- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07812103
Water-Inertia-Based Dynamic Stability Training for Balance and Postural Control in Healthy Young Women
Effects of Water-Inertia-Based Dynamic Stability Training on Dynamic Balance and Single-Leg Postural Control in Healthy Young Women: A Randomized Controlled Trial
Study Overview
Status
Detailed Description
This study was designed to examine whether dynamic stability training performed with a mobile water-based external load produces different physical and postural adaptations from the same training performed with a mass-matched stable external load in healthy young women. The study used a randomized, parallel-group design.
Healthy female university students aged 19-25 years who had not participated in resistance training during the previous 12 months were recruited. After baseline assessment, 30 eligible participants were randomly assigned in a 1:1 ratio to an unstable-load training group or a stable-load training group.
Both groups completed the same supervised dynamic stability training program three times per week for 10 weeks, for a total of 30 training sessions. Each session lasted approximately 50 minutes. The exercise content, training frequency, session duration, set-repetition structure, rest intervals, vest mass, and any additional prescribed exercise loads were matched between groups. During the main training block, participants completed three sets of each exercise, with 12 repetitions per set during weeks 1-5 and 15 repetitions per set during weeks 6-10.
The unstable-load group trained while wearing an Aqua Vest containing a total external load of 5 kg, consisting of approximately 4 kg of water and a 1-kg vest. Because the water pouches were partially filled, the internal water could move during exercise and change the distribution of the external load. The stable-load group wore a mass-matched weighted vest containing approximately 4 kg of steel rods and a 1-kg vest. The steel rods were arranged to approximate the spatial distribution of the water pouches. Thus, the primary experimental difference between groups was the mobility of the external load rather than total vest mass or prescribed exercise content.
Assessments were conducted at baseline, after 5 weeks of training, and after 10 weeks of training. Dynamic postural control was evaluated using the Y-Balance Test. Participants completed reaching tasks in the anterior, posteromedial, and posterolateral directions while standing on one limb. The maximum valid reach distance in each direction was retained and normalized to limb length, and a composite score was also calculated.
Postural sway was evaluated during single-leg stance using force-platform-derived center-of-pressure measures under eyes-open and eyes-closed conditions. Eyes-open trials lasted 30 seconds and eyes-closed trials lasted 20 seconds. Center-of-pressure outcomes included total path distance and direction-specific root-mean-square displacement in the anteroposterior and mediolateral directions.
The broader study protocol also included lower-extremity physical-performance assessments. The registration record is intended to describe the original study protocol and design; individual publications arising from the study may focus on specific subsets of the collected outcomes.
The purpose of the comparison was to determine whether introducing load mobility through a water-filled vest, while keeping the prescribed exercise program and external mass closely matched, resulted in different adaptations from training with a stable weighted vest.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Busan, South Korea
- Busan University of Foreign Studies
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Female undergraduate students aged 19 to 25 years.
- Generally healthy at the time of enrollment.
- No surgery within the previous 6 months.
- No congenital, neurological, vestibular, or musculoskeletal disorder affecting the foot, pelvis, or spine.
- No participation in resistance training during the previous 12 months. Able and willing to participate in the 10-week supervised exercise intervention and study assessments.
- Provided written informed consent to participate.
Exclusion Criteria:
- Did not meet any of the inclusion criteria.
- Participated in resistance training or functional training outside the study intervention during the 10-week study period.
- Developed a health condition, injury, or other circumstance during the study that prevented safe participation in the prescribed exercise program or outcome assessments.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Experimental: Water-Inertia-Based Unstable-Load Training
Participants assigned to this arm completed a supervised 10-week dynamic stability training program three times per week while wearing an Aqua Vest with a total external load of 5 kg, consisting of approximately 4 kg of water and a 1-kg vest.
The partially filled water pouches allowed internal water movement during exercise, creating a mobile external load.
Exercise content, session duration, set-repetition structure, rest intervals, and any additional prescribed exercise loads were matched to the stable-load training arm.
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Participants completed a supervised dynamic stability training program three times per week for 10 weeks (30 sessions), with each session lasting approximately 50 minutes.
During training, participants wore a vest providing a total external load of 5 kg, consisting of approximately 4 kg of water in partially filled pouches and a 1-kg vest.
Internal water movement allowed the external load distribution to change during exercise.
Exercises were performed for three sets, with 12 repetitions per set during weeks 1-5 and 15 repetitions per set during weeks 6-10, with 30 seconds of rest between sets.
Exercise content and any additional prescribed implement loads were matched to the stable-load intervention.
Other Names:
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Active Comparator: Stable-Load Training
Participants assigned to this arm completed the same supervised 10-week dynamic stability training program three times per week while wearing a mass-matched stable weighted vest with a total external load of 5 kg, consisting of approximately 4 kg of steel rods and a 1-kg vest.
The steel rods were arranged to approximate the spatial loading configuration of the water pouches.
Exercise content, session duration, set-repetition structure, rest intervals, and any additional prescribed exercise loads were matched to the unstable-load training arm.
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Participants completed the same supervised dynamic stability training program three times per week for 10 weeks (30 sessions), with each session lasting approximately 50 minutes.
During training, participants wore a stable weighted vest providing a total external load of 5 kg, consisting of approximately 4 kg of steel rods and a 1-kg vest.
The steel rods were arranged to approximate the spatial loading configuration of the water pouches used in the water-inertia intervention.
Exercises were performed for three sets, with 12 repetitions per set during weeks 1-5 and 15 repetitions per set during weeks 6-10, with 30 seconds of rest between sets.
Exercise content and any additional prescribed implement loads were matched between groups.
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Normalized Anterior Reach Distance on the Y-Balance Test
Time Frame: Baseline, Week 5, and Week 10
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Dynamic postural control was assessed using the lower-quarter Y-Balance Test.
Participants performed three valid anterior reach trials while maintaining single-leg stance.
The maximum reach distance was retained and normalized to the corresponding limb length: normalized reach distance (%) = maximum reach distance / limb length × 100.
Higher values indicate greater normalized reach performance.
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Baseline, Week 5, and Week 10
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Normalized Posteromedial Reach Distance on the Y-Balance Test
Time Frame: Baseline, Week 5, and Week 10
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Participants performed three valid posteromedial reach trials during the lower-quarter Y-Balance Test.
The maximum reach distance was retained and normalized to the corresponding limb length: normalized reach distance (%) = maximum reach distance / limb length × 100.
Higher values indicate greater normalized reach performance.
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Baseline, Week 5, and Week 10
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Normalized Posterolateral Reach Distance on the Y-Balance Test
Time Frame: Baseline, Week 5, and Week 10
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Participants performed three valid posterolateral reach trials during the lower-quarter Y-Balance Test.
The maximum reach distance was retained and normalized to the corresponding limb length: normalized reach distance (%) = maximum reach distance / limb length × 100.
Higher values indicate greater normalized reach performance.
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Baseline, Week 5, and Week 10
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Y-Balance Test Composite Score
Time Frame: Baseline, Week 5, and Week 10
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The composite score was calculated from the maximum valid anterior, posteromedial, and posterolateral reach distances normalized to limb length: composite score (%) = (maximum anterior + maximum posteromedial + maximum posterolateral reach distance) / (3 × limb length) × 100.
Higher values indicate greater overall Y-Balance Test performance.
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Baseline, Week 5, and Week 10
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Center-of-Pressure Total Distance During Eyes-Open Single-Leg Stance
Time Frame: Baseline, Week 5, and Week 10
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Postural sway was assessed using a force platform during 30-second eyes-open single-leg stance.
Total CoP distance (cm) represented the cumulative path length of the center-of-pressure trajectory during each valid trial.
Three trial-specific values were averaged for analysis.
Lower values represent a shorter CoP trajectory during the test condition.
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Baseline, Week 5, and Week 10
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Anteroposterior CoP RMS During Eyes-Open Single-Leg Stance
Time Frame: Baseline, Week 5, and Week 10
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Anteroposterior root-mean-square (AP RMS) displacement of the center of pressure was calculated during 30-second eyes-open single-leg stance and expressed in centimeters.
AP RMS represents the dispersion of CoP displacement about its mean position in the anteroposterior direction.
Three trial-specific values were averaged for analysis.
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Baseline, Week 5, and Week 10
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Mediolateral CoP RMS During Eyes-Open Single-Leg Stance
Time Frame: Baseline, Week 5, and Week 10
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Mediolateral root-mean-square (ML RMS) displacement of the center of pressure was calculated during 30-second eyes-open single-leg stance and expressed in centimeters.
ML RMS represents the dispersion of CoP displacement about its mean position in the mediolateral direction.
Three trial-specific values were averaged for analysis.
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Baseline, Week 5, and Week 10
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Center-of-Pressure Total Distance During Eyes-Closed Single-Leg Stance
Time Frame: Baseline, Week 5, and Week 10
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Postural sway was assessed using a force platform during 20-second eyes-closed single-leg stance.
Total CoP distance (cm) represented the cumulative path length of the center-of-pressure trajectory during each valid trial.
Three trial-specific values were averaged for analysis.
Lower values represent a shorter CoP trajectory during the test condition.
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Baseline, Week 5, and Week 10
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Anteroposterior CoP RMS During Eyes-Closed Single-Leg Stance
Time Frame: Baseline, Week 5, and Week 10
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Anteroposterior root-mean-square (AP RMS) displacement of the center of pressure was calculated during 20-second eyes-closed single-leg stance and expressed in centimeters.
AP RMS represents the dispersion of CoP displacement about its mean position in the anteroposterior direction.
Three trial-specific values were averaged for analysis.
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Baseline, Week 5, and Week 10
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Mediolateral CoP RMS During Eyes-Closed Single-Leg Stance
Time Frame: Baseline, Week 5, and Week 10
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Mediolateral root-mean-square (ML RMS) displacement of the center of pressure was calculated during 20-second eyes-closed single-leg stance and expressed in centimeters.
ML RMS represents the dispersion of CoP displacement about its mean position in the mediolateral direction.
Three trial-specific values were averaged for analysis.
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Baseline, Week 5, and Week 10
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Knee Extension Peak Torque Relative to Body Weight at 60°/s
Time Frame: Baseline, Week 5, and Week 10
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Concentric knee extension strength was assessed using an isokinetic dynamometer at an angular velocity of 60°/s.
Peak torque was normalized to body weight and expressed as a percentage of body weight (PT/BW, %).
Higher values indicate greater knee extensor torque relative to body weight.
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Baseline, Week 5, and Week 10
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Knee Flexion Peak Torque Relative to Body Weight at 60°/s
Time Frame: Baseline, Week 5, and Week 10
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Concentric knee flexion strength was assessed using an isokinetic dynamometer at an angular velocity of 60°/s.
Peak torque was normalized to body weight and expressed as a percentage of body weight (PT/BW, %).
Higher values indicate greater knee flexor torque relative to body weight.
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Baseline, Week 5, and Week 10
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Ankle Inversion Peak Torque Relative to Body Weight at 60°/s
Time Frame: Baseline, Week 5, and Week 10
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Concentric ankle inversion strength was assessed using an isokinetic dynamometer at an angular velocity of 60°/s.
Peak torque was normalized to body weight and expressed as a percentage of body weight (PT/BW, %).
Higher values indicate greater inversion torque relative to body weight.
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Baseline, Week 5, and Week 10
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Ankle Eversion Peak Torque Relative to Body Weight at 60°/s
Time Frame: Baseline, Week 5, and Week 10
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Concentric ankle eversion strength was assessed using an isokinetic dynamometer at an angular velocity of 60°/s.
Peak torque was normalized to body weight and expressed as a percentage of body weight (PT/BW, %).
Higher values indicate greater eversion torque relative to body weight.
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Baseline, Week 5, and Week 10
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Ankle Inversion Peak Torque Relative to Body Weight at 120°/s
Time Frame: Baseline, Week 5, and Week 10
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Concentric ankle inversion strength was assessed using an isokinetic dynamometer at an angular velocity of 120°/s.
Peak torque was normalized to body weight and expressed as a percentage of body weight (PT/BW, %).
Higher values indicate greater inversion torque relative to body weight.
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Baseline, Week 5, and Week 10
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Ankle Eversion Peak Torque Relative to Body Weight at 120°/s
Time Frame: Baseline, Week 5, and Week 10
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Concentric ankle eversion strength was assessed using an isokinetic dynamometer at an angular velocity of 120°/s.
Peak torque was normalized to body weight and expressed as a percentage of body weight (PT/BW, %).
Higher values indicate greater eversion torque relative to body weight.
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Baseline, Week 5, and Week 10
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Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Knee Extension Test Range of Motion at 60°/s
Time Frame: Baseline, Week 5, and Week 10
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Range of motion recorded by the isokinetic dynamometer during the knee extension test performed at 60°/s, expressed in degrees.
This measure represents the angular range recorded during the corresponding isokinetic testing condition.
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Baseline, Week 5, and Week 10
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Knee Flexion Test Range of Motion at 60°/s
Time Frame: Baseline, Week 5, and Week 10
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Range of motion recorded by the isokinetic dynamometer during the knee flexion test performed at 60°/s, expressed in degrees.
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Baseline, Week 5, and Week 10
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Ankle Inversion Test Range of Motion at 60°/s
Time Frame: Baseline, Week 5, and Week 10
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Range of motion recorded by the isokinetic dynamometer during the inversion test performed at 60°/s, expressed in degrees.
This measure represents the angular range recorded during the corresponding isokinetic testing condition.
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Baseline, Week 5, and Week 10
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Ankle Eversion Test Range of Motion at 60°/s
Time Frame: Baseline, Week 5, and Week 10
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Range of motion recorded by the isokinetic dynamometer during the eversion test performed at 60°/s, expressed in degrees.
This measure represents the angular range recorded during the corresponding isokinetic testing condition.
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Baseline, Week 5, and Week 10
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Ankle Inversion Test Range of Motion at 120°/s
Time Frame: Baseline, Week 5, and Week 10
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Range of motion recorded by the isokinetic dynamometer during the inversion test performed at 120°/s, expressed in degrees.
This measure represents the angular range recorded during the corresponding isokinetic testing condition.
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Baseline, Week 5, and Week 10
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Ankle Eversion Test Range of Motion at 120°/s
Time Frame: Baseline, Week 5, and Week 10
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Range of motion recorded by the isokinetic dynamometer during the eversion test performed at 120°/s, expressed in degrees.
This measure represents the angular range recorded during the corresponding isokinetic testing condition.
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Baseline, Week 5, and Week 10
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Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- 2024-0666-001
- P01-202407-01-004 (Other Identifier: Public Institutional Bioethics Committee, Republic of Korea)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Access Criteria
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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