ANZCTR - Registration

Please note the ANZCTR will be unattended from Friday 20 December 2024 for the holidays. The Registry will re-open on Tuesday 7 January 2025. Submissions and updates will not be processed during that time.

Registering a new trial?

To achieve prospective registration, we recommend submitting your trial for registration at the same time as ethics submission.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers

Trial registered on ANZCTR

Registration number

ACTRN12621000649819

Ethics application status

Approved

Date submitted

23/04/2021

Date registered

31/05/2021

Date last updated

2/05/2022

Date data sharing statement initially provided

31/05/2021

Type of registration

Prospectively registered

Titles & IDs

Public title

Brain structure, inner ear function and brain age in people who are long- term exercisers

Scientific title

Brain structure, inner ear function and brain age in people who are long- term exercisers

Secondary ID [1]

None

Universal Trial Number (UTN)

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Aging

Dementia

Balance Disorder

Mild Cognitive Impairment

Condition category

Condition code

Neurological

Studies of the normal brain and nervous system

Physical Medicine / Rehabilitation

Other physical medicine / rehabilitation

Neurological

Dementias

Intervention/exposure

Study type

Observational

Patient registry

False

Target follow-up duration

Target follow-up type

Description of intervention(s) / exposure

This cross-sectional observational study will recruit 15 healthy older adults between the ages of 60-65 years who have been regularly practicing Tai chi (TC) for at least 5 years from TC classes in the community. Participants undergo a battery of tests over 2 X 2.5 hour visits within a 2 week period including Cognitive tests, MRI, Vestibular testing and Balance testing and spatial navigation testing.

Intervention code [1]

Not applicable

Comparator / control treatment

Fifteen participants who have never participated in TC or another long term exercise programme, will be recruited from the community and be matched for age, gender and years of education. They will undergo the same testing as the exercise group.

Control group

Active

Outcomes

Primary outcome [1]

3T MAGNETOM SKYRA MRI- MRI assessing Brain Structure

Timepoint [1]

Single timepoint study

Primary outcome [2]

Video head impulse testing- vestibular function

Timepoint [2]

Single timepoint study

Primary outcome [3]

Cervical and ocular vestibular evoked myogenic potentials (VEMPS)- vestibular function

Timepoint [3]

Single timepoint study

Secondary outcome [1]

Pure-tone audiometry- auditory function

Timepoint [1]

Single timepoint study

Secondary outcome [2]

tympanometry- acoustic evaluation of the middle ear

Timepoint [2]

Single timepoint study

Secondary outcome [3]

Postural sway- Gait and Balance app

Timepoint [3]

Single timepoint study

Secondary outcome [4]

Clinical Test of Sensory Integration in Balance (CTSOB- M)

Timepoint [4]

Single timepoint study

Secondary outcome [5]

Vanderberg Mental Rotation Task

Timepoint [5]

Single timepoint study

Secondary outcome [6]

Design Memory, a sub-test of the Wechler Memory Scale- Fourth Edition (WMS-IV)

Timepoint [6]

Single timepoint study

Secondary outcome [7]

The Four Mountains Test- spatial memory

Timepoint [7]

Single timepoint study

Secondary outcome [8]

Triangle Completion Task- spatial navigation

Timepoint [8]

Single timepoint study

Secondary outcome [9]

Physical activity questionnaire adapted from Section B of the Healthy New Zealand questionnaire

Timepoint [9]

Single timepoint study

Eligibility

Key inclusion criteria

Over all inclusion criteria: Adult between the ages of 60-65 inclusive with a t-MoCA of 19 or more.
In addition:
Exercise group: Have participated in a community Tai Chi class once a week or more most weeks for the past 5 or more years.
Control group: Have not participated in a regular group exercise programme over the past 5 years.

Minimum age

60 Years

Maximum age

65 Years

Sex

Both males and females

Can healthy volunteers participate?

Yes

Key exclusion criteria

Exclusion Criteria both groups:
MRI exclusions:
Cardiac pacemaker or defibrillator
Retained cardiac pacing wires
Surgical clips in the brain
Prosthetic heart valves (unless MR compatable)
Electronic inner ear implants
Metal fragments in your eyes
Electronic stimulators
Implanted pumps
Permanent eye liner
claustrophobia

Diagnosis of a neurological condition
Previous diagnosis of a vestibular condition (bar a single episode of BPPV)
Medically required to restrict head movements

Exclusion criteria specific to the control group
Have participated in an exercise group for more than 12 weeks in the previous year.

Study design

Purpose

Natural history

Duration

Cross-sectional

Selection

Defined population

Timing

Prospective

Statistical methods / analysis

For univariate analyses concerning specific differences between outcomes in the different groups, generalised linear mixed models (GLMMs) will be used, because they can accommodate highly correlated repeated measures data and also non-normally distributed variables via link functions. The relationships between different variables will be explored using multiple linear regression as well as machine learning methods such as random forest regression.

Recruitment

Recruitment status

Not yet recruiting

Date of first participant enrolment

Anticipated

1/06/2022

Actual

Date of last participant enrolment

Anticipated

30/05/2023

Actual

Date of last data collection

Anticipated

Actual

Sample size

Target

Accrual to date

Final

Recruitment outside Australia

Country [1]

New Zealand

State/province [1]

Auckland

Funding & Sponsors

Funding source category [1]

Charities/Societies/Foundations

Name [1]

Eisdell Moore Centre

Address [1]

c/o University of Auckland
Clinical research centre
85 Grafton Rd,
Auckland 1010

Country [1]

New Zealand

Primary sponsor type

University

Name

Auckland University of Technology

Address

90 Akoranga Drive
Northcote
Auckland 0627

Country

New Zealand

Secondary sponsor category [1]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Auckland University of Technology Ethics Committee

Ethics committee address [1]

AUT
90 Akoranga Drive
Northcote
Auckland 0627

Ethics committee country [1]

New Zealand

Date submitted for ethics approval [1]

28/04/2021

Approval date [1]

27/05/2021

Ethics approval number [1]

21/123

Summary

Brief summary

New Zealand, like other countries, has an ageing population. By 2034 it is expected that more than a fifth of the New Zealand population will be older than 65 years. Maintaining brain health into older age to minimise the effect of age-related declines in memory, cognitive and motor functions is a priority aim of New Zealand Healthy Ageing Strategy. It is known that exercise has positive benefits for brain health but there is little information available about effect of long-term participation in low-level balance related exercise. Tai Chi (TC) is a low-impact form of exercise that involves coordinated movements, challenges balance, has cognitive involvement and occurs as a 3-dimensional movement. For some practitioners it is a lifelong habitual practice and as such is a good model for investigating long-term engagement with balance related exercise.

The vestibular system has an important role in balance and there is a growing awareness of its importance in cognition. There is some evidence in human studies that poor vestibular function is associated with reduced hippocampal volumes. A recent study that examined the association between age-related variation in vestibular function and brain structure in multiple brain areas that receive vestibular input and reported that the shape and volume of hippocampal and entorhinal cortical areas were strongly related to vestibular function.

We are interested in exploring the relationship between brain structure measured by MRI, vestibular and balance function and habitual exercise. We will compare the MRI and vestibular function tests of people who are expert Tai Chi practitioners and age matched controls who have not participated in organised and regular exercise over the last 5 years.

Trial website

Trial related presentations / publications

Public notes

Contacts

Principal investigator

Name

Prof Denise Taylor

Address

Auckland University of Technology
90 Akoranga Drive
Northcote
Auckland 0627
New Zealand

Country

New Zealand

Phone

+64 09 921 9680

Fax

denise.taylor@aut.ac.nz

Contact person for public queries

Name

Denise Taylor

Address

Auckland University of Technology
90 Akoranga Drive
Northcote
Auckland 0627
New Zealand

Country

New Zealand

Phone

+64 09 921 9680

Fax

denise.taylor@aut.ac.nz

Contact person for scientific queries

Name

Denise Taylor

Address

Auckland University of Technology
90 Akoranga Drive
Northcote
Auckland 0627
New Zealand

Country

New Zealand

Phone

+64 09 921 9680

Fax

denise.taylor@aut.ac.nz

Data sharing statement

Will individual participant data (IPD) for this trial be available (including data dictionaries)?

No/undecided IPD sharing reason/comment

We have not made this an option on our ethics application.

What supporting documents are/will be available?

No Supporting Document Provided

Results publications and other study-related documents

Documents added manually

No documents have been uploaded by study researchers.

Documents added automatically

No additional documents have been identified.

Trial Review

Registering a new trial?

Documents added manually

Documents added automatically