Postural BalanceNCT05539690
Effect of Balance Training on White Matter Tracts in Healthy Elderly Population
A study testing Balance training in people with Postural Balance and Neuronal Plasticity, run by The Catholic University of Korea at 1 site in South Korea.
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. Read more about this study
- Who is it for?
- Ages 60 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Postural Balance, Neuronal Plasticity, Elderly Population
- What is being tested?
- Balance training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteSouth Korea
- Study dates
- 24 Aug 2022to 29 Feb 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 to 85 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Mini-mental state examination ≥ 26
- Independent outdoor ambulator
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
Yeouido St. Mary's Hospital
Seoul, Yeongdeungpo-gu, 07345
Youngkook Kim, MD, PhD
Youngkook Kim, MD, PhD
About this study
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.
- Conditions
- Postural Balance, Neuronal Plasticity, Elderly Population
- Being tested
- Balance training
- Keywords
- Postural Balance, White Matter, Neuronal Plasticity, Elderly Population, Rehabilitation, Diffusion Tensor Imaging
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Balance trainingBehavioural
- Step-by-step training (5 levels)
- 30 minute per training
- 3 times per week
- 4 weeks
| Study group | Role | What they receive |
|---|---|---|
| Balance training group | Experimental | A single training group Receives: Behavioral: Balance training |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 4 weeks
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.
Measured: 4 weeks
Secondary outcomes (2)
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.
Measured: 4 weeks
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.
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Sep 2022
- Study start24 Aug 2022
- Primary completion31 Aug 2023 (estimated)
- Study completion29 Feb 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Postural BalanceStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Catholic University of Korea
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Youngkook Kim, The Catholic University of Korea
- Investigators
- Youngkook Kim, MD, PhD, Principal investigator, Yeouido St. Mary's Hospital, College of Medicine, The Catholic University of Korea
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05539690
- Sponsor's protocol ID
- SC22FISI0069
- Status last verified
- Sep 2022
- First submitted
- 11 Sep 2022
- Last updated
- 15 Sep 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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 30703272Surgent 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 31082657Scholz 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 19820707Kim 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 31446886Kim 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
Study at a glance
From the registry record, last updated by the sponsor on 15 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Balance Training on White Matter Tracts in Healthy Elderly Population
- ClinicalTrials.gov ID
- NCT05539690
- Acronym / sponsor ID
- SC22FISI0069
- Conditions
- Postural Balance, Neuronal Plasticity, Elderly Population
- Keywords
- Postural Balance, White Matter, Neuronal Plasticity, Elderly Population, Rehabilitation, Diffusion Tensor Imaging
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- The Catholic University of KoreaUniversity, hospital or other
- Study start
- 24 Aug 2022 (actual)
- Primary completion
- 31 Aug 2023 (estimated)
- Study completion
- 29 Feb 2024 (estimated)
- First posted
- 14 Sep 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Balance training group | Experimental | Behavioral: Balance trainingA single training group |
Who may qualify
- Ages
- 60 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Mini-mental state examination ≥ 26
- Independent outdoor ambulator
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Balance training* Step-by-step training (5 levels) * 30 minute per training * 3 times per week * 4 weeks | Behavioural | Balance training group |
Primary outcome
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.
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.
2 secondary outcomes
Mean diffusivity of the motor-related white matter tracts
Time frame: 4 weeks
Tract volume of the motor-related white matter tracts
Time frame: 4 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Sep 2022.
- Results publication: PubMed 30703272Sherrington 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.
- Results publication: PubMed 31082657Surgent 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.
- Results publication: PubMed 19820707Scholz 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.
- Results publication: PubMed 31446886Kim 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.
- Results publication: PubMed 34655972Kim 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Youngkook Kim, MD, PhD principal investigator
Yeouido St. Mary's Hospital, College of Medicine, The Catholic University of Korea
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Balance training in people with Postural Balance and Neuronal Plasticity, run by The Catholic University of Korea at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 15 Sep 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Youngkook Kim, MD, PhD (+8237791383, england2@hamail.net), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Fractional anisotropy of the motor-related white matter tracts (time frame: 4 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05539690, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Sep 2022.