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Trial registered on ANZCTR
Registration number
ACTRN12624000913572
Ethics application status
Approved
Date submitted
8/07/2024
Date registered
26/07/2024
Date last updated
26/07/2024
Date data sharing statement initially provided
26/07/2024
Type of registration
Prospectively registered
Titles & IDs
Public title
Investigating an Exercise and Wellbeing Program for Australian University Students with Disability: A Pilot Study
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Scientific title
Evaluating the feasibility and acceptability of an exercise-based wellbeing program for students with disability in an Australian university: A mixed methods pilot study
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Secondary ID [1]
312473
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None
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Disability (defined as any interaction between a health condition, the individual and contextual factors which renders a person unable to partake fully in their community)
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Condition category
Condition code
Physical Medicine / Rehabilitation
330973
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0
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Other physical medicine / rehabilitation
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
The intervention will consist of ten (10) weeks of individually prescribed exercise programming delivered by Accredited Exercise Physiologists (AEPs). The program will be co-designed with each participant during a baseline consultation (Week 1) to ensure personalisation and address individual needs and preferences. A 60-minute in-person consultation at the on-campus fitness and aquatic center will be conducted to gather baseline data and co-design the individual exercise program. Participants will receive ten (10) one-on-one supervised sessions with an AEP, lasting between 15-60 minutes each. Sessions can be delivered via telehealth or face-to-face at the on-campus facility, based on participant preference. The program will prescribe light to moderate-intensity exercise, targeting a perceived exertion of 10-12 on the Borg Rating of Perceived Exertion (RPE) scale (out of 20). A mix of aerobic (e.g., treadmill, stationary bikes, rowing machines, walking, swimming, yoga) and anaerobic (e.g., body weight, free weights, resistance bands, machine weights, hydrotherapy) activities will be incorporated, aiming for at least 150 minutes of moderate-intensity exercise per week. This physical activity target includes physical activity achieved within the weekly supervised session and that accrued outside of these supervised sessions (i.e. unsupervised), either prescribed by the AEP or self-determined by the participant and completed in the on-campus training facility or at the participant's home. Resistance training will be included 2-3 times per week, consisting of 1-4 sets of 5-10 repetitions for 2-8 exercises each. The resistance training target includes exercise achieved within the weekly supervised session and that accrued outside of these supervised sessions (i.e. unsupervised), either prescribed by the AEP or self-determined by the participant and completed in the on-campus training facility or at the participant's home. A final 60-minute consultation will be conducted to review progress, address any adjustments, and collect follow-up data. Both the baseline and final consultations are included in the 10 supervised sessions provided to the participants. A participant handbook will be provided, outlining the program and promoting the utilisation of university support services. A practitioner manual, designed specifically for this study, will be provided to AEPs employed in the trial. It will detail program protocols, exercise counseling techniques, motivational interviewing principles, and positive psychology strategies. The manual will also encourage referrals to other relevant university support services. A similar handbook, designed specifically for this study, will be provided to participants, outlining the program logistics, promoting healthy behaviors, and encouraging the use of positive psychology strategies and university support services. Following program completion, participants will participate in a semi-structured, individual interview lasting approximately 30 minutes. This interview will serve as a Patient Reported Experience Measure (PREM) and explore participant experiences, program benefits and challenges, barriers to participation, and the program's impact on health, wellbeing, and academic performance. A pre-defined interview guide will be used to ensure consistency across interviews, with the lead investigator acting as the interviewer. Program adherence will be assessed weekly through specific questioning included in the progress notes templates designed specifically for this study.
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Intervention code [1]
328992
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Treatment: Other
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Comparator / control treatment
No control group.
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Control group
Uncontrolled
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Outcomes
Primary outcome [1]
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Feasibility
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Assessment method [1]
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Composite primary outcome: retention, adherence, compliance, resource requirements and issues with implementation will be recorded through weekly progress notes maintained by the attending Exercise Physiologist. These logs will be overseen by the primary investigator. Program expenditure will be recorded throughout the program implementation.
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Timepoint [1]
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Week 1,2,3,4,5,6,7,8,9 and 10 post-intervention commencement
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Primary outcome [2]
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Acceptability
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Assessment method [2]
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Composite primary outcome: Data collected in the individual, in-depth exit interviews with participants of the program will explore the perceived acceptability of the program along with all participants completing the Short Assessment of Patient Satisfaction (SAPS) questionnaire included in week 10 data collection timepoint.
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Timepoint [2]
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Week 10 (immediately post-intervention completion - SAPS questionnaire) and within 2 weeks post-intervention completion (between week 10-12 - exit interview)
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Secondary outcome [1]
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Quality of life
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Assessment method [1]
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Assessment of Quality of Life 8 Dimensions
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Timepoint [1]
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Baseline and at Week 10 (immediately post-intervention completion)
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Secondary outcome [2]
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Social Connectedness
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Assessment method [2]
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Social Connectedness Scale Revised
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Timepoint [2]
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Baseline and at Week 10 (immediately post-intervention completion)
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Secondary outcome [3]
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Authenticity
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Assessment method [3]
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Kernis-Goldman Authenticity Inventory Short Form
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Timepoint [3]
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Baseline and at Week 10 (immediately post-intervention completion)
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Secondary outcome [4]
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Social Identification
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Assessment method [4]
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Four Item Measure of Social Identification
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Timepoint [4]
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Baseline and at Week 10 (immediately post-intervention completion)
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Secondary outcome [5]
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Seated Resting Blood Pressure
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Assessment method [5]
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Blood Pressure Monitor
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Timepoint [5]
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Baseline and at Week 10 (immediately post-intervention completion)
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Secondary outcome [6]
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Seated Resting Pulse Rate
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Assessment method [6]
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Finger Pulse Oximeter
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Timepoint [6]
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Baseline and at Week 10 (immediately post-intervention completion)
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Secondary outcome [7]
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Body Mass
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Assessment method [7]
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Weighing Scale
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Timepoint [7]
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Baseline and at Week 10 (immediately post-intervention completion)
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Secondary outcome [8]
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Waist to Hip Ratio
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Assessment method [8]
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Waist Circumference Tape Measurement After Normal Exhale divided by Hip Circumference Tape Measurement After Normal Exhale
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Timepoint [8]
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Baseline and at Week 10 (immediately post-intervention completion)
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Secondary outcome [9]
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Height
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Assessment method [9]
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Stadiometer reading
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Timepoint [9]
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Baseline and at Week 10 (immediately post-intervention completion)
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Secondary outcome [10]
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Grip Strength
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Assessment method [10]
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Mean of 3 x Hand-Held Dynomometer Measurement at 90 Degrees elbow Flexion Bilaterally
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Timepoint [10]
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Baseline and at Week 10 (immediately post-intervention completion)
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Secondary outcome [11]
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Cardiopulmonary Fitness
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Assessment method [11]
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6 Minute Walk Test
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Timepoint [11]
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Baseline and at Week 10 (immediately post-intervention completion)
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Secondary outcome [12]
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Impact of Disability
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Assessment method [12]
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World Health Organisation Disability Assessment Schedule 2.0
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Timepoint [12]
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Baseline and at Week 10 (immediately post-intervention completion)
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Secondary outcome [13]
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Subjective Global Health Score
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Assessment method [13]
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Patient Reported Outcome Measure Information System Global Health
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Timepoint [13]
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Baseline and at Week 10 (immediately post-intervention completion)
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Secondary outcome [14]
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Health Behaviour
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Assessment method [14]
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Health-Promoting Lifestyle Profile II (HPLP II)
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Timepoint [14]
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Baseline and at Week 10 (immediately post-intervention completion)
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Eligibility
Key inclusion criteria
participants are students enrolled at and attend the Queensland University of Technology, Brisbane university campuses; participants have a university Access Equity Plan and consider themselves to experience disability as defined by the ICF Framework; able and willing to complete 10 weeks of the health and wellbeing program either online or on-campus, minimum of one day per week and attend the on-campus fitness and aquatic centre for both physiological data collection sessions (week one and week 10) over the 10-week period; willing to be individually interviewed about their experience participating in the intervention.
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
Nil
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Study design
Purpose of the study
Educational / counselling / training
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Allocation to intervention
Non-randomised trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
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Who is / are masked / blinded?
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Intervention assignment
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Other design features
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Phase
Not Applicable
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Not yet recruiting
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Date of first participant enrolment
Anticipated
29/07/2024
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Actual
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Date of last participant enrolment
Anticipated
16/08/2024
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Actual
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Date of last data collection
Anticipated
1/12/2024
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Actual
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Sample size
Target
20
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
QLD
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Funding & Sponsors
Funding source category [1]
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University
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Name [1]
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Queensland University of Technology Administrative Division
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Address [1]
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Country [1]
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Australia
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Primary sponsor type
University
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Name
Queensland University of Technology
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Address
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Country
Australia
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Secondary sponsor category [1]
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None
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Name [1]
319140
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Address [1]
319140
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Country [1]
319140
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
315653
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Queensland University of Technology University Human Research Ethics Committee
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Ethics committee address [1]
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https://www.qut.edu.au/research/why-qut/ethics-and-integrity
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Ethics committee country [1]
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Australia
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Date submitted for ethics approval [1]
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01/07/2024
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Approval date [1]
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05/07/2024
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Ethics approval number [1]
315653
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Summary
Brief summary
This trial aims to evaluate the feasibility and acceptability of a 10-week, individualised exercise-based wellbeing program designed for students with disability at an Australian university. Conducted through a mixed-methods pilot study, the program will be delivered by Accreditted Exercise Physiologists both online via Zoom and on-campus, collaborating closely with other student support services. The program being investigated is funded by the administrative division of the university and will assess various aspects such as program retention, adherence, resource requirements, and participant satisfaction. It is expected to improve participants' quality of life, psychosocial health, health behaviors, and physical health measures. The study will involve 20 participants, recruited through the university's accessibility and disability services, and will be conducted from July to November 2024.
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Trial website
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Dr Justin Holland
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Address
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Queensland University of Technology, Faculty of Health, School of Exercise and Nutrition Sciences, 149 Victoria Park Road, Kelvin Grove, Queensland, 4059
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Country
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Australia
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Phone
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+61731380669
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Fax
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Email
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[email protected]
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Contact person for public queries
Name
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Gabriel Dillon
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Address
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Queensland University of Technology, Faculty of Health, School of Exercise and Nutrition Sciences, 149 Victoria Park Road, Kelvin Grove, Queensland, 4059
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Country
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Australia
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Phone
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+61 481881757
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Fax
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Email
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[email protected]
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Contact person for scientific queries
Name
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Gabriel Dillon
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Address
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Queensland University of Technology, Faculty of Health, School of Exercise and Nutrition Sciences, 149 Victoria Park Road, Kelvin Grove, Queensland, 4059
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Country
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Australia
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Phone
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+61 481881757
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Fax
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Email
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[email protected]
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Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
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No/undecided IPD sharing reason/comment
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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.
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