- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06705946
Effects of Water Inertia Load Training on Lower Limb Joint Moments, Gait, and Balance in Elderly Women
Effects of Dynamic Stability Training Using Water Inertia Load on Lower Limb Joint Moments, Gait and Balance in Elderly Women
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Geumjeong-gu
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Busan, Geumjeong-gu, South Korea, 46234
- University of Foreign Studies of Busan
-
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Healthy women over the age of 65
Exclusion Criteria:
- 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Aqua vest group
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
|
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
|
|
Active Comparator: Weight vest group
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
|
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
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in step
Time Frame: 6 weeks and 12 weeks after baseline
|
Step time is measured in seconds using a 3D motion capture system
|
6 weeks and 12 weeks after baseline
|
|
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.
|
6 weeks and 12 weeks after baseline
|
|
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.
|
6 weeks and 12 weeks after baseline
|
|
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
|
6 weeks and 12 weeks after baseline
|
|
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.
|
6 weeks and 12 weeks after baseline
|
|
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
|
6 weeks and 12 weeks after baseline
|
|
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
|
6 weeks and 12 weeks after baseline
|
|
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
|
6 weeks and 12 weeks after baseline
|
|
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
|
6 weeks and 12 weeks after baseline
|
|
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.
|
6 weeks and 12 weeks after baseline
|
|
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
|
6 weeks and 12 weeks after baseline
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Hyun Ju Kim, MSc, Department of Sports and Health Convergence
Publications and helpful links
General Publications
- 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.
- 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.
- 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.
- 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.
- Narici MV, Maffulli N, Maganaris CN. Ageing of human muscles and tendons. Disabil Rehabil. 2008;30(20-22):1548-54. doi: 10.1080/09638280701831058.
- 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.
- 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.
- 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.
- 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.
- 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.
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 (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- BUFS-DST-2024
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
- SAP
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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