Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12609000004268
Ethics application status
Approved
Date submitted
28/11/2008
Date registered
6/01/2009
Date last updated
29/11/2021
Date data sharing statement initially provided
29/11/2021
Type of registration
Retrospectively registered

Titles & IDs
Public title
Randomised controlled trial of exercise duration and mood in adolescents
Scientific title
Randomised controlled trial on the effect of exercise duration on mood in adolescents
Secondary ID [1] 283529 0
nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Adolescent mental health and exercise 4043 0
Condition category
Condition code
Mental Health 4246 4246 0 0
Studies of normal psychology, cognitive function and behaviour

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
In this cross-over randomised controlled trial, the adolescents will undertake each of three regimens on different days: (1) participate in a single bout of moderate intensity exercise on a cycle ergometer for 10 minutes; (2) participate in a single bout of moderate intensity exercise on a cycle ergometer for 20 minutes; or (3) no exercise (control condition). The order of the regimens will be randomly allocated for each adolescent. A washout period of at least 18 hours is used.
Intervention code [1] 3763 0
Lifestyle
Comparator / control treatment
No exercise
Control group
Active

Outcomes
Primary outcome [1] 5132 0
The primary outcome is change in mood and affect, using the Subjective Exercise Experiences Scale (SEES) to assess mood and the Feeling Scale and the Felt Arousal Scale to assess affect
Timepoint [1] 5132 0
Baseline, 25 minutes and 50 minutes from commencement of the exercise or rest regimen, for mood. Baseline, 5, 10, 15, 20, 25 and 50 minutes from commencement of the exercise or rest regimen, for affect scales
Secondary outcome [1] 8640 0
Heart rate (using an electronic heart rate monitor) and blood pressure (using a manual sphigmomanometer, taking the average of two readings at each time point)
Timepoint [1] 8640 0
Baseline, 25 minutes and 50 minutes from commencement of the exercise or rest regimen.

Eligibility
Key inclusion criteria
14 to 18 years old inclusive
Minimum age
14 Years
Maximum age
18 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Undertaking at least 5 hours of exercise or sports training per week on a regular basis.
Pre-existing injuries or mental or physical condition that would preclude their ability to do the required exercise.

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
The study was advertised at a local secondary school and on campus for volunteers. Those interested are provided with a patient information sheet and consent form. If under 16 years of age, parent consent forms and participant assent forms are completed. Baseline measures will be done after enrolment and before allocation of randomisation (of order of regimens). Allocation of randomisation will be by numbered, enclosed, opaque envelopes.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computer-generated random sequence was undertaken by an independent statistician.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



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

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/12/2008
Actual
1/12/2008
Date of last participant enrolment
Anticipated
9/01/2009
Actual
9/01/2009
Date of last data collection
Anticipated
Actual
30/01/2009
Sample size
Target
30
Accrual to date
Final
30
Recruitment outside Australia
Country [1] 1421 0
New Zealand
State/province [1] 1421 0
Auckland

Funding & Sponsors
Funding source category [1] 4220 0
University
Name [1] 4220 0
University of Auckland
Country [1] 4220 0
New Zealand
Primary sponsor type
University
Name
University of Auckland
Address
Private Bag 92019
Auckland
Country
New Zealand
Secondary sponsor category [1] 3794 0
None
Name [1] 3794 0
Address [1] 3794 0
Country [1] 3794 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 6274 0
University of Auckland Human Participants Ethics Committee
Ethics committee address [1] 6274 0
Ethics committee country [1] 6274 0
New Zealand
Date submitted for ethics approval [1] 6274 0
Approval date [1] 6274 0
17/09/2008
Ethics approval number [1] 6274 0
2008/361

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

Contacts
Principal investigator
Name 29178 0
A/Prof Carolyn (Raina) Elley
Address 29178 0
University of Auckland,
Private Bag 92019,
Auckland 1142,
New Zealand
Country 29178 0
New Zealand
Phone 29178 0
+64 9 3737599
Fax 29178 0
Email 29178 0
[email protected]
Contact person for public queries
Name 12335 0
Carolyn (Raina) Elley
Address 12335 0
University of Auckland Private Bag 92019 Auckland 1142,
Country 12335 0
New Zealand
Phone 12335 0
+64 9 3737599
Fax 12335 0
Email 12335 0
[email protected]
Contact person for scientific queries
Name 3263 0
Carolyn (Raina) Elley
Address 3263 0
University of Auckland Private Bag 92019 Auckland 1142,
Country 3263 0
New Zealand
Phone 3263 0
+64 9 3737599
Fax 3263 0
Email 3263 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Summer studentship project only and data no longer available


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.