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.

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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]

N/A

Universal Trial Number (UTN)

Trial acronym

Linked study record

Health condition

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

Polycystic Ovarian Syndrome

Cardiometabolic health

Mental Health

Cardiorespiratory Fitness

Immune response

Reproductive health

Condition category

Condition code

Metabolic and Endocrine

Other endocrine disorders

Reproductive Health and Childbirth

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]

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]

Cardiometabolic Health

Timepoint [1]

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]

Reproductive Health

Timepoint [2]

Baseline, post-completion of intervention program (12 weeks, primary timepoint), and at 3 and 6 months follow-up.

Primary outcome [3]

Psychological Health.

Timepoint [3]

Baseline, post-completion of intervention program (12 weeks, primary timepoint) and at 3 and 6 months follow up.

Secondary outcome [1]

Physical Activity

Timepoint [1]

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]

Barriers and Facilitators

Timepoint [2]

Post-completion of intervention program (12 weeks) and at 3 and 6 months follow-up.

Secondary outcome [3]

Dietary Habits

Timepoint [3]

Baseline, post-completion of intervention program (12 weeks) and at 3 and 6 months follow-up.

Secondary outcome [4]

Physical Health Assessment

Timepoint [4]

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?

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

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

VIC

Funding & Sponsors

Funding source category [1]

University

Name [1]

Victoria University

Address [1]

Country [1]

Australia

Primary sponsor type

University

Name

Victoria University

Address

Country

Australia

Secondary sponsor category [1]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Victoria University Human Research Ethics Committee

Ethics committee address [1]

https://www.vu.edu.au/researchers/research-lifecycle/conducting-research/human-research-ethics/vu-human-research-ethics-committee-vuhrec

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

23/05/2024

Approval date [1]

12/08/2024

Ethics approval number [1]

Summary

Brief summary

The primary purpose of this study is to compare the effects of home-based High-Intensity Interval Training (HIIT) with laboratory-based HIIT on the health of women with Polycystic Ovary Syndrome (PCOS) who are overweight or obese. The study will examine various health outcomes over a 12-week period, including cardiorespiratory fitness, body composition, and glycaemic control. The hypothesis is that home-based HIIT will be as effective as laboratory-based HIIT in improving these health outcomes. This study aims to provide a more accessible exercise option for women with PCOS, potentially offering a cost-effective and convenient way to manage their condition through home-based training. Participants will undergo baseline testing, engage in the HIIT program, and complete follow-up assessments to evaluate the long-term benefits post 12- week intervention. The study involves researchers from Victoria University, the University of Adelaide, and Monash University, ensuring a comprehensive approach to improving the quality of life for women with PCOS.

Trial website

Trial related presentations / publications

Public notes

Contacts

Principal investigator

Name

Prof Andrew McAinch

Address

Victoria University - Footscray Park Campus 70/104 Ballarat Rd, Footscray VIC 3011

Country

Australia

Phone

+61 3 9919 2019

Fax

andrew.mcainch@vu.edu.au

Contact person for public queries

Name

Naina Tyagi

Address

Victoria University - Footscray Park Campus 70/104 Ballarat Rd, Footscray VIC 3011

Country

Australia

Phone

+61 478644570

Fax

naina.tyagi@live.vu.edu.au

Contact person for scientific queries

Name

Andrew McAinch

Address

Victoria University - Footscray Park Campus 70/104 Ballarat Rd, Footscray VIC 3011

Country

Australia

Phone

+61 39919 2019

Fax

andrew.mcainch@vu.edu.au

Data sharing statement

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

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.	Type	Citation	Link	Email	Other Details	Attachment
24138	Informed 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

No documents have been uploaded by study researchers.

Documents added automatically

No additional documents have been identified.

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