Trial Review

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Trial registered on ANZCTR


Registration number
Help: Registration number
ACTRN12626001303336p
Ethics application status
Help: Ethics application status
Not yet submitted
Date submitted
Help: Date submitted
28/09/2026
Date registered
Help: Date registered
28/10/2026
Date last updated
Help: Date last updated
28/10/2026
Date data sharing statement initially provided
Help: Data sharing statement date
28/10/2026
Type of registration
Help: Type of registration
Prospectively registered

Titles & IDs
Public title
Cyclists perception of comfort, metabolic demand and biomechanics in cyclists with a novel bicycle saddle
Scientific title
Cyclists perception of comfort, metabolic demand and biomechanics of cycling with a novel bicycle saddle
Additional trial identifiers [1] 318540 0
Nil
Universal Trial Number (UTN)
Trial acronym
Related trial records

Health condition
Health condition(s) studied:
cardiovascular health 343733 0
Condition category
Condition code
Cardiovascular 339852 339852 0 0
Other cardiovascular diseases

Intervention/exposure
Study type
Interventional
Description of the intervention or exposure
Participants will be assessed on a cycle ergometer when cycling with a control saddle vs. the novel saddle (vabsRider, Ataraxy, Australia). The vabsRider saddle has a dual support system with a full cut out which both parts move over a sliding system (https://ataraxybsc.com/products/vabsrider-virtual-axis-bike-seat). This design is marked different from regular saddle, which are fixed on the seat tube.
Each trial will be conducted for 5-min with a rest period off the bike of 5-min (wash-out).
All data will be collected in the Exercise Physiology laboratory by and Accredited Exercise and Sports Scientist and an Accredited Physiotherapist.
Intervention code [1] 335441 0
Other interventions
Description of the comparator or control
Control saddle (i.e. Wattbike, UK).
Control group
Active

Outcomes
Primary outcome [1] 347029 0
Perception of comfort/discomfort (safety component)
Timepoint [1] 347029 0
Perception of comfort/discomfort will be collected at 2.5-min and at the end of each bout of exercise.
Secondary outcome [1] 468626 0
Metabolic demand
Timepoint [1] 468626 0
Throughout the exercise bout using the continuous mode of the metabolic cart.
Secondary outcome [2] 468627 0
Biomechanics of cycling (composite secondary outcome)
Timepoint [2] 468627 0
At 4-min into each bout of exercise.

Eligibility
Key inclusion criteria
Participants eligible for the study will be apparently healthy adults (18-to less than 65 years of age) that currently cycle on a bicycle outdoors or indoors for a minimum of 30-min each week and should have been cycling for a minimum of three months prior to volunteering for the study, in line with prior studies (Bing et al., 2024; Bini, 2020). Participants should not have any medical contra-indications to perform exercise, and no musculoskeletal, neurological or cardiorespiratory illness. Participants should also be meeting the current guidelines for physical activity (i.e. 75 min of vigorous exercise or 150 min of moderate intensity exercise or an equivalent combination of moderate-vigorous exercise per week) including cycling as a component of their volume of exercise. Due to a limitation in the cycle ergometer utilised in this study (Wattbike, UK) when using the novel saddle (vabsRider, Ataraxy, Australia), participants with less than 170 cm of stature will not be included to avoid an excessively high saddle height.
Minimum age
18 Years
Maximum age
65 Years
Sex
Both males and females
Healthy volunteers
No
Key exclusion criteria
None

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Central randomisation
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computer-generated random sequence
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Crossover
Other design features
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis
We conducted a sample size calculation using a t-test for paired samples model to determine the effect of the novel saddle on the perception of comfort. We used the mean and SD from Keytel and Noakes (2017), estimating an effect size of 1.70. The calculation required a sample size of five participants, an alfa = 0.05 and a power of 0.80, which we deemed small. Therefore, we ran a second calculation using hip range of motion data from Bini and Hume (2023), estimating an effect size of 0.80. This second calculation required 15 participants using the same level of significance and power.
Data distribution will be analysed using the Shapiro-Wilks tests. If normality of distribution is confirmed, parametric tests will be used.
Missing data points will not be manipulated and treated as missing information in the analysis.
A paired samples t-test will be used to compare the outcomes between both saddles.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
4/01/2027
Actual
Date of last participant enrolment
Anticipated
23/04/2027
Actual
Date of last data collection
Anticipated
30/04/2027
Actual
Sample size
Target
15
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC

Funding & Sponsors
Funding source category [1] 323121 0
Commercial sector/Industry
Name [1] 323121 0
Ataraxy Australia (in-kind support - novel saddle)
Country [1] 323121 0
Australia
Primary sponsor type
University
Name
La Trobe University
Address
Country
Australia
Secondary sponsor category [1] 326072 0
University
Name [1] 326072 0
La Trobe
Address [1] 326072 0
Country [1] 326072 0
Australia
Other collaborator category [1] 284117 0
Commercial sector/Industry
Name [1] 284117 0
Ataraxy
Address [1] 284117 0
Country [1] 284117 0
Australia

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 321521 0
La Trobe University Human Research Ethics Committee
Ethics committee address [1] 321521 0
Ethics committee country [1] 321521 0
Australia
Date submitted for ethics approval [1] 321521 0
30/10/2026
Approval date [1] 321521 0
Ethics approval number [1] 321521 0

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

Contacts
Principal investigator
Name 153970 0
A/Prof Rodrigo Rico Bini
Address 153970 0
Health Sciences 1, room 301, Sharon Street, Flora Hill - 3550, Victoria, La Trobe University
Country 153970 0
Australia
Phone 153970 0
+61 0354447466
Fax 153970 0
Email 153970 0
[email protected]
Contact person for public queries
Name 153971 0
Rodrigo Rico Bini
Address 153971 0
Health Sciences 1, room 301, Sharon Street, Flora Hill - 3550, Victoria, La Trobe University
Country 153971 0
Australia
Phone 153971 0
+61 0354447466
Fax 153971 0
Email 153971 0
[email protected]
Contact person for scientific queries
Name 153972 0
Rodrigo Rico Bini
Address 153972 0
Health Sciences 1, room 301, Sharon Street, Flora Hill - 3550, Victoria, La Trobe University
Country 153972 0
Australia
Phone 153972 0
+61 0354447466
Fax 153972 0
Email 153972 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:
• Anyone
Conditions for requesting access:
• No requirements
What individual participant data might be shared?
• All de-identified individual participant data
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:
At the end of the study
To:
No end date
Where can requests to access individual participant data be made, or data be obtained directly?
• Data repository: La Trobe OPAL - https://www.latrobe.edu.au/library/research/opal - where data will be directly downloadable.

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.