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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05539690
Other study ID # SC22FISI0069
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date August 24, 2022
Est. completion date February 29, 2024

Study information

Verified date September 2022
Source The Catholic University of Korea
Contact Youngkook Kim, MD, PhD
Phone +8237791383
Email england2@hamail.net
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 40
Est. completion date February 29, 2024
Est. primary completion date August 31, 2023
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 60 Years to 85 Years
Eligibility Inclusion Criteria: - Mini-mental state examination = 26 - Independent outdoor ambulator 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

Study Design


Related Conditions & MeSH terms


Intervention

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

Locations

Country Name City State
Korea, Republic of Yeouido St. Mary's Hospital Seoul Yeongdeungpo-gu

Sponsors (1)

Lead Sponsor Collaborator
The Catholic University of Korea

Country where clinical trial is conducted

Korea, Republic of, 

References & Publications (5)

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.119.0 — View Citation

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 202 — View Citation

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. — View Citation

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:CD012424. doi: 10.1002/14651858. — View Citation

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. Rev — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Fractional anisotropy of the motor-related white matter tracts Measurement of the change of DTI-derived parameter before and after balance training
Tracts of interest
Corticospinal tract (CST)
Cortico-ponto-cerebellar tract (CPCT)
Dentato-rubro-thalamo-cortical tract (DRTCT)
Dorsal spinocerebellar tract (DSCT)
Measurement of DTI-derived parameter
Fractional anisotropy (FA) values of the CST, CPCT, DRTCT, and DSCT
Units and scoring of the Measurement
FA
No unit.
The measurement ranges from 0 to 1
Higher scores indicate better microstructural integrity.
4 weeks
Primary Community Balance & Mobility Scale Performance measure before and after balance training
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
Scoring of the Measurement
No units.
The measurement ranges from 0 to 96
Higher scores indicate better postural balance and mobility.
4 weeks
Secondary Mean diffusivity of the motor-related white matter tracts Measurement of the change of DTI-derived parameter before and after balance training
Tracts of interest
CST
CPCT
DRTCT
DSCT
Measurement of DTI-derived parameter
Mean Diffusivity (MD) values of the CST, CPCT, DRTCT, and DSCT
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.
4 weeks
Secondary Tract volume of the motor-related white matter tracts Measurement of the change of DTI-derived parameter before and after balance training
Tracts of interest
CST
CPCT
DRTCT
DSCT
Measurement of DTI-derived parameter
Tract volume (TV) values of the CST, CPCT, DRTCT, and DSCT
Units and scoring of the Measurement
TV
mm^3
There is no limit on the range.
Higher scores indicate better microstructural integrity.
4 weeks
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