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Trial registered on ANZCTR


Registration number
ACTRN12622000639729
Ethics application status
Approved
Date submitted
20/04/2022
Date registered
2/05/2022
Date last updated
19/09/2023
Date data sharing statement initially provided
2/05/2022
Type of registration
Prospectively registered

Titles & IDs
Public title
High-Intensity Functional Training for Polycystic Ovary Syndrome
Scientific title
The Effect of High-Intensity Functional Training on Physical Fitness and Cardiometabolic Health in Women with Polycystic Ovary Syndrome: A Randomised Controlled Trial
Secondary ID [1] 306972 0
None
Universal Trial Number (UTN)
Trial acronym
HIFTPCOS
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Polycystic Ovary Syndrome 326088 0
Condition category
Condition code
Metabolic and Endocrine 323399 323399 0 0
Other endocrine disorders
Reproductive Health and Childbirth 323440 323440 0 0
Other reproductive health and childbirth disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Group 1 - High-intensity functional training (HIFT)
The HIFT intervention will be supervised by a certified fitness professional. HIFT will include both “cardio” or “resistance” sessions. The cardio sessions include body weight and dynamic movements which target the aerobic and anaerobic energy systems. The resistance sessions use weighted functional movement patterns to target muscle mass, strength, and power. Both the cardio and resistance sessions last a total of 45 minutes. Participants will initially be prescribed one exercise session per week (aerobic session) in week 1, two exercise sessions per week (1 aerobic sessions and 1 resistance session) in week 2. From week 3, participants will be asked to attend three HIFT (2 aerobic sessions and 1 resistance session) classes per week.

Location where intervention will be delivered: F45® Bulli or Corrimal,
Mode of delivery: the exercise sessions will be delivered in groups of no more than 30 people per class.
Duration of intervention: 12 weeks.
Intensity of duration: participants will be asked to work out at an intensity equivalent to 13-17 RPE during the active exercise period.
Examples of exercises prescribed as part of the intervention: squats (bodyweight and weighted back squats), deadlift, push-press, medicine ball throws, skipping (including double-unders) and more.
Adherence: Adherence will be monitored through session attendance checklists and HR will be recorded by a HR monitor.

Group 2 - Physical Activity Guidelines (PAG)
Participants in PAG will be prescribed an exercise program that is consistent with current Australian physical activity guidelines for 12 weeks. This includes instruction to undertake 150 min of moderate-intensity or 75 min of vigorous-intensity aerobic exercise per week in addition to two resistance training sessions per week. Participants will be asked to attend the Illawarra Health and Medical Research Institute to undertake supervised resistance training sessions two times per week which will include 4 upper body exercises, 2 lower body exercises, and 1 core exercise. Participants will have their exercise behaviour monitored weekly via text messages.
Duration of intervention: 12 weeks.
Duration of resistance training sessions: 1-hr.
Supervision of exercise: resistance training will be supervised by an Accredited Exercise Scientist, Accredited Exercise Physiologist, or by an Accredited Exercise Physiologist clinical placement student under the guidance of an Accredited Exercise Physiologist.
Mode of delivery: one-on-one or in groups of no more than 6 people.
Resistance training prescription: 3 Sets of 10-12 repetitions at 55-75% 1RM.
Text messages: Weekly text messages will be sent to remind participants to undertake 150 minutes of moderate aerobic exercise per week. the text messages will also include their resistance training session details including time and locations.
Adherence: resistance training sessions will be monitored by session attendance sheets and aerobic exercise will be monitored through a Fitbit wrist monitor.

Once the 12-week intervention period has elapsed and the follow-up assessments have been completed, participants will be offered HIFT but no further data will be collected.
Intervention code [1] 323412 0
Lifestyle
Intervention code [2] 323443 0
Treatment: Other
Comparator / control treatment
Group 3 - Control

Participants in CTRL will be asked to maintain their current levels of physical activity and dietary behaviours for 12 weeks. After the 12-week control period, the participants will be offered HIFT (on week 13) but no further data will be collected.
Control group
Active

Outcomes
Primary outcome [1] 331138 0
Cardiorespiratory fitness assessed via graded exercise test and gas analysis.
Timepoint [1] 331138 0
Assessed at baseline and at 13 weeks post-intervention commencement.
Primary outcome [2] 331139 0
Muscular strength assessed via one repetition maximum of chest press and leg press exercises.
Timepoint [2] 331139 0
Assessed at baseline and at 13 weeks post-intervention commencement.
Primary outcome [3] 331233 0
Muscle endurance via maximal repetitions to failure at 70% 1RM for the bench press and back squat exercises.
Timepoint [3] 331233 0
Assessed at baseline and at 13 weeks post-intervention commencement.
Secondary outcome [1] 408950 0
Body composition (fat mass, lean mass, body fat %) will be assessed using dual x-ray absorptiometry.
Timepoint [1] 408950 0
Assessed at baseline and at 13 weeks post-intervention commencement.
Secondary outcome [2] 408951 0
Insulin sensitivity measured via homeostatic model of insulin resistance (HOMA-IR) and oral glucose tolerance test.
Timepoint [2] 408951 0
Assessed at baseline and at 13 weeks post-intervention commencement.
Secondary outcome [3] 408952 0
Arterial stiffness measured via pulse wave velocity assessment.
Timepoint [3] 408952 0
Assessed at baseline and at 13 weeks post-intervention commencement.
Secondary outcome [4] 408953 0
Quality of life via 36-Item Short Form Health Survey (SF36) and Modified Polycystic Ovary Syndrome Health-Related Quality of Life Questionnaire (MPCOSQ)
Timepoint [4] 408953 0
Assessed at baseline and at 13 weeks post-intervention commencement.
Secondary outcome [5] 408954 0
Blood biochemistry: serum glucose, insulin, lipids, inflammatory markers, and liver enzymes
Timepoint [5] 408954 0
Assessed at baseline and at 13 weeks post-intervention commencement.
Secondary outcome [6] 409100 0
Anthropometry (body mass, height, waist circumference, hip circumference)
Timepoint [6] 409100 0
Assessed at baseline and at 13 weeks post-intervention commencement.
Secondary outcome [7] 409101 0
Physical activity enjoyment scale (PACES Questionnaire)
Timepoint [7] 409101 0
Assessed at baseline and at 13 weeks post-intervention commencement.

Eligibility
Key inclusion criteria
To participate in this study, participants must:
• be between the ages of 18-40 years;
• have a diagnosis of polycystic ovary syndrome (PCOS) as per Rotterdam 2003 criteria;
• be physically inactive (undertaking < 150 minutes of exercise per week or exercising < 3 days per week);
• have overweight or obesity (BMI between 25 to 40 kg/m2);
• able to attend three training sessions per week at F45® Bulli or Corrimal for 12 weeks;
• ability to read and communicate in the English language.
Minimum age
18 Years
Maximum age
40 Years
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
Participants will be excluded from this study if they:
• have a condition for which high-intensity exercise is contraindicated (such as uncontrolled hypertension, stroke, or other cardiovascular diseases);
• are pregnant or were pregnant in the last 6 months;
• have type 2 diabetes;
• consume more than 20g/day of alcohol;
• have a rapidly progressive disease.

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)
Randomisation will be conducted by a research officer at NICM Health Research Institute external to the primary research team (investigators listed at the start of this document). This person will allocate 60 consecutively numbered identifiers to sealed opaque envelopes that will contain the ID number and allocation ( 20 HIFT, 20 PAG, and 20 control).
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
The research officer (external to research group) will produce computer generated randomisation treatment sequences, which randomly associate a randomisation number with either the HIFT, PAG, or control group. Randomisation numbers will be allocated in permuted blocks of 6 randomisation numbers starting from 01 to 60 with each block containing 2 HIFT, 2 PAG and 2 CTRL assigned randomisation numbers.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
The primary analysis will determine the effects between the interventions and CTRL groups for change in physical performance and cardiometabolic outcomes, which will be assessed by ANCOVA using the baseline value as the covariate. Within-group changes will be determined via paired-sample t tests or the non-parametric alternative (Wilcoxon signed-rank test) for non-normally distributed data.

Secondary analyses will determine the relationships among changes in key cardiometabolic outcomes with associated demographic, psychometric, biochemical and inflammatory, and exercise performance parameters through correlation coefficients. Separate linear regressions will be undertaken to determine the relative contribution of changes in specific variables on key cardiometabolic outcomes.

Recruitment
Recruitment status
Stopped early
Data analysis
No data analysis planned
Reason for early stopping/withdrawal
Other reasons/comments
Other reasons
The site where the training intervention was being delivered ceased operations.
Date of first participant enrolment
Anticipated
29/07/2022
Actual
5/08/2022
Date of last participant enrolment
Anticipated
26/05/2023
Actual
12/04/2023
Date of last data collection
Anticipated
28/08/2023
Actual
7/06/2023
Sample size
Target
60
Accrual to date
Final
4
Recruitment in Australia
Recruitment state(s)
NSW

Funding & Sponsors
Funding source category [1] 311284 0
University
Name [1] 311284 0
Western Sydney University
Country [1] 311284 0
Australia
Primary sponsor type
University
Name
Western Sydney University
Address
Western Sydney University
Locked Bag 1797, Penrith, NSW, 2751
Country
Australia
Secondary sponsor category [1] 312648 0
None
Name [1] 312648 0
none
Address [1] 312648 0
none
Country [1] 312648 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 310791 0
Western Sydney University Human Research Ethics Committee
Ethics committee address [1] 310791 0
Ethics committee country [1] 310791 0
Australia
Date submitted for ethics approval [1] 310791 0
25/11/2021
Approval date [1] 310791 0
07/04/2022
Ethics approval number [1] 310791 0
H14738

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

Contacts
Principal investigator
Name 118878 0
Dr Angelo Sabag
Address 118878 0
NICM Health Research Institute
Western Sydney University
Locked Bag 1797, Penrith, NSW, 2751
Country 118878 0
Australia
Phone 118878 0
+61298524720
Fax 118878 0
Email 118878 0
a.sabag@westernsydney.edu.au
Contact person for public queries
Name 118879 0
Angelo Sabag
Address 118879 0
NICM Health Research Institute
Western Sydney University
Locked Bag 1797, Penrith, NSW, 2751
Country 118879 0
Australia
Phone 118879 0
+61298524720
Fax 118879 0
Email 118879 0
a.sabag@westernsydney.edu.au
Contact person for scientific queries
Name 118880 0
Angelo Sabag
Address 118880 0
NICM Health Research Institute
Western Sydney University
Locked Bag 1797, Penrith, NSW, 2751
Country 118880 0
Australia
Phone 118880 0
+61298524720
Fax 118880 0
Email 118880 0
a.sabag@westernsydney.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


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
15835Ethical approval    383955-(Uploaded-20-04-2022-17-26-00)-Study-related document.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.