Trial Review

The ANZCTR website will be unavailable from 1pm until 3pm (AEDT) on Wednesday the 30th of October for website maintenance. Please be sure to log out of the system in order to avoid any loss of data.

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
ACTRN12624001195549p
Ethics application status
Submitted, not yet approved
Date submitted
16/09/2024
Date registered
30/09/2024
Date last updated
30/09/2024
Date data sharing statement initially provided
30/09/2024
Type of registration
Prospectively registered

Titles & IDs
Public title
Physiological and biomechanical responses from using mini-bikes
Scientific title
Physiological and biomechanical responses from using mini-bikes in healthy adults
Secondary ID [1] 312921 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Metabolic disorders 335083 0
Condition category
Condition code
Metabolic and Endocrine 331587 331587 0 0
Normal metabolism and endocrine development and function

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The study will require participants to attend a single laboratorial session to complete the following:
• the Exercise and Sports Science Australia (ESSA ) pre-exercise screening questionnaire,
• Stature and body mass using a stadiometer and a weight scales, respectively,
• Cardiorespiratory assessment using a mini-bike and a cycle ergometer, in random order between participants.

Mini-bikes (https://www.kogan.com/au/buy/casami-portable-exerciser-mini-bike-trainer-exercise-machine-desk-home-gym-pedal-cycle-7646650302616/?utm_source=Bing&utm_medium=product_listing_ads%7Bifpe%3Aproduct_extension_ads%7D&utm_campaign=Kogan+AU+-+Standard+Shopping+-+Placeholder&utm_term=4574930466662083&utm_content=Ad+group+%231) are small size bikes with shorter cranks enabling cycling when sitting on a sofa or chair.

After completing these questionnaires and measurements of stature and body mass, participants will be prepared with a heart rate monitor and 17 wearable sensors attached to their body to monitor body movements when using a mini-bike and a cycle ergometer. These sensors are small and light weight (3x3 cm with ~5g each) and will be attached using velcro straps in their feet, lower legs, upper legs, pelvis, upper arms, forearms, head (using a head band) and torso (using a customised jersey). The sensors communicate wirelessly with the computer. Participants will then warm-up for 10-min on a treadmill.

Upon completion of the warm-up (i.e. walking at self-selected intensity on a motorised treadmill), participants will be randomly assigned to the cycle ergometer or the mini-bike (using a random number generator tool). They will be equipped with a mask to enable collection of gas exchanges using a metabolic cart. They will perform 15-min in each mode of exercise at self-selected intensity. Instructions will be provided to ensure that they cycle at an intensity that would enable them to perform other activities such as phone browsing or TV watching. After the first block of 15-min, they will rest for 15-min before transitioning to the other mode of exercise. Direct observation will be used to ensure adherence to the interventions.

During both modes of exercise, gas exchange and heart rate will be collected continuously. Rate of perceived exertion (RPE) will be collected every 5-min along with movement using the wearable sensors. The mini-bike and the cycle ergometers will be instrumented to collect pedal forces, which will be later used to determine joint loads.
Intervention code [1] 329455 0
Prevention
Comparator / control treatment
No control group. Participants will perform both the intervention (mini-bike) and the comparator (cycle ergometer).
Control group
Active

Outcomes
Primary outcome [1] 339327 0
Physical activity
Timepoint [1] 339327 0
Continuously during the exercise test (15-min each)
Secondary outcome [1] 439493 0
Lower limb joint loads (hip, knee and ankle): this will be assessed as a composite outcome
Timepoint [1] 439493 0
Pedal force data and movement obtained from a 3D motion capture system will be collected at the last 2-min of each mode of exercise.

Eligibility
Key inclusion criteria
Participants eligible for the study will be apparently healthy adults (18-to less than 65 years of age).
No medical contra-indication to perform exercise, no musculoskeletal, neurological or cardiorespiratory illness. Participants who are familiarised with bicycle riding will be eligible to participate in this study. This will involve prior experience riding a bicycle.
Minimum age
18 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
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)
None
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Crossover
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Data distribution will be analysed using the Shapiro-Wilks tests. If normality of distribution is confirmed, parametric tests will be used.
For comparison of levels of physical activity (MET) and joint loads between the mini-bike and the cycle ergometer, a paired samples t-test (or Wilcoxon Signed Rank Test) will be utilised.
Statistical differences were deemed significant when p<0.05.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
6/01/2025
Actual
Date of last participant enrolment
Anticipated
3/02/2025
Actual
Date of last data collection
Anticipated
17/02/2025
Actual
Sample size
Target
14
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment postcode(s) [1] 43149 0
3550 - Flora Hill

Funding & Sponsors
Funding source category [1] 317353 0
Charities/Societies/Foundations
Name [1] 317353 0
Holsworth Research Initiative
Country [1] 317353 0
Australia
Primary sponsor type
University
Name
La Trobe Rural Health School
Address
Country
Australia
Secondary sponsor category [1] 319643 0
None
Name [1] 319643 0
Address [1] 319643 0
Country [1] 319643 0

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 316084 0
La Trobe University Human Ethics Committee
Ethics committee address [1] 316084 0
Ethics committee country [1] 316084 0
Australia
Date submitted for ethics approval [1] 316084 0
12/09/2024
Approval date [1] 316084 0
Ethics approval number [1] 316084 0

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

Contacts
Principal investigator
Name 136730 0
Dr Rodrigo Rico Bini
Address 136730 0
La Trobe Rural Health School, Flora Hill campus, Sharon Street, Bendigo, Victoria - 3550
Country 136730 0
Australia
Phone 136730 0
+61 3 54447466
Fax 136730 0
Email 136730 0
[email protected]
Contact person for public queries
Name 136731 0
Rodrigo Rico Bini
Address 136731 0
La Trobe Rural Health School, Flora Hill campus, Sharon Street, Bendigo, Victoria - 3550
Country 136731 0
Australia
Phone 136731 0
+61 3 54447466
Fax 136731 0
Email 136731 0
[email protected]
Contact person for scientific queries
Name 136732 0
Rodrigo Rico Bini
Address 136732 0
La Trobe Rural Health School, Flora Hill campus, Sharon Street, Bendigo, Victoria - 3550
Country 136732 0
Australia
Phone 136732 0
+61 3 54447466
Fax 136732 0
Email 136732 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
Deidentified summary data from each participant during each mode of exercise
When will data be available (start and end dates)?
When paper is published and available for 5 years after publication
Available to whom?
Open access
Available for what types of analyses?
Meta-analysis and secondary analyses
How or where can data be obtained?
From La Trobe Opal. Dr. Rodrigo Bini ([email protected]) will be the contact person until the data is made available through OPAL.


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.