sheet test
Exclusion criteria
Have a history of cognitive problems, orthopedics, neurology, cardiovascular disease
receive help from other persons or device to walk
Lower limb fracture in the last 3 months
BMI higher than 35
Intervention groups
The present study consisted of two intervention and control groups. The intervention group consisting of male and female, exercising for six weeks, three days a week, 90 minutes per session of balance exercise with an unstable device under the supervision of the researcher (practitioner).
The control group also includes male and female with no intervention.
Main outcome variables
Posture control;
the balance;
Falling Danger;
Gait speed
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20190410043229N1
Registration date:2019-11-09, 1398/08/18
Registration timing:retrospective
Last update:2019-11-09, 1398/08/18
Update count:1
Registration date
2019-11-09, 1398/08/18
Registrant information
Name
Zahra Mohammadian
Name of organization / entity
Faculty of Physical Education and Sports Sciences university of tehran
Country
Iran (Islamic Republic of)
Phone
+98 21 8131 3178
Email address
zahra.md70@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-08-29, 1398/06/07
Expected recruitment end date
2019-10-22, 1398/07/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Designing of a 6-weeks training program with shuttle balance and investigating its effects on postural control, balance, gait speed and the risk of falls in elderly
Public title
Effect of an exercise program with shuttle balance on postural control, balance, gait speed and risk of falling in elderly
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Age over 60 years
Ability to move independently
The satisfaction of the patient and his/her family to participate in the research
make the point 37 to 50 in the balance sheet test
Exclusion criteria:
Have a history of cognitive problems, orthopedics, neurology, cardiovascular disease
Receive help from other persons or device to walk
Lower limb fracture in the last 3 months
BMI higher than 35
Age
From 60 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
32
Randomization (investigator's opinion)
Randomized
Randomization description
In this study, subjects (female, male) will randomly be drawn and divided into two intervention and control groups.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
The present study has two intervention and control groups (both male and female in each group) that has the intervention group with balance training using shuttle balance but the control group is considered without any intervention.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
sport sciences research institute
Street address
No. 5 Fifth Alley, Mirmad St, Motahhari St., Tehran
City
tehran
Postal code
1587958711
Approval date
2019-03-11, 1397/12/20
Ethics committee reference number
IR.SSRC.REC.1398.026
Health conditions studied
1
Description of health condition studied
Posture control
ICD-10 code
ICD-10 code description
2
Description of health condition studied
Balance
ICD-10 code
ICD-10 code description
3
Description of health condition studied
Gait speed
ICD-10 code
ICD-10 code description
4
Description of health condition studied
Risk of fall
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Postural control
Timepoint
Before the intervention and 6 weeks after the intervention
Method of measurement
FDM-S pressure distribution device manufactured by ZBIS company
2
Description
Balance
Timepoint
Before the intervention and 6 weeks after the intervention
Method of measurement
Berg scale
3
Description
Gait speed
Timepoint
Before the intervention and 6 weeks after the intervention
Method of measurement
Timed Up and Go Test
4
Description
Risk of fall
Timepoint
Before the intervention and 6 weeks after the intervention
Method of measurement
The falls effiacacy scale-international
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: In this study, a group consisting of (male, female) receive intervention, the intervention is applied to people using shuttle balance. The present study uses the shuttle balance in the Corrective Movement Laboratory of the Faculty of Physical Education, University of Tehran, manufactured by Pajouhesh Sport today company. People practice the exercises under the supervision of a researcher for 90 minutes per session, 3 times a week for 6 weeks. Subjects warm-up for 15 minutes before starting the exercise. The exercise program lasts 60 minutes. Then they cool down for 15 minutes.
Category
Prevention
2
Description
Control group: The control group also includes (male, female). The people in this group do not receive any intervention.
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Compassionate Elderly Home
Full name of responsible person
دکتر غفوریان
Street address
Tehran Province, Tehran, District 5, Fahimi Street
City
Tehran
Province
Tehran
Postal code
1471864771
Phone
+98 21 4401 2062
Email
zahra.md70@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Faculty of Physical Education and Sport Science
Full name of responsible person
Dr. Reza Rajabi
Street address
Faculty of Physical Education and Sport Sciences, between 15th and 16th St., North Kargar st., Tehran, Islamic Republic
City
Tehran
Province
Tehran
Postal code
۱۴۱۷۴۱۴۴۱۸
Phone
+98 21 8835 1730
Email
infosport@ut.ac.ir
Web page address
http://sport.ut.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Faculty of Physical Education and Sport Science
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
Faculty of Physical Education and Sports Sciences
Full name of responsible person
zahra mohammadian
Position
Student
Latest degree
Master
Other areas of specialty/work
Sport Medicine
Street address
Tehran Monirieh Makhsous Avenue, Greece Alley, No5, Unit 4th
City
Tehran
Province
Tehran
Postal code
۱۴۱۷۴۱۴۴۱۸
Phone
+98 21 8831 3178
Email
zahra.md70@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Faculty of Physical Education and Sports Sciences university of tehran
Full name of responsible person
zahra mohammadian
Position
coach
Latest degree
Master
Other areas of specialty/work
Sport Medicine
Street address
Monirieh Street 5 Greece Alley No. 4 Unit 4
City
Tehran
Province
Tehran
Postal code
۱۴۱۷۴۱۴۴۱۸
Phone
+98 21 8131 3178
Email
zahra.md70@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Faculty of Physical Education and Sports Sciences University of Tehran
Full name of responsible person
Zahra /Mohammadian
Position
Coach
Latest degree
Master
Other areas of specialty/work
Sport Medicine
Street address
Monirieh, Makhsous Street, Greece Alley No. 5, Unit 4th
City
Tehran
Province
Tehran
Postal code
۱۴۱۷۴۱۴۴۱۸
Phone
+98 21 8131 3178
Email
zahra.md70@gmail.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
The data file cannot be published to the article due to its illegal use without the author's permission.
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
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 data from the efficacy results are unavailable but information on its consequences is available.
When the data will become available and for how long
After submitting the results of the articles, it is possible to make the data available.
To whom data/document is available
All people in the community who are interested and need data.
Under which criteria data/document could be used
To confirm that the research is correct and if the researcher himself is present
From where data/document is obtainable
zahra.md70@gmail.com
09304354565
What processes are involved for a request to access data/document