Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12624001354572
Ethics application status
Approved
Date submitted
10/10/2024
Date registered
12/11/2024
Date last updated
12/11/2024
Date data sharing statement initially provided
12/11/2024
Type of registration
Prospectively registered

Titles & IDs
Public title
Virtual sailing exercise on major depressive disorder
Scientific title
Investigating the therapeutic potential of virtual sailing exercise on major depressive disorder in Patients aged between 18 and 64 (inclusive)
Secondary ID [1] 312824 0
None
Universal Trial Number (UTN)
Trial acronym
VSAIL
Linked study record

Health condition
Health condition(s) or problem(s) studied:
major depressive disorder 335334 0
Condition category
Condition code
Mental Health 331923 331923 0 0
Depression

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This project aims to investigate whether a simulated (virtual) sailing exercise could improve depression and the quality of life for adults with major depressive disorder. Under the supervision of an exercise scientist, each consenting participant will participate a 6-week virtual sailing program (one session per week, 30mins per session).

The participants will train on a virtual Sydney harbour Trapezoid course used in the Sydney 2000 Olympic games. Before testing each eligible participant will be briefed on the simulator, equipment, and safety features. After being seated in the V-Sail simulator, participants will be given sailing instructions, starting with all the information that the simulator provides on the TV screen. The information provided on the TV screen relates to wind direction, twin tails attached to sails, the angle of the boat and course. Once the participants have grasped the sailing fundamentals they will be taught how to steer the yacht and how to sail around objects (e.g. rocks and buoys) and how to berth the yacht. When they are comfortable with steering the yacht, we will then introduce the mainsheet. Participants will learn how to adjust the main sail in order to control the speed of the yacht.

Participants will be assessed with depression and functioning, motor coordination and brain activity at baseline (prior to the first sailing session) and post-intervention (after the last sailing session). This will be a one-to-one training session and exercise attendance will be recorded. The virtual sailing exercise program will be conducted at the Future of Factory Lab, Ground floor, Advanced Manufacturing and Design Centre, Swinburne University of Technology, Burwood Road, Hawthorn, Victoria 3122.
Intervention code [1] 329648 0
Treatment: Other
Comparator / control treatment
This is a pilot trial so there is no need for a control group.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 339521 0
Depression
Timepoint [1] 339521 0
Baseline (pre-intervention), post-intervention (post-completion of 6-week intervention program) and 3 month follow up
Primary outcome [2] 339759 0
Quality of Life
Timepoint [2] 339759 0
Baseline (pre-intervention), post-intervention (post-completion of 6-week intervention program) and 3 month follow up
Secondary outcome [1] 440311 0
Motor coordination
Timepoint [1] 440311 0
Baseline (pre-intervention) and post-intervention (post-completion of 6-week intervention program)
Secondary outcome [2] 440312 0
Brain plasticity
Timepoint [2] 440312 0
Baseline (pre-intervention) and post-intervention (post-completion of 6-week intervention program)
Secondary outcome [3] 441400 0
Anxiety (self report)
Timepoint [3] 441400 0
Baseline (pre-intervention), post-intervention (post-completion of 6-week intervention program) and 3 month follow up
Secondary outcome [4] 441401 0
Depression (self-report)
Timepoint [4] 441401 0
Baseline (pre-intervention), post-intervention (post-completion of 6-week intervention program) and 3 month follow up
Secondary outcome [5] 441402 0
Stress (self report)
Timepoint [5] 441402 0
Baseline (pre-intervention), post-intervention (post-completion of 6-week intervention program) and 3 month follow up
Secondary outcome [6] 441403 0
Global improvement or change
Timepoint [6] 441403 0
Baseline (pre-intervention), post-intervention (post-completion of 6-week intervention program) and 3 month follow up
Secondary outcome [7] 441404 0
Overall functioning (self report)
Timepoint [7] 441404 0
Baseline (pre-intervention), post-intervention (post-completion of 6-week intervention program) and 3 month follow up
Secondary outcome [8] 441405 0
Behaviour and social functioning
Timepoint [8] 441405 0
Baseline (pre-intervention), post-intervention (post-completion of 6-week intervention program) and 3 month follow up
Secondary outcome [9] 441406 0
Hand grip strength
Timepoint [9] 441406 0
Baseline (pre-intervention), post-intervention (post-completion of 6-week intervention program

Eligibility
Key inclusion criteria
• Aged between 18- and 64-year-old
• A diagnosis of major depression disorders
• Sufficient fluency in English to complete all baseline and outcome assessments.
• Have the capacity to participate in virtual sailing exercises determined by the pre-exercise screening.
• Have the capacity to consent. to the study and to follow its instructions and procedures.
Minimum age
18 Years
Maximum age
64 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
• Aged under 18- or above 64-year-old,
• Any diagnosis or history of impaired visual acuity, or cerebellar function impairment.
• Already received any exercise therapy (e.g. undertaking prescribed physical activity to correct, restore and/or maintain a stature of function or well-being) at another service (a gym or health care setting) within the last 2 years, to avoid contamination.
• A diagnosis of bipolar disorder and/or another psychotic disorder and/or current substance use disorder.
• Undergoing electroconvulsive therapy or transcranial magnetic stimulus therapy within one month of the recruitment of the study.
• Current enrolment in another mental health intervention study.
• Participants with current suicidal ideation with a specific plan.
• Participants with motion sickness

Study design
Purpose of the study
Treatment
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
Descriptive statistics will be reported for the demographic and outcome variables. Categorical data will be presented as counts and proportions. Means and standard deviations, skewness and kurtosis will be reported for all continuous variables. Pearson Product Moment Correlations will be used to examine the relationships between symptoms and brain plasticity change.

An effect size (SMD) of 0.4 is considered the minimum threshold of clinical importance. This trial is designed to detect a difference of this magnitude over the 6-week trial. To provide 80% power to detect a change of this magnitude (alpha set at 0.05, 2-tailed primary hypothesis), 58 participants will be required.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/01/2025
Actual
Date of last participant enrolment
Anticipated
30/06/2027
Actual
Date of last data collection
Anticipated
31/12/2027
Actual
Sample size
Target
58
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 27178 0
The Northern Hospital - Epping
Recruitment postcode(s) [1] 43260 0
3076 - Epping

Funding & Sponsors
Funding source category [1] 317262 0
Government body
Name [1] 317262 0
Department of Health, Victoria State Government
Country [1] 317262 0
Australia
Primary sponsor type
University
Name
Swinburne University of Technology
Address
Country
Australia
Secondary sponsor category [1] 319540 0
None
Name [1] 319540 0
Address [1] 319540 0
Country [1] 319540 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 316000 0
Swinburne University of Technology Human Research Ethics Committee
Ethics committee address [1] 316000 0
Ethics committee country [1] 316000 0
Australia
Date submitted for ethics approval [1] 316000 0
19/11/2023
Approval date [1] 316000 0
05/03/2024
Ethics approval number [1] 316000 0
2024579

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

Contacts
Principal investigator
Name 136462 0
Dr Junhua Xiao
Address 136462 0
John Street, Hawthorn, School of Health Sciences, Swinburne University of Technology, Hawthorn, VIC 3122
Country 136462 0
Australia
Phone 136462 0
+61 3 9214 5042
Fax 136462 0
Email 136462 0
[email protected]
Contact person for public queries
Name 136463 0
Junhua Xiao
Address 136463 0
John Street, Hawthorn, School of Health Sciences, Swinburne University of Technology,Hawthorn, Victoria, 3122
Country 136463 0
Australia
Phone 136463 0
+61 3 9214 5042
Fax 136463 0
Email 136463 0
[email protected]
Contact person for scientific queries
Name 136464 0
Junhua Xiao
Address 136464 0
John Street, Hawthorn, School of Health Sciences, Swinburne University of Technology, Hawthorn, Victoria, 3122, Australia
Country 136464 0
Australia
Phone 136464 0
+61 3 9214 5042
Fax 136464 0
Email 136464 0
[email protected]

Data sharing statement
Will the study consider sharing individual participant data?
No


What supporting documents are/will be available?

TypeCitationLinkEmailOther DetailsAttachment
Ethical approval2024579 [email protected] 2024579_VSail Ethics SUT Approval Letter.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.