ANZCTR - Registration

The ANZCTR website is back online for trial registration and updates. We apologise for any inconvenience caused while the site was inactive.

Reset your password and enable multi-factor authentication (MFA)

For ANZCTR account holders: to help ensure the cyber safety of your account, you’ll need to reset your password and set-up multi-factor authentication (MFA) as per the instructions below.

Go to the Login page, click ‘reset password’ and follow the instructions.
Check your email for the link to set a new password.
Create a new password that meets requirements. New passwords must include at least one lowercase letter, one uppercase letter, one number and one special character (e.g. !#$%&@).
Return to the Login page and enter your new password. A verification code will be sent to your email.
Check your email for the code and enter it on the Login page. If the code is entered incorrectly, you can re-enter the correct one or request a new one.

Learn more about MFA and its importance on the Australian Signals Directorate website.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers

Trial registered on ANZCTR

Registration number

ACTRN12625000398404

Ethics application status

Approved

Date submitted

10/02/2025

Date registered

2/05/2025

Date last updated

2/05/2025

Date data sharing statement initially provided

2/05/2025

Type of registration

Retrospectively registered

Titles & IDs

Public title

"Comparing Blood Flow Restriction Devices: How They Measure Limb Pressure"

Scientific title

Comparison of different blood flow restriction devices in assessing the limb occlusion pressure in healthy active athletes

Secondary ID [1]

Nil known

Universal Trial Number (UTN)

Trial acronym

Linked study record

Health condition

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

blood flow restriction

Condition category

Condition code

Cardiovascular

Normal development and function of the cardiovascular system

Intervention/exposure

Study type

Interventional

Description of intervention(s) / exposure

Our objective is to compare limb occlusion pressure (LoP) measurements obtained using different devices in recreationally active individuals. This study employs a crossover design, with 21 participants undergoing LoP assessments in both supine and standing positions using each of the following five devices:

ZIMMER Tourniquet System – a medical-grade pneumatic device commonly used in surgical and clinical settings for controlled occlusion.

SUJI BFR Cuff – a semi-automated blood flow restriction system that connects to a smartphone app for guided occlusion pressure application.

AIRBANDs – manually inflated cuffs with a handheld pump and integrated pressure gauge, typically used in fitness environments.

SMART Cuffs Pro – an automated BFR system that determines LoP via pulse detection technology.

Pulse oximeter paired with a standard blood pressure cuff – a traditional method used to estimate LoP based on the disappearance of pulse signal, serving as a reference technique.

Participant anthropometrics including height, weight, and leg dominance will be recorded prior to testing. All device applications will be performed by a certified exercise physiologist to ensure consistency and safety.

For each device, participants will undergo two trials: one trial to determine LoP in the supine position and one trial to determine LoP in the standing position. No exercise protocols will be performed during these trials; the trials will only involve inflation of the cuff to determine LoP. The time to determine LoP will vary between devices, typically ranging from 20 seconds to 2 minutes.

Devices will be applied in a randomized order, and two trials will be conducted per device on the dominant leg, with a 15-minute rest (washout) period between trials to allow for full vascular recovery and eliminate carryover effects. A brief familiarization session with each device will be provided before formal testing.

After each LoP trial, participants will rate their perceived discomfort using a standard 0–10 numerical scale.

All testing will be conducted in a single session lasting approximately 120 to 150 minutes per participant. This crossover protocol, incorporating randomization and washout periods, is designed to ensure the internal validity of comparisons across devices.

Intervention code [1]

Treatment: Other

Intervention code [2]

Rehabilitation

Comparator / control treatment

Pulse oximeter paired with a standard blood pressure cuff

Control group

Active

Outcomes

Primary outcome [1]

LoP measurement using all 5 equipment's supine– This is the pressure required to to occlude the blood supply in the lower limb.

Timepoint [1]

Each equipment will be used to assess Limb Occlusion Pressure (LoP) twice in the supine position—at baseline and again 15 minutes later, prior to standing.

Primary outcome [2]

LoP measurement using all 5 equipment's standing– This is the pressure required to to occlude the blood supply in the lower limb.

Timepoint [2]

Each equipment will also be used to assess LoP while the participant is standing at 31 minutes and 46 minutes post-commencement of occlusion.

Secondary outcome [1]

Ratings of discomfort – Is a subjective method used to measure an individual's perception of how difficult they are perceiving during pressure inflation.

Timepoint [1]

After each equipment scale will be asked for participants to respond.

Eligibility

Key inclusion criteria

aged 18-40 years,
recreationally active with an IPAQ score above 600 METs per week equivalent to 150-300 minutes of physical exercise involvement,
no known medical conditions, and
no injuries in the last six months

Minimum age

18 Years

Maximum age

40 Years

Sex

Both males and females

Can healthy volunteers participate?

Yes

Key exclusion criteria

Any known medical condition and any injuries in the last six months.
resting blood pressure greater than 150/100 mmHg

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)

Methods used to generate the sequence in which subjects will be randomised (sequence generation)

Masking / blinding

Who is / are masked / blinded?

Intervention assignment

Other design features

Phase

Not Applicable

Type of endpoint/s

Statistical methods / analysis

Recruitment

Recruitment status

Completed

Date of first participant enrolment

Anticipated

Actual

14/08/2024

Date of last participant enrolment

Anticipated

Actual

30/08/2024

Date of last data collection

Anticipated

Actual

30/08/2024

Sample size

Target

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

VIC

Funding & Sponsors

Funding source category [1]

University

Name [1]

Deakin University

Address [1]

Country [1]

Australia

Primary sponsor type

University

Name

Deakin 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]

Deakin University Human Research Ethics Committee (DUHREC)

Ethics committee address [1]

https://www.deakin.edu.au/research/support-for-researchers/research-integrity?a=438168

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

10/05/2024

Approval date [1]

25/06/2024

Ethics approval number [1]

Summary

Brief summary

Blood flow restriction (BFR) training has become increasingly popular for improving muscle strength, size, and endurance using lighter loads. A key factor in the safe and effective use of BFR is accurately measuring limb occlusion pressure (LoP)—the pressure needed to restrict blood flow to the limb without causing harm.
While many devices are available to assess LoP, few studies have compared their accuracy and consistency. This study aims to evaluate and compare the performance of five commonly used BFR devices in measuring LoP in recreationally active individuals.
We hypothesize that some devices will be more accurate and reliable than others, helping users make safer, evidence-based choices in both clinical and fitness settings.

Trial website

Trial related presentations / publications

Public notes

Contacts

Principal investigator

Name

A/Prof Stuart Warmington

Address

School of Exercise and Nutrition Sciences, Deakin University, 221 Burwood Highway, Burwood, Victoria 3125

Country

Australia

Phone

+61 3 925 17013

Fax

[email protected]

Contact person for public queries

Name

Stuart Warmington

Address

School of Exercise and Nutrition Sciences, Deakin University, 221 Burwood Highway, Burwood, Victoria 3125

Country

Australia

Phone

+61 3 925 17013

Fax

[email protected]

Contact person for scientific queries

Name

Stuart Warmington

Address

School of Exercise and Nutrition Sciences, Deakin University, 221 Burwood Highway, Burwood, Victoria 3125

Country

Australia

Phone

+61 3 925 17013

Fax

[email protected]

Data sharing statement

Will the study consider sharing individual participant data?

What supporting documents are/will be available?

Doc. No.	Type	Citation	Link	Email	Other Details	Attachment
24526	Ethical approval					HEAG-H 105_2024-240625-Approval memo.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.

Trial Review

Documents added manually

Documents added automatically