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IRCT20260516069421N1 IRCT 2026-06-03 Guilan univercity “The Effect of Exercises with Unstable and Stable Loads on Balance and Motor Function in Older Adults with a History of Falls” Comparing The Effects Of Selected Training With And Without Water Inertia Load On Motor Performance, Gait Kinematic Parameters, Postural sway, And Fear Of Falling In Elderly People With A History Of Falls 2026-06-10 anticipated 45 Complete https://irct.ir/trial/90276 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Other design features: “The present study follows a standard design, and its design specifications have been described in detail in previous sections. There are no unique features that require separate explanation.”, Randomization description: Participants will be randomly assigned to three groups: control, water-unstable load training, and constant load training in a 1:1:1 ratio. Randomization will be performed in a block-wise manner with block sizes of 3 and 6 using Random Allocation Software (version 2.0). To conceal allocation, opaque, sealed, and numbered envelopes will be used, prepared by an individual independent of the study team, and opened as participants arrive, Blinding description: This study is designed as a single-blind (assessor-blinded) trial. Given the nature of the exercise interventions, blinding of participants and exercise instructors is not feasible. However, all outcome assessors (those measuring motor function) remain fully blinded to participant group assignments to prevent assessment bias. Furthermore, the data analyst will also remain blinded to participant group assignments until the completion of the analysis. N/A Comparing The Effects Of Selected Training With And Without Water Inertia Load On Motor Performance, Gait Kinematic Parameters, Postural sway, And Fear Of Falling In Elderly People With A History Of Falls. Intervention 1: Intervention group: "The training protocol used in this research was designed and implemented based on the neuromotor training model with unstable loads [56]. This approach specifically utilizes the dynamic and inertial properties of water within aqua bags to create controlled perturbations and enhance balance capabilities in older adults. Its primary mechanism involves continuous stimulation of the sensorimotor systems to maintain postural stability when faced with shifts in the center of gravity caused by water movement.For the implementation of neuromotor training with unstable water inertia loads and a two-month follow-up, participants will attend the training hall for 8 weeks (three sessions per week) from 9 to 10 AM. (The first experimental group attends on odd days from 9 to 10 AM). Each training session will last for 60 minutes, consisting of 10 minutes of warm-up (including dynamic stretching), 40 minutes of the training protocol, and 10 minutes of cool-down (including static stretching and walking).The structure of this protocol is divided into two sequential phases to ensure that the principles of progressive overload are applied with priority given to safety and movement quality control. The phases of the protocol and their respective overload levels will be finalized in a pilot test.Phase 1: Adaptation, Baseline Stability, and Safety (Weeks 1-4)The first phase is the foundational stage of the protocol, focusing on adaptation to the equipment and exercises.Primary Goal of Phase 1: Complete body adaptation to the variable weight and dynamics of the aqua bag, improve postural control in standing, strengthen hip movement foundations, and enhance core stability within a limited range of motion.Loading in Phase 1: At the beginning of the phase, the suggested load for most exercises will be considered empty (0 kg) so that the body solely focuses on stabilizing the aqua bag.Safety and Exercise Exclusion: Exercises requiring strong single-leg hip function, such as single-leg stands and overhead presses with the aqua bag, as well as single-leg hip hinges, are excluded in this phase to minimize the risk of injury.Phase 2: Controlled Progression and Overload Application (Weeks 5-8)Transition to Phase 2 will occur after the successful completion of Phase 1 and stabilization of movement quality without any falls or loss of balance.Primary Goal of Phase 2: Gradually and controlledly apply progressive overload, slightly increase the range of motion in foundational movements, and gradually incorporate more complex exercises excluded from Phase 1.Overload Strategy: Progression in Phase 2 includes increasing the following parameters:Increased Duration: Extending the execution time for endurance exercises, such as walking, up to 3 consecutive minutes.Increased Weight: Gradually adding weight to the aqua bag (0.5 kg per week) to core movements after ensuring complete stability.Increased Range/Repetitions: Improving the depth of movements like hip hinges and increasing repetitions.Critical Safety Requirements Throughout the Period:The execution of the protocol is contingent upon constant supervision by a qualified professional. Immediate cessation is required in case of dizziness or severe pain, and regular breathing must be maintained. Changes in training difficulty should be applied to only one parameter per week, and movement quality always takes precedence over increasing weight or repetitions. Intervention 2: Intervention group2: Intervention group 2: The training protocol used in this study includes a period of training using a stable load (dumbbells) and a two-month follow-up for 8 weeks (three sessions per week, 60 minutes each session). This protocol relies on applying a constant and predictable external load and there are no movements due to environmental instability. In order to perform exercises with a stable load, the subjects participate in training sessions for 8 weeks (three sessions per week). Each session is 60 minutes long, including 10 minutes of warm-up, 40 minutes of performing the training protocol, and 10 minutes of cooling down. The training sessions of the second experimental group are held on even-numbered days from 9 to 10 am in the training hall. Intervention 3: Control group: The control group does not receive any intervention. Yes - There is a plan to make this available What will be shared: “De-identified individual participant data will be shared in full. Supporting study documents, such as the study protocol and statistical analysis plan, will also be available upon request.” When: The 6-month access period begins after the results are published. To whom: Access to the data and documents will be open to all academic and industry researchers interested in using them. Applicants can request access by submitting a formal application, which will be reviewed for eligibility before granting access. Conditions: Use of the data and documents is permitted solely for research and academic purposes, and any commercial use or republication without written permission is prohibited. Applicants must commit to preserving individual anonymity and using the data only in accordance with approved ethical protocols. Where to obtain: Applicants can send their requests to nahid_jalil@yahoo.com. After reviewing the request, the necessary information will be sent back through the same channel. How to obtain: After sending the email, your request will be reviewed and approved within 3 to 5 business days. Once the review process is complete, the data or documents will be sent to you via the same email address. Comments: No additional information is available.
public Nahid Jalil Piran
68, Abolghasemi Alley, Karaj.
Karaj Iran (Islamic Republic of) 3134786111 +98 26 3224 9599 nahid@webmail.guilan.ac.ir Guilan univercity scientific Nahid Jalil Piran
68, Abolghasemi Alley, Karaj.
Karaj Iran (Islamic Republic of) 3134786111 +98 26 3224 9599 nahid@wemail.guilan.ac.ir Guilan university Iran (Islamic Republic of) Iran (Islamic Republic of) Has a history of falling Age 60 to 75 years 60 years 75 years Female Having a cognitive disorder M63 Disorders of muscle in diseases classified elsewhere Rehabilitation Rehabilitation Rehabilitation Intervention group: "The training protocol used in this research was designed and implemented based on the neuromotor training model with unstable loads [56]. This approach specifically utilizes the dynamic and inertial properties of water within aqua bags to create controlled perturbations and enhance balance capabilities in older adults. Its primary mechanism involves continuous stimulation of the sensorimotor systems to maintain postural stability when faced with shifts in the center of gravity caused by water movement.For the implementation of neuromotor training with unstable water inertia loads and a two-month follow-up, participants will attend the training hall for 8 weeks (three sessions per week) from 9 to 10 AM. (The first experimental group attends on odd days from 9 to 10 AM). Each training session will last for 60 minutes, consisting of 10 minutes of warm-up (including dynamic stretching), 40 minutes of the training protocol, and 10 minutes of cool-down (including static stretching and walking).The structure of this protocol is divided into two sequential phases to ensure that the principles of progressive overload are applied with priority given to safety and movement quality control. The phases of the protocol and their respective overload levels will be finalized in a pilot test.Phase 1: Adaptation, Baseline Stability, and Safety (Weeks 1-4)The first phase is the foundational stage of the protocol, focusing on adaptation to the equipment and exercises.Primary Goal of Phase 1: Complete body adaptation to the variable weight and dynamics of the aqua bag, improve postural control in standing, strengthen hip movement foundations, and enhance core stability within a limited range of motion.Loading in Phase 1: At the beginning of the phase, the suggested load for most exercises will be considered empty (0 kg) so that the body solely focuses on stabilizing the aqua bag.Safety and Exercise Exclusion: Exercises requiring strong single-leg hip function, such as single-leg stands and overhead presses with the aqua bag, as well as single-leg hip hinges, are excluded in this phase to minimize the risk of injury.Phase 2: Controlled Progression and Overload Application (Weeks 5-8)Transition to Phase 2 will occur after the successful completion of Phase 1 and stabilization of movement quality without any falls or loss of balance.Primary Goal of Phase 2: Gradually and controlledly apply progressive overload, slightly increase the range of motion in foundational movements, and gradually incorporate more complex exercises excluded from Phase 1.Overload Strategy: Progression in Phase 2 includes increasing the following parameters:Increased Duration: Extending the execution time for endurance exercises, such as walking, up to 3 consecutive minutes.Increased Weight: Gradually adding weight to the aqua bag (0.5 kg per week) to core movements after ensuring complete stability.Increased Range/Repetitions: Improving the depth of movements like hip hinges and increasing repetitions.Critical Safety Requirements Throughout the Period:The execution of the protocol is contingent upon constant supervision by a qualified professional. Immediate cessation is required in case of dizziness or severe pain, and regular breathing must be maintained. Changes in training difficulty should be applied to only one parameter per week, and movement quality always takes precedence over increasing weight or repetitions. Intervention group2: Intervention group 2: The training protocol used in this study includes a period of training using a stable load (dumbbells) and a two-month follow-up for 8 weeks (three sessions per week, 60 minutes each session). This protocol relies on applying a constant and predictable external load and there are no movements due to environmental instability. In order to perform exercises with a stable load, the subjects participate in training sessions for 8 weeks (three sessions per week). Each session is 60 minutes long, including 10 minutes of warm-up, 40 minutes of performing the training protocol, and 10 minutes of cooling down. The training sessions of the second experimental group are held on even-numbered days from 9 to 10 am in the training hall. Control group: The control group does not receive any intervention. Motor Performance. Timepoint: One day before, 60 and 120 days later. Method of measurement: Using the Sorenson-Magill test and the Madison ball throw. Guilan univercity Approved 2026-04-13 Ethics committee of Guilan University 8th kilometer of Qazvin Road, Faculty of Physical Education, Rasht. Rasht Guilan Iran (Islamic Republic of)