The effect of the simulated balance exercises using smart computer (xbox Kinect) on balance and fear of falling in older adults with high risk of falling in the nursing homes
Determining the effect of the simulated balance exercises, using smart computer on balance and fear of falling in older adults with high risk of falling in the nursing homes
Design
Parallel group randomized trial in which participants will be divided into two groups by permuted block randomization.
Sample size was calculated 54.
Settings and conduct
All interested elderlies in ُShiraz nursing homes will be invited to participate in the study. After that, the balance of participants will be assessed using Time up and going (TUG) scale. Ones with TUG grade 14 or higher seconds will be selected for the study. Then the fear of falling, balance status and physical function of participants will be assessed using "Falling efficacy", "Burg" and "TUG" scales. Then participants will be divided into two groups by permuted block randomization. Intervention group will undertake twice a week simulated balance exercises for 6 weeks and control group will receive routine cares. At the end, the balance status, physical function and fear of falling of all participants in both groups are assessed and compared with the data before intervention.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
Subjects older than 60 years and at risk of falling
Exclusion criteria:
- Past medical history of any acute or chronic physical, cognitive or mental disease that prevent doing exercise
- Participating in other similar exercise
Intervention groups
Intervention group will undertake twice a week simulated balance exercises for 6 weeks and control group will receive routine nursing homes cares.
Main outcome variables
Balance status; fear of falling
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20190727044347N1
Registration date:2019-08-17, 1398/05/26
Registration timing:prospective
Last update:2019-08-17, 1398/05/26
Update count:0
Registration date
2019-08-17, 1398/05/26
Registrant information
Name
Fatemeh Shirazi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 71 3647 4254
Email address
shirazifa@sums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-08-23, 1398/06/01
Expected recruitment end date
2020-02-20, 1398/12/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of the simulated balance exercises using smart computer (xbox Kinect) on balance and fear of falling in older adults with high risk of falling in the nursing homes
Public title
The effect of the simulated balance exercises on balance and fear of falling in older adults
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
subjects older than 60 years old
Older adults with high risk of falling according to the TUG test (time > 14 seconds)
Subjects who can walk with/without any aid
Getting permission from the nursing home's physician
Being interested to participate in the study
Exclusion criteria:
Past medical history of any acute or chronic physical, cognitive or mental disease that prevent doing exercise
Participating in other exercise that are similar to this study intervention
Having problems that cause banning on exercise
Not treated hearing and vision loss
Having balance disorders related to cerebellar and vestibular disorders
Age
From 60 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
54
Randomization (investigator's opinion)
Randomized
Randomization description
After selecting eligible individuals to participate in the study based on inclusion criteria, these individuals will be assigned to two study groups based on double randomized permutation block with foursome blocks.
The random list is generated by a statistician using "Random Allocation" software. Foursome blocks are the combination of different status such as: ABBA, BAAB, BABA, ABAB, BBAA, AABB. Using random list that is generated by computer,15 blocks are selected for forming the two study groups.
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
Research Ethics Committee of Shiraz University of Medical Sciences
Street address
Vice-Chancellor for Research, Shiraz University of Medical Sciences, Zand Blvd
City
Shiraz
Province
Fars
Postal code
7134814336
Approval date
2019-06-23, 1398/04/02
Ethics committee reference number
IR.SUMS.REC.1398.573
Health conditions studied
1
Description of health condition studied
Older adults with high risk of falling
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Balance status score based on Berg Balance Scale
Timepoint
At the beginning of the study (before intervention) and after 6 weeks of intervention
Method of measurement
Berg Balance Scale
2
Description
Fear of falling score based on falling efficacy scale
Timepoint
At the beginning of the study (before intervention) and after 6 weeks of intervention
Method of measurement
Falling efficacy scale
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group will do simulated computerized balance exercise for 6 weeks. Exercises are twice weekly for 30 -60 minutes in each session. Simulated exercises like tennis, golf and skiing will be used. Each session covers various aspects of balance in elderlies.
Category
Rehabilitation
Recruitment centers
1
Recruitment center
Name of recruitment center
Zagros Elderly Rehabilitation Center
Full name of responsible person
Majid Jalali
Street address
No. 134, 9th Ave., Tachara Blvd.
City
Shiraz
Province
Fars
Postal code
7175957111
Phone
+98 71 3625 5909
Email
web@zagros-salmandan.com
Web page address
http://salmandan-zagros.com/
2
Recruitment center
Name of recruitment center
Yas-haye-sepeed Elderly Home
Full name of responsible person
Zahra Farrokh Mehr
Street address
6th street, Hosin Abad Town, Sanaye Square
City
Shiraz
Province
Fars
Postal code
7196743197
Phone
+98 71 3635 4799
Fax
+98 71 3635 8037
Email
salmandan.yashayesepid@gmail.com
3
Recruitment center
Name of recruitment center
Shiraz Elderly Home
Full name of responsible person
Abdol Majid Jamshidi
Street address
Parsian Blvd., Akbar abad Town
City
Shiaz
Province
Fars
Postal code
7149675511
Phone
+98 71 3242 4074
Email
sarayesalmandan_shiraz@gmail.com
4
Recruitment center
Name of recruitment center
Farzangan elderly home
Full name of responsible person
Shahzad Etemaad
Street address
After science and technology park, Arian town, Shiraz, Iran.
City
Shiraz
Province
Fars
Postal code
7197687876
Phone
+98 71 5800 3227
Email
Shiraz.farzanegan@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Dr. Younes Ghasemi
Street address
Vice-Chancellor for Research, Shiraz University of Medical Sciences, Zand Blvd.
City
Shiraz
Province
Fars
Postal code
7134814336
Phone
+98 71 3235 7282
Fax
+98 71 3230 7594
Email
vcrdep@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
Fatemeh Shirazi
Position
Assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
School of Nursing and Midwifery (SA), Namazi Square, Namazi Hospital
City
Shiraz
Province
Fars
Postal code
13119–71936
Phone
+98 71 3647 4254
Fax
Email
shirazifa@sums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Fatemeh Shirazi
Position
Assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
School of Nursing and Midwifery (SA), Namazi Square
City
Shiraz
Province
Fars
Postal code
13119–71936
Phone
+98 71 3647 4254
Fax
Email
shirazifa@sums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Fatemeh Shirazi
Position
Assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
School of Nursing and Midwifery (SA), Namazi Square
City
Shiraz
Province
Fars
Postal code
13119–71936
Phone
+98 71 3647 4254
Fax
Email
shirazifa@sums.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Not applicable
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available