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IRCT20260623069934N1 IRCT 2026-08-10 shahid beheshti University Comparison of Two Exercise Programs on Balance in Elderly Women Comparison of the Effects of Square Stepping Exercises and Rhythmic Aerobic Exercises on Balance in Elderly Women: a Randomized Controlled Trial 2026-08-16 anticipated 45 Recruiting https://irct.ir/trial/92290 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Prevention, Randomization description: Randomization will be performed using simple lottery method with a 1:1:1 allocation ratio. Each participant receives a unique code, then codes are written on small papers, placed in a container, and sequentially allocated to three groups (square stepping, rhythmic aerobic, and control). Sealed, numbered envelopes will be used for allocation concealment, Blinding description: Due to the nature of the exercise-based interventions (square stepping and rhythmic aerobic exercises), complete blinding of participants and intervention providers is not feasible. However, to minimize detection bias, the outcome assessor and statistician will be blinded to group allocation. Participants: Not blinded (aware of their group due to the nature of the exercise protocols). Principal Investigator and Intervention Providers: Not blinded (supervise execution of specific exercise protocols). Outcome Assessor: Fully Blinded. All pre- and post-intervention assessments (Sharpened Romberg, Y-Balance, Berg Balance Scale, TUG, and SF-36) will be performed by an independent assessor with no knowledge of group allocation. Participants will be instructed not to reveal their training protocol to the assessor. Data Collectors/Support Staff: Blinded to group allocation. Data Analyst: Blinded. Data will be analyzed using coded groups (e.g., A, B, C) until the final statistical analysis is completed. Data Safety and Monitoring Committee: Not applicable (low-risk exercise interventions). Manuscript Writers: Not blinded (after completion of analysis and unblinding). N/A Balance Disorder in Elderly. Balance impairment in elderly women, associated with increased fall risk, reduced functional independence, and decreased quality of life.. Intervention 1: Intervention group: Intervention group 1: Square stepping exercises for 8 weeks, 3 sessions/week, 60 minutes/session (including 10 min warm-up, 40 min main exercise with 196 stepping patterns on a 250×100 cm mat, and 10 min cool-down). Exercises are performed in four directions (forward, backward, lateral, diagonal) with progressive difficulty from beginner to advanced levels. Intervention 2: Intervention group: Intervention group 2: Rhythmic aerobic exercises for 8 weeks, 3 sessions/week, 60 minutes/session (including 10 min warm-up, 30 min basic aerobic movements such as step touch, cross step, lunge, high knee, butterfly, mambo, and 10 min cool-down). Exercise intensity is progressively increased. Intervention 3: Control group: Control group: Receives no exercise intervention; participants continue their normal daily routine and are instructed not to initiate any new regular exercise program during the study period. Yes - There is a plan to make this available What will be shared: De-identified individual participant data including demographic information (age, height, weight) and raw data for all primary outcome variables (Sharpened Romberg test scores, Y-Balance test scores, Berg Balance Scale scores, Timed Up and Go test scores, and SF-36 Quality of Life questionnaire scores) along with the data dictionary, study protocol, statistical analysis plan, and informed consent form will be fully shared. When: Access to data and documents will begin three months after publication of the main results and will continue for two years. To whom: Data and documents will be available to all researchers affiliated with academic, research, and scientific institutions (public and private), as well as clinical specialists (physiotherapists, geriatricians) who provide a methodologically sound proposal and demonstrate the capacity to analyze balance and aging-related data. Access for industry professionals is also possible upon submission of a valid research proposal and ethics committee approval. Conditions: Permitted Purpose: Exclusively for scientific research and educational purposes in the fields of balance, aging, corrective exercises, and fall prevention. Conditions: Submission of a formal written request to the principal investigator including the title and objectives of the proposed analysis Provision of a methodologically sound analytical proposal (specifying variables, statistical tests, and software) Obtaining ethics committee approval from the requesting institution (if applicable) Signing a data confidentiality agreement and commitment to not re-identify participants Prohibition of commercial, legal use, or re-identification of participants Acknowledging the data source in all resulting publications and reports Providing a summary report of findings to the principal investigator upon completion of analysis Where to obtain: Applicants may contact the Principal Investigator (Dr. Mostafa Zarei) through the following methods (in order of priority): First Priority (Email): mostafazarei@sbu.ac.ir Second Priority (Postal Mail): Shahid Beheshti University, Faculty of Sport Sciences and Health, Tehran, Iran, Postal Code: 1983969411 Third Priority (Phone): +98-21-29905838 How to obtain: Step 1 (Days 1-3): Sending a formal email including the analytical proposal and identification documents to the principal investigator Step 2 (Days 4-7): Initial review by the principal investigator and request for possible revisions Step 3 (Days 8-10): Sending and signing the confidentiality agreement and commitment forms Step 4 (Days 11-14): Final review and approval by the principal investigator Step 5 (Days 15-21): Data de-identification and delivery via email or secure link Total Estimated Duration: Approximately 2 to 4 weeks (maximum 21 working days) Comments: All data sharing procedures will be conducted in accordance with the International Committee of Medical Journal Editors (ICMJE) guidelines and with full respect for participant confidentiality and privacy. Data will only be shared with researchers who provide a methodologically sound proposal and commit to full compliance with ethical research standards. This trial has been registered in the Iranian Registry of Clinical Trials (IRCT) with the ID (to be inserted).
public Mostafa Zarei
Shahid Shahriari Square, Daneshjou Boulevard, Shahid Beheshti University, Faculty of Sport Sciences and Health, Tehran, Iran
Tehran Iran (Islamic Republic of) 1983969411 +98 21 2990 5838 m_zareei@sbu.ac.ir Shahid Beheshti University scientific Mostafa Zarei
Shahid Shahriari Square, Daneshjou Boulevard, Shahid Beheshti University, Faculty of Sport Sciences and Health, Tehran, Iran
Tehran Iran (Islamic Republic of) 1983969411 +98 21 2990 5838 m_zareei@sbu.ac.ir Shahid Beheshti University Iran (Islamic Republic of) Age 60-80 years Female gender No regular physical activity during the three months prior to the study No contraindication for physical activity No neurological diseases, Parkinson's disease, or Multiple Sclerosis (MS) 60 years 80 years Female Presence of acute or chronic diseases affecting balance (e.g., chronic vertigo, vestibular disorders, orthostatic hypotension) History of fracture or surgery in the lower extremity or spine within the past 6 months Regular use of medications affecting balance or the central nervous system (e.g., benzodiazepines, antidepressants, muscle relaxants) Inability to walk independently without assistance (need for cane, walker, or helper) Severe visual or hearing impairment affecting exercise performance or instruction comprehension Concurrent participation in other regular training or rehabilitation programs Body Mass Index (BMI) greater than 35 kg/m² Prevention Prevention Prevention Intervention group: Intervention group 1: Square stepping exercises for 8 weeks, 3 sessions/week, 60 minutes/session (including 10 min warm-up, 40 min main exercise with 196 stepping patterns on a 250×100 cm mat, and 10 min cool-down). Exercises are performed in four directions (forward, backward, lateral, diagonal) with progressive difficulty from beginner to advanced levels. Intervention group: Intervention group 2: Rhythmic aerobic exercises for 8 weeks, 3 sessions/week, 60 minutes/session (including 10 min warm-up, 30 min basic aerobic movements such as step touch, cross step, lunge, high knee, butterfly, mambo, and 10 min cool-down). Exercise intensity is progressively increased. Control group: Control group: Receives no exercise intervention; participants continue their normal daily routine and are instructed not to initiate any new regular exercise program during the study period. Static Balance. Timepoint: Pre-test (one week before intervention) and post-test (48 hours after the last training session). Method of measurement: Sharpened Romberg Test using a stopwatch (time recorded in seconds). Dynamic Balance. Timepoint: Pre-test (one week before intervention) and post-test (48 hours after the last training session). Method of measurement: Y-Balance Test using the standard Y-Balance Test kit and a tape measure (distance in centimeters, normalized to leg length). Functional Balance. Timepoint: Pre-test (one week before intervention) and post-test (48 hours after the last training session). Method of measurement: Berg Balance Scale (14 items, each scored 0-4, maximum score 56). Walking Ability. Timepoint: Pre-test (one week before intervention) and post-test (48 hours after the last training session). Method of measurement: Timed Up and Go Test using an armless chair, a stopwatch, and a measured 2.45-meter distance (time recorded in seconds). Quality of Life. Timepoint: Pre-test (one week before intervention) and post-test (48 hours after the last training session). Method of measurement: SF-36 Quality of Life Questionnaire (36 items assessing four domains: physical health, mental health, social health, and general health; score range 0-135). shahid beheshti University Approved 2026-06-13 کمیته ی اخلاق در پژوهش دانشگاه شهید بهشتی تهران Shahid Shahriari Square, Daneshjou Boulevard, Shahid Chamran Highway, Tehran, Iran Tehran Tehran Iran (Islamic Republic of)