The comparison of the effects of physical activity and neurofeedback training on postural stability and risk of fall in elderly women: a double- blind randomized controlled trial
(1) Objectives
The aim of this study is to compare the effects of physical activity and neurofeedback training on postural stability and risk of fall in elderly women.
(2) Design (study groups and phase, sample size, blinding, randomization, single or multi center)
This is a double-blind randomized controlled trial. 45 women will be recruited from one center. Participants are randomly (closed envelop with the name of the assigned group) divided into three groups including control, physical activity and neurofeedback training (15 per group).
(3) Setting and conduct
Fereshtegahn Elderly care center in Shiraz
(4) Participants including major eligibility criteria
45 physically independent women who are older than 65 years old and in appropriate health status will be recruited. Older adults who are advanced in age (> 85 years) and at high risk for falls, participants with injury-related fall within past six months, and those who are suffering from a medical condition, such as musculoskeletal impairments, cardiovascular problems, and declines in sensory functioning and cognitive capabilities, or other neurological disease are excluded from the study.
(5) Intervention
Participants in exercise group will train the Kavern and Cooksey training protocol for 12 weeks (3 days per week and 30 minutes per each session). Another experimental group will perform the Neurofeedback intervention protocol that has been defined by Hammond in 2005 under the name of balance protocol (reduction of theta wave frequency in 4-7 Hz and reinforcement of beta wave frequency in 15-18 Hz) in the same duration and frequency.
(6) main outcome measures (primary and secondary outcome variables)
The Biodex Balance System is going to be used to assess the main outcomes of the study that include risk of fall and postural stability. The training and assessment will be performed with 2 different persons to be sure that there would not be any bias in the evaluation. Analysis of covariance is applied to determine the effects of interventions on outcome variables while controlling the effects of pre test scores.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2017071235037N1
Registration date:2017-08-22, 1396/05/31
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2017-08-22, 1396/05/31
Registrant information
Name
Shahnaz Shahrbanian
Name of organization / entity
Tarbiat Modares University
Country
Iran (Islamic Republic of)
Phone
+98 21 8288 5063
Email address
sh.shahrbanian@ut.ac.ir
Recruitment status
Recruitment complete
Funding source
myself
Expected recruitment start date
2017-07-20, 1396/04/29
Expected recruitment end date
2017-09-20, 1396/06/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The comparison of the effects of physical activity and neurofeedback training on postural stability and risk of fall in elderly women: a double- blind randomized controlled trial
Public title
Exercise and Neurofeedback Intervention for improving postural stability and reducing risk of fall in elderly women.
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion:
female, physically independent, appropriate health status, older than 65 years
Exclusion:
Older adults who are advanced in age (> 85 years) and at high risk for falls, participants with injury-related fall within past six months, those who are suffering from an acute medical condition, or have a chronic condition or a history of stroke and other neurological disease are excluded from the study. Furthermore, participants are withdrawn if they suffer a medical condition, such as musculoskeletal impairments, cardiovascular problems, and declines in sensory functioning and cognitive capabilities, during the study period that affect their ability to perform the tests.
Age
From 65 years old to 85 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
45
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Faculty of Sport Science, Kharazmi University
Street address
Kharazmi University, Faculty of Sport Science, MirDamad, Razan, Keshvari sport complex
City
Tehran
Postal code
Approval date
2017-06-28, 1396/04/07
Ethics committee reference number
KHU.SS.4-1-6-2017
Health conditions studied
1
Description of health condition studied
not applicable
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
risk of fall
Timepoint
before intervention- 3 months after intervention
Method of measurement
biodex balance system
2
Description
postural stability
Timepoint
before intervention- 3 months after intervention
Method of measurement
biodex balance system
Secondary outcomes
empty
Intervention groups
1
Description
physical activity
Category
Rehabilitation
2
Description
neurofeedback training
Category
Rehabilitation
3
Description
control group
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Fereshteghan Elderly Care Center
Full name of responsible person
Ayoub Hashemi
Street address
Shiraz, Amir Kabir Boulvar, Meysam Boulvar, East Soroush St. Second alley, right hand, Fereshtegan elderly care center
City
Shiraz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
shahnaz shahrbanian
Full name of responsible person
shahnaz shahrbanian
Street address
amir abad shomali, n 15
City
tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
shahnaz shahrbanian
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
Bou Ali Sina University/ Tehran University
Full name of responsible person
Shahnaz Shahrbanian
Position
Assistant professor/ phd
Other areas of specialty/work
Street address
Tehran, Amir abad, faculty of sport science tehran universit
City
Tehran
Postal code
Phone
+98 21 6111 8903
Fax
Email
sh.shahrbanian@ut.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
tehran university
Full name of responsible person
Shahnaz Shahrbanian
Position
phd
Other areas of specialty/work
Street address
Tehran, Amir abad, faculty of sport science tehran universit
City
tehran
Postal code
Phone
+98 21 6111 8903
Fax
Email
shahnaz.shahrbanian@mail.mcgill.ca
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Bou Ali Sina University/ Tehran University
Full name of responsible person
Shahnaz Shahrbanian
Position
Assistant professor/ phd
Other areas of specialty/work
Street address
City
Tehran
Postal code
Phone
+98 21 6111 8903
Fax
Email
shahnaz.shahrbanian@mail.mcgill.ca
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)