Balance and Gait Impairment in Elderly WomenNCT06705946
Effects of Water Inertia Load Training on Lower Limb Joint Moments, Gait, and Balance in Elderly Women
A study testing Aqua vest group and Weight vest group in people with Balance and Gait Impairment in Elderly Women, run by Hyun Ju Kim at 1 site in South Korea.
Trial summary
This study highlights that age-related neuromuscular changes negatively impact muscle strength, balance, joint mobility, and cardiovascular health, which in turn affect daily life activities and independence. Read more about this study
- Who is it for?
- Ages 65 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Balance and Gait Impairment in Elderly Women
- What is being tested?
- Aqua vest group and Weight vest group
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteSouth Korea
- Study dates
- 1 Dec 2024to 1 Apr 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- Women only
- Healthy volunteers accepted
- Older adult
Who may be able to join
- Healthy women over the age of 65
Who cannot join
- Musculoskeletal injury within the last 3 months Severe cardiopulmonary disease (heart failure, myocardial infarction) Use of anxiolytics, antidepressants, or sedatives Chronic lung disease Surgery within the last 6 months
Trial locations and contacts
1 site in 1 country.
South Korea1 site
University of Foreign Studies of Busan
Busan, Geumjeong-gu, 46234
About this study
Official title: Effects of Dynamic Stability Training Using Water Inertia Load on Lower Limb Joint Moments, Gait and Balance in Elderly Women
This study highlights that age-related neuromuscular changes negatively impact muscle strength, balance, joint mobility, and cardiovascular health, which in turn affect daily life activities and independence. In particular, aging leads to slower gait speeds and increased metabolic costs associated with shifting the body's center of mass, which are closely linked to functional decline in older adults. While previous studies have focused primarily on spatiotemporal variables like stride length and walking speed, there is a lack of research examining exercise interventions that analyze lower limb joint moments. This study aims to assess the effects of dynamic stability training using water inertia load on the distribution of lower limb joint moments, gait, and balance in older adults, ultimately providing valuable insights to support improvements in efficient gait function among the elderly.
Read the detailed description
- Study Participants This study targets healthy women aged 65 and older who have not engaged in regular exercise in the past six months. Participants will be recruited through posted announcements at Mirine Center and Busan University of Foreign Studies in Busan. Individuals who express interest and sign the consent form after being informed of the study's purpose and eligibility criteria will be selected as participants. The appropriate sample size was determined using G*Power 3.1 software, with an effect size of 0.32, a power of 0.8, and a significance level of 0.05, resulting in an estimated sample size of 18 participants. However, to account for potential dropouts, the study will proceed with a total of 30 participants, divided into 15 in the experimental group and 15 in the control group. Participants will be randomly assigned to either the experimental or control group on the first day of exercise at a 1:1 ratio.
- Measurement
- Balance Measurement For this study, a ground reaction force plate (AMTI-OR6, Watertown, MA, USA) will be used to evaluate static balance. The device assesses the range, velocity, and Root Mean Square (RMS) of the center of pressure (COP) using pressure sensors. To prevent visual distractions during balance assessment, the surrounding environment will be blocked off with curtains. Both legs will be evaluated. For the single-leg standing test, participants will be instructed to stand barefoot, with arms crossed in front of their chest, supporting one leg while lifting the other leg with the knee bent at a 90-degree angle, maintaining the position for 40 seconds. This duration was set at 40 seconds to ensure sufficient time for data collection and to remove any errors at the beginning and end of the trial. To ensure accurate results, participants will be given sufficient rest between attempts, and the test will only be conducted once the participant feels fully prepared. Given that it may be challenging for elderly individuals to maintain this position for the full duration, if they cannot reach 40 seconds, the longest time achieved out of five attempts will be averaged for analysis.
- Gait Measurement In this study, gait spatial and temporal assessments will be conducted using a 6-meter walkway and six 3D infrared motion capture cameras (Vicon camera MX-T20, Oxford Metrics, Oxford, UK). The measured variables include cadence, step time, stride time, walking speed, step length, stride length, foot-off timing, single support time, and double support time. Gait measurements will be conducted in an environment free of external distractions. Participants will perform several practice walks at their preferred walking speed until they become accustomed to the evaluation. Once a normal walking speed is achieved, three trials will be recorded. Additionally, sufficient rest will be provided between each trial to ensure accurate data collection.
- kinetic Measurement To evaluate lower limb joint moments, this study will use a 6-meter walkway, six 3D infrared motion capture cameras (Vicon camera MX-T20, Oxford Metrics, Oxford, UK), and sixteen reflective markers (14mm). The reflective markers will be attached to the following anatomical landmarks: bilateral anterior superior iliac spines, posterior superior iliac spines, mid-thigh lateral sides, lateral femoral epicondyles, mid-shanks, lateral malleoli, second metatarsals, and heels. For analysis, participants' height, weight, leg length, and knee and ankle joint widths will be measured and input into the system. The analysis will track the movement of reflective markers to calculate hip and ankle joint moments and angular velocities using the Vicon Plug-in Gait system at a sampling rate of 100Hz. Hip and ankle joint moments will be analyzed for maximum moment, average values, and positive work during the terminal stance phase of the gait cycle. Each joint moment will be categorized into flexion and extension moments for analysis.
- Dynamic Stability Training The Dynamic Stability Training (DST) program is based on the Instability Neuromuscular Training program proposed by Kang (2024) and consists of exercises structured in progressive stages. The program spans 12 weeks, with two sessions per week, totaling 24 sessions. Each session lasts 50 minutes and includes a 10-minute warm-up, 30 minutes of DST exercises, and a 10-minute cool-down. From weeks 0 to 6, the DST program focuses on bilateral support and weight shifting. From weeks 7 to 12, the exercises progress to include single-leg support movements to enhance balance on one leg, while also increasing speed to adjust exercise intensity. The program incorporates movements involving a step box. Each exercise adheres to the ACSM exercise guidelines. During weeks 0 to 6, exercises are performed at low intensity (RPE 9-11) for 30 seconds of activity with 60 seconds of rest, totaling two sets using a weight of 3 kg. From weeks 7 to 12, exercises are conducted at moderate intensity (RPE 12-13) for 45 seconds of activity with 90 seconds of rest, totaling one set using a weight of 4 kg. Rest time between sets is 1 minute. The experimental group wears an aqua vest filled with water, while the control group wears a weight vest, performing the same exercises. The load of water and weights is determined based on the Rating of Perceived Exertion (RPE). The training sessions will be led by the researcher of this study, who has 13 years of experience. Additionally, two assistant instructors will be assigned to monitor participants throughout the sessions, as the participants are elderly individuals.
- Statistical Analysis
All data collected in this study will be analyzed using SPSS 28.0 to calculate means and standard deviations. The Shapiro-Wilks test will assess the normality of participants' general characteristics and variables. An independent t-test will verify group homogeneity. To compare intervention effects between groups and changes before, during, and after the intervention within groups, a two-way repeated measures ANOVA will be applied. All statistical significance levels will be set at 0.05.
- Being tested
- Aqua vest group, Weight vest group
- Keywords
- elderly women, gait, balance, dynamic stability training, water Inertia Load
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Aqua vest groupBehavioural
Participants in this group will perform Dynamic Stability Training (DST) sessions twice a week for 12 weeks while wearing an aqua vest. Each session will focus on dynamic stability exercises aimed at improving balance, lower limb joint moment distribution, and gait. Each session will last for 50 minutes
Weight vest groupBehavioural
Participants in this group will perform the same Dynamic Stability Training (DST) sessions twice a week for 12 weeks, but with a weight vest instead of an aqua vest. Each session will focus on balance, lower limb joint moment distribution, and gait, lasting for 50 minutes
| Study group | Role | What they receive |
|---|---|---|
| Aqua vest group | Experimental | Participants in this group will perform Dynamic Stability Training (DST) sessions twice a week for 12 weeks while wearing an aqua vest. Each session will focus on dynamic stability exercises aimed at improving balance, lower limb joint moment distribution, and gait. Each session will last for 50 minutes Receives: Behavioral: Aqua vest group |
| Weight vest group | Active comparator | Participants in this group will perform the same Dynamic Stability Training (DST) sessions twice a week for 12 weeks, but with a weight vest instead of an aqua vest. Each session will focus on balance, lower limb joint moment distribution, and gait, lasting for 50 minutes Receives: Behavioral: Weight vest group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in step
Step time is measured in seconds using a 3D motion capture system
Measured: 6 weeks and 12 weeks after baseline
Change in stride time
Stride time is measured in seconds using a 3D motion capture system.
Measured: 6 weeks and 12 weeks after baseline
Change in walking speed
Walking speed is measured in meters per second using a 3D motion capture system.
Measured: 6 weeks and 12 weeks after baseline
Change in cadence
Cadence is measured in steps per minute using a 3D motion capture system
Measured: 6 weeks and 12 weeks after baseline
Change in foot off
Foot off is measured as a percentage of the gate cycle using a 3D motion capture system.
Measured: 6 weeks and 12 weeks after baseline
Change in step length
Step length is measured in meters per second (m/s) using a 3D motion capture system
Measured: 6 weeks and 12 weeks after baseline
Change in stride length
Stride length is measured in meters per second (m/s) using a 3D motion capture system
Measured: 6 weeks and 12 weeks after baseline
Change in single support phase
The single support phase of the gait cycle is measured as a percentage using a 3D motion capture system
Measured: 6 weeks and 12 weeks after baseline
Change in dubble support phase
The double support phase of the gait cycle is measured as a percentage using a 3D motion capture system
Measured: 6 weeks and 12 weeks after baseline
Change in balance stability
Balance was assessed using a single-leg stance test, measuring the center of pressure(COP) sway in both anterior posterior (AP) and medial-lateral (ML) directions.
Measured: 6 weeks and 12 weeks after baseline
Change in Lower limb joint moments
The moments of the lower limb joints, specifically at the hip and ankle, are measured
Measured: 6 weeks and 12 weeks after baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Nov 2024
- Study start1 Dec 2024
- Primary completion15 Feb 2025
- Study completion1 Apr 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for Balance and Gait Impairment in Elderly WomenStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hyun Ju Kim
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Hyun Ju Kim, Busan University of Foreign Studies
- Investigators
- Hyun Ju Kim, MSc, Principal investigator, Department of Sports and Health Convergence
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06705946
- Sponsor's protocol ID
- BUFS-DST-2024
- Status last verified
- Sep 2025
- First submitted
- 23 Nov 2024
- Last updated
- 19 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified individual participant data (IPD) will be shared via Figshare. The data will include demographic information, raw data from the assessments, and any other relevant data collected during the study.
Publications
Laughton CA, Slavin M, Katdare K, Nolan L, Bean JF, Kerrigan DC, Phillips E, Lipsitz LA, Collins JJ. Aging, muscle activity, and balance control: physiologic changes associated with balance impairment. Gait Posture. 2003 Oct;18(2):101-8. doi: 10.1016/s0966-6362(02)00200-x.
PubMed 14654213Karamanidis K, Arampatzis A. Mechanical and morphological properties of different muscle-tendon units in the lower extremity and running mechanics: effect of aging and physical activity. J Exp Biol. 2005 Oct;208(Pt 20):3907-23. doi: 10.1242/jeb.01830.
PubMed 16215218Narici MV, Maffulli N, Maganaris CN. Ageing of human muscles and tendons. Disabil Rehabil. 2008;30(20-22):1548-54. doi: 10.1080/09638280701831058.
PubMed 18608375Kang HG, Dingwell JB. Dynamics and stability of muscle activations during walking in healthy young and older adults. J Biomech. 2009 Oct 16;42(14):2231-7. doi: 10.1016/j.jbiomech.2009.06.038. Epub 2009 Aug 6.
PubMed 19664776Chale-Rush A, Guralnik JM, Walkup MP, Miller ME, Rejeski WJ, Katula JA, King AC, Glynn NW, Manini TM, Blair SN, Fielding RA. Relationship between physical functioning and physical activity in the lifestyle interventions and independence for elders pilot. J Am Geriatr Soc. 2010 Oct;58(10):1918-24. doi: 10.1111/j.1532-5415.2010.03008.x. Epub 2010 Aug 24.
PubMed 20738437Rygiel KA, Picard M, Turnbull DM. The ageing neuromuscular system and sarcopenia: a mitochondrial perspective. J Physiol. 2016 Aug 15;594(16):4499-512. doi: 10.1113/JP271212. Epub 2016 May 7.
PubMed 26921061Mayfield DL, Cronin NJ, Lichtwark GA. Understanding altered contractile properties in advanced age: insights from a systematic muscle modelling approach. Biomech Model Mechanobiol. 2023 Feb;22(1):309-337. doi: 10.1007/s10237-022-01651-9. Epub 2022 Nov 6.
PubMed 36335506Newman AB, Visser M, Kritchevsky SB, Simonsick E, Cawthon PM, Harris TB. The Health, Aging, and Body Composition (Health ABC) Study-Ground-Breaking Science for 25 Years and Counting. J Gerontol A Biol Sci Med Sci. 2023 Oct 28;78(11):2024-2034. doi: 10.1093/gerona/glad167.
PubMed 37431156Cooper R, Kuh D, Cooper C, Gale CR, Lawlor DA, Matthews F, Hardy R; FALCon and HALCyon Study Teams. Objective measures of physical capability and subsequent health: a systematic review. Age Ageing. 2011 Jan;40(1):14-23. doi: 10.1093/ageing/afq117. Epub 2010 Sep 15.
PubMed 20843964Studenski S, Perera S, Patel K, Rosano C, Faulkner K, Inzitari M, Brach J, Chandler J, Cawthon P, Connor EB, Nevitt M, Visser M, Kritchevsky S, Badinelli S, Harris T, Newman AB, Cauley J, Ferrucci L, Guralnik J. Gait speed and survival in older adults. JAMA. 2011 Jan 5;305(1):50-8. doi: 10.1001/jama.2010.1923.
PubMed 21205966
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Dynamic Stability Training Using Water Inertia Load on Lower Limb Joint Moments, Gait and Balance in Elderly Women
- ClinicalTrials.gov ID
- NCT06705946
- Acronym / sponsor ID
- BUFS-DST-2024
- Keywords
- elderly women, gait, balance, dynamic stability training, water Inertia Load
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Hyun Ju KimUniversity, hospital or other
- Study start
- 1 Dec 2024 (actual)
- Primary completion
- 15 Feb 2025 (actual)
- Study completion
- 1 Apr 2025 (actual)
- First posted
- 26 Nov 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study highlights that age-related neuromuscular changes negatively impact muscle strength, balance, joint mobility, and cardiovascular health, which in turn affect daily life activities and independence. In particular, aging leads to slower gait speeds and increased metabolic costs associated with shifting the body's center of mass, which are closely linked to functional decline in older adults. While previous studies have focused primarily on spatiotemporal variables like stride length and walking speed, there is a lack of research examining exercise interventions that analyze lower limb joint moments. This study aims to assess the effects of dynamic stability training using water inertia load on the distribution of lower limb joint moments, gait, and balance in older adults, ultimately providing valuable insights to support improvements in efficient gait function among the elderly.
Detailed description
- Study Participants This study targets healthy women aged 65 and older who have not engaged in regular exercise in the past six months. Participants will be recruited through posted announcements at Mirine Center and Busan University of Foreign Studies in Busan. Individuals who express interest and sign the consent form after being informed of the study's purpose and eligibility criteria will be selected as participants. The appropriate sample size was determined using G*Power 3.1 software, with an effect size of 0.32, a power of 0.8, and a significance level of 0.05, resulting in an estimated sample size of 18 participants. However, to account for potential dropouts, the study will proceed with a total of 30 participants, divided into 15 in the experimental group and 15 in the control group. Participants will be randomly assigned to either the experimental or control group on the first day of exercise at a 1:1 ratio.
- Measurement
- Balance Measurement For this study, a ground reaction force plate (AMTI-OR6, Watertown, MA, USA) will be used to evaluate static balance. The device assesses the range, velocity, and Root Mean Square (RMS) of the center of pressure (COP) using pressure sensors. To prevent visual distractions during balance assessment, the surrounding environment will be blocked off with curtains. Both legs will be evaluated. For the single-leg standing test, participants will be instructed to stand barefoot, with arms crossed in front of their chest, supporting one leg while lifting the other leg with the knee bent at a 90-degree angle, maintaining the position for 40 seconds. This duration was set at 40 seconds to ensure sufficient time for data collection and to remove any errors at the beginning and end of the trial. To ensure accurate results, participants will be given sufficient rest between attempts, and the test will only be conducted once the participant feels fully prepared. Given that it may be challenging for elderly individuals to maintain this position for the full duration, if they cannot reach 40 seconds, the longest time achieved out of five attempts will be averaged for analysis.
- Gait Measurement In this study, gait spatial and temporal assessments will be conducted using a 6-meter walkway and six 3D infrared motion capture cameras (Vicon camera MX-T20, Oxford Metrics, Oxford, UK). The measured variables include cadence, step time, stride time, walking speed, step length, stride length, foot-off timing, single support time, and double support time. Gait measurements will be conducted in an environment free of external distractions. Participants will perform several practice walks at their preferred walking speed until they become accustomed to the evaluation. Once a normal walking speed is achieved, three trials will be recorded. Additionally, sufficient rest will be provided between each trial to ensure accurate data collection.
- kinetic Measurement To evaluate lower limb joint moments, this study will use a 6-meter walkway, six 3D infrared motion capture cameras (Vicon camera MX-T20, Oxford Metrics, Oxford, UK), and sixteen reflective markers (14mm). The reflective markers will be attached to the following anatomical landmarks: bilateral anterior superior iliac spines, posterior superior iliac spines, mid-thigh lateral sides, lateral femoral epicondyles, mid-shanks, lateral malleoli, second metatarsals, and heels. For analysis, participants' height, weight, leg length, and knee and ankle joint widths will be measured and input into the system. The analysis will track the movement of reflective markers to calculate hip and ankle joint moments and angular velocities using the Vicon Plug-in Gait system at a sampling rate of 100Hz. Hip and ankle joint moments will be analyzed for maximum moment, average values, and positive work during the terminal stance phase of the gait cycle. Each joint moment will be categorized into flexion and extension moments for analysis.
- Dynamic Stability Training The Dynamic Stability Training (DST) program is based on the Instability Neuromuscular Training program proposed by Kang (2024) and consists of exercises structured in progressive stages. The program spans 12 weeks, with two sessions per week, totaling 24 sessions. Each session lasts 50 minutes and includes a 10-minute warm-up, 30 minutes of DST exercises, and a 10-minute cool-down. From weeks 0 to 6, the DST program focuses on bilateral support and weight shifting. From weeks 7 to 12, the exercises progress to include single-leg support movements to enhance balance on one leg, while also increasing speed to adjust exercise intensity. The program incorporates movements involving a step box. Each exercise adheres to the ACSM exercise guidelines. During weeks 0 to 6, exercises are performed at low intensity (RPE 9-11) for 30 seconds of activity with 60 seconds of rest, totaling two sets using a weight of 3 kg. From weeks 7 to 12, exercises are conducted at moderate intensity (RPE 12-13) for 45 seconds of activity with 90 seconds of rest, totaling one set using a weight of 4 kg. Rest time between sets is 1 minute. The experimental group wears an aqua vest filled with water, while the control group wears a weight vest, performing the same exercises. The load of water and weights is determined based on the Rating of Perceived Exertion (RPE). The training sessions will be led by the researcher of this study, who has 13 years of experience. Additionally, two assistant instructors will be assigned to monitor participants throughout the sessions, as the participants are elderly individuals.
- Statistical Analysis
All data collected in this study will be analyzed using SPSS 28.0 to calculate means and standard deviations. The Shapiro-Wilks test will assess the normality of participants' general characteristics and variables. An independent t-test will verify group homogeneity. To compare intervention effects between groups and changes before, during, and after the intervention within groups, a two-way repeated measures ANOVA will be applied. All statistical significance levels will be set at 0.05.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Aqua vest group | Experimental | Behavioral: Aqua vest groupParticipants in this group will perform Dynamic Stability Training (DST) sessions twice a week for 12 weeks while wearing an aqua vest. Each session will focus on dynamic stability exercises aimed at improving balance, lower limb joint moment distribution, and gait. Each session will last for 50 minutes |
| Weight vest group | Active comparator | Behavioral: Weight vest groupParticipants in this group will perform the same Dynamic Stability Training (DST) sessions twice a week for 12 weeks, but with a weight vest instead of an aqua vest. Each session will focus on balance, lower limb joint moment distribution, and gait, lasting for 50 minutes |
Who may qualify
- Ages
- 65 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (1 listed)
- Healthy women over the age of 65
Key exclusion criteria (1 listed)
- Musculoskeletal injury within the last 3 months Severe cardiopulmonary disease (heart failure, myocardial infarction) Use of anxiolytics, antidepressants, or sedatives Chronic lung disease Surgery within the last 6 months
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Aqua vest groupParticipants in this group will perform Dynamic Stability Training (DST) sessions twice a week for 12 weeks while wearing an aqua vest. Each session will focus on dynamic stability exercises aimed at improving balance, lower limb joint moment distribution, and gait. Each session will last for 50 minutes | Behavioural | Aqua vest group |
| Weight vest groupParticipants in this group will perform the same Dynamic Stability Training (DST) sessions twice a week for 12 weeks, but with a weight vest instead of an aqua vest. Each session will focus on balance, lower limb joint moment distribution, and gait, lasting for 50 minutes | Behavioural | Weight vest group |
Primary outcome
Change in step
Time frame: 6 weeks and 12 weeks after baseline
Step time is measured in seconds using a 3D motion capture system
Change in stride time
Time frame: 6 weeks and 12 weeks after baseline
Stride time is measured in seconds using a 3D motion capture system.
Change in walking speed
Time frame: 6 weeks and 12 weeks after baseline
Walking speed is measured in meters per second using a 3D motion capture system.
Change in cadence
Time frame: 6 weeks and 12 weeks after baseline
Cadence is measured in steps per minute using a 3D motion capture system
Change in foot off
Time frame: 6 weeks and 12 weeks after baseline
Foot off is measured as a percentage of the gate cycle using a 3D motion capture system.
Change in step length
Time frame: 6 weeks and 12 weeks after baseline
Step length is measured in meters per second (m/s) using a 3D motion capture system
Change in stride length
Time frame: 6 weeks and 12 weeks after baseline
Stride length is measured in meters per second (m/s) using a 3D motion capture system
Change in single support phase
Time frame: 6 weeks and 12 weeks after baseline
The single support phase of the gait cycle is measured as a percentage using a 3D motion capture system
Change in dubble support phase
Time frame: 6 weeks and 12 weeks after baseline
The double support phase of the gait cycle is measured as a percentage using a 3D motion capture system
Change in balance stability
Time frame: 6 weeks and 12 weeks after baseline
Balance was assessed using a single-leg stance test, measuring the center of pressure(COP) sway in both anterior posterior (AP) and medial-lateral (ML) directions.
Change in Lower limb joint moments
Time frame: 6 weeks and 12 weeks after baseline
The moments of the lower limb joints, specifically at the hip and ankle, are measured
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2025.
- Background: PubMed 14654213Laughton CA, Slavin M, Katdare K, Nolan L, Bean JF, Kerrigan DC, Phillips E, Lipsitz LA, Collins JJ. Aging, muscle activity, and balance control: physiologic changes associated with balance impairment. Gait Posture. 2003 Oct;18(2):101-8. doi: 10.1016/s0966-6362(02)00200-x.
- Background: PubMed 16215218Karamanidis K, Arampatzis A. Mechanical and morphological properties of different muscle-tendon units in the lower extremity and running mechanics: effect of aging and physical activity. J Exp Biol. 2005 Oct;208(Pt 20):3907-23. doi: 10.1242/jeb.01830.
- Background: PubMed 18608375Narici MV, Maffulli N, Maganaris CN. Ageing of human muscles and tendons. Disabil Rehabil. 2008;30(20-22):1548-54. doi: 10.1080/09638280701831058.
- Background: PubMed 19664776Kang HG, Dingwell JB. Dynamics and stability of muscle activations during walking in healthy young and older adults. J Biomech. 2009 Oct 16;42(14):2231-7. doi: 10.1016/j.jbiomech.2009.06.038. Epub 2009 Aug 6.
- Background: PubMed 20738437Chale-Rush A, Guralnik JM, Walkup MP, Miller ME, Rejeski WJ, Katula JA, King AC, Glynn NW, Manini TM, Blair SN, Fielding RA. Relationship between physical functioning and physical activity in the lifestyle interventions and independence for elders pilot. J Am Geriatr Soc. 2010 Oct;58(10):1918-24. doi: 10.1111/j.1532-5415.2010.03008.x. Epub 2010 Aug 24.
- Background: PubMed 26921061Rygiel KA, Picard M, Turnbull DM. The ageing neuromuscular system and sarcopenia: a mitochondrial perspective. J Physiol. 2016 Aug 15;594(16):4499-512. doi: 10.1113/JP271212. Epub 2016 May 7.
- Background: PubMed 36335506Mayfield DL, Cronin NJ, Lichtwark GA. Understanding altered contractile properties in advanced age: insights from a systematic muscle modelling approach. Biomech Model Mechanobiol. 2023 Feb;22(1):309-337. doi: 10.1007/s10237-022-01651-9. Epub 2022 Nov 6.
- Background: PubMed 37431156Newman AB, Visser M, Kritchevsky SB, Simonsick E, Cawthon PM, Harris TB. The Health, Aging, and Body Composition (Health ABC) Study-Ground-Breaking Science for 25 Years and Counting. J Gerontol A Biol Sci Med Sci. 2023 Oct 28;78(11):2024-2034. doi: 10.1093/gerona/glad167.
- Background: PubMed 20843964Cooper R, Kuh D, Cooper C, Gale CR, Lawlor DA, Matthews F, Hardy R; FALCon and HALCyon Study Teams. Objective measures of physical capability and subsequent health: a systematic review. Age Ageing. 2011 Jan;40(1):14-23. doi: 10.1093/ageing/afq117. Epub 2010 Sep 15.
- Background: PubMed 21205966Studenski S, Perera S, Patel K, Rosano C, Faulkner K, Inzitari M, Brach J, Chandler J, Cawthon P, Connor EB, Nevitt M, Visser M, Kritchevsky S, Badinelli S, Harris T, Newman AB, Cauley J, Ferrucci L, Guralnik J. Gait speed and survival in older adults. JAMA. 2011 Jan 5;305(1):50-8. doi: 10.1001/jama.2010.1923.
- Individual participant dataSharing planned: Yes. De-identified individual participant data (IPD) will be shared via Figshare. The data will include demographic information, raw data from the assessments, and any other relevant data collected during the study.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hyun Ju Kim, MSc principal investigator
Department of Sports and Health Convergence
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Aqua vest group and Weight vest group in people with Balance and Gait Impairment in Elderly Women, run by Hyun Ju Kim at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in step (time frame: 6 weeks and 12 weeks after baseline). The study lists 11 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06705946, which also lists 10 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Sep 2025.