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IRCT20230219057454N3 IRCT 2025-11-26 Esfahan University of Medical Sciences Comparing the Effectiveness of Otago and Fall Proof Exercises on Balance, Fear of Falling and Quality of Life in Elderly people with Knee Osteoarthritis Comparing the Effectiveness of Otago and Fall Proof Exercises on Balance , Fear of Falling and Quality of Life in Elderly people with Knee Osteoarthritis 2025-11-21 anticipated 60 Complete https://irct.ir/trial/86867 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Prevention, 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, 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. N/A Osteoarthritis of knee. Intervention 1: 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. Intervention 2: 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. Intervention 3: 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. Yes - There is a plan to make this available What will be shared: En All data is potentially shareable after de-identifying individuals. When: En Access begins after results are printed To whom: En All people working in academic, scientific, and industrial sectors are able to receive data Conditions: 1-Using information to conduct scientific and research studies 2- Not changing information and observing ethical standards Where to obtain: 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 How to obtain: 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. Comments:
public Hossein Shahnazi
Hezarjarib Ave, School of Health, Isfahan university of Medical Sciences,
Isfahan Iran (Islamic Republic of) 81746-73461 +98 31 3792 3200 h_shahnazi@hlth.mui.ac.ir Esfahan University of Medical Sciences scientific Hossein Shahnazi
Hezarjarib Ave, School of Health, Isfahan university of Medical Sciences,
Isfahan Iran (Islamic Republic of) 81746-73461 +98 31 3792 3200 h_shahnazi@hlth.mui.ac.ir Esfahan University of Medical Sciences Iran (Islamic Republic of) 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) 60 years no limit Both 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 M17 Osteoarthritis of knee Treatment - Other Treatment - Other N/A 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. 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. 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. 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. 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. Static balance score in the elderly in Sharpened Romberg Test. Timepoint: Before the intervention, immediately after the intervention. Method of measurement: Sharpened Romberg Test. Dynamic balance score in elderly in (TUG). Timepoint: Before the intervention, immediately after the intervention. Method of measurement: Time Up and Go Test. Esfahan University of Medical Sciences Approved 2025-11-25 Ethical Committee of Isfahan university of Medical Sciences Isfahan city, Hazar Jarib Street, Isfahan university of Medical Sciences Isfahan Isfehan Iran (Islamic Republic of)