Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12622000970741
Ethics application status
Approved
Date submitted
6/06/2022
Date registered
8/07/2022
Date last updated
8/07/2022
Date data sharing statement initially provided
8/07/2022
Type of registration
Retrospectively registered

Titles & IDs
Public title
Where there’s exercise, there should be enjoyment: Comparing an enjoyment-regulated vs. intensity-regulated exercise intervention for adults
Scientific title
Examing the effects of an enjoyment-regulated vs. intensity-regulated exercise intervention on aerobic capacity and mental wellbeing in adults
Secondary ID [1] 306662 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
High blood pressure 325593 0
cardiopulmonary disease 325594 0
cardiovascular disease 326442 0
Obesity 326880 0
High cholesterol 326881 0
Condition category
Condition code
Cardiovascular 322957 322957 0 0
Hypertension
Cardiovascular 323725 323725 0 0
Other cardiovascular diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This project is a two phased (acute and chronic) randomised controlled pilot trial. Participants will complete a cardiopulmonary exercise test (CPET), questionnaires related to mental health, physical activity and perceived enjoyment of exercise as well as a semi-structured interview focusing on their beliefs about exercise and enjoyment of exercise. Following these baseline assessments, participants will then be randomised in a cross-over design to complete an acute enjoyment-driven and an intensity-driven exercise session, with one week washout in-between. Following one week washout post acute exercise sessions, all participants will then be further randomised into parallel groups and complete 4 weeks (three 30 minute exercise sessions per week, with total session time of approximately 40 minutes including resting and post measures ) of either intensity-driven (standard prescription of moderate intensity 40% -60% heart rate reserve [HRR]) or enjoyment driven (novel prescription) exercise. Affective response (Feeling Scale, FS), and heartrate (HR), Rating of perceived exertion (RPE) and blood pressure (BP) will be measured each session. On completion of the four weeks of training, all participants will repeat the baseline assessments. Finally, four weeks following post assessment completion, participants will be asked to complete the same questionnaires one final time.

Each session of the enjoyment regulated exercise prescription within the acute or chronic phase will use the FS to guide intensity. There will be no minimum intensity set for the enjoyment-regulated sessions. Sessions will be deivered by trained exercise physiologists or by student exercise physiologists under direct supervision of certified exercise physiologists. The sessions will each last approximately 40 minutes (30 minutes exercise, 5 mins each for pre/post measures). Participants will be blinded to the treadmill intensities in both sessions, but will be able to modify the intensity of the treadmill themselves for the enjoyment-regulated sessions. The sessions will be delivered in an individualised manner (1:1).

Adherence will be monitored for all acute/chronic sessions (attendence).
Intervention code [1] 323099 0
Prevention
Intervention code [2] 323100 0
Lifestyle
Comparator / control treatment
There will be an active control arm of the study whereby participants will complete exercise that is guided by current exercise guidelines (intensity based). They will complete the same number of sessions (3/week x 4 weeks) for 40 minutes total (30 minutes exercise, 5 mins each for pre post data collection).

Each session of the intensity regulated exercise prescription within the acute or chronic phase will mirror the enjoyment-regulated exercise precisely, with the exception of the use of the heart rate reserve (HRR, 40-60%, targeting 50%, +/- 10%) to guide the intensity for the intensity-regulated sessions. Participants must maintain a minimum of 40% HRR for the intensity-regulated sessions. Sessions will be delivered by trained exercise physiologists or by student exercise physiologists under direct supervision of certified exercise physiologists. The sessions will each last approximately 40 minutes. Participants will be blinded to the treadmill intensities. The sessions will be delivered in an individualised manner (1:1).

Adherence will be monitored for all acute/chronic sessions (attendence).
Control group
Active

Outcomes
Primary outcome [1] 331473 0
The primary endpoint of the acute phase of the project is exercise intensity (HR) between the acute intensity driven session and the acute enjoyment driven session. HR will be monitored via polar HR monitors.
Timepoint [1] 331473 0
Week 1 and Week 2 (after each acute session)
Primary outcome [2] 331474 0
The primary outcome measure of the chronic phase will be aerobic capacity (VO2peak) assessed on a treadmill using the modified bruce protocol.
Timepoint [2] 331474 0
6 weeks (post 4 weeks chronic training)
Secondary outcome [1] 410032 0
Visual Analog Scale (remembered enjoyment)
Timepoint [1] 410032 0
Post each exercise session
Secondary outcome [2] 410033 0
Empirical Valence Scale (forecasted pleasure)
Timepoint [2] 410033 0
Post each exercise session
Secondary outcome [3] 410034 0
Warwick-Edinburgh Mental Wellbeing Scale
Timepoint [3] 410034 0
6 weeks (post 4 weeks chronic training)
Secondary outcome [4] 410035 0
The Behavioural Regulations in Exercise Questionnaire (BREQ3)-autonomous motivation to participate in exercise
Timepoint [4] 410035 0
6 weeks (post 4 weeks chronic training)
Secondary outcome [5] 410036 0
Depression Anxiety Stress Scale (DASS-10)
Timepoint [5] 410036 0
6 weeks (post 4 week exercise intervention)
Secondary outcome [6] 411510 0
Beliefs about exercise-Interviews- Semi Structured
30 minute, one-on-one face-to-face or online (zoom), semi-structured interview with a trained member of the research team
Timepoint [6] 411510 0
Pre- Intervention
Secondary outcome [7] 411511 0
Affective Response to Exercise-Interviews- Semi Structured
30 minute, one-on-one face-to-face or online (zoom), semi-structured interview with a trained member of the research team
Timepoint [7] 411511 0
Pre-Intervention
Secondary outcome [8] 411512 0
Cognitive response to exercise-Interviews- Semi Structured
30 minute, one-on-one face-to-face or online (zoom), semi-structured interview with a trained member of the research team
Timepoint [8] 411512 0
Pre-Intervention
Secondary outcome [9] 411513 0
Affective Response to Intervention- Semi-Structured Interview
30 minute, one-on-one face-to-face or online (zoom), semi-structured interview with a trained member of the research team
Timepoint [9] 411513 0
Post chronic exercise training (those who completed enjoyment-regulated exercise)
Secondary outcome [10] 411514 0
Intervention Improvements- Semi Structured Interview

30 minute, one-on-one face-to-face or online (zoom), semi-structured interview with a trained member of the research team
Timepoint [10] 411514 0
Post chronic exercise training

Eligibility
Key inclusion criteria
I. Aged 18 years or older
II. No major changes in medications for at least 3 months
III. GP Clearance (if required by screening forms and or >40years old)
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
I. A major cardiovascular event with the previous 6 weeks or a planned hospitalization within the next 2 months
II. Involvement in regular physical activity (3 or more days/week and/or >120min of exercise at moderate or high intensity per week).
III. Abnormal response to cardiopulmonary exercise testing

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)
Allocation is not concealed
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Block randomisation using a randomisation table created by computer software (i.e. computerised sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Other
Other design features
Phase 1 is a cross-over acute study and phase 2 is a parallel chronic study. The same participants that complete phase one will continue into phase 2.
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
This is a pilot study, and will be used to develop power calculations. The primary endpoint of the acute phase of the project is exercise intensity (HR) and RPE between the acute intensity driven session and the acute enjoyment driven session. Secondary outcome measure for this phase include FS and VAS. A paired t-test will be used to determine whether the HR, RPE, FS and VAS are different between the two sessions. The primary outcome measure of the chronic phase will be aerobic capacity (VO2peak) and secondary outcomes will include the Warwick-Edinburgh Mental Wellbeing Scale, BREQ3 and DASS-10. A two way ANOVA will be used to compare the differences between groups post exercise for the primary and secondary outcomes. Interviews will be transcribed using Otter, an online, password secured program. The transcription will be read over by a researcher to ensure clarity of transcription and then coded via a thematic analysis in NVIVO.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
7/06/2022
Date of last participant enrolment
Anticipated
23/05/2023
Actual
Date of last data collection
Anticipated
25/08/2023
Actual
Sample size
Target
40
Accrual to date
5
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment postcode(s) [1] 37638 0
3000 - Melbourne
Recruitment postcode(s) [2] 37647 0
3011 - Footscray

Funding & Sponsors
Funding source category [1] 310990 0
University
Name [1] 310990 0
Victoria University, Institute for Health and Sport
Country [1] 310990 0
Australia
Primary sponsor type
University
Name
Victoria University
Address
PO Box 14428, Melbourne VIC 8001, Australia
Country
Australia
Secondary sponsor category [1] 312933 0
None
Name [1] 312933 0
None
Address [1] 312933 0
None
Country [1] 312933 0
Other collaborator category [1] 282319 0
University
Name [1] 282319 0
California State University, Bakersfield
Address [1] 282319 0
California State University, Bakersfield
9001 Stockdale Hwy, Mail Stop: 22
Bakersfield, CA 93311

Country [1] 282319 0
United States of America

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 310543 0
Victoria University Human Research Ethics Committee
Ethics committee address [1] 310543 0
PO Box 14428
Melbourne, VIC 8001
Australia
Ethics committee country [1] 310543 0
Australia
Date submitted for ethics approval [1] 310543 0
25/01/2022
Approval date [1] 310543 0
22/03/2022
Ethics approval number [1] 310543 0

Summary
Brief summary
This project aims to determine whether a protocol of 30 minutes of exercise prescribed based on enjoyment can elicit similar physiological responses (heart rate, rating of perceived exertion, and blood pressure) compared to aerobic exercise prescribed based on intensity-driven guidelines (moderate intensity, 40-60% Heart rate). A secondary aim will be to determine if 4 weeks of enjoyment-driven aerobic exercise (three 40 minute sessions per week, 30 mins exercise, 5 mins each for pre post assessments) can provide similar benefits (aerobic capacity, physical and mental wellbeing) to a 4 week intensity-driven aerobic exercise program.

I will recruit up to 40 adults (aged 18 years or older) to participate in a two phase randomised controlled clinical trial. Participants will complete a graded exercise test pre and post intervention. Measurements of current physical activity (PAQ), autonomous motivation to participate in exercise (BREQ3 questionnaire), symptoms of depression and anxiety (via the DASS-21 questionnaire) and psychological distress (using the K10) will also be measured. Participants will then be randomised in a cross-over design to complete an acute enjoyment-driven and an intensity driven exercise session, with one week washout in-between. All participants will then be randomised into parallel groups and complete 4 weeks (three 30 minute sessions per week) of either intensity-driven (standard prescription) or enjoyment driven (novel prescription) exercise. Affective response (FS), and HR, RPE and BP will be measured each session.

Significance:
This project proposes a transformative approach to exercise prescription whereby the focus of exercise prescription would shift away from objective intensity measures and instead centre on the individual’s level of enjoyment. If proven successful, this project has the potential to transform how exercise is prescribed and can be translated to the community and the health care system.
Trial website
Trial related presentations / publications
Public notes
* Recent diagnosis of COVID-19*, or identified as a close contact of someone with COVID-19, or symptoms suggestive of COVID-19 . Once the individual has been cleared of COVID-19 from DHHS, they will be invited to participate in the study, pending GP clearance. Screening for COVID-19 will occur within 24 hours of each in-person visit.

Contacts
Principal investigator
Name 118026 0
Dr Mary Woessner
Address 118026 0
Victoria University
PO Box 14428
Melbourne, VIC 8001
Australia
Country 118026 0
Australia
Phone 118026 0
+610421692161
Fax 118026 0
Email 118026 0
mary.woessner@vu.edu.au
Contact person for public queries
Name 118027 0
Dr Mary Woessner
Address 118027 0
Victoria University
PO Box 14428
Melbourne, VIC 8001
Australia
Country 118027 0
Australia
Phone 118027 0
+610421692161
Fax 118027 0
Email 118027 0
mary.woessner@vu.edu.au
Contact person for scientific queries
Name 118028 0
Dr Mary Woessner
Address 118028 0
Victoria University
PO Box 14428
Melbourne, VIC 8001
Australia
Country 118028 0
Australia
Phone 118028 0
+610421692161
Fax 118028 0
Email 118028 0
mary.woessner@vu.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


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.