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Comparing the Effectiveness of Otago and Fall Proof Exercises on Balance , Fear of Falling and Quality of Life in Elderly people with Knee Osteoarthritis

Protocol summary

Study aim
Comparison of the effectiveness of FallProof and Otago exercise programs on balance and functional indices in elderly people with knee osteoarthritis, including static and dynamic balance, fear of falling, and quality of life.
Design
This study is a parallel-group, clinical trial of the before-and-after type .it has two interventions group and a control group. The sample size is 60 persons.
Settings and conduct
this study is a before-and-after trial that will be conducted randomly in three daily rehabilitation centers for the elderly in Chaharmahal and Bakhtiari province on 60 elderly people who meet the inclusion criteria
Participants/Inclusion and exclusion criteria
1. Age over 60 years 2. Mild to moderate knee osteoarthritis according to the WOMAC questionnaire 3. Informed consent to participate in the study 4. Body mass index (BMI) between 20 and 35 kg/m2 5. Sufficient cognitive ability to understand instructions 6. Motor ability (ability to walk at least 6 meters, without dependence on a walker, ability to perform exercises) 7. No inner ear disorders 8. No severe cardiovascular problems and severe heart failure 9. No neurological disorders 10. No advanced visual or hearing impairment 11. No use of strong sedatives and benzodiazepines 12.No lower limb injury in the past 12 month.
Intervention groups
Intervention group1 (Otago exercises): Participants in this group will receive 3 sessions of the Otago exercise program per week for 8 weeks. Intervention group 2 (Fall-proof exercises): Participants in this group will receive 3 sessions of the Fall-proof exercise program per week for 8 weeks. Control group: This group will not receive any intervention and will only participate in the initial and final assessments.
Main outcome variables
Static balance, dynamic balance, fear of falling, quality of life

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20230219057454N3
Registration date: 2025-11-26, 1404/09/05
Registration timing: registered_while_recruiting

Last update: 2025-11-26, 1404/09/05
Update count: 0
Registration date
2025-11-26, 1404/09/05
Registrant information
Name
Hossein Shahnazi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 31 3792 3243
Email address
h_shahnazi@hlth.mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2025-11-21, 1404/08/30
Expected recruitment end date
2026-06-19, 1405/03/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparing the Effectiveness of Otago and Fall Proof Exercises on Balance , Fear of Falling and Quality of Life in Elderly people with Knee Osteoarthritis
Public title
Comparing the Effectiveness of Otago and Fall Proof Exercises on Balance, Fear of Falling and Quality of Life in Elderly people with Knee Osteoarthritis
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Age over 60 years Mild to moderate knee osteoarthritis based on the WOMAC questionnaire. Informed consent to participate in the study. Having a body mass index (BMI) in the range of 20 to 35 kg/m square Sufficient cognitive ability to understand instructions according to the medical record Motor ability (Ability to walk at least 6 meters, without dependence on a walker- Ability to perform exercises)
Exclusion criteria:
Presence of inner ear disorders, as documented in the medical records Presence of severe cardiovascular diseases or severe heart failure (evidenced by limited activity tolerance), as documented in the medical records. Presence of neurological disorders (such as stroke, severe Parkinson's disease, Multiple Sclerosis, dementia, or Alzheimer's), as documented in the medical records. Presence of advanced visual or hearing impairment (which would pose a risk of falling during exercises), as documented in the medical records. Current use of strong sedatives or benzodiazepines, as documented in the medical records. History of lower limb injuries within the past 12 months, as documented in the medical records
Age
From 60 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 60
Randomization (investigator's opinion)
Randomized
Randomization description
At first among the active elderly rehabilitation centers in Chaharmahal and Bakhtiari province, three centers will be selected by simple random method. Then, the centers will be randomly assigned to the study groups as follows: one center for the Otago exercise intervention, one center for the Fall-proof exercise intervention, and one center as the control group, which will be assigned by simple random method. Finally, among the elderly referring to each center who are eligible for inclusion in the study, samples will be selected by convenient sampling method and will participate in the study.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
The allocation to study groups is as follows: two groups are considered intervention groups (one intervention group will receive Otago exercises and one intervention group will receive Fall-proof exercises) and one group is considered control and will not receive any intervention.

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethical Committee of Isfahan university of Medical Sciences
Street address
Isfahan city, Hazar Jarib Street, Isfahan university of Medical Sciences
City
Isfahan
Province
Isfehan
Postal code
81746-73461
Approval date
2025-11-25, 1404/09/04
Ethics committee reference number
IR.MUI.DHMT.REC.1404.159

Health conditions studied

1

Description of health condition studied
Osteoarthritis of knee
ICD-10 code
M17
ICD-10 code description
Osteoarthritis of knee

Primary outcomes

1

Description
Fear of falling score in the elderly in the (FES-I) questionnaire
Timepoint
Before the intervention, immediately after the intervention
Method of measurement
(FES-I) questionnaire

2

Description
Quality of life score of the elderly in (SF-36) questionnaire
Timepoint
Before the intervention, immediately after the intervention
Method of measurement
(SF-36) questionnaire

3

Description
Static balance score in the elderly in Sharpened Romberg Test
Timepoint
Before the intervention, immediately after the intervention
Method of measurement
Sharpened Romberg Test

4

Description
Dynamic balance score in elderly in (TUG)
Timepoint
Before the intervention, immediately after the intervention
Method of measurement
Time Up and Go Test

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: Participants in this group will receive the Otago exercise program.This program consists of 24 sessions (3 sessions per week for 8 weeks), with each session lasting approximately 45 minutes. The exercise content focuses on strengthening the lower limb muscles and performing static and dynamic balance exercises. All sessions will be conducted in a group format, under the direct supervision of the researcher, in a standard and safe environment.
Category
Treatment - Other

2

Description
Intervention group: This group will undergo the FallProof exercise program.This program is also conducted over 24 sessions (3 sessions per week for 8 weeks), with each session lasting approximately 45 minutes. The exercise content includes improving proprioception and performing exercises that shift the center of gravity in different directions. These sessions will also be held in a group format under the direct supervision of the researcher in a safe environment.
Category
Treatment - Other

3

Description
Control group: Participants in this group will only continue their usual routine activities at the center and will not receive any of the structured exercise interventions(Otago or FallProof) during the study period. To adhere to ethical considerations, upon completion of the study and the final assessments, the necessary training regarding the exercises will be provided to this group.
Category
N/A

Recruitment centers

1

Recruitment center
Name of recruitment center
Welfare Organization
Full name of responsible person
Razieh Dorali Beni
Street address
45 Alley, Shariati Street. Shahrekord City
City
Shahrekord
Province
Chahar-Mahal-va-Bakhtiari
Postal code
8816788646
Phone
+98 38 3222 3232
Fax
+98 38 3224 3298
Email
raziehdooralibeni@gmail.com
Web page address
http://www.chbehzisty.ir/index.php/fa/

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Gholamreza Asgari
Street address
Hezarjarib Ave. Isfahan university of Medical Sciences
City
Isfahan
Province
Isfehan
Postal code
81756-73461
Phone
+98 31 3792 3200
Fax
+98 31 3792 3200
Email
research@mui.ac.ir
Web page address
http://mui.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Esfahan 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
Esfahan University of Medical Sciences
Full name of responsible person
Hossein Shahnazi
Position
Faculty member
Latest degree
Ph.D.
Other areas of specialty/work
Health Promotion
Street address
Hezarjarib Ave, School of Health, Isfahan university of Medical Sciences,
City
Isfahan
Province
Isfehan
Postal code
81746-73461
Phone
+98 31 3792 3200
Email
h_shahnazi@hlth.mui.ac.ir
Web page address
http://mui.ac.ir/en/school-hlth/Executive-board

Person responsible for scientific inquiries

Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Hossein Shahnazi
Position
Faculty member
Latest degree
Ph.D.
Other areas of specialty/work
Health Promotion
Street address
Hezarjarib Ave, School of Health, Isfahan university of Medical Sciences,
City
Isfahan
Province
Isfehan
Postal code
81746-73461
Phone
+98 31 3792 3200
Email
h_shahnazi@hlth.mui.ac.ir
Web page address
http://mui.ac.ir/en/school-hlth/Executive-board

Person responsible for updating data

Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Razieh Dorali Beni
Position
Master's Student
Latest degree
Bachelor
Other areas of specialty/work
Geriatrics
Street address
Hezarjarib Ave, School of Health, Isfahan university of Medical Sciences,
City
Isfahan
Province
Isfehan
Postal code
81746-73461
Phone
+98 31 3792 3200
Email
raziehdooralibeni@gmail.com
Web page address
http://mui.ac.ir/en/school-hlth/Executive-board

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
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
En All data is potentially shareable after de-identifying individuals.
When the data will become available and for how long
En Access begins after results are printed
To whom data/document is available
En All people working in academic, scientific, and industrial sectors are able to receive data
Under which criteria data/document could be used
1-Using information to conduct scientific and research studies 2- Not changing information and observing ethical standards
From where data/document is obtainable
Research project implementers and authors 2- Research assistant of the relevant university and educational institution (Isfahan University of Medical Sciences). Contact information for research project implementers: 1-Ms. Razieh Dorali Beni, Address: Shahrekord.Takhti street.Alley38.Sign 3, Contact number 09902280525,Emailaddress:raziehdooralibeni@gmail.com, 2:Mr. Dr. Hossein Shahnazi Address, Isfahan, Hezar Jerib Street, Isfahan University of Medical Sciences, School of Public Health Department of Public Health Education, Contact number: 09133360148. Email address: h_shahnazi@yahoo.com
What processes are involved for a request to access data/document
En After contacting the project implementers and reviewing the applicant's scientific and ethical qualifications, the information will be provided to him/her as soon as possible.
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