Comparison of the Effects of Square Stepping Exercises and Rhythmic Aerobic Exercises on Balance in Elderly Women: a Randomized Controlled Trial

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Random, 3 parallel groups, single-blind, 45 elderly (15 each)

Rah-e Novin Health Center, Qazvin Randomization:Simple lottery (1:1:1), allocation concealment with sealed numbered envelopes. Blinding: Outcome assessor and statistician blinded; participants and providers not blinded.

Inclusion Criteria: Age 60-80 years؛ Female gender؛ No regular physical activity in past 3 months؛ No contraindication for exercise؛ No neurological diseases, Parkinson's, or MS. Exclusion Criteria: Acute/chronic disease affecting balance (e.g., vertigo, vestibular disorders)؛ Fracture/surgery in lower extremity/spine in past 6 months؛ Use of medications affecting balance/CNS (e.g., benzodiazepines)؛ Inability to walk independently؛ Severe visual or hearing impairment؛ Concurrent participation in other training programs؛ BMI > 35.

Group 1: 8 weeks square stepping (3 sessions/week, 60 min); Group 2: 8 weeks rhythmic aerobic (3 sessions/week, 60 min); Control: no intervention

Static balance (Sharpened Romberg – seconds) Dynamic balance (Y-Balance – % leg length) Functional balance (Berg Scale – score 0-56) Walking ability (TUG – seconds) Quality of life (SF-36 – score 0-135)

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.

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).

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.

Access to data and documents will begin three months after publication of the main results and will continue for two years.

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.

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

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

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)

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).