ClinicalTrials.gg
Status unknownNCT05539690Updated Sep 15, 2022

Effect of Balance Training on White Matter Tracts in Healthy Elderly Population

An interventional study of Balance training in Postural Balance, Neuronal Plasticity and Elderly Population, sponsored by The Catholic University of Korea. Status unknown at 1 site in South Korea. Open to participants aged 60 Years to 85 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-09-15.

Sponsored by The Catholic University of Korea · Not applicable, Interventional, and Basic science

The sponsor has not verified this record recently (last verified Sep 2022), so the status shown — last known as Recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
40
Allocation
Not applicable
Ages
60 Years to 85 Years
Sex
All
01

Study summary

Balance impairment increases the risk of falling and is associated with a fear of falling and immobility. Balance impairment can ultimately affect the morbidity of cardiovascular disease, cognitive impairment, and mortality, especially in an older population. Among the multiple types of exercise, balance training is the most effective in preventing falls. This study aims to investigate white matter plasticity in healthy elderly population, based on stepwise balance training. Healthy elderly participants will undergo four weeks of balance training. The investigators will analyze longitudinal changes in the microstructural integrity of the white matter tracts pre- and post-training.

Read the detailed description

Balance is an essential element of daily living. Balance impairment increases the risk of falling and is associated with a fear of falling and immobility. Balance impairment can ultimately affect the morbidity of cardiovascular disease, cognitive impairment, and mortality, especially in an older population. Among the multiple types of exercise, balance training is the most effective in preventing falls. Specific structures of the brain are highly associated with balance, and the integration of functions from these structures maintains balance function.

Training-induced behavioral changes accompany white matter plasticity. White matter plasticity by practicing expert skills has been of particular interest because characteristic changes in white matter are expected to occur through repetitive and intensive motor skill training. Training-induced white matter plasticity regarding balance is less understood in the healthy adult population. Previous neuroimaging studies have focused on elucidating the cross-sectional associations between balance function and disease-specific characteristics in various clinical populations, such as patients with stroke, traumatic brain injury, Parkinson's disease, and other neurodegenerative diseases.

Developing neuroimaging biomarkers is essential to provide individualized training or rehabilitation intervention and to evaluate its efficacy. Diffusion tensor imaging is a sensitive neuroimaging tool to detect myelin change quantitatively in human white matter in vivo. DTI is used to measure water molecules' diffusion anisotropy, called fractional anisotropy (FA).

This study will explore white matter plasticity in a healthy elderly population which practices stepwise balance training for 4 weeks. The investigators adopt a longitudinal design to contrast the neuroplastic changes in white matter tracts linked to balance function. The investigators hypothesize that balance training would change the microstructural integrity of white matter tracts associated with balance improvement.

02

Conditions studied

  • Postural Balance
  • Neuronal Plasticity
  • Elderly Population

Keywords

  • Postural Balance
  • White Matter
  • Neuronal Plasticity
  • Elderly Population
  • Rehabilitation
  • Diffusion Tensor Imaging
03

In context

Lead sponsor

The Catholic University of Korea is the lead sponsor of 155 studies on the registry; 4 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
60 Years to 85 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Mini-mental state examination ≥ 26
  • Independent outdoor ambulator

Exclusion criteria

Exclusion Criteria:

  • Men/women with any metal implants in their body
  • A prior history of psychopathology or a neurological disorders
  • A prior history of osteoporosis, advanced osteoarthritis (K-L grade >=3), surgical history of hip or knee arthroplasty
  • If any structural abnormalities are detected on their scan
05

Study design

Phase
Not applicable
Primary purpose
Basic science
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
40 participants (estimated)

Study arms

  • Experimental
    Balance training group

    A single training group

    Behavioral: Balance training

Interventions

  • BehavioralBalance training

    * Step-by-step training (5 levels) * 30 minute per training * 3 times per week * 4 weeks

06

What researchers measure

Primary outcomes

  1. Fractional anisotropy of the motor-related white matter tracts

    Measurement of the change of DTI-derived parameter before and after balance training 1. Tracts of interest * Corticospinal tract (CST) * Cortico-ponto-cerebellar tract (CPCT) * Dentato-rubro-thalamo-cortical tract (DRTCT) * Dorsal spinocerebellar tract (DSCT) 2. Measurement of DTI-derived parameter * Fractional anisotropy (FA) values of the CST, CPCT, DRTCT, and DSCT 3. Units and scoring of the Measurement * FA * No unit. * The measurement ranges from 0 to 1 * Higher scores indicate better microstructural integrity.

    Time frame: 4 weeks

  2. Community Balance & Mobility Scale

    Performance measure before and after balance training 1. Measurement * 13 domain * Unilateral stance, Tandem walking, 180° tandem pivot, Lateral foot scooting, Hopping forward, Crouch and walk, Lateral dodging, Walking \& looking, Running with controlled stop, Forward to backward walking, Walk look and carry, Descending stairs, Step-ups x 1 step 2. Scoring of the Measurement * No units. * The measurement ranges from 0 to 96 * Higher scores indicate better postural balance and mobility.

    Time frame: 4 weeks

Secondary outcomes

  1. Mean diffusivity of the motor-related white matter tracts

    Measurement of the change of DTI-derived parameter before and after balance training 1. Tracts of interest * CST * CPCT * DRTCT * DSCT 2. Measurement of DTI-derived parameter * Mean Diffusivity (MD) values of the CST, CPCT, DRTCT, and DSCT 3. Units and scoring of the Measurement * MD * mm\^2/second * There is no limit on the range (usually ranges 0.00005 - 0.0001 mm\^2/second). * Higher scores indicate worse microstructural integrity.

    Time frame: 4 weeks

  2. Tract volume of the motor-related white matter tracts

    Measurement of the change of DTI-derived parameter before and after balance training 1. Tracts of interest * CST * CPCT * DRTCT * DSCT 2. Measurement of DTI-derived parameter * Tract volume (TV) values of the CST, CPCT, DRTCT, and DSCT 3. Units and scoring of the Measurement * TV * mm\^3 * There is no limit on the range. * Higher scores indicate better microstructural integrity.

    Time frame: 4 weeks

07

Study locations

1 of 1 sites recruiting
  • Yeouido St. Mary's Hospital
    Seoul, Yeongdeungpo-gu 07345, South Korea
    • Youngkook Kim, MD, PhD · Contact
    • Youngkook Kim, MD, PhD · Principal investigator
    Recruiting
08

References and documents

Publications

  • Sherrington C, Fairhall NJ, Wallbank GK, Tiedemann A, Michaleff ZA, Howard K, Clemson L, Hopewell S, Lamb SE. Exercise for preventing falls in older people living in the community. Cochrane Database Syst Rev. 2019 Jan 31;1(1):CD012424. doi: 10.1002/14651858.CD012424.pub2. PubMed 30703272 ↗
  • Surgent OJ, Dadalko OI, Pickett KA, Travers BG. Balance and the brain: A review of structural brain correlates of postural balance and balance training in humans. Gait Posture. 2019 Jun;71:245-252. doi: 10.1016/j.gaitpost.2019.05.011. Epub 2019 May 6. PubMed 31082657 ↗
  • Scholz J, Klein MC, Behrens TE, Johansen-Berg H. Training induces changes in white-matter architecture. Nat Neurosci. 2009 Nov;12(11):1370-1. doi: 10.1038/nn.2412. Epub 2009 Oct 11. PubMed 19820707 ↗
  • Kim JS, Kim SH, Lim SH, Im S, Hong BY, Oh J, Kim Y. Degeneration of the Inferior Cerebellar Peduncle After Middle Cerebral Artery Stroke: Another Perspective on Crossed Cerebellar Diaschisis. Stroke. 2019 Oct;50(10):2700-2707. doi: 10.1161/STROKEAHA.119.025723. Epub 2019 Aug 26. PubMed 31446886 ↗
  • Kim Y, Kim SH, Hong BY, Oh J, Chang SY. Integrity of the Inferior Cerebellar Peduncle Correlates with Ambulatory Function after Hemorrhagic Stroke. J Stroke Cerebrovasc Dis. 2021 Dec;30(12):106164. doi: 10.1016/j.jstrokecerebrovasdis.2021.106164. Epub 2021 Oct 13. PubMed 34655972 ↗

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 15, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05539690
Responsible party
Youngkook Kim (Assistant professor, The Catholic University of Korea) — Principal investigator
First posted
Sep 14, 2022
Start date
Aug 24, 2022
Primary completion
Aug 31, 2023 (estimated)
Completion
Feb 29, 2024 (estimated)
Last update
Sep 15, 2022

Study contacts

Youngkook Kim, MD, PhD
Contact
england2@hamail.net
+8237791383
Youngkook Kim, MD, PhD
principal investigator · Yeouido St. Mary's Hospital, College of Medicine, The Catholic University of Korea

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Sep 2022. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion