Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12619001291178
Ethics application status
Approved
Date submitted
4/09/2019
Date registered
19/09/2019
Date last updated
13/06/2023
Date data sharing statement initially provided
19/09/2019
Date results provided
13/06/2023
Type of registration
Prospectively registered

Titles & IDs
Public title
Brain health in trained and untrained middle aged to older adults
Scientific title
Cerebrovascular function, mood and cognition in aerobic endurance trained and untrained middle aged and older adults
Secondary ID [1] 299181 0
none
Universal Trial Number (UTN)
U1111-1239-6652
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Cognitive impairment 314280 0
Dementia 314281 0
Condition category
Condition code
Neurological 312629 312629 0 0
Dementias
Mental Health 312726 312726 0 0
Studies of normal psychology, cognitive function and behaviour

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
We will aim to recruit one hundred and thirty-five participants for this study. Recruitment will occur via an approved media release that incorporates physical advertisement, social media and information on the USQ website. The individuals will be recruited from community organisations in and around Ipswich, Toowoomba and Brisbane. Respondents will initially be screened for suitability using the Lifetime Physical Activity Questionnaire (LPAQ), Exercise and Sports Science Australia (ESSA) Adult Pre-exercise Screening System, the Yale Physical Activity Survey and a medical history questionnaire to determine whether participants meet the inclusion and/or exclusion criteria.

Once participants are recruited, voluntary written informed consent will be obtained prior to any assessment being performed. Further, participants will be asked to complete a nutritional questionnaire, so that this can be assessed and that any effects that are noted throughout the study are due to exercise and not just due to changes in nutritional behaviour.

The two arms of this study will consist of the untrained adults who do not participate in any exercise training, and a second arm will consist of the aerobic exercise trained adults, as determined by the aforementioned surveys.

Once informed about the study and its requirements, by providing potential participants with a participant information sheet, participants that meet part of the inclusion criteria will attend USQ Ipswich for baseline screening and testing. The first screening visit will take approximately 2-2.5hrs and the second visit will take approximately 30-40min. These visits will occur on consecutive days. Prior to the start of any testing during visit 1, informed consent will be first voluntarily obtained and, once acknowledged, testing and screening will commence. These visits will incorporate the following methods:
• Cerebrovascular responsiveness to hypercapnia and cognitive stimuli (NIH Toolbox, Trail Making Task) using transcranial Doppler sonography;
• Profile of Mood States to ascertain current mood;
• Anthropometry, determined by body weight and height (body mass index calculation), waist and hip circumferences (waist to hip ratio calculation) and Dual-energy X-ray absorptiometry (DEXA) which will ascertain body composition of total fat mass, lean mass, body fat percentage, and bone mineral content and density;
• Systolic and diastolic blood pressure and arterial elasticity will be measured non-invasively using a Research Cardiovascular Profiling System;
• Biomarker analyses after blood is collected; and
• Exercise capacity will be assessed using a 6 minute walk test and handgrip strength will be determined using hand dynamometry.
Intervention code [1] 315473 0
Early Detection / Screening
Comparator / control treatment
The first arm of the study will be the control group, as they are physically inactive and we are assessing the impact that physical activity has on brain health.
Control group
Active

Outcomes
Primary outcome [1] 321281 0
Cerebrovascular responsiveness to hypercapnia using a transcranial Dopper sonography
Timepoint [1] 321281 0
There are no extended timepoints for this study. We are only conducting 2 visits (visits 1 and 2). We are comparing the impacts of lifelong physical activity against prolonged physical inactivity.
Primary outcome [2] 321282 0
Cerebrovascular responsiveness to cognitive stimuli using the NIH Toolbox, Corsi-block sorting test and the trail making task (parts A and B). This is a composite primary outcome.
Timepoint [2] 321282 0
Visits 1 and 2 only.
Secondary outcome [1] 374526 0
Mean profile of mood states score
Timepoint [1] 374526 0
Visits 1 and 2 only.
Secondary outcome [2] 374527 0
Mean cognitive tests scores using NIH Toolbox battery, Trail Making Task (Parts A & B) and Corsi-block sorting test. This is a composite secondary outcome.
Timepoint [2] 374527 0
Visits 1 and 2 only.
Secondary outcome [3] 374528 0
Cardiovascular profile (arterial stiffness and blood pressure) using a non-invasive HDI/Pulsewave™ CR-2000 Research Cardiovascular Profiling System. This is a composite secondary outcome.
Timepoint [3] 374528 0
Visits 1 and 2 only.
Secondary outcome [4] 374529 0
Metabolic, inflammatory, haematological and general biochemical markers (serum and plasma). These are exploratory outcomes. This is a composite secondary outcome.
Timepoint [4] 374529 0
Visits 1 and 2 only.
Secondary outcome [5] 374530 0
Differences in 6 minute walk test
Timepoint [5] 374530 0
Visits 1 and 2 only.
Secondary outcome [6] 374531 0
Differences in handgrip strength test using a digital dynamometer.
Timepoint [6] 374531 0
Visits 1 and 2 only.
Secondary outcome [7] 374532 0
Differences in body composition using a Dual-energy X-ray absorptiometry (DEXA) (Luna Corp Prodigy Advancer Model GE). Total fat mass, lean mass, body fat percentage, and bone mineral content and density will be assessed. This is a composite secondary outcome.
Timepoint [7] 374532 0
Visits 1 and 2 only.

Eligibility
Key inclusion criteria
Be aged 50-80 years
Be physically inactive (Control - (<150 minutes physical activity per week)
Be physical active and aerobic exercise trained (Arm 2 - >150 minutes physical activity per week and a high score on the Lifetime Physical Activity Questionnaire).
Have blood pressure below 160/100mmHg (we will determine this at the screening visit)
Have an adequate ultrasound signal (we will determine this at the screening visit).
Not have heart, kidney or liver disease (excluding fatty liver disease), cancer or a neurological disorder (e.g. stroke)
Not taking insulin, anticoagulants or hormone replacement therapy
Minimum age
50 Years
Maximum age
80 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Cognitive impairment and/or dementia
Resting blood pressure greater than 160/100mmHg
Chronic kidney disease
Chronic liver disease (excluding fatty liver disease)
Coronary heart disease
Congestive heart failure
Atrial fibrillation
Prior myocardial infarction
Carcinoma (unless in remission or similar)
Stroke
Aneurysm
Epilepsy
Multiple sclerosis
Parkinson’s disease
Neuropathies
Presence of a fistulae
Smoker
Prescribed insulin, hormone-replacement therapy, oral anticoagulants
Middle cerebral artery signal absent on Doppler ultrasound

Study design
Purpose
Screening
Duration
Cross-sectional
Selection
Defined population
Timing
Both
Statistical methods / analysis
Thirty-two participants will be recruited for this study. This allows for 20% attrition as 24 participants are required to give 80% power to detect a significant (p<0.05) 5% change in cerebrovascular function, based on a 10% standard deviation observed in previously run studies that measure cerebrovascular function.

Data will presented as mean ± standard error of the mean (SEM). These data will be normally distributed and analysed using factor repeated analysis of variance (ANOVA) using SPSS or the like thereof.. The repeated measures ANOVA will be performed on the CVR to hypercapnia and cognitive stimuli, as well as the overall cognitive performance to determine the significance of differences between each level of exercise. P-value < 0.05 for the primary outcome (CVR) will be considered significant. A sequential Bonferroni procedure for multiple comparisons of the remaining measurements will be used. Pearson’s correlation analyses with false discovery adjustments, which is used to minimise the occurrence of a type 1 error (i.e. a false-positive), will used to evaluate baseline measurements in CVR to hypercapnia and/or cognitive stimuli, physiological measurements and psychological markers. A P-value < 0.05 for the remainder measures will be considered significant.

Recruitment
Recruitment status
Stopped early
Data analysis
Data analysis is complete
Reason for early stopping/withdrawal
Participant recruitment difficulties
Date of first participant enrolment
Anticipated
7/10/2019
Actual
7/10/2019
Date of last participant enrolment
Anticipated
4/05/2020
Actual
7/03/2020
Date of last data collection
Anticipated
5/05/2020
Actual
7/03/2020
Sample size
Target
32
Accrual to date
Final
46
Recruitment in Australia
Recruitment state(s)
QLD

Funding & Sponsors
Funding source category [1] 303723 0
University
Name [1] 303723 0
University of Southern Queensland
Country [1] 303723 0
Australia
Primary sponsor type
University
Name
University of Southern Queensland
Address
University of Southern Queensland
West Street
Toowoomba Qld 4350
Australia
Country
Australia
Secondary sponsor category [1] 303838 0
None
Name [1] 303838 0
Address [1] 303838 0
Country [1] 303838 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 304248 0
University of Southern Queensland Human Ethics Committee
Ethics committee address [1] 304248 0
Ethics committee country [1] 304248 0
Australia
Date submitted for ethics approval [1] 304248 0
20/11/2018
Approval date [1] 304248 0
19/03/2019
Ethics approval number [1] 304248 0
H19REA015

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 96278 0
Mr Edward Bliss
Address 96278 0
University of Southern Queensland
West Street
Toowoomba Qld 4350
Australia
Country 96278 0
Australia
Phone 96278 0
+61 746315477
Fax 96278 0
Email 96278 0
[email protected]
Contact person for public queries
Name 96279 0
Edward Bliss
Address 96279 0
University of Southern Queensland
West Street
Toowoomba Qld 4350
Australia
Country 96279 0
Australia
Phone 96279 0
+61 746315477
Fax 96279 0
Email 96279 0
[email protected]
Contact person for scientific queries
Name 96280 0
Edward Bliss
Address 96280 0
University of Southern Queensland
West Street
Toowoomba Qld 4350
Australia
Country 96280 0
Australia
Phone 96280 0
+61 746315477
Fax 96280 0
Email 96280 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
Only data underlying published results collected during the trial will be made available, after de-identification.
When will data be available (start and end dates)?
Once published and Edward Bliss has completed his PhD (~31/12/2020). Hence, immediately following publication of Edward's thesis and any journal articles that are generated throughout the course of the study. No end date
Available to whom?
Individual data will also be available to the participants of the study on request.
De-identified data will be available for journal/conference proceedings.
Researchers on the project (i.e. co-investigators).
Available for what types of analyses?
Only to achieve the aims in the approved proposal
How or where can data be obtained?
Restricted access via USQ data portal (password protected) and this will be granted subject to approvals by Principal Investigator ([email protected]).


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.