Trial Review

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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
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
Secondary ID [1] 312473 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

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) 334318 0
Condition category
Condition code
Physical Medicine / Rehabilitation 330973 330973 0 0
Other physical medicine / rehabilitation

Intervention/exposure
Study type
Interventional
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.
Intervention code [1] 328992 0
Treatment: Other
Comparator / control treatment
No control group.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 338741 0
Feasibility
Timepoint [1] 338741 0
Week 1,2,3,4,5,6,7,8,9 and 10 post-intervention commencement
Primary outcome [2] 338742 0
Acceptability
Timepoint [2] 338742 0
Week 10 (immediately post-intervention completion - SAPS questionnaire) and within 2 weeks post-intervention completion (between week 10-12 - exit interview)
Secondary outcome [1] 437242 0
Quality of life
Timepoint [1] 437242 0
Baseline and at Week 10 (immediately post-intervention completion)
Secondary outcome [2] 437243 0
Social Connectedness
Timepoint [2] 437243 0
Baseline and at Week 10 (immediately post-intervention completion)
Secondary outcome [3] 437244 0
Authenticity
Timepoint [3] 437244 0
Baseline and at Week 10 (immediately post-intervention completion)
Secondary outcome [4] 437245 0
Social Identification
Timepoint [4] 437245 0
Baseline and at Week 10 (immediately post-intervention completion)
Secondary outcome [5] 437246 0
Seated Resting Blood Pressure
Timepoint [5] 437246 0
Baseline and at Week 10 (immediately post-intervention completion)
Secondary outcome [6] 437247 0
Seated Resting Pulse Rate
Timepoint [6] 437247 0
Baseline and at Week 10 (immediately post-intervention completion)
Secondary outcome [7] 437248 0
Body Mass
Timepoint [7] 437248 0
Baseline and at Week 10 (immediately post-intervention completion)
Secondary outcome [8] 437249 0
Waist to Hip Ratio
Timepoint [8] 437249 0
Baseline and at Week 10 (immediately post-intervention completion)
Secondary outcome [9] 437250 0
Height
Timepoint [9] 437250 0
Baseline and at Week 10 (immediately post-intervention completion)
Secondary outcome [10] 437251 0
Grip Strength
Timepoint [10] 437251 0
Baseline and at Week 10 (immediately post-intervention completion)
Secondary outcome [11] 437252 0
Cardiopulmonary Fitness
Timepoint [11] 437252 0
Baseline and at Week 10 (immediately post-intervention completion)
Secondary outcome [12] 437254 0
Impact of Disability
Timepoint [12] 437254 0
Baseline and at Week 10 (immediately post-intervention completion)
Secondary outcome [13] 437255 0
Subjective Global Health Score
Timepoint [13] 437255 0
Baseline and at Week 10 (immediately post-intervention completion)
Secondary outcome [14] 437256 0
Health Behaviour
Timepoint [14] 437256 0
Baseline and at Week 10 (immediately post-intervention completion)

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.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Nil

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
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
29/07/2024
Actual
Date of last participant enrolment
Anticipated
16/08/2024
Actual
Date of last data collection
Anticipated
1/12/2024
Actual
Sample size
Target
20
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD

Funding & Sponsors
Funding source category [1] 316889 0
University
Name [1] 316889 0
Queensland University of Technology Administrative Division
Country [1] 316889 0
Australia
Primary sponsor type
University
Name
Queensland University of Technology
Address
Country
Australia
Secondary sponsor category [1] 319140 0
None
Name [1] 319140 0
Address [1] 319140 0
Country [1] 319140 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 315653 0
Queensland University of Technology University Human Research Ethics Committee
Ethics committee address [1] 315653 0
Ethics committee country [1] 315653 0
Australia
Date submitted for ethics approval [1] 315653 0
01/07/2024
Approval date [1] 315653 0
05/07/2024
Ethics approval number [1] 315653 0

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

Contacts
Principal investigator
Name 135382 0
Dr Justin Holland
Address 135382 0
Queensland University of Technology, Faculty of Health, School of Exercise and Nutrition Sciences, 149 Victoria Park Road, Kelvin Grove, Queensland, 4059
Country 135382 0
Australia
Phone 135382 0
+61731380669
Fax 135382 0
Email 135382 0
justin.holland@qut.edu.au
Contact person for public queries
Name 135383 0
Gabriel Dillon
Address 135383 0
Queensland University of Technology, Faculty of Health, School of Exercise and Nutrition Sciences, 149 Victoria Park Road, Kelvin Grove, Queensland, 4059
Country 135383 0
Australia
Phone 135383 0
+61 481881757
Fax 135383 0
Email 135383 0
n11127821@qut.edu.au
Contact person for scientific queries
Name 135384 0
Gabriel Dillon
Address 135384 0
Queensland University of Technology, Faculty of Health, School of Exercise and Nutrition Sciences, 149 Victoria Park Road, Kelvin Grove, Queensland, 4059
Country 135384 0
Australia
Phone 135384 0
+61 481881757
Fax 135384 0
Email 135384 0
n11127821@qut.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.