Objective: Comparison the effect of two protocols of balance training on quality of life and balance in elders with balance impairments
Study design: single blinded randomized control trial
Participants: twenty-four elders (8 males, 16 females) older than or equal to 60 years old with balance impairments from Jahandidegan elderly center
Randomization: simple randomization
Inclusion criteria:
acquiring scores less than 52 in Berg test, less than 7 in GDS test and more than 24 in MMSE
Exclusion criteria:
neurological diseases, visual and auditory disorders, color blindness and orthostatic blood pressure
Interventions: single task balance training and dual task balance training
Main Outcome Measures: balance status, quality of life
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2016020624149N4
Registration date:2016-06-21, 1395/04/01
Registration timing:retrospective
Last update:
Update count:0
Registration date
2016-06-21, 1395/04/01
Registrant information
Name
Fahimeh Kamali
Name of organization / entity
Shiraz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 71 1627 1551
Email address
kamalif@sums.ac.ir
Recruitment status
Recruitment complete
Funding source
Shiraz University of Medical Sciences
Expected recruitment start date
2015-12-11, 1394/09/20
Expected recruitment end date
2016-02-09, 1394/11/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparing the effect of two protocols of balance training on quality of life and balance in the elderly with balance impairments
Public title
Effect of balance training on quality of life and balance in the elderly
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
older than or equal to 60 years old; acquiring Berg balance scale score less than 52; obtaining MMSE score more than 24; acquiring Geriatrics Depression Scale (GDS) less than 7
Exclusion criteria:
neurological diseases; visual or auditory disorders; color blindness; orthostatic blood pressure
Age
From 60 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
24
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single 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, Shiraz University of Medical Sciences
Street address
Central Building of Shiraz University of Medical Sciences, Zand Blvd. Shiraz
City
Shiraz
Postal code
71348-14336
Approval date
2015-11-21, 1394/08/30
Ethics committee reference number
IR.SUMS.REC.1394.148
Health conditions studied
1
Description of health condition studied
balance impairment
ICD-10 code
R29.6
ICD-10 code description
Tendency to fall because of old age or other unclear health problems
Primary outcomes
1
Description
Balance level
Timepoint
Before exercises and 4 weeks after the beginning of exercises
Method of measurement
Fullerton Advanced Balance scale (FAB) test
2
Description
Quality of life
Timepoint
Bexercises and 4 weeks after the beginning of exercises
Method of measurement
SF-36 questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
single-task balance training
including:
1- controlling balance on ball, with free movements of upper limb, trunk and lower limb
2-standing in romberg, semi-tandem, tandem and single-leg positions
3-passing ball between subjects in standing position
4-position changing from lying to standing
Category
Rehabilitation
2
Description
dual-task balance training
1- mention various flowers, streets, etc.
2- backward counting of numbers
3-backward calling of the months, days and etc.
These exercises are added to the single-task exercises
Category
Rehabilitation
Recruitment centers
1
Recruitment center
Name of recruitment center
Shiraz Jahandidegan Center
Full name of responsible person
Roya Razavi
Street address
Kholdebarin Park, Beesat St.
City
Shiraz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellery for research affairs, Shiraz University of Medical Sciences
Full name of responsible person
Basir Hashemi
Street address
Central Building of Shiraz University of Medical Sciences, Zand Blvd. Shiraz
City
Shiraz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellery for research affairs, Shiraz University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Shiraz University of Medical Sciences, School of Rehabilitation Sciences
Full name of responsible person
Fahimeh Kamali
Position
Associate Professor
Other areas of specialty/work
Street address
School of Rehabilitation Sciences, Abiverdi St, Chamran Blvd. Shiraz
City
Shiraz
Postal code
Phone
+98 71 3627 1551
Fax
Email
kamalif@sums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shiraz University of Medical Sciences, School of Rehabilitation Sciences
Full name of responsible person
Fahimeh Kamali
Position
Associate Professor
Other areas of specialty/work
Street address
School of Rehabilitation Sciences, Abiverdi St. Chamran Blvd. Shiraz
City
Shiraz
Postal code
Phone
+98 71 3627 1551
Fax
Email
kamalif@sums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Shiraz University of Medical Sciences, School of Rehabilitation Sciences
Full name of responsible person
Fahimeh Kamali
Position
Associate Professor
Other areas of specialty/work
Street address
School of Rehabilitation Sciences, Abiverdi St. Chamran Blvd. Shiraz
City
Shiraz
Postal code
Phone
+98 71 3627 1551
Fax
Email
kamalif@sums.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)