Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12623000021673
Ethics application status
Approved
Date submitted
21/12/2022
Date registered
10/01/2023
Date last updated
28/09/2023
Date data sharing statement initially provided
10/01/2023
Type of registration
Prospectively registered

Titles & IDs
Public title
Does volume of exercise affect symptoms of depression, anxiety, and stress in tertiary students?
Scientific title
Does volume of exercise affect symptoms of depression, anxiety, and stress in tertiary students?
Secondary ID [1] 308649 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Mental health 328567 0
Depression 328568 0
Anxiety 328569 0
Stress 328570 0
Condition category
Condition code
Mental Health 325583 325583 0 0
Depression
Mental Health 325584 325584 0 0
Anxiety
Mental Health 325645 325645 0 0
Other mental health disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Participants will be asked to complete a 90-minute initial assessment consisting of initial screening and the Depression, Anxiety and Stress 21-item Scale (DASS-21) to determine depression, anxiety and stress levels and study eligibility. If eligible to continue, a treadmill test, quality of life survey, perceived stress scale and an arm and leg strength test, along with resting blood pressure, heart rate, height, weight, body mass index and waist circumference will also be performed. Participants will then be randomly allocated to one of two groups (150-minute or 300-minute exercise group).
Participants will be asked to complete two 60-minute supervised exercise sessions consisting of moderate intensity aerobic and resistance training each week. This could include aerobic exercises such as treadmill walking/jogging, cycling or rowing and resistance exercises that work the large muscles of the body such as squats/leg press, calf raises, standing row, triceps extensions and bicep curls. These sessions will be supervised by an accredited exercise scientist and/or an accredited exercise physiologist at an instructor to participant ratio of 1:10. Group size will be limited to a maximum of 20 participants during the supervised sessions. Intensity will be determined using heart rate and a Borg 6-20 rating of perceived exertion scale. Attendance at the supervised sessions will be documented on each individual's gym program, which will document all exercises undertaken that day. Two days (48 hours) will be scheduled between the supervised exercise sessions, as these include resistance training. The remaining 30 or 180 minutes of exercise (dependent upon group allocation) will be unsupervised and self-reported using an adapted Godin Leisure Time Exercise Questionnaire. Participants will be provided with examples of how to structure their unsupervised exercise sessions (i.e. 30-40 minutes of walking for the five days of unsupervised exercise), however it will be up to the participant's own discretion as to the type of activity and duration of activity they complete, up to their allocated weekly minutes. Participants will also be informed that they can undertake moderate intensity aerobic exercise daily without any rest days required, however if they undertake resistance training unsupervised, this should be for no more than 1 session and they should allow 2 days (48 hours) between the unsupervised resistance session and the two supervised resistance sessions. Participants will be provided with a copy of their gym program if they choose to complete an additional session unsupervised.
Following the six week intervention, participants will attend a 90-minute post-intervention assessment to conduct the same tests performed during the initial assessment, to determine intervention effect.
Intervention code [1] 325117 0
Lifestyle
Intervention code [2] 325119 0
Behaviour
Intervention code [3] 325120 0
Rehabilitation
Comparator / control treatment
The 150-minute exercise group will be the comparator group
Control group
Active

Outcomes
Primary outcome [1] 333427 0
21-item depression, anxiety and stress scale (DASS-21)
Timepoint [1] 333427 0
pre- and post- intervention (0 weeks/baseline and 7 weeks)
Secondary outcome [1] 417037 0
Cardiovascular capacity- submaximal graded exercise test using a treadmill Bruce protocol
Timepoint [1] 417037 0
pre- and post- intervention (0 weeks/baseline and 7 weeks)
Secondary outcome [2] 417038 0
SF-36 Quality of life survey
Timepoint [2] 417038 0
pre- and post- intervention (0 weeks/baseline and 7 weeks)
Secondary outcome [3] 417039 0
Perceived stress scale
Timepoint [3] 417039 0
pre- and post- intervention (0 weeks/baseline and 7 weeks)
Secondary outcome [4] 417040 0
Godin Leisure time exercise questionnaire
Timepoint [4] 417040 0
Pre-intervention (weekly) and every week during the six week exercise intervention
Secondary outcome [5] 417041 0
3-Repetition Maximum strength testing for assessment of arm strength
Timepoint [5] 417041 0
pre- and post- intervention (0 weeks/baseline and 7 weeks)
Secondary outcome [6] 417042 0
Anthropometry (height, weight, body mass index and waist circumference).
Height and weight will be assessed using a digital scale and stadiometer with these results being used to calculate body mass index. Waist circumference will be assessed using an anthropometic measuring tape)
Timepoint [6] 417042 0
pre- and post- intervention (0 weeks/baseline and 7 weeks)
Secondary outcome [7] 417270 0
3-Repetition Maximum strength testing for assessment of leg strength
Timepoint [7] 417270 0
pre- and post- intervention (0 weeks/baseline and 7 weeks)

Eligibility
Key inclusion criteria
Participants will be aged 18 to 64 years old, currently exercising for less than 150 minutes per week and be in at least their second year of study at a tertiary institution. Participants’ will also need to have mild to moderate depression, anxiety and/or stress, as categorised using the DASS-21. The maximum age will be set at 64yo, so that the study population is limited to adults, rather than older adults. There is no restriction on gender for inclusion.
Minimum age
18 Years
Maximum age
64 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Only participants with mild or moderate symptoms will be eligible for inclusion. Anyone who has severe or extremely severe symptoms, will be advised to contact their GP to discuss the symptoms they are having, as they may not be formally diagnosed or may be experiencing and exacerbation in condition requiring intervention beyond the scope of this project.
Participants who have been formally diagnosed with depression and/or anxiety AND have been medicated for less than 12 months will be excluded from participating.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled 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
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Stopped early
Data analysis
Data analysis is complete
Reason for early stopping/withdrawal
Participant recruitment difficulties
Date of first participant enrolment
Anticipated
13/02/2023
Actual
13/03/2023
Date of last participant enrolment
Anticipated
15/09/2023
Actual
17/04/2023
Date of last data collection
Anticipated
3/11/2023
Actual
30/06/2023
Sample size
Target
45
Accrual to date
Final
3
Recruitment in Australia
Recruitment state(s)
VIC

Funding & Sponsors
Funding source category [1] 312883 0
University
Name [1] 312883 0
Federation University Australia
Country [1] 312883 0
Australia
Primary sponsor type
Individual
Name
Dr Jacqueline Pengelly
Address
P330, University Drive, Mount Helen, Victoria 3350
Country
Australia
Secondary sponsor category [1] 314560 0
None
Name [1] 314560 0
None
Address [1] 314560 0
N/A
Country [1] 314560 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 312162 0
Federation University Australian Human Research Ethics Committee
Ethics committee address [1] 312162 0
Ethics committee country [1] 312162 0
Australia
Date submitted for ethics approval [1] 312162 0
Approval date [1] 312162 0
21/12/2022
Ethics approval number [1] 312162 0

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

Contacts
Principal investigator
Name 123690 0
Dr Jacqueline Pengelly
Address 123690 0
Federation University Australia
Office 330, Building P
University Drive, Mount Helen, Victoria 3350
Country 123690 0
Australia
Phone 123690 0
+61 353276933
Fax 123690 0
Email 123690 0
j.pengelly@federation.edu.au
Contact person for public queries
Name 123691 0
Jacqueline Pengelly
Address 123691 0
Federation University Australia
Office 330, Building P
University Drive, Mount Helen, Victoria 3350
Country 123691 0
Australia
Phone 123691 0
+61 353276933
Fax 123691 0
Email 123691 0
j.pengelly@federation.edu.au
Contact person for scientific queries
Name 123692 0
Jacqueline Pengelly
Address 123692 0
Federation University Australia
Office 330, Building P
University Drive, Mount Helen, Victoria 3350
Country 123692 0
Australia
Phone 123692 0
+61 353276933
Fax 123692 0
Email 123692 0
j.pengelly@federation.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
De-identified individual participant data of published results only will be made available upon written request to the PI and at the discretion of the PI.
When will data be available (start and end dates)?
Data will be available following publication of the study findings or 21/12/2027, whichever occurs first. Data will be available for 5 years after publication.
Available to whom?
Researchers with approved study proposals who are conducting IPD meta-analyses.
Available for what types of analyses?
Only to achieve the aims in the approved proposal, for IPD meta-analyses. Individual participant data will not be made available for inclusion or comparison to any similar studies.
How or where can data be obtained?
Data can be obtained via written contact from the PI, Dr Jacqueline Pengelly at j.pengelly@federation.edu.au


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
17912Informed consent form    385158-(Uploaded-21-12-2022-11-50-08)-Study-related document.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.