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

September 13, 2022 updated by: Youngkook Kim, The Catholic University of Korea
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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Korea, Republic of
    • Yeongdeungpo-gu
      • Seoul, Yeongdeungpo-gu, Korea, Republic of, 07345
        • Recruiting
        • Yeouido St. Mary's Hospital
        • Contact:
          • Youngkook Kim, MD, PhD
        • Principal Investigator:
          • Youngkook Kim, MD, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

58 years to 83 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Balance training group
A single training group
Behavioral: Balance training
  • Step-by-step training (5 levels)
  • 30 minute per training
  • 3 times per week
  • 4 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Fractional anisotropy of the motor-related white matter tracts
Time Frame: 4 weeks

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
Time Frame: 4 weeks

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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mean diffusivity of the motor-related white matter tracts
Time Frame: 4 weeks

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.
4 weeks
Tract volume of the motor-related white matter tracts
Time Frame: 4 weeks

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.
4 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The Catholic University of Korea

Investigators

  • Principal Investigator: Youngkook Kim, MD, PhD, Yeouido St. Mary's Hospital, College of Medicine, The Catholic University of Korea

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 24, 2022

Primary Completion (Anticipated)

August 31, 2023

Study Completion (Anticipated)

February 29, 2024

Study Registration Dates

First Submitted

September 11, 2022

First Submitted That Met QC Criteria

September 11, 2022

First Posted (Actual)

September 14, 2022

Study Record Updates

Last Update Posted (Actual)

September 15, 2022

Last Update Submitted That Met QC Criteria

September 13, 2022

Last Verified

September 1, 2022

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • SC22FISI0069

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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