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Trial registered on ANZCTR


Registration number
ACTRN12624001236583
Ethics application status
Approved
Date submitted
28/08/2024
Date registered
9/10/2024
Date last updated
9/10/2024
Date data sharing statement initially provided
9/10/2024
Type of registration
Prospectively registered

Titles & IDs
Public title
Comparative analysis of Home-based vs. Laboratory-based High-Intensity Interval Training in Females with Polycystic Ovary Syndrome who are overweight/obese.
Scientific title
Comparative analysis of Cardiometabolic, Reproductive and Mental Health Outcomes Following Home-based vs. Laboratory-based High-Intensity Interval Training in Females with Polycystic Ovary Syndrome who are overweight/obese.
Secondary ID [1] 312458 0
N/A
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Polycystic Ovarian Syndrome 334312 0
Cardiometabolic health 334313 0
Mental Health 334314 0
Cardiorespiratory Fitness 334400 0
Immune response 334401 0
Reproductive health 334402 0
Condition category
Condition code
Metabolic and Endocrine 330967 330967 0 0
Other endocrine disorders
Reproductive Health and Childbirth 331770 331770 0 0
Other reproductive health and childbirth disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This study will investigate the effects of 12 weeks of high-intensity interval training (HIIT) on females with polycystic ovary syndrome (PCOS). Participants will be randomly assigned to one of two groups: Home-Based HIIT (H-HIIT, intervention) and Laboratory-Based HIIT (L-HIIT, comparator). The H-HIIT intervention will involve three weekly sessions, with two sessions consisting of 12 x 1-minute intervals at 90-100% of maximum heart rate (HRmax) and one session of 8 x 4-minute intervals at 90-95% HRmax, all followed by active recovery periods. These sessions will be conducted remotely via Zoom and will be supervised by an experienced member of the research team. Participants will be provided with a magnetic bike trainer to convert their regular bicycles into stationary bikes. Each session will include a warm-up, intervals, active recovery periods, and a cooldown period. A smartwatch with a heart rate sensor will be used to record and store data for each participant, with adherence tracked through session attendance and compliance assessed by exercise intensity data from the monitors.
Intervention code [1] 329045 0
Treatment: Other
Comparator / control treatment
Participants in the Laboratory-Based HIIT (L-HIIT) group will undertake two weekly sessions, each comprising 12 x 1-minute intervals at 90-100% of their maximum heart rate (HRmax) with one-minute active recovery, as well as one session consisting of 8 x 4-minute intervals at 90-95% HRmax with 2-minute active recovery. These sessions will be conducted in a laboratory setting at Victoria University on a stationary cycle ergometer, and will be supervised by an experienced member of the research team. Each session will include a warm-up, intervals, active recovery periods, and a cooldown period. A smartwatch equipped with a heart rate sensor will be used to record and store data for each participant. Adherence will be monitored through session attendance, and compliance will be evaluated using the exercise intensity data collected from the monitors.
Control group
Active

Outcomes
Primary outcome [1] 338803 0
Cardiometabolic Health
Timepoint [1] 338803 0
Baseline, post-completion of intervention program (12 weeks, primary timepoint), and at 3 and 6-months follow-up.
Additionally, the CGM will be used for 7-day monitoring periods at four distinct timepoints: Baseline, immediately after the 12-week intervention, and at the 3-month and 6-month follow-ups.
Primary outcome [2] 338806 0
Reproductive Health
Timepoint [2] 338806 0
Baseline, post-completion of intervention program (12 weeks, primary timepoint), and at 3 and 6 months follow-up.
Primary outcome [3] 338807 0
Psychological Health.
Timepoint [3] 338807 0
Baseline, post-completion of intervention program (12 weeks, primary timepoint) and at 3 and 6 months follow up.
Secondary outcome [1] 437520 0
Physical Activity
Timepoint [1] 437520 0
The accelerometer will be worn continuously for 24 hours a day over a 7-day period at baseline, post-completion of intervention program (12 weeks), and during the 3-month and 6-month follow-ups.
Secondary outcome [2] 438393 0
Barriers and Facilitators
Timepoint [2] 438393 0
Post-completion of intervention program (12 weeks) and at 3 and 6 months follow-up.
Secondary outcome [3] 438750 0
Dietary Habits
Timepoint [3] 438750 0
Baseline, post-completion of intervention program (12 weeks) and at 3 and 6 months follow-up.
Secondary outcome [4] 438980 0
Physical Health Assessment
Timepoint [4] 438980 0
Baseline, post-completion of intervention program (12 weeks), and at 6-months follow-up.

Eligibility
Key inclusion criteria
The inclusion criteria for the study require participants to be females aged between 18-45 years (pre-menopausal), diagnosed with Polycystic Ovary Syndrome (PCOS), insufficiently active (do not meet the minimum physical activity recommendations of 150 min of moderate to vigorous activity per week) and have a Body Mass Index (BMI) greater than 25 kg/m².
Minimum age
18 Years
Maximum age
45 Years
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
The exclusion criteria include pregnancy or breastfeeding, smoking, diabetes, uncontrolled hypertension (greater than 160/100 mmHg), established cardiovascular disease (CVD), renal impairment, malignancy, or taking medications that interfere with the study endpoints (such as insulin sensitizers and anti-obesity drugs).

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
The allocation concealment for this study will be implemented using central randomization by computer.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation will be done using a randomisation table created by computer software. Participants will be stratified by BMI and age and allocated to the intervention groups at a 1:1 ratio.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis
Data will be checked for normality using the Shapiro- wilk test and non-normally distributed variables will be log-transformed before analysis. Group comparisons [home-based HIIT vs. lab-based HIIT] will be made with independent samples t-tests for baseline characteristics. Outcomes will be assessed using linear mixed models or generalised linear mixed models to determine the effect of exercise mode (group) over time. Estimated marginal means will be calculated from the linear mixed models to examine the within-group changes. Thematic analysis will be done to analyse the interview data. Significance will be accepted when p < 0.05.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
4/11/2024
Actual
Date of last participant enrolment
Anticipated
1/12/2025
Actual
Date of last data collection
Anticipated
30/01/2026
Actual
Sample size
Target
40
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC

Funding & Sponsors
Funding source category [1] 316873 0
University
Name [1] 316873 0
Victoria University
Country [1] 316873 0
Australia
Primary sponsor type
University
Name
Victoria University
Address
Country
Australia
Secondary sponsor category [1] 319116 0
None
Name [1] 319116 0
Address [1] 319116 0
Country [1] 319116 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 315633 0
Victoria University Human Research Ethics Committee
Ethics committee address [1] 315633 0
Ethics committee country [1] 315633 0
Australia
Date submitted for ethics approval [1] 315633 0
23/05/2024
Approval date [1] 315633 0
12/08/2024
Ethics approval number [1] 315633 0

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

Contacts
Principal investigator
Name 135326 0
Prof Andrew McAinch
Address 135326 0
Victoria University - Footscray Park Campus 70/104 Ballarat Rd, Footscray VIC 3011
Country 135326 0
Australia
Phone 135326 0
+61 3 9919 2019
Fax 135326 0
Email 135326 0
andrew.mcainch@vu.edu.au
Contact person for public queries
Name 135327 0
Naina Tyagi
Address 135327 0
Victoria University - Footscray Park Campus 70/104 Ballarat Rd, Footscray VIC 3011
Country 135327 0
Australia
Phone 135327 0
+61 478644570
Fax 135327 0
Email 135327 0
naina.tyagi@live.vu.edu.au
Contact person for scientific queries
Name 135328 0
Andrew McAinch
Address 135328 0
Victoria University - Footscray Park Campus 70/104 Ballarat Rd, Footscray VIC 3011
Country 135328 0
Australia
Phone 135328 0
+61 39919 2019
Fax 135328 0
Email 135328 0
andrew.mcainch@vu.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
No, individual participant data (IPD) for this trial will not be available. This ensures the confidentiality and privacy of participants' personal information and data collected during the study.


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
24138Informed consent form    388067-(Uploaded-08-08-2024-00-31-16)-Information to participant form.pdf



Results publications and other study-related documents

Documents added manually
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Documents added automatically
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