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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.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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
What is being tested?
Aqua vest group and Weight vest group
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

Other trials in South Korea

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
  1. 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.
  2. Measurement
  3. 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.
  4. 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.
  5. 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.
  6. 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.
  7. 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 groups in NCT06705946
Study groupRoleWhat they receive
Aqua vest groupExperimentalParticipants 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 groupActive comparatorParticipants 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.

  1. Change in step

    Step time is measured in seconds using a 3D motion capture system

    Measured: 6 weeks and 12 weeks after baseline

  2. Change in stride time

    Stride time is measured in seconds using a 3D motion capture system.

    Measured: 6 weeks and 12 weeks after baseline

  3. 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

  4. Change in cadence

    Cadence is measured in steps per minute using a 3D motion capture system

    Measured: 6 weeks and 12 weeks after baseline

  5. 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

  6. 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

  7. 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

  8. 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

  9. 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

  10. 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

  11. 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.

  1. First posted26 Nov 2024
  2. Study start1 Dec 2024
  3. Primary completion15 Feb 2025
  4. Study completion1 Apr 2025

Resources

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)
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 14654213
  • Karamanidis 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 16215218
  • Narici MV, Maffulli N, Maganaris CN. Ageing of human muscles and tendons. Disabil Rehabil. 2008;30(20-22):1548-54. doi: 10.1080/09638280701831058.

    PubMed 18608375
  • Kang 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 19664776
  • Chale-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 20738437
  • Rygiel 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 26921061
  • Mayfield 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 36335506
  • Newman 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 37431156
  • Cooper 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 20843964
  • Studenski 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

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.

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