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IRCT20251214068338N1 IRCT 2026-02-06 Allameh Tabataba’i University Bodyweight exercise for fall prevention in older adults The effect of combined bodyweight strength training on dynamic balance, muscle strength, functional movement stability, and fall risk in older adults in 2026-01-06 anticipated 40 Complete https://irct.ir/trial/88126 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Randomization description: The unit of randomization in this study is the individual. After initial screening, confirmation of eligibility, and obtaining written informed consent, participants are randomly allocated to the intervention and control groups. Participants are assigned to the intervention and control groups using block randomization with a fixed block size of 4 and a 1:1 allocation ratio. The random allocation sequence is generated by an independent researcher using SPSS software (version 26). To ensure allocation concealment, the allocation sequence is placed in sequentially numbered, opaque, sealed envelopes. After final enrollment of each participant, the corresponding envelope is opened in numerical order and the group assignment is revealed. Random sequence generation and group allocation are performed by a researcher independent of the intervention delivery and outcome assessment, Blinding description: This study will be conducted as a single-blind trial, in which the outcome assessors will be blinded to group allocation. Due to the nature of the exercise intervention, blinding of participants and intervention providers is not feasible. N/A Balance impairment and functional mobility limitation in older adults. Intervention 1: Intervention group: Participants in the intervention group will take part in a combined bodyweight strength training program. The program will be conducted for 8 weeks, with two sessions per week, and each session will last approximately 60 minutes.The training intervention focuses on strengthening the lower limb and core muscles and is designed to improve functional abilities related to balance and movement stability.Each training session consists of three components: 1. Warm-up (approximately 10 minutes), including light activities and stretching exercises; 2. Main training phase (approximately 40 minutes), consisting of bodyweight strength exercises targeting the lower limbs and core muscles, as well as functional balance-related exercises; 3. Cool-down (approximately 10 minutes), including gentle stretching exercises.Training sessions are delivered according to a structured exercise program and are performed in a group-based format. Exercise intensity and difficulty are progressively adjusted according to participants’ abilities. All exercises are conducted with careful consideration of older adults’ safety, and all training sessions are carried out under the direct supervision of the researcher or a trained instructor. Intervention 2: Control group:Participants in the control group do not receive any structured exercise intervention during the study period and continue their usual daily activities. No specific exercise program or physical activity recommendations are provided, and participants are instructed to maintain their habitual level of physical activity throughout the study. No - There is not a plan to make this available Justification or reason for not sharing IPD is Due to the limited sample size and the nature of functional and performance-related data in older adults, there is a potential risk of indirect participant identification. Therefore, to ensure data confidentiality and comply with ethical considerations, there is no plan to share individual participant data (IPD).
public Bahar Jafari
Unit 1, No. 199, Azadi 22, Azadi Boulevard, Semnan, Iran
Semnan Iran (Islamic Republic of) 3519833751 +98 999 181 5566 bhrjfri@gmail.com Allameh Tabataba’i University scientific Bahar Jafari
Unit 1, No. 199, Azadi 22, Azadi Boulevard, Semnan, Iran
Semnan Iran (Islamic Republic of) 3519833751 +98 999 181 5566 bhrjfri@gmail.com Allameh Tabataba’i University Iran (Islamic Republic of) Age ≥ 60 years Ability to walk independently (with or without assistive devices) No history of acute cardiovascular disease, neurological, neuromuscular, or orthopedic conditions that would preclude participation in physical activity No severe cognitive impairment that would interfere with understanding or performing exercise instructions No participation in any regular or structured exercise program within the past six months 60 years no limit Both Any medical contraindication to physical activity or lack of medical clearance to participate. History of lower-limb or spinal orthopedic surgery affecting balance or gait. Rehabilitation Rehabilitation Intervention group: Participants in the intervention group will take part in a combined bodyweight strength training program. The program will be conducted for 8 weeks, with two sessions per week, and each session will last approximately 60 minutes.The training intervention focuses on strengthening the lower limb and core muscles and is designed to improve functional abilities related to balance and movement stability.Each training session consists of three components: 1. Warm-up (approximately 10 minutes), including light activities and stretching exercises; 2. Main training phase (approximately 40 minutes), consisting of bodyweight strength exercises targeting the lower limbs and core muscles, as well as functional balance-related exercises; 3. Cool-down (approximately 10 minutes), including gentle stretching exercises.Training sessions are delivered according to a structured exercise program and are performed in a group-based format. Exercise intensity and difficulty are progressively adjusted according to participants’ abilities. All exercises are conducted with careful consideration of older adults’ safety, and all training sessions are carried out under the direct supervision of the researcher or a trained instructor. Control group:Participants in the control group do not receive any structured exercise intervention during the study period and continue their usual daily activities. No specific exercise program or physical activity recommendations are provided, and participants are instructed to maintain their habitual level of physical activity throughout the study Static balance. Timepoint: Outcome measures are assessed at two time points: 1. Baseline (pre-intervention) 2. Post-intervention (after completion of the 8-week training program). Method of measurement: Static balance is measured using the Single-Leg Stance Test, assessed with a Force Plate. Dynamic balance. Timepoint: Outcome measures are assessed at two time points: 1. Baseline (pre-intervention) 2. Post-intervention (after completion of the 8-week training program). Method of measurement: Dynamic balance is evaluated using the 10-Meter Walk Test, assessed with a Force Plate. Lower-limb muscle strength. Timepoint: Outcome measures are assessed at two time points: 1. Baseline (pre-intervention) 2. Post-intervention (after completion of the 8-week training program). Method of measurement: Muscle strength of the knee flexor and extensor muscles is measured using a Biodex System 3 isokinetic dynamometer. Functional movement stability. Timepoint: Outcome measures are assessed at two time points: 1. Baseline (pre-intervention) 2. Post-intervention (after completion of the 8-week training program). Method of measurement: .Functional movement stability is assessed using a motion analysis system during the performance of the 10-Meter Walk Test. Fall risk. Timepoint: Outcome measures are assessed at two time points: 1. Baseline (pre-intervention) 2. Post-intervention (after completion of the8-week training program). Method of measurement: Falls Efficacy Scale–International (FES-I). Allameh Tabataba’i University Approved 2025-12-13 Research Ethics Committee of Allameh Tabataba’i University Allameh Tabataba’i University (Central Campus), Dehkadeh Olympic Blvd., Shahid Hemmat Expressway Intersection Tehran, Iran Tehran Tehran Iran (Islamic Republic of)