Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12621000672853
Ethics application status
Approved
Date submitted
19/04/2021
Date registered
2/06/2021
Date last updated
2/06/2021
Date data sharing statement initially provided
2/06/2021
Type of registration
Retrospectively registered

Titles & IDs
Public title
Feasibility and impact of a school-based exercise program on stress in older adolescents: The ‘STress Reactivity after Exercise in Senior Secondary EDucation’ (STRESSED) pilot randomized controlled trial
Scientific title
Feasibility and impact of a school-based exercise program on stress in older adolescents: The ‘STress Reactivity after Exercise in Senior Secondary EDucation’ (STRESSED) pilot randomized controlled trial
Secondary ID [1] 300821 0
Nil known
Universal Trial Number (UTN)
Trial acronym
STRESSED
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Stress reactivity (cortisol) 316708 0
Perceived stress 322041 0
Psychological distress 322042 0
Condition category
Condition code
Mental Health 314951 314951 0 0
Studies of normal psychology, cognitive function and behaviour
Public Health 314958 314958 0 0
Health promotion/education

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The aim of the STRESSED study is to examine chronic effects of physical activity on stress reactivity. Participants allocated to one of the intervention groups will engage in 2 x 30 minute school-based exercise sessions per week over the 6-week study period. Exercise sessions will be delivered by an external fitness instructor at the study school. The exercise sessions will not disrupt scheduled academic lessons and will therefore be offered mornings before school, during recess or lunch time, or afternoons after class. Participants will be randomised to a non-exercise/usual care control condition, or one of the following exercise interventions:

(i) Light-intensity physical activity: Participants randomly allocated to this group will engage in light-intensity exercises (e.g., walking, stretching activities), corresponding to < 60% of age-predicted maximum heart-rate

(ii) Moderate-to-vigorous intensity physical activity: Participants randomly allocated to this group will engage in Moderate-to-vigorous intensity exercises (e.g., group-based fitness activities, including aerobic [running on the spot] and body weight resistance [push-ups, squats] exercises), corresponding to 65-90% of age-predicted maximum heart rate

Session attendance will be captured using an attendance log completed at the commencement of each session by the instructor.
Intervention code [1] 317155 0
Lifestyle
Comparator / control treatment
Usual practice control: Participants randomly allocated to this group will not engage in any school-based exercise, and will be asked to continue with their usual physical activity during the study period
Control group
Active

Outcomes
Primary outcome [1] 323268 0
Stress-reactivity to acute psychosocial stress will be assessed by analysis of salivary cortisol following completion of the Socially Evaluated Cold-Pressor Task (baseline) and Trier Social Stress Test (posttest). These two tests are different, but evaluate the same underlying physiological mechanism (i.e., activation of the HPA-axis in response to a stressor), and the outcome measure is the same (acute cortisol reactivity). Different tests are used, as novelty is a key attribute that supports the efficacy of these tests to induce a stress-response making repeated measures with the same test problematic
Timepoint [1] 323268 0
Baseline, 6-weeks post baseline assessments
Secondary outcome [1] 381360 0
Perceived stress will be assessed by the Perceived Stress Scale
Timepoint [1] 381360 0
Baseline, 6-weeks post baseline assessments
Secondary outcome [2] 381364 0
Cardiorespiratory fitness will be assessed using the Progressive Aerobic Cardiovascular Endurance Run (laps)
Timepoint [2] 381364 0
Baseline, 6-weeks post baseline assessments
Secondary outcome [3] 381366 0
Upper body muscular endurance will be measured by a timed push-up test
Timepoint [3] 381366 0
Baseline, 6-weeks post baseline assessments
Secondary outcome [4] 381367 0
Psychological distress will be assessed using the K-10 Psychological Distress Scale.
Timepoint [4] 381367 0
Baseline, 6-weeks post baseline assessments
Secondary outcome [5] 395980 0
Lower body muscular power will be assessed by the standing broad jump test.
Timepoint [5] 395980 0
Baseline, 6-weeks post-baseline assessments

Eligibility
Key inclusion criteria
Study participants must be in Grade 11 at the study school.
Minimum age
15 Years
Maximum age
18 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Unable to participate in physical activity

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)
Participants will be aware of each other's intervention condition allocation, as concealing this information is not feasible in an exercise trial conducted within a school setting (at one school).

Therefore, allocation is not concealed.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Following baseline assessments, participants will be stratified by psychological distress (pres-screening questionnaire) and sex, and randomised at the individual-level to one of three experimental conditions: (i) CG: no-exercise control, (ii) EG1: light-intensity exercise (i.e., walking/stretching group), (iii) EG2: moderate-to-vigorous intensity exercise (i.e., fitness activities).
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis
All analyses will be conducted using SPSS Version 24, and will use an alpha level of .05. Descriptive statistics (mean and standard deviation, and proportions) will be calculated to evaluate program feasibility. Intervention effects for cortisol reactivity will be assessed using linear mixed models. Mixed models will assess the effect of group (control, EG1, EG2), time (baseline, post-test), and the group-by-time interaction. The potential moderating effect of sex will also be explored by including an interaction term. Given this is a pilot trial and may therefore be insufficiently powered to detect significant intervention effects, Cohen’s d effect sizes will also be calculated. Mediation analyses will be conducted using the SPSS PROCESS macro, with cardio-respiratory and muscular fitness treated as potential mediators.

Recruitment
Recruitment status
Active, not recruiting
Date of first participant enrolment
Anticipated
Actual
19/04/2021
Date of last participant enrolment
Anticipated
Actual
30/04/2021
Date of last data collection
Anticipated
25/06/2021
Actual
Sample size
Target
60
Accrual to date
Final
37
Recruitment in Australia
Recruitment state(s)
NSW

Funding & Sponsors
Funding source category [1] 305279 0
Other Collaborative groups
Name [1] 305279 0
Hunter Medical Research Institute
Country [1] 305279 0
Australia
Primary sponsor type
Individual
Name
Jordan Smith
Address
University of Newcastle, Health and Physical Education Building, HPE 312, University Drive, Callaghan, NSW, 2308
Country
Australia
Secondary sponsor category [1] 305639 0
None
Name [1] 305639 0
Address [1] 305639 0
Country [1] 305639 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 305619 0
University of Newcastle Human Research Ethics Committee
Ethics committee address [1] 305619 0
Ethics committee country [1] 305619 0
Australia
Date submitted for ethics approval [1] 305619 0
Approval date [1] 305619 0
23/07/2020
Ethics approval number [1] 305619 0
H-2019-0410

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

Contacts
Principal investigator
Name 100982 0
Dr Jordan Smith
Address 100982 0
University of Newcastle, Health and Physical Education Building, HPE 312, University Drive, Callaghan, NSW, 2308
Country 100982 0
Australia
Phone 100982 0
+61 2 49217704
Fax 100982 0
Email 100982 0
[email protected]
Contact person for public queries
Name 100983 0
Jordan Smith
Address 100983 0
University of Newcastle, Health and Physical Education Building, HPE 312, University Drive, Callaghan, NSW, 2308
Country 100983 0
Australia
Phone 100983 0
+61 2 49217704
Fax 100983 0
Email 100983 0
[email protected]
Contact person for scientific queries
Name 100984 0
Jordan Smith
Address 100984 0
University of Newcastle, Health and Physical Education Building, HPE 312, University Drive, Callaghan, NSW, 2308
Country 100984 0
Australia
Phone 100984 0
+61 2 49217704
Fax 100984 0
Email 100984 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


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.