Effectiveness of short -term Conditional-Equilibrium Exercises on Functional Limitations of fear of falling in Aged Women with Frailty Syndrome in Shiraz Farzanegan Foundation
Design
Controlled clinical trial
parallel
Randomized
Settings and conduct
Individuals are divided into intervention and control groups. For the intervention group, 6 training sessions are held every week for 6 weeks with the subject of situational-balance exercises. While there will be no intervention in the control group.
Participants/Inclusion and exclusion criteria
1. Over 55 years old
2. Having at least 3 items from the frailty Index
3. Earn at least 21 points on the leaf test
4. Earn at least 22 points from the Fear of the Fall and Movement Restriction Questionnaire
5. No orthopedic and neurological disorders
6. No severe visual and auditory impairment
Intervention groups
Conditional-Equilibrium Exercises training to women with frailty syndrome in experimental group
Lack of Conditional-Equilibrium Exercises training in women with Frailty syndrome in the control group
Main outcome variables
Improved fear of falling, functional limitations, and reduced frailty consequences.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20180514039648N1
Registration date:2020-07-07, 1399/04/17
Registration timing:retrospective
Last update:2020-07-07, 1399/04/17
Update count:0
Registration date
2020-07-07, 1399/04/17
Registrant information
Name
Abdolrahim Asadollahi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 71 3725 1001
Email address
a_asadollahi@sums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-12-08, 1398/09/17
Expected recruitment end date
2020-02-06, 1398/11/17
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effectiveness of short -term Conditional-Equilibrium Exercises on Functional Limitations of fear of falling in Aged Women with Frailty Syndrome
Public title
The effect of balance exercises on women with Frailty syndrome
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Over 55 years old
Having at least 3 items from the Frailty Index
No orthopedic and neurological disorders
No Severe visual and auditory impairment
Earn at least 22 points on the survey of activities and fear of falling Questionnaire
Exclusion criteria:
Age
From 55 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
120
Randomization (investigator's opinion)
Randomized
Randomization description
The randomly assigned by equal permutation blocks method using PASS 11 (2017) software. Effron method was performed one thousand times and according to this method, despite the randomization of the allocation process, individuals in each block were finally provided with equal number of samples in both control and intervention groups. In randomization, an equal chance is provided for the whole sample to fall into one of two groups. The researcher does not intervene in determining the group for the samples.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
The samples were randomly divided into control and experimental groups. The experimental group then receives training based on short -term Conditional-Equilibrium Exercises on Functional Limitations of fear of falling. not receive any intervention during the training.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Faculty of Rehabilitation Sciences, Shiraz University of Medical Sciences
Street address
Abbeyvard Street 1, Chamran Boulevard,shiraz
City
shiraz
Province
Fars
Postal code
۳۳۶۶۹-۷۱۹۴۷
Approval date
2019-12-08, 1398/09/17
Ethics committee reference number
IR.SUMS.REHAB.REC.1398.035
Health conditions studied
1
Description of health condition studied
frailty syndrom
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Frailty
Timepoint
At the beginning and immediately after the intervention is completed
Method of measurement
FSC,5 Item ,2001
2
Description
Fear of falling and activity restriction
Timepoint
At the beginning and immediately after the intervention is completed
Method of measurement
The survey of activities and fear of falling in the elderly (SAFE)
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: The central intervention in this study was a situational-equilibrium short-term training program. The training program was based on the general content of the exercise, which aims to "improve functional limitations due to the fear of falling in elderly women with frailty syndrome using short-term situational-equilibrium exercises." The treatment program used in this study is in accordance with the official and standard protocol of "Prevention and safety techniques in falling for the elderly" (Team, 2014), which actually improves muscle strength, increases coordination and flexibility and maintains a state of stability, stability and They become physically balanced, and the exercises were performed in the supine, posterior, side, four-legged, and standing positions. The exercises are designed to be graded and, at the discretion of the therapist and the physical condition of the elderly, can be made more difficult or easier during sessions or even unchanged. According to Rina's standard studies, Benazar and Diaz will be practiced for a short period of time, for 6 weeks and 2 sessions a week for 1 hour and in groups. Prior to the intervention, short training sessions on fall conditions and compensatory techniques required during the fall, as well as the correct posture of the subjects during the training sessions, the correct angle of the joints and the correct way to walk, sleep and sit. During the sessions, they will be reminded regularly as a reminder. One session will be held to familiarize the participants with how to do the exercises and how to hold the training sessions. Educational media such as PowerPoint presentations, video educational video clips, and educational pamphlets will be used for teaching.
Category
Rehabilitation
2
Description
Control group: No special training will be provided for the control group.
Category
Rehabilitation
Recruitment centers
1
Recruitment center
Name of recruitment center
Shiraz Farzanegan Foundation
Full name of responsible person
Mrs.Tahereh sokout
Street address
mirza shirazi Ave. front of 8 th.st
City
shiraz
Province
Fars
Postal code
7196844938
Phone
+98 71 3625 0306
Email
f_sokout@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
Seventh floor, Central Building of Shiraz University of Medical Sciences, Zand Avenue, Shiraz
City
shiraz
Province
Fars
Postal code
7134814336
Phone
+98 71 3235 7282
Fax
+98 71 3212 2430
Email
vcrdep@sums.ac.ir
Web page address
http://research.sums.ac.ir/fa/index.html
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
Dr. Abdolrahim Asadollahi
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Geriatrics
Street address
3rd.floor,Razi Ave.school of Health , Shiraz University of Medical Sciences shiraz
City
shiraz
Province
Fars
Postal code
1005010010
Phone
+98 71 3725 6216
Email
a_asadollahi@sums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Dr. Abdolrahim Asadollahi
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Geriatrics
Street address
School of Health,Shiraz University of Medical Sciences,3rd floor, Razi Ave
City
Shiraz
Province
Fars
Postal code
1005010010
Phone
+98 71 3725 6216
Email
a_asadollahi@sums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Dr. Abdolrahim Asadollahi
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Geriatrics
Street address
School of Health,Shiraz University of Medical Sciences,3rd floor, Razi Ave
City
Shiraz
Province
Fars
Postal code
1005010010
Phone
+98 71 3725 6216
Email
a_asadollahi@sums.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is 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
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be 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
Undecided - It is not yet known if there will be a plan to make this available
Title and more details about the data/document
The data file will be shared in Mendeley's database in the form of spss software version 25.
When the data will become available and for how long
2020
To whom data/document is available
faculty members of schools of health and Rehabilitation , Shiraz University of Medical Sciences
Under which criteria data/document could be used
more study
From where data/document is obtainable
Researchers
What processes are involved for a request to access data/document