Trial Review

Did you know?

The ANZCTR now automatically displays published trial results and simplifies the addition of trial documents such as unpublished protocols and statistical analysis plans.

These enhancements will offer a more comprehensive view of trials, regardless of whether their results are positive, negative, or inconclusive.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
ACTRN12624001076561
Ethics application status
Approved
Date submitted
9/08/2024
Date registered
5/09/2024
Date last updated
5/09/2024
Date data sharing statement initially provided
5/09/2024
Type of registration
Retrospectively registered

Titles & IDs
Public title
A Peer-Led Exercise Program for University of Newcastle Students
Scientific title
Feasibility of a Peer-Led Exercise Program for University of Newcastle Students
Secondary ID [1] 312728 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Physical inactivity 334749 0
Condition category
Condition code
Physical Medicine / Rehabilitation 331308 331308 0 0
Other physical medicine / rehabilitation
Public Health 331309 331309 0 0
Health promotion/education

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Participants will undergo a 6-week exercise program, delivered in groups of up to 10 by exercise physiology/exercise science students. The program will be overseen by an Accredited Exercise Physiologist. Participants will complete two 45-minute supervised sessions per week, which will include exercise and psychoeducation. The two sessions will ideally be separated by at least 24 hours. Participants will be provided with an individualised exercise program to complete outside of these sessions; the duration, frequency, intensity and type of these will be individualised to the participants' goals and preferences.

The exercise sessions will include aerobic and resistance training, targeting all major muscle groups using body weight, free weight, and machine-based exercise. The intensity of the sessions will vary depending on the participants' goals, abilities and preferences, but will be of at least a moderate intensity (i.e., Borg 4-6/10). While the exercises will be prescribed with a view to gain mental and physical health benefits, a focus will be placed on correct technique and use of equipment, varying exercise based on goals, and finding different ways of being active.

In addition to the exercise, the participants will receive psychoeducation during their sessions. The Counselling and Psychological services staff will develop a suite of topics to be covered including benefits of exercise on mental health and wellbeing and academic functionality, overcoming barriers to exercise, and goal setting. These staff members will provide the exercise physiology/exercise science student facilitators with training to deliver this information during the sessions in the two weeks prior to the start of the intervention; these training sessions will be a single two hour session either in-person or via Zoom. These will be delivered in tandem with the exercise sessions (i.e., whilst the participants are exercising) via group discussions, rather than separately before or after.
Intervention code [1] 329249 0
Lifestyle
Comparator / control treatment
N/A
Control group
Uncontrolled

Outcomes
Primary outcome [1] 339074 0
Feasibility
Timepoint [1] 339074 0
At the conclusion of the program.
Secondary outcome [1] 438465 0
Mental wellbeing
Timepoint [1] 438465 0
Change from baseline to follow-up (6 weeks post-commencement of intervention)
Secondary outcome [2] 438466 0
Psychological distress
Timepoint [2] 438466 0
Change from baseline to follow-up (6 weeks post-commencement of intervention)
Secondary outcome [3] 438467 0
Exercise self-efficacy
Timepoint [3] 438467 0
Change from baseline to follow-up (6 weeks post-commencement of intervention)
Secondary outcome [4] 438468 0
Social connectedness
Timepoint [4] 438468 0
Change from baseline to follow-up (6 weeks post-commencement of intervention)
Secondary outcome [5] 438469 0
Physical activity levels
Timepoint [5] 438469 0
Change from baseline to follow-up (6 weeks post-commencement of intervention)
Secondary outcome [6] 438470 0
Handgrip strength
Timepoint [6] 438470 0
Change from baseline to follow-up (6 weeks post-commencement of intervention)

Eligibility
Key inclusion criteria
Students currently enrolled at the University of Newcastle, Australia
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
People will be ineligible if they have any condition as per the absolute contraindications to exercise, are meeting the physical activity guidelines (150minutes/week moderate intensity or 75minutes/week vigorous intensity exercise), have severe mental illness (e.g., psychoses), have planned medical operations during the research period, are pregnant or expecting to be pregnant during the study period, and are non-English speaking. People will also be ineligible if they are enrolled in a degree within the Exercise and Sport Science discipline.

Study design
Purpose of the study
Prevention
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
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
1/08/2024
Date of last participant enrolment
Anticipated
4/08/2025
Actual
Date of last data collection
Anticipated
31/10/2025
Actual
Sample size
Target
40
Accrual to date
8
Final
Recruitment in Australia
Recruitment state(s)
NSW

Funding & Sponsors
Funding source category [1] 317156 0
University
Name [1] 317156 0
University of Newcastle
Country [1] 317156 0
Australia
Primary sponsor type
University
Name
The University of Newcastle
Address
Country
Australia
Secondary sponsor category [1] 319425 0
None
Name [1] 319425 0
Address [1] 319425 0
Country [1] 319425 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 315906 0
The University of Newcastle Human Research Ethics Committee
Ethics committee address [1] 315906 0
Ethics committee country [1] 315906 0
Australia
Date submitted for ethics approval [1] 315906 0
Approval date [1] 315906 0
12/03/2024
Ethics approval number [1] 315906 0

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

Contacts
Principal investigator
Name 136170 0
Dr Emily Cox
Address 136170 0
University of Newcastle, School of Biomedical Sciences and Pharmacy, University Drive, Callaghan, NSW 2308
Country 136170 0
Australia
Phone 136170 0
+61 2 4985 4515
Fax 136170 0
Email 136170 0
emily.cox10@newcastle.edu.au
Contact person for public queries
Name 136171 0
Emily Cox
Address 136171 0
University of Newcastle, School of Biomedical Sciences and Pharmacy, University Drive, Callaghan, NSW 2308
Country 136171 0
Australia
Phone 136171 0
+61 2 4985 4515
Fax 136171 0
Email 136171 0
emily.cox10@newcastle.edu.au
Contact person for scientific queries
Name 136172 0
Emily Cox
Address 136172 0
University of Newcastle, School of Biomedical Sciences and Pharmacy, University Drive, Callaghan, NSW 2308
Country 136172 0
Australia
Phone 136172 0
+61 2 4985 4515
Fax 136172 0
Email 136172 0
emily.cox10@newcastle.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.