Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12625000344493
Ethics application status
Approved
Date submitted
7/04/2025
Date registered
23/04/2025
Date last updated
23/04/2025
Date data sharing statement initially provided
23/04/2025
Type of registration
Prospectively registered

Titles & IDs
Public title
Effect of exercise training intensity on vascular health during late perimenopause
Scientific title
The effect of exercise training intensity on cerebrovascular and peripheral vascular health in late perimenopausal women
Secondary ID [1] 314080 0
Nil Known
Universal Trial Number (UTN)
Trial acronym
PERI-VASC Study
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Arterial stiffness 336844 0
Cerebrovascular function 336840 0
body composition 336842 0
Menopausal symptoms 336843 0
peripheral endothelial function 336841 0
cardiorespiratory fitness 336845 0
Condition category
Condition code
Cardiovascular 333321 333321 0 0
Normal development and function of the cardiovascular system
Reproductive Health and Childbirth 333323 333323 0 0
Menstruation and menopause
Neurological 333322 333322 0 0
Studies of the normal brain and nervous system

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This study aims to compare the effects of a 3 sessions a week, 12-week high-intensity interval training (4x4 HIIT: 5 min warmup, 4 x 4min at 85%-95% max HR with 3 min of rest, 5 min cool down, total ~35 min) on brain and systemic vascular function in healthy late perimenopausal women against an energy matched moderate-intensity interval training ( 6.5x4 MIIT: 5 min warmup, 4 x 6.5min at 65%-75% max HR with 3 min of rest, 5 min cool down, total ~45 min) and non-exercising time control group.

This will be investigated as a randomized controlled trial at the University of Queensland. Participants will be randomized into either a 4x4 HIIT, an energy-matched MIIT or a time-control group. Measures of brain and peripheral vascular function, arterial stiffness, hormone levels, vasomotor symptoms (hot flushes), cardiorespiratory fitness and body composition, will be taken prior, during, and following the intervention.

Exercise sessions will be conducted in small groups (<=6 at a time) prescribedand supervised by at least one trained exercise physiologists at the University of Queensland. During these exercise sessions participants will only be asked to conduct the prescribed cycling exercise (HIIT and MIIT as described above).

Adherance will be monitered via attendance checklists and exercise training data.
Intervention code [1] 330701 0
Lifestyle
Comparator / control treatment
A non exercising time control group will be included. Participants will be asked to continue with their current levels of physical activity. Participants will only be attending the labratory to conduct baseline, intermediate and follow up assesments outlined above.
Control group
Active

Outcomes
Primary outcome [1] 340966 0
Cerebrovascular reactivity of the middle cerebral artery to a 5% CO2 breathing stimulus
Timepoint [1] 340966 0
Baseline vs 13 week post-intervention commencment
Secondary outcome [1] 445642 0
7 day composite physical activity and sedentary behaviour tracking
Timepoint [1] 445642 0
baseline and 13 week post-intervention commencment
Secondary outcome [2] 445643 0
body composition (% fat mass)
Timepoint [2] 445643 0
baseline and 13 week post-intervention commencment
Secondary outcome [3] 445641 0
Menopausal Symptoms Questionnaire
Timepoint [3] 445641 0
baseline, 6 week. and 13 week post-intervention commencment
Secondary outcome [4] 445633 0
spontaneous cerebral autoregulation
Timepoint [4] 445633 0
baseline, 6 week. and 13 week post-intervention commencment
Secondary outcome [5] 446350 0
Hot flush composite severity and frequency tracking
Timepoint [5] 446350 0
baseline, 6 week. and 13 week post-intervention commencment
Secondary outcome [6] 445636 0
Carotid Femoral Pulse Wave Velocity
Timepoint [6] 445636 0
baseline, 6 week. and 13 week post-intervention commencment
Secondary outcome [7] 445637 0
Fasted estrogen concentration
Timepoint [7] 445637 0
baseline, 6 week. and 13 week post-intervention commencment
Secondary outcome [8] 446348 0
Exercising and recovery hormone concentration (DHEA)
Timepoint [8] 446348 0
1 week, 6 week. and 13 week post-intervention commencment
Secondary outcome [9] 445644 0
Exercising and recovery hormone concentration (estradiol)
Timepoint [9] 445644 0
1 week, 6 week. and 13 week post-intervention commencment
Secondary outcome [10] 445634 0
Resting internal carotid artery blood flow
Timepoint [10] 445634 0
baseline, 6 week. and 13 week post-intervention commencment
Secondary outcome [11] 445632 0
Neurovascular coupling of the posterior cerebral artery to a visual stimulus
Timepoint [11] 445632 0
baseline, 6 week. and 13 week post-intervention commencment
Secondary outcome [12] 446349 0
body composition (% fat free mass)
Timepoint [12] 446349 0
baseline and 13 week post-intervention commencment
Secondary outcome [13] 445640 0
Cardiorespiratory Fitness (VO2 max)
Timepoint [13] 445640 0
baseline, and 13 week post-intervention commencment
Secondary outcome [14] 445631 0
Brachial artery Flow mediated-dilation response
Timepoint [14] 445631 0
baseline, 6 week. and 13 week post-intervention commencment
Secondary outcome [15] 446347 0
Exercising and recovery hormone concentration (testosterone)
Timepoint [15] 446347 0
1 week, 6 week. and 13 week post-intervention commencment
Secondary outcome [16] 445635 0
Internal Carotid Artery Response to a 5% CO2 breathing stimulus
Timepoint [16] 445635 0
baseline, 6 week. and 13 week post-intervention commencment
Secondary outcome [17] 446353 0
Dynamic cerebral autoregulation
Timepoint [17] 446353 0
baseline, 6 week. and 13 week post-intervention commencment

Eligibility
Key inclusion criteria
1. Are female
2. Are in late perimenopause =>60 days between consecutive menstrual cycles
3. Are physically able to engage in cycling exercise
4. Are free of any preexisting cardiovascular, respiratory, or metabolic disease.
5. Are not exceeding current physical activity aerobic exercise guidelines (i.e. 300 min/week of moderate-vigorous intensity exercise)
Minimum age
18 Years
Maximum age
No limit
Sex
Females
Can healthy volunteers participate?
Yes
Key exclusion criteria
1. Are taking hormone therapy or have taken hormone therapy in the last 3 months
2. Are currently taking/using hormonal contraceptives (ie. OCP, IUD, transdermal patch, etc.)
3. Have a cognitive impairment that limits your ability to understand verbal instructions
4. Present with anatomical characteristics which obstruct obtaining a satisfactory ultrasound image of your brain blood vessels
5. Are a current smoker/vaper or have smoked or vaped in the last year
6. Have a history of cardiovascular events (e.g., heart attack and stroke), or diagnosed diseases (e.g., angina, coronary heart disease, carotid artery stenosis, hypertension).
7. Have a history of respiratory disease (e.g., COPD, emphysema, chronic bronchitis).
8. Have a history of metabolic disease (e.g., diabetes, kidney disease, liver disease, dyslipidemia).
9. Are taking any medications which may affect blood vessel function (anti-hypertensives, diabeites medication, inhalers, etc.)
10. Have a Body Mass Index (BMI) =>35 kg/m2 AND a waist circumference of >88 cm
11. Are unable to attend the data collection study visits within the required timeframe

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation is not concealed
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer software
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
In line with intention to treat (ITT) clinical trial design all participant data will be analysed using a mixed-effects linear model to assess changes over time, with group and time as fixed factors and participant ID as a random factor. Pairwise comparisons will be conducted using Bonferroni's post hoc test for significant findings, with significance set at P<0.05. An identical per-protocol analysis will also be conducted, including only participants who had successfully completed at least 70% of their scheduled exercising visits within the study’s 12 week time frame.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
30/04/2025
Actual
Date of last participant enrolment
Anticipated
31/01/2026
Actual
Date of last data collection
Anticipated
31/03/2026
Actual
Sample size
Target
36
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD

Funding & Sponsors
Funding source category [1] 318589 0
University
Name [1] 318589 0
University of Queensland
Country [1] 318589 0
Australia
Primary sponsor type
University
Name
University of Queensland
Address
Country
Australia
Secondary sponsor category [1] 321043 0
None
Name [1] 321043 0
Address [1] 321043 0
Country [1] 321043 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 317187 0
The University of Queensland Human Research Ethics Committee A
Ethics committee address [1] 317187 0
Ethics committee country [1] 317187 0
Australia
Date submitted for ethics approval [1] 317187 0
29/10/2024
Approval date [1] 317187 0
20/03/2025
Ethics approval number [1] 317187 0
HE001370

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

Contacts
Principal investigator
Name 140286 0
Dr Jenna Taylor
Address 140286 0
University of Queensland, School of Human Movement and Nutrition Sciences, 26 Blair Drive, St Lucia , QLD, 4067
Country 140286 0
Australia
Phone 140286 0
+61 733656768
Fax 140286 0
Email 140286 0
[email protected]
Contact person for public queries
Name 140287 0
Conan Shing
Address 140287 0
University of Queensland, School of Human Movement and Nutrition Sciences, 26 Blair Drive, St Lucia , QLD, 4067
Country 140287 0
Australia
Phone 140287 0
+61434785883
Fax 140287 0
Email 140287 0
[email protected]
Contact person for scientific queries
Name 140288 0
Conan Shing
Address 140288 0
University of Queensland, School of Human Movement and Nutrition Sciences, 26 Blair Drive, St Lucia , QLD, 4067
Country 140288 0
Australia
Phone 140288 0
+61434785883
Fax 140288 0
Email 140288 0
[email protected]

Data sharing statement
Will the study consider sharing individual participant data?
No


What supporting documents are/will be available?

TypeCitationLinkEmailOther DetailsAttachment
Ethical approval    Decision notification letter.pdf
Informed consent form    PERI-VASC_PICF_REV2.pdf
Study protocol    PERI-VASC_Study Protocol Document_REV2.pdf


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.