Trial Review

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Trial registered on ANZCTR


Registration number
Help: Registration number
ACTRN12626001286336
Ethics application status
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Approved
Date submitted
Help: Date submitted
7/10/2026
Date registered
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27/10/2026
Date last updated
Help: Date last updated
27/10/2026
Date data sharing statement initially provided
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27/10/2026
Type of registration
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Retrospectively registered

Titles & IDs
Public title
Acute effects of chest binding on maximal exercise performance binder-naïve people presumed female at birth: a randomised counterbalanced crossover study
Scientific title
Acute effects of chest binding on maximal exercise performance binder-naïve people presumed female at birth: a randomised counterbalanced crossover study
Additional trial identifiers [1] 318589 0
Nil
Universal Trial Number (UTN)
Trial acronym
Related trial records

Health condition
Health condition(s) studied:
Physiological responses to chest binding 343793 0
Chest binding during maximal exercise 343947 0
Condition category
Condition code
Physical Medicine / Rehabilitation 339924 339924 0 0
Other physical medicine / rehabilitation
Public Health 339925 339925 0 0
Other public health
Respiratory 339926 339926 0 0
Normal development and function of the respiratory system
Musculoskeletal 340084 340084 0 0
Normal musculoskeletal and cartilage development and function

Intervention/exposure
Study type
Interventional
Description of the intervention or exposure
Each participant completes two testing sessions in a randomised, counterbalanced crossover design: one wearing a chest binder (intervention) and one without a binder (control). Each session takes approximately 1 hour. Sessions are scheduled 3 to 10 days apart, with the interval determined by participant availability and laboratory availability. A minimum washout period of 3 days and a maximum interval of 10 days are maintained between sessions. Both sessions are held at the same time of day. A familiarisation session precedes testing, during which body composition (dual-energy X-ray absorptiometry) and anthropometry are measured, and the binder is fitted.

The binder is a commercially available compression garment (Chest Binder Short, Sock Drawer Heroes, Sydney, Australia; 74% nylon and 26% elastane outer shell, 100% cotton inner panel). Researchers trained in binder fitting select the size according to the manufacturer's specifications and written instructions. Participants wear the binder under their usual sporting attire. In the control condition, they wear their usual garment instead.

All testing sessions are supervised by an Accredited Exercise Physiologist or physiotherapist. In both conditions, participants complete the same battery of tests in the same order in a climate-controlled laboratory (22 to 23 °C): resting spirometry, spinal and shoulder flexion range of motion, five-repetition maximum chest press and back pulldown strength tests, and a graded treadmill test to volitional exhaustion with expired gas analysis (4-minute stages, with speed increasing by 1 to 2 km/h at each stage). Perceived exertion, breathlessness and comfort are rated during testing. Participants avoid maximal exertion for 48 hours before each session and keep food and fluid intake consistent the day before. Testers are blinded to condition order.
Intervention code [1] 335496 0
Rehabilitation
Intervention code [2] 335497 0
Lifestyle
Intervention code [3] 335498 0
Behaviour
Description of the comparator or control
The control condition involves the same participants completing testing without a chest binder, using a within-participant crossover design. Participants wear their usual garment under their sporting attire, such as a sports bra or their usual underwear. They complete the identical battery of tests in the same order, at the same time of day, in the same climate-controlled laboratory (22 to 23 °C). The control and binder sessions are scheduled 3 to 10 days apart, with the interval determined by participant and laboratory availability.

No placebo or sham garment is used. Participants wear sporting attire designed to conceal their garment from the tester in both conditions.
Control group
Active

Outcomes
Primary outcome [1] 347094 0
Maximal oxygen uptake (Vo2max)
Timepoint [1] 347094 0
At each of the two testing sessions (binder and no-binder conditions), held 3 to 10 days apart and after one familiarisation session. Measured once per session, at the end of the testing battery.
Secondary outcome [1] 468918 0
Chest press strength
Timepoint [1] 468918 0
At each of the two testing sessions (with and without a binder), 3 to 10 days apart.
Secondary outcome [2] 468919 0
Back pulldown strength
Timepoint [2] 468919 0
At each of the two testing sessions (with and without a binder), 3 to 10 days apart.
Secondary outcome [3] 468920 0
Spinal flexion range of motion
Timepoint [3] 468920 0
At each of the two testing sessions (with and without a binder), 3 to 10 days apart.
Secondary outcome [4] 468921 0
Shoulder flexion range of motion
Timepoint [4] 468921 0
At each of the two testing sessions (with and without a binder), 3 to 10 days apart.
Secondary outcome [5] 468922 0
Forced expiratory volume in six seconds
Timepoint [5] 468922 0
At each of the two testing sessions (with and without a binder), 3 to 10 days apart.
Secondary outcome [6] 468929 0
Participant perceptions of exertion
Timepoint [6] 468929 0
At each of the two testing sessions during and at the end of the session (with and without a binder), 3 to 10 days apart.
Secondary outcome [7] 469655 0
Participant perceptions of dyspnoea
Timepoint [7] 469655 0
At each of the two testing sessions (with and without a binder), 3 to 10 days apart.
Secondary outcome [8] 469656 0
Participant perceptions of comfort
Timepoint [8] 469656 0
At each of the two testing sessions (with and without a binder), 3 to 10 days apart.

Eligibility
Key inclusion criteria
a) 18-45 years of age; b) presumed female at birth c) recreationally active (see below
definition); d) chest binding naïve (reported no prior experience of wearing a chest binder)
*Recreationally active was defined as meeting the current World Health Organization (2020) physical activity guidelines.
Minimum age
18 Years
Maximum age
45 Years
Sex
Females
Healthy volunteers
Yes
Key exclusion criteria
Exclusion criteria consisted of: a) chest dysphoria; b) chest or upper torso surgery; c) currently pregnant or breast/chest feeding; and d) medical contraindications to maximal exercise.

Study design
Purpose of the study
Educational / counselling / training
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation is not concealed. The order of the binder and no-binder sessions is randomised and counterbalanced using block randomisation by binder size. A researcher not involved in data collection performs the randomisation. Testers are blinded to condition, with participants wearing sporting attire that conceals the garment from the tester in both sessions. No placebo or sham garment is used.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Block randomisation via binder size selection based on participant chest girth measures.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Crossover
Other design features
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis
Data were analysed using SPSS 29.0 (IBM Corp., Armonk, NY, USA). Descriptive statistics for age and anthropometric measurements were calculated. For each paired variable, Shapiro-Wilk tests were performed to ensure the data met the normality assumptions of statistical tests used. Paired t-tests and effect size (Cohen’s d) were used to examine differences between the test scenarios. Ordinal perceptual ratings, which were not normally distributed, were compared between conditions using the sign test. A p-value = .05 was considered statistically significant. Effect sizes are expressed as absolute Cohen's d values. Effect sizes are classified as very small when d is less than 0.2, small when d is greater than or equal to 0.2 and less than 0.5, medium when d is greater than or equal to 0.5 and less than 0.8, large when d is greater than or equal to 0.8 and less than 1.3, and very large when d is greater than or equal to 1.3.
Sample size - Due to the limited available binder-specific literature, research on externally applied chest wall restriction during maximal cycling was used as the closest physiological analogue to determine appropriate sample size. Previous research in this area reported large within-subject effects on VO2max and ventilatory mechanics under restricted versus unrestricted conditions.27 Assuming a large within-subject effect size (Cohen’s d ˜ 0.7), alpha set to .05, and 80% power, our power calculation indicated that 19 paired observations would be required to reject the null hypothesis of no difference (H0). Our final sample size exceeded this estimate and was larger than has been previously reported for similar studies in this field. This calculation assumed a large effect (d˜0.7) drawn from a chest-wall-restriction analogue rather than binder-specific data.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
31/05/2025
Date of last participant enrolment
Anticipated
Actual
30/09/2025
Date of last data collection
Anticipated
Actual
6/10/2025
Sample size
Target
19
Accrual to date
Final
21
Recruitment in Australia
Recruitment state(s)
WA

Funding & Sponsors
Funding source category [1] 323165 0
Charities/Societies/Foundations
Name [1] 323165 0
Thriving in Motion
Country [1] 323165 0
Australia
Funding source category [2] 323297 0
University
Name [2] 323297 0
University of Western Australia
Country [2] 323297 0
Australia
Funding source category [3] 323298 0
University
Name [3] 323298 0
Curtin University
Country [3] 323298 0
Australia
Primary sponsor type
University
Name
The University of Western Australia
Address
Country
Australia
Secondary sponsor category [1] 326266 0
None
Name [1] 326266 0
Address [1] 326266 0
Country [1] 326266 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 321570 0
The University of Western Australia Human Research Ethics Committee
Ethics committee address [1] 321570 0
Ethics committee country [1] 321570 0
Australia
Date submitted for ethics approval [1] 321570 0
28/03/2025
Approval date [1] 321570 0
28/03/2025
Ethics approval number [1] 321570 0

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

Contacts
Principal investigator
Name 154110 0
A/Prof Bonnie Furzer
Address 154110 0
School of Human Science, University of Western Australia, 35 Stirling Highway Perth WA 6009 Australia
Country 154110 0
Australia
Phone 154110 0
+61 8 64885533
Fax 154110 0
Email 154110 0
[email protected]
Contact person for public queries
Name 154111 0
Dr Claire Munsie
Address 154111 0
School of Human Science, University of Western Australia, 35 Stirling Highway Perth WA 6009 Australia
Country 154111 0
Australia
Phone 154111 0
+61 8 9266 9801
Fax 154111 0
Email 154111 0
[email protected]
Contact person for scientific queries
Name 154112 0
Dr Claire Munsie
Address 154112 0
School of Human Science, University of Western Australia, 35 Stirling Highway Perth WA 6009 Australia
Country 154112 0
Australia
Phone 154112 0
+61 8 9266 9801
Fax 154112 0
Email 154112 0
[email protected]

Data sharing statement
Will the study consider sharing individual participant data?
Yes
Will there be any conditions when requesting access to individual participant data?
Persons/groups eligible to request access:
• Researchers
Conditions for requesting access:
• Yes, conditions apply:
• Requires review on a case-by-case basis by the trial custodian, sponsor or data sharing committee
• Requires a scientifically sound proposal or protocol
• Requires approval by an ethics committee
• Requires a data sharing agreement between data requester and trial custodian or sponsor
What individual participant data might be shared?
• De-identified individual participant data:
• Published results
What types of analyses could be done with individual participant data?
• Any type of analysis (i.e. no restrictions on data re-use)
When can requests for individual participant data be made (start and end dates)?
From:
After publication of main results
To:
A finite period of: 5 years
Where can requests to access individual participant data be made, or data be obtained directly?
• Email of trial custodian, sponsor or committee: [email protected]

Are there extra considerations when requesting access to individual participant data?
No


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.