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IRCT20251102067858N1 IRCT 2025-11-23 Tehran University of Medical Sciences Multifaceted Intervention on Balance in Older Adults MFI Evaluating the Effectiveness of a Multifaceted Intervention Program Including Activity and Balance Exercises, Nutritional, Biomechanical, Pharmacological, and Psychological Components on Improving Balance in Older Adults 2025-12-06 anticipated 80 Complete https://irct.ir/trial/87373 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: In this study, after assessing the inclusion and exclusion criteria, participants will be randomly assigned to two groups: intervention and control. The randomization method will be performed in four-block randomization using Random Allocation Software (RAS). To avoid bias in allocation, the randomization process will be performed by an individual independent of the research team, Blinding description: For blinding, due to the nature of the intervention, blinding of participants is not possible. However, the outcome assessors and the data analyst will be blinded to the group allocation (single-blind study design). To ensure that blinding is maintained, the groups will be coded and will only be opened after the statistical analysis is completed. 2-3 balance impairment in elderly. Intervention 1: Intervention group:. Intervention 2: Control group:. Yes - There is a plan to make this available What will be shared: Information about the main research findings will be published in the form of an article. When: After the results are published, up to two years later To whom: Employees at academic institutions and well-known researchers Conditions: For verification by the editor of the journal or journals in which the articles are published and for researchers who wish to conduct further research in this field. Where to obtain: Email the principal investigator. How to obtain: After receiving the email, it is discussed with the research center's research council and, with the center's permission, the information is made available to the researchers by removing the subjects' names and carrying out other legal and ethical considerations. Comments:
public Farhad Moradi Shahpar
No7, Ahmadi Street, Jalal-e-Al-e-Ahmad Highway
Tehran Iran (Islamic Republic of) 1411734141 +98 21 8863 0228 drfmoradi@yahoo.com Tehran University of Medical Sciences scientific Farhad Moradi Shahpar
Sports Medicine Research Center, No 7, Ahmadi Street, Jalal-e-Al-e-Ahmad Highway
Tehran Iran (Islamic Republic of) 1411734141 +98 21 8863 0228 f_moradishahpar@sbu.ac.ir Tehran University of Medical Sciences Iran (Islamic Republic of) - Age ≥ 65 years- Ability to walk independently with or without a mobility aid- Score of 21 to 40 on the Berg Balance Scale, indicating moderate balance- Written informed consent to participate in the study 65 years no limit Both - Severe neurological disorders (such as stroke or advanced Parkinson's) Moderate to severe dementia (MMSE score less than 20) Severe musculoskeletal problems Inability to participate in interventions for more than 2 weeks R26.81 Unsteadiness on feet Treatment - Other Treatment - Other Intervention group: Control group: Berg Balance Scale. Timepoint: Pre-test before intervention and at the end of 12 weeks intervention. Method of measurement: 14 items in Berg balance Test. Time of Timed Up and Go Test. Timepoint: Pre-test before intervention and at the end of 12 weeks intervention. Method of measurement: Time taken by the participant to cover the 3-meter distance. Nutritional situation in Mini Nutritional Assessment. Timepoint: Pre-test before intervention and at the end of 12 weeks intervention. Method of measurement: Short Form Nutrition Assessment Score. Score of the Medication Appropriateness Index. Timepoint: Pre-test before intervention and at the end of 12 weeks intervention. Method of measurement: Score from the quality of medication use assessment for the elderly based on the Medication Appropriateness Index. Level of Anxiety and Depression. Timepoint: Pre-test before intervention and at the end of 12 weeks intervention. Method of measurement: The scores of Geriatric Depression Scale and Geriatric Anxiety Inventory tests. The strength of lower limbs. Timepoint: Pre-test before intervention and at the end of 12 weeks intervention. Method of measurement: 30 -Second Chair Stand Test score. The Speed of Gait. Timepoint: Pre-test before intervention and at the end of 12 weeks intervention. Method of measurement: Average gait speed of the participant on the 4-meter path. Tehran University of Medical Sciences Approved 2025-07-13 Ethics Committee of Tehran University of Medical Sciences Poorsina ave., Enghelab Sq., Tehran, Iran Tehran Tehran Iran (Islamic Republic of)