Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12624001012561p
Ethics application status
Not yet submitted
Date submitted
6/08/2024
Date registered
20/08/2024
Date last updated
20/08/2024
Date data sharing statement initially provided
20/08/2024
Type of registration
Prospectively registered

Titles & IDs
Public title
Effect of education and e-bikes on rates of physical activity in sedentary adults
Scientific title
Effect of MI-CBT and e-bikes on rates of physical activity in sedentary adults
Secondary ID [1] 312632 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
sedentary behaviour 334695 0
Condition category
Condition code
Physical Medicine / Rehabilitation 331262 331262 0 0
Other physical medicine / rehabilitation
Cardiovascular 331339 331339 0 0
Normal development and function of the cardiovascular system

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The study will require participants to attend two laboratorial sessions to complete the following:
• The Physical activity stage of change questionnaire
• The International physical activity questionnaire-short form (IPAQ-SF)
• A bespoke process evaluation questionnaire (at post-testing only)
• The Barriers to Being Active Quiz
• 24-hr food record
• Stature and body mass
• Cardiometabolic health outcomes; resting blood pressure and fasted blood glucose
• Cardiorespiratory fitness: Graded exercise test to assess peak oxygen consumption (VO2peak).
• Maximal leg power: Vertical jump.

After completing these questionnaires and tests, participants will be provided with an e-bike (a pedal-powered bicycle with electric motor assistance) to ride on an indoor circuit for 10-min, to familiarise with the equipment. Participants will then be asked to rank their likelihood of using an e-bike from a visual analogue scale (VAS) where zero will indicate ‘very unlikely’ and ten will indicate ‘very likely’. Participants will then be asked to record reasons for their given VAS score. Motion during the 10-min ride will be collected using a portable motion capture system to determine balance and steering of the e-bike.

Laboratory testing will be conducted before the use of an e-bike, and after 4 weeks of using an e-bike. Participants will also be asked to use, as often as possible, an e-bike for 4 weeks before returning to the laboratory for testing. Travel data from their e-bike use will be monitored using the e-bike odometer. After this, they will return to the laboratory to repeat the tests. We expect that pre and post intervention tests will require a total of 60-min in each visit, along with 4 weeks of use of the e-bike.

Motivational Interviewing with Cognitive Behavior Therapy (MI-CBT) will be incorporated into weekly audio meeting for participants (15-20 min each) with a trained member of the research team to discuss weekly the participants goals and expectations from the exercise intervention, past experiences with physical activity, how to identify potential barriers to long-term physical activity and strategies to overcome the identified barriers. Research team will implement MI-CBT strategies including open ended questions, affirmations, reflection, and summary to guide the participants through the intervention for four weeks engaging individually with participants.
Adherence to the intervention would be through Polar Flow, with adherence to the MI-CBT intervention session attendance.
Intervention code [1] 329221 0
Behaviour
Intervention code [2] 329222 0
Prevention
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 339032 0
Volume of physical activity measured using the IPAQ before vs. after the intervention
Timepoint [1] 339032 0
Before vs. after completion of the intervention program
Secondary outcome [1] 438313 0
Changes in body mass
Timepoint [1] 438313 0
Before vs. after completion of the intervention program
Secondary outcome [2] 438550 0
Cardiorespiratory fitness (VO2max)
Timepoint [2] 438550 0
Before vs. after completion of the intervention program
Secondary outcome [3] 438551 0
Muscular power
Timepoint [3] 438551 0
Before vs. after completion of the intervention program
Secondary outcome [4] 438552 0
Blood pressure
Timepoint [4] 438552 0
Before vs. after completion of the intervention program
Secondary outcome [5] 438553 0
Capillary glucose
Timepoint [5] 438553 0
Before vs. after completion of the intervention program

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. Participants should not 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).
Minimum age
18 Years
Maximum age
64 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Medical contra-indication to perform exercise, musculoskeletal, neurological or cardiorespiratory illness, no prior experience using a bicycle, and 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).

Study design
Purpose of the study
Educational / counselling / training
Allocation to intervention
Non-randomised 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
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
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 levels of physical activity before and after the intervention (primary outcome), data from the current physical activity participation questionnaire will be utilised to describe change in physical activity from the intervention.
Correlations between changes in health, cardiorespiratory and musculoskeletal health in relation to the physical activity performed during the intervention will be analysed. Correlations coefficients were ranked as poor (0–0.5), moderate (0.5–0.75), good (0.75–0.90), and excellent (> 0.9) (Dancey & Reidy, 2004). Statistical differences were deemed significant when p<0.05.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/11/2024
Actual
Date of last participant enrolment
Anticipated
31/10/2025
Actual
Date of last data collection
Anticipated
28/11/2025
Actual
Sample size
Target
19
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC

Funding & Sponsors
Funding source category [1] 317067 0
University
Name [1] 317067 0
La Trobe University - Holsworth Research Initiative
Country [1] 317067 0
Australia
Primary sponsor type
University
Name
La Trobe University - Holsworth Research Initiative
Address
Country
Australia
Secondary sponsor category [1] 319316 0
None
Name [1] 319316 0
Address [1] 319316 0
Country [1] 319316 0

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 315815 0
La Trobe University Human Ethics Committee
Ethics committee address [1] 315815 0
Ethics committee country [1] 315815 0
Australia
Date submitted for ethics approval [1] 315815 0
06/09/2024
Approval date [1] 315815 0
Ethics approval number [1] 315815 0

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

Contacts
Principal investigator
Name 135894 0
Dr Rodrigo Rico Bini
Address 135894 0
La Trobe Rural Health School, Flora Hill Campus. Sharon Street, Flora Hill, Victoria (3550)
Country 135894 0
Australia
Phone 135894 0
+61 03 54447466
Fax 135894 0
Email 135894 0
[email protected]
Contact person for public queries
Name 135895 0
Rodrigo Rico Bini
Address 135895 0
La Trobe Rural Health School, Flora Hill Campus. Sharon Street, Flora Hill, Victoria (3550)
Country 135895 0
Australia
Phone 135895 0
+61 03 54447466
Fax 135895 0
Email 135895 0
[email protected]
Contact person for scientific queries
Name 135896 0
Rodrigo Rico Bini
Address 135896 0
La Trobe Rural Health School, Flora Hill Campus. Sharon Street, Flora Hill, Victoria (3550)
Country 135896 0
Australia
Phone 135896 0
+61 03 54447466
Fax 135896 0
Email 135896 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?
Non-identified summarised data will be included in the publication as supplementary materials.
When will data be available (start and end dates)?
When paper is published. No end date
Available to whom?
All of those with access to the paper
Available for what types of analyses?
Follow-up analysis, systematic reviews and meta-analyses.
How or where can data be obtained?
Through the publication link contacting the chief-investigator (Rodrigo Bini - [email protected])


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.