NCT05539690

Brief 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Aug 2022

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 24, 2022

Completed
18 days until next milestone

First Submitted

Initial submission to the registry

September 11, 2022

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 14, 2022

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 31, 2023

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 29, 2024

Completed
Last Updated

September 15, 2022

Status Verified

September 1, 2022

Enrollment Period

1 year

First QC Date

September 11, 2022

Last Update Submit

September 13, 2022

Conditions

Keywords

Postural BalanceWhite MatterNeuronal PlasticityElderly PopulationRehabilitationDiffusion Tensor Imaging

Outcome Measures

Primary Outcomes (2)

  • 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.

    4 weeks

  • 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.

    4 weeks

Secondary Outcomes (2)

  • Mean diffusivity of the motor-related white matter tracts

    4 weeks

  • Tract volume of the motor-related white matter tracts

    4 weeks

Study Arms (1)

Balance training group

EXPERIMENTAL

A single training group

Behavioral: Balance training

Interventions

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

Balance training group

Eligibility Criteria

Age60 Years - 85 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Yeouido St. Mary's Hospital

Seoul, Yeongdeungpo-gu, 07345, South Korea

RECRUITING

Related Publications (5)

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

Study Officials

  • Youngkook Kim, MD, PhD

    Yeouido St. Mary's Hospital, College of Medicine, The Catholic University of Korea

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Youngkook Kim, MD, PhD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant professor

Study Record Dates

First Submitted

September 11, 2022

First Posted

September 14, 2022

Study Start

August 24, 2022

Primary Completion

August 31, 2023

Study Completion

February 29, 2024

Last Updated

September 15, 2022

Record last verified: 2022-09

Data Sharing

IPD Sharing
Will not share

Locations