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Trial registered on ANZCTR


Registration number
ACTRN12623000125628
Ethics application status
Approved
Date submitted
29/01/2023
Date registered
7/02/2023
Date last updated
7/02/2023
Date data sharing statement initially provided
7/02/2023
Type of registration
Prospectively registered

Titles & IDs
Public title
ExTRA - Exercise Therapy to Reduce Anxiety Pilot Study
Scientific title
ExTRA - Exercise Therapy to Reduce Anxiety - a pilot study to evaluate the feasibility and acceptability of an 8-week web-based self-directed exercise intervention to reduce anxiety in middle-aged and older adults with clinically significant anxiety
Secondary ID [1] 308817 0
None
Universal Trial Number (UTN)
U1111-1287-4376
Trial acronym
ExTRA
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Anxiety 328819 0
Condition category
Condition code
Mental Health 325825 325825 0 0
Anxiety

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
ExTRA will develop and pilot an 8-week self-directed web-based exercise intervention to reduce anxiety in middle-aged and older people with clinically significant anxiety. Participants will undertake the program independently in the community and receive strategies/prompts/encouragement/reminders to their email tailored to activity level measured by a wearable activity monitor (e.g. Fitbit), and rating scale responses – this process will be pre-determined so that it can become an automated or semi-automated
process in future research. It will aim to be cost-effective and scalable to increase access.

Feasibility and acceptability will be investigated with 20-30 participants. It will target mid-life onwards (40-79 years of age) to maximise impact given the higher risk of chronic disease in this age group.

Participants will be orientated to the use of the web-based intervention platform and wearable activity monitor (WAM). The platform will provide education about national physical activity guideline recommendations and provide information resources to assist participants to work towards meeting them; or to maintain or increase beyond if appropriate. The format of the platform includes text, diagrams and links to videos and other useful resource websites. It will also include a dashboard containing their WAM data and links to behaviour change strategies. There will also be templates for goal setting and a weekly planner on the platform. The time involved using the web-based platform is estimated to be around 30 minutes at the beginning of the program and then around 10 minutes per week to be done any time at the participant's discretion.

The physical activity undertaken will generally be 150 minutes of moderate intensity aerobic physical activity, with walking being the default activity, although participants can continue or increase an activity type that they are already engaged in such as cycling, swimming or sport. It will be designed with consumer input, including from within the project team. It will link to evidence-based resources including those developed by the team for previous intervention studies such as EXCEL (registration number ACTRN12621001152819).

Participants will receive tailored behaviour change strategies, prompts, encouragement and reminders to participants via email and the platform. Tailored strategies will be based on both PA level through WAM data integration with the platform and participant responses to measures including the barriers self-efficacy scale. These emails will be 1-2 short paragraphs including a summary of their WAM data as well as links to selected strategies and will be sent once per week. The strategies used in the program will be informed by previous qualitative research findings led by the research team. Acceptability and usability is being measured via number of log ins and pages clicked which will provide indirect data about fidelity of the intervention.
Intervention code [1] 325293 0
Lifestyle
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 333668 0
Acceptability and usability measured by website usage data including number of log ins and pages clicked on the internet platform, online outcome measure completion, and the evaluation questionnaire which is specifically designed for this study.
Timepoint [1] 333668 0
Ongoing measurement from baseline until 8 weeks post intervention commencement; evaluation questionnaire at 8 weeks post intervention commencement.
Primary outcome [2] 333669 0
Feasibility measured by screening, recruitment and retention rates. This will be calculated by examining study records, in particular, number of participants who undertake screening for the study, proportion who provide informed consent to participate and proportion of participants who complete the study.
Timepoint [2] 333669 0
Ongoing measurement from baseline until 8 weeks post intervention commencement; retention rate at 8 weeks post intervention commencement.
Primary outcome [3] 333670 0
Anxiety measured by the Depression, Anxiety and Stress Scale (DASS-21)
Timepoint [3] 333670 0
Baseline and Week 8 (primary timepoint) post intervention commencement
Secondary outcome [1] 417889 0
Primary outcome: Physical activity (PA) level measured by wearable activity monitor (WAM) steps/day
Timepoint [1] 417889 0
Baseline, Weeks 1-8 (primary timepoint) post intervention commencement
Secondary outcome [2] 417890 0
Primary outcome: Global Physical Activity Questionnaire (GPAQ WHO)
Timepoint [2] 417890 0
Baseline, Weeks 4 and 8 (primary timepoint) post intervention commencement
Secondary outcome [3] 417891 0
Adapted exercise self-efficacy scale (EXSE)
Timepoint [3] 417891 0
Baseline, Weeks 4 and 8 post intervention commencement
Secondary outcome [4] 417892 0
Adapted exercise barrier self-efficacy scale (BARSE)
Timepoint [4] 417892 0
Baseline, Weeks 1-8 post intervention commencement
Secondary outcome [5] 417893 0
Depression measured by the DASS-21
Timepoint [5] 417893 0
Baseline and Week 8 post intervention commencement
Secondary outcome [6] 417989 0
Stress measured by the DASS-21
Timepoint [6] 417989 0
Baseline and Week 8 post intervention commencement
Secondary outcome [7] 417990 0
Dementia risk measured by the ANU-Alzheimer’s Disease Risk Index Short Form (ANU-ADRI-SF)
Timepoint [7] 417990 0
Baseline, Week 8 post intervention commencement

Eligibility
Key inclusion criteria
Community dwelling adults aged 40-79 years with clinically significant anxiety, defined by a Depression, Anxiety and Stress Scale (DASS-21) anxiety score >7.
Participants need to have capacity to consent, internet/email/ZOOM access and ability to safely undertake an unsupervised exercise intervention.
Minimum age
40 Years
Maximum age
79 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Exclusions include a significant medical condition(s) that precludes participation in the exercise intervention, insufficient English literacy to complete outcome measures and having another mental health symptom as the focus of their presentation, e.g. psychosis or mania, acute risk such as suicidality. These criteria are intentionally broad given this is a “real world” pragmatic study.

Study design
Purpose of the study
Treatment
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
We will recruit 20-30 participants which is a sample size consistent with recommendations for the design of pilot studies.
Descriptive statistics will be used to describe the demographic and outcome measures collected. Acceptability and feasibility measures will be presented using descriptive statistics and free text responses reported as qualitative data. Paired t-tests will be used to compare pre and post levels of anxiety, physical activity, self-efficacy, depression, stress and dementia risk. Non-parametric tests will be used where data is not normally distributed. Preliminary estimates of effect sizes will be calculated using Cohen’s d which will inform power calculations for future RCTs. Alpha will be set at 0.05 and the Bonferroni correction used where applicable.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/03/2023
Actual
Date of last participant enrolment
Anticipated
31/08/2023
Actual
Date of last data collection
Anticipated
30/11/2023
Actual
Sample size
Target
30
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC

Funding & Sponsors
Funding source category [1] 313036 0
University
Name [1] 313036 0
The University of Melbourne
Country [1] 313036 0
Australia
Primary sponsor type
University
Name
The University of Melbourne
Address
Grattan Street, Parkville,
Victoria, 3010, Australia
Country
Australia
Secondary sponsor category [1] 314724 0
None
Name [1] 314724 0
Address [1] 314724 0
Country [1] 314724 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 312293 0
The University of Melbourne Human Ethics STEMM 2 Ethics Committee
Ethics committee address [1] 312293 0
Ethics committee country [1] 312293 0
Australia
Date submitted for ethics approval [1] 312293 0
Approval date [1] 312293 0
17/01/2023
Ethics approval number [1] 312293 0
2022-25560-35490-3

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

Contacts
Principal investigator
Name 124138 0
Prof Nicola Lautenschlager
Address 124138 0
Melbourne Medical School
The University of Melbourne,
Grattan Street, Parkville,
Victoria, 3010, Australia
Country 124138 0
Australia
Phone 124138 0
+61 3 8344 8049
Fax 124138 0
Email 124138 0
nicolatl@unimelb.edu.au
Contact person for public queries
Name 124139 0
Terence Chong
Address 124139 0
Academic Unit for Psychiatry of Old Age,
The University of Melbourne,
283 Cotham Road, Kew,
Victoria, 3101, Australia
Country 124139 0
Australia
Phone 124139 0
+61 3 9231 8485
Fax 124139 0
Email 124139 0
extra-project@unimelb.edu.au
Contact person for scientific queries
Name 124140 0
Terence Chong
Address 124140 0
Academic Unit for Psychiatry of Old Age,
The University of Melbourne,
283 Cotham Road, Kew,
Victoria, 3101, Australia
Country 124140 0
Australia
Phone 124140 0
+61 3 9231 8485
Fax 124140 0
Email 124140 0
extra-project@unimelb.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.