In order to teach the effect of equilibrium exercises on improving balance and improving the quality of life in elderly people in Shiraz, it will be done
Design
Initially, the two main daily aging centers were selected by random sampling method (milk and line) in the experimental and control groups and individuals using the goal-oriented method from among the clients participating in the training programs of the mentioned centers and then by random allocation of the block Equal to the experimental (30) and control (30) groups
Settings and conduct
After identifying the test and control group, the researcher begins to evaluate the subjects through various tests and, after the end of the assessment, begins the training instructor.
Participants/Inclusion and exclusion criteria
Include criteria: Falling over the past 6 to 12 months
Exclude criteria: Unwillingness to cooperate
Intervention groups
Cawthorne-cooksey training for two weeks each week is provided to the experimental group, during which the experimental group will receive no training. At the end of the study, the control group will be presented to the control group for observing the ethics of the training sessions.
Main outcome variables
Improve balance, quality of life and reduce the frequency of falls
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20180730040644N1
Registration date:2018-08-15, 1397/05/24
Registration timing:retrospective
Last update:2018-08-15, 1397/05/24
Update count:0
Registration date
2018-08-15, 1397/05/24
Registrant information
Name
Farzaneh Bahadori
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 71 3824 8333
Email address
bahadori_farzaneh@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2017-08-23, 1396/06/01
Expected recruitment end date
2017-10-22, 1396/07/30
Actual recruitment start date
2017-10-23, 1396/08/01
Actual recruitment end date
2017-11-21, 1396/08/30
Trial completion date
empty
Scientific title
Effect of exercise on balance status and quality of life among sample of Iranian elderly in Shiraz, south of IRAN, 2017
Public title
Effect of exercise on balance status and quality of life among sample of Iranian elderly in Shiraz, south of IRAN, 2017
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
age (60- 74 years)
basic literacy (ability to read and write),
history of falling over the past 6-12 months
positive Romberg sign
obtaining minimum score 24 in the mini-mental state examination (MMSE)
obtaining minimum score 21in Berg Balance Scale (BBS)
lack of visual impairment
lack of neck disability
non-use of ambulatory assistive devices (AAD)
lack of cognitive impairment and lack of orthopedic and neural impairments
Exclusion criteria:
Unwillingness to continue cooperation
incidence of musculoskeletal disorders requiring the use of ambulatory assistive devices or needing treatment.
Age
From 60 years old to 74 years old
Gender
Female
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
60
Actual sample size reached:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Initially, the clients referring to two main daily care ageing centers were randomly (via coin flipping) assigned to the experimental and control groups in order to prevent data transmission between the participants in both groups. A total of 60 older people (30 individuals from each center) were selected using the goal-based approach from the clients participating in the educational programs of these two centers
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Other
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Shiraz University of Medical Sciences
Street address
Zand Street, opposite Palestine Street, Central Building of Shiraz University of Medical Sciences
City
Shiraz
Province
Fars
Postal code
۱۴۳۳۶ - ۷۱۳۴۸
Approval date
2018-01-15, 1396/10/25
Ethics committee reference number
IR.SUMS.REC.1396.142
Health conditions studied
1
Description of health condition studied
Disorders of vestibular function Fall in the elderly
ICD-10 code
H81.8X1
ICD-10 code description
Other disorders of vestibular function, right ear
Primary outcomes
1
Description
The Effect of Balanced Exercise Training to Improve Balance and Quality of Life in the Elderly
Timepoint
At the beginning of the intervention (before the study began) and immediately after the completion of the study and 2 months after the end of the study
Method of measurement
VNG, BBS.DHI.FES-I,Romberg,Leipad Test
Secondary outcomes
1
Description
To determine and compare the effect of equilibrium training on improving balance and improving the quality of life before and after intervention in two groups of test and control
Timepoint
At the beginning of the study (before the start of the study), immediately after the end of the intervention and 2 months after the last training sessions
Method of measurement
assess the effect of equilibrium training on improving balance (BBS and Roemberg questionnaires) and quality of life (Leipad)
2
Description
Evaluating the effect of equilibrium exercise training on reducing the number of falls in the elderly
Timepoint
At the beginning of the study (before the start of the study), immediately after the end of the intervention and 2 months after the last training sessions
Method of measurement
Evaluating the effect of equilibrium exercise training on reducing the frequency of falls (taking patient records and performing BBS and Römberg tests)
Intervention groups
1
Description
Intervention group: Conducting training courses that include Cawthorne Cooksey (to improve the Vestibular system) and deep-seated strengthening exercises (including tensile and strength exercises)
Category
Rehabilitation
2
Description
Control group: After the intervention in the intervention group, a training session entitled "Equal Exercise Exercise" was provided to the control group.
Category
Rehabilitation
Recruitment centers
1
Recruitment center
Name of recruitment center
Soroush's Elderly Center
Full name of responsible person
Tahreh Sokut
Street address
Mirza Shirazi Blvd. - 16 m Dinakan facing Alavi Park
City
Shiraz
Province
Fars
Postal code
71776-73548
Phone
+98 71 3635 1362
Email
af_sokout@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Mohammad-Hossein Kaveh
Street address
Razi Blvd. School of Public Health
City
Shiraz
Province
Fars
Postal code
7762514751
Phone
+98 71 3725 1005
Email
Schealth@sums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shiraz 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
Shiraz University of Medical Sciences
Full name of responsible person
Farzaneh Bahadori
Position
Masters student
Latest degree
Bachelor
Other areas of specialty/work
Geriatrics
Street address
Razi Blvd. School of Public Health
City
Shiraz
Province
Fars
Postal code
7756245321
Phone
+98 71 3725 1001
Email
bahadori_farzaneh@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Mohammad-Hossein Kaveh
Position
Associate Professor, Faculty Member of Shiraz University of Medical Sciences
Latest degree
Ph.D.
Other areas of specialty/work
Health Promotion
Street address
Razi Blvd. School of Public Health
City
Shiraz
Province
Fars
Postal code
77415724120
Phone
+98 71 3725 1001
Email
kaveh@sums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Mohammad-Hossein Kaveh
Position
Associate Professor, Faculty Member of Shiraz University of Medical Sciences
Latest degree
Ph.D.
Other areas of specialty/work
Health Promotion
Street address
Razi Blvd. School of Public Health
City
Shiraz
Province
Fars
Postal code
7741253461
Phone
+98 71 3725 1001
Email
kaveh@sums.ac.ir
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
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Not applicable
Title and more details about the data/document
Only final analysis and data file initialization
When the data will become available and for how long
Time to print the article up to a year later
To whom data/document is available
All researchers
Under which criteria data/document could be used
There is no manipulation in the data
From where data/document is obtainable
Send a request by email, if not answered, phone call
What processes are involved for a request to access data/document
The requested time is about a week after the request is sent