Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12623001118695
Ethics application status
Approved
Date submitted
31/08/2023
Date registered
27/10/2023
Date last updated
6/07/2024
Date data sharing statement initially provided
27/10/2023
Type of registration
Prospectively registered

Titles & IDs
Public title
The feasibility and preliminary effectiveness of exercise therapy in transdiagnostic mental health services.
Scientific title
The feasibility and preliminary effectiveness of exercise therapy in transdiagnostic mental health services.
Secondary ID [1] 310520 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Severe mental illness 331331 0
Psychotic Disorders 331636 0
Bipolar Disorders 331637 0
Personality Disorders 331639 0
Anxiety Disorders 331640 0
Depressive Disorders 331641 0
Psychosis 331642 0
Condition category
Condition code
Mental Health 328084 328084 0 0
Schizophrenia
Mental Health 328085 328085 0 0
Psychosis and personality disorders
Mental Health 328086 328086 0 0
Anxiety
Mental Health 328087 328087 0 0
Depression

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Two distinct types of supported exercise therapy will be evaluated within a transdiagnostic mental health service, low-support, and high-support exercise therapy. Both arms of this research trial consist of 12-weeks of active exercise therapy (intervention) with each arm containing different styles and components of therapy (e.g., face-to-face instructed exercise sessions, or self-directed home exercise programs). Following the 12-week supported intervention, participants in both arms will complete a 12-week maintenance period where they are encouraged to be independently active to meet Australian physical activity recommendations (Department of Health and Aged Care, 2021).

Within Fremantle Hospital Mental Health Service (FHMHS) an Exercise Physiology team currently provide tailored exercise services for inpatient and community consumers as part of standard care. All community consumers referred to Exercise Physiology undertake an initial assessment covering pre-exercise risk screening, and determination of baseline characteristics (e.g., physical health, psychosocial outcomes, health behaviours, and quality of life) as part of standard care. If the consumer meets the participant inclusion criteria, they will be invited to participate in the research trial and if accepting, informed consent will be obtained, The consumer will then be allocated to either treatment arm through a pre-determined allocation method. A secondary consultation will be conducted to conclude any additional assessments required, provide health and activity recommendations, inform of the exercise intervention plan, and provide instructions for either arm of the intervention. The allocation method within this research trial is a pragmatic allocation, representing current practice within this transdiagnostic mental health hospital exercise therapy service. Allocation into either intervention arm will be determined based on participants individual circumstances and preferences, guided by clinical discretion. The allocation method used in this research trial is from a client focused perspective, in which there is communication and discussion between the participant and clinician on how best to allocate the participant to the treatment arm that is most suited to them.

Trial arm 1 (low support therapy): The low support exercise intervention will include provision of a home exercise program with additional activity scheduling related to structured physical activity goals. The home exercise programs, and activity scheduling will be individually tailored by Accredited Exercise Physiologists and prescribed based on the initial assessment, participant goals, participant preferences, resources available, and physical capacity.

The prescribed home-based exercise programs will be individually tailored and pragmatic in nature but will consist of strength-based major muscle group exercises including free-weight and body weight exercises, and cardiovascular exercise such as outdoor walking, outdoor cycling, or stationary exercise depending on the participants access to equipment.

The goal of the home-based exercise program will be for participants to complete a minimum of 150 minutes of moderate intensity exercise per week, incorporating components of muscle strength and cardiovascular exercise as per Australian public health recommendations (Department of Health and Aged Care, 2021). To meet recommendations participants will be supplied with an individually tailored, multimodal exercise program, that will consist of a minimum 150 minutes of exercise per week, split across 5 sessions of 30 minutes duration. Three of these sessions per week will be completion of a strength-based exercise program, with the other 2 sessions being completion of 30 minutes of cardiovascular exercise. Despite the planned 2 cardiovascular exercise sessions per week, for best practice, participant centred care, the total 60 minutes of total cardiovascular exercise can be separated throughout the week into bouts of a minimum of 10 minutes in discussion with the Exercise Physiologist (e.g., 20 minutes of cardiovascular exercise 3 times per week). The programs will be individualised and progressive, so participants will be provided programs that aligns with their current activity levels and capabilities. For example, they may commence with shorter, more frequent bouts of exercise (e.g., 5 x 10 minutes of cardiovascular exercise such as outdoor walking and 3 x 10 minutes of their strength programs per week); however, this will be progressively increased to meet the 150-minute target at the conclusion of the initial 4 weeks.

Participants will be instructed to record instances of exercise program completion, including time, type, repetitions or distance, and intensity (e.g., load, rating of perceived exertion) on a provided paper-based exercise program and participant tracking sheet. The planned exercise volume during this intervention arm if participants were to commence at 150 minutes per week in the initial week is 1800 minutes; however, this is unlikely for all participants. From week 5 until the end of the 12-week intervention, the participants will be aiming to complete 150 minutes of exercise per week and as such should complete a minimum of 1200 minutes in this time. There are no minimum exercise sessions planned as this will be altered per participant; however, if participants complete 3 x strength sessions and 2 x cardiovascular sessions per week there is an expected 60 instances of exercise within this intervention arm.

During the 12-week intervention period, every two weeks a research team member will contact the participant via telephone, email, or SMS (depending on participant preference) to check-in, discuss their progress and challenges, and provide any increase or alterations to their exercise program. During check-in’s, exercise and activity planning is likely to be adjusted in discussion with the participant due to anticipated improvements in exercise capacity and tolerance, or to adjust for any periods of health decline. A written copy of any changes to exercise programs will be given post check in, either via SMS, email, mail, or face-to-face based on participant preference. Each week of a scheduled contact, the research team member will attempt to contact the participant a maximum of three times, if there is no response or contact from the participant after three attempts, that week will be deemed as concluded and marked as unable to contact, with the researcher to contact in the next scheduled contact week. All attempts to contact and the replies from participants will be recorded by staff on duplicates of the exercise programs and tracking sheets retained by staff, with brief text detailing the outcome of each contact.

Trial arm 2 (high support therapy): As part of the Exercise Physiology department standard practice, group exercise sessions are provided for consumers at an on-site gymnasium, and an off-site community gym, with participants in the high support intervention being enrolled in these groups. Participants will attend 3 supported exercise sessions per week at either the on-site or off-site gym, with all sessions supervised by Accredited Exercise Physiologists from FHMHS or the research team.

The high-support participants will be provided an individually tailored, pragmatic exercise program, supervised by Accredited Exercise Physiologists during access to an exercise facility. The exercise programs will be prescribed based on the results of initial assessment, participant goals, participant preferences, and physical capacity. In conjunction with the individualised nature and participant goals of the exercise therapy, the goal of the supported exercise program will be to increase participants weekly exercise level towards public health guidelines of a minimum of 150 minutes of moderate intensity physical activity and incorporate components of resistance and cardiovascular exercise (Department of Health and Aged Care, 2021).
To meet these recommendations, the 12-week exercise intervention will consist of 3 times weekly gym attendance of 50-minutes of exercise per session, with completion of a multimodal (resistance and cardiovascular) exercise program. Participants will have the option of session attendance across five days of the working week (Monday through Friday), with suggestion for practicality for participants to attend any 3 days of their choosing.

As in the low support arm, participants may commence with shorter bouts; however, this will progress so that at the conclusion of the initial 4 weeks participants are attending for 3, 50-minute sessions. The planned physical activity volume is 1800 minutes from week 1 to week 12; however, from week 5 until the end of the 12-week intervention, the participants are expected to be complete a minimum of 1200 minutes of physical activity. There will be 36 sessions in total over the course of 12 weeks in the event of 100% attendance.

The programs will be individually tailored, progressive and pragmatic in nature, with participants prescribed a program considering their current activity levels, capabilities, preference, and daily presentation. The intervention will have the goal of consisting of 30 minutes of moderate intensity resistance exercise (i.e., major muscle groups including free-weight and machine equipment), and 20 minutes of moderate intensity cardiovascular exercise per session (e.g., stationary exercise cycling, ski ergometer, arm ergometer).
As an additional component available in the high-support intervention, heart rate will be measured during cardiovascular exercises to examine the accuracy of the participants perceived exertion; however, this will not be able to be implemented in the low support exercise therapy.

Participants will be instructed to record instances of exercise program completion, including time, type, repetitions or distance, and intensity (e.g., load, heart rate, rating of perceived exertion) with support from Exercise Physiology staff on a provided paper-based exercise program and participant tracking sheet.

Participants in both intervention arms will be given physical activity recommendations to be active on most days of the week and reduce time spent sedentary in line with physical activity recommendations (Department of Health and Aged Care, 2021), in addition to their prescribed exercise programs.

For both intervention arms, the specific exercise and session intensity will be ascertained using a 10-point visual analogue scale of rating of perceived exertion, with moderate intensity being defined as between 5-7 on a 10-point scale. Perceived exertion in the high support exercise intervention will be determined at the conclusion of each session with assistance from staff to monitor session intensity, while also during exercise sessions to determine specific exercise intensity and loads. In the low-support exercise intervention rating of perceived exertion will also be recorded per exercise and per session; however, will be participant recorded. Loads for all exercises will increase through progressive overload principles (Kent, 2006), with increases of load per exercise and per session as exercise capacity increases and perceived exertion decreases, to ensure participants are continually completing moderate intensity exercise. Participants will be provided education on the use of the Rating of Perceived Exertion scale at baseline.

Participants in both intervention arms will be given a participant workbook that includes information, examples, and graphics on general physical activity recommendations, rating of perceived exertion, rating of breathlessness, exercise and muscle soreness, exercise and hydration, and general dietary guidelines for improving diet quality, created in line with Australian health recommendations and available research evidence.

Post-intervention and at follow-up the participants will be invited to partake in semi-structured interviews to discuss their experiences, perceptions, and beliefs of the exercise intervention, with no negative consequences for participants if they decline invitation to these interviews.
Intervention code [1] 326915 0
Lifestyle
Intervention code [2] 326916 0
Rehabilitation
Comparator / control treatment
There is no active control group for this research trial as the study design is that of a two-arm hybrid implementation-effectiveness trial, with effectiveness outcomes based on individual difference (e.g., pre-post, magnitude of change). For examination of effectiveness measures (e.g., clinical outcomes), a historical control will be utilised based on previous data collected as part of standard practice monitoring of mental health consumers physical health.

Historical controls will be identified through Digital Medical Records, with historical controls being selected based on matching of age, sex, and psychiatric diagnoses of participants within the two-arm intervention trial.

Historical consumer data may only be utilised if they satisfy the same participant requirements as the intervention arms and have been managed by the mental health service between 2018 and 2023 for a minimum of 27 ± 2 weeks (in line with intervention and follow-up periods). As the historical controls will be matched to intervention participants, the historical control data will not be recruited until at least the first intervention participant has concluded their intervention.

Additional to comparison of effects to the historical control, between group comparisons will be made for the two interventions in relation to the intervention effectiveness measures, with the low support group being considered the comparator arm for between group comparisons.
Control group
Historical

Outcomes
Primary outcome [1] 335950 0
Feasibility of recruitment and retention assessed using study data on recruitment, drop out, withdrawal, and lost to follow-up status (composite outcomes).
Timepoint [1] 335950 0
At all time points within the 27 week study:
Intake assessment, during the intervention, post 12-week intervention assessment (study week 14), during follow-up period, post 12-week follow-up (study week 27).
Primary outcome [2] 336336 0
Feasibility of adherence assessed by examining exercise session completion status at the end of the intervention period (e.g., completed 20 of a possible 36 exercise session)
Timepoint [2] 336336 0
Post 12-week intervention assessment (study week 14)
Primary outcome [3] 336337 0
Feasibility of compliance to the exercise intervention assessed by examining study data of reported exercise completion within sessions, rating of perceived exertion of sessions and exercises, duration of sessions (composite outcomes)
Timepoint [3] 336337 0
Post 12-week intervention assessment (study week 14)
Secondary outcome [1] 426246 0
PRIMARY OUTCOME.
Qualitative feasibility outcomes assessed through semi-structured interviews. Participant reported experiences of intervention, perceptions of intervention, exercise motivations (composite outcomes)
Timepoint [1] 426246 0
Semi-structured interviews, 2 time points:
Post 12 week intervention
Post 12 week follow-up period
Secondary outcome [2] 427323 0
Seated blood pressure assessed using digital sphygmomanometer.
Timepoint [2] 427323 0
Intervention Midpoint (study week 7)
Post 12-week intervention (study week 14)
Post 12-week follow-up (study week 27)
Secondary outcome [3] 427324 0
Seated heart rate assessed using digital sphygmomanometer.
Timepoint [3] 427324 0
Intervention Midpoint (study week 7)
Post 12-week intervention (study week 14)
Post 12-week follow-up (study week 27)
Secondary outcome [4] 427325 0
Blood glucose level assessed using fasting blood glucose test.
Timepoint [4] 427325 0
Post 12-week intervention (study week 14)
Post 12-week follow-up (study week 27)
Secondary outcome [5] 427326 0
Total cholesterol assessed using serum assay.
Timepoint [5] 427326 0
Post 12-week intervention (study week 14)
Post 12-week follow-up (study week 27)
Secondary outcome [6] 427327 0
High-density lipoprotein level assessed using serum assay.
Timepoint [6] 427327 0
Post 12-week intervention (study week 14)
Post 12-week follow-up (study week 27)
Secondary outcome [7] 427328 0
Low-density lipoprotein level assessed using serum assay.
Timepoint [7] 427328 0
Post 12-week intervention (study week 14)
Post 12-week follow-up (study week 27)
Secondary outcome [8] 427329 0
Triglyceride level assessed using serum assay.
Timepoint [8] 427329 0
Post 12-week intervention (study week 14)
Post 12-week follow-up (study week 27)
Secondary outcome [9] 427330 0
Body Weight assessed using digital weight scale.
Timepoint [9] 427330 0
Intervention Midpoint (study week 7)
Post 12-week intervention (study week 14)
Post 12-week follow-up (study week 27)
Secondary outcome [10] 427331 0
Body mass index calculated by dividing total body weight (kg's) by height (metres) squared.
Timepoint [10] 427331 0
Intervention Midpoint (study week 7)
Post 12-week intervention (study week 14)
Post 12-week follow-up (study week 27)
Secondary outcome [11] 427332 0
Waist circumference assessed using a tape measure.
Timepoint [11] 427332 0
Intervention Midpoint (study week 7)
Post 12-week intervention (study week 14)
Post 12-week follow-up (study week 27)
Secondary outcome [12] 427333 0
Leg muscle endurance assessed using maximum duration wall sit test time.
Timepoint [12] 427333 0
Intervention Midpoint (study week 7)
Post 12-week intervention (study week 14)
Post 12-week follow-up (study week 27)
Secondary outcome [13] 427334 0
Total muscle endurance assessed using maximum duration plank test time.
Timepoint [13] 427334 0
Intervention Midpoint (study week 7)
Post 12-week intervention (study week 14)
Post 12-week follow-up (study week 27)
Secondary outcome [14] 427896 0
Total muscle strength assessed using maximum push-up test.
Timepoint [14] 427896 0
Intervention Midpoint (study week 7)
Post 12-week intervention (study week 14)
Post 12-week follow-up (study week 27)
Secondary outcome [15] 427897 0
Cardiorespiratory fitness: Predicted Volume of Maximal Oxygen Consumption assessed using a submaximal graded exercise test.
Timepoint [15] 427897 0
Intervention Midpoint (study week 7)
Post 12-week intervention (study week 14)
Post 12-week follow-up (study week 27)
Secondary outcome [16] 427898 0
Lower limb physical function assessed using the thirty second sit-to-stand test.
Timepoint [16] 427898 0
Intervention Midpoint (study week 7)
Post 12-week intervention (study week 14)
Post 12-week follow-up (study week 27)
Secondary outcome [17] 427899 0
General physical function assessed using the timed up and go
Timepoint [17] 427899 0
Intervention Midpoint (study week 7)
Post 12-week intervention (study week 14)
Post 12-week follow-up (study week 27)
Secondary outcome [18] 427900 0
Single leg balance assessed using a maximum duration single leg stand test.
Timepoint [18] 427900 0
Intervention Midpoint (study week 7)
Post 12-week intervention (study week 14)
Post 12-week follow-up (study week 27)
Secondary outcome [19] 427901 0
Tobacco smoking status assessed by screening the participant on self-reported tobacco smoking status.
Timepoint [19] 427901 0
Intervention Midpoint (study week 7)
Post 12-week intervention (study week 14)
Post 12-week follow-up (study week 27)
Secondary outcome [20] 427902 0
Tobacco smoking amount assessed by the participants self-reported total number of cigarettes consumed per day.
Timepoint [20] 427902 0
Intervention Midpoint (study week 7)
Post 12-week intervention (study week 14)
Post 12-week follow-up (study week 27)
Secondary outcome [21] 427903 0
Alcohol use and behaviours assessed using the 10-item Alcohol Use Disorders Identification Test (AUDIT). (composite outcomes)
Timepoint [21] 427903 0
Intervention Midpoint (study week 7)
Post 12-week intervention (study week 14)
Post 12-week follow-up (study week 27)
Secondary outcome [22] 427904 0
Exercise Confidence, Attitudes and Beliefs assessed using a novel 19-item questionnaire created by the research team, that is used to examine participants exercise self-efficacy and attitudes and beliefs towards exercise. (composite outcomes)
Timepoint [22] 427904 0
Intervention Midpoint (study week 7)
Post 12-week intervention (study week 14)
Post 12-week follow-up (study week 27)
Secondary outcome [23] 427905 0
Physical activity level assessed using the Simple Physical Activity Questionnaire.
Timepoint [23] 427905 0
Intervention Midpoint (study week 7)
Post 12-week intervention (study week 14)
Post 12-week follow-up (study week 27)
Secondary outcome [24] 427906 0
Sedentary Time assessed using the Simple Physical Activity Questionnaire.
Timepoint [24] 427906 0
Intervention Midpoint (study week 7)
Post 12-week intervention (study week 14)
Post 12-week follow-up (study week 27)
Secondary outcome [25] 427907 0
Sleep assessed using the Simple Physical Activity Questionnaire.
Timepoint [25] 427907 0
Intervention Midpoint (study week 7)
Post 12-week intervention (study week 14)
Post 12-week follow-up (study week 27)
Secondary outcome [26] 427908 0
Diet Quality - Healthy score assessed using a 16-item novel questionnaire created by the research team adapted from previous surveys in mental health and diet used in Australia. Part 1, the Healthy Diet Score contains 7 items enquiring as to healthy diet habits related to healthy food and drink consumption.
Timepoint [26] 427908 0
Intervention Midpoint (study week 7)
Post 12-week intervention (study week 14)
Post 12-week follow-up (study week 27)
Secondary outcome [27] 427909 0
Diet Quality - Unhealthy score assessed using a 16-item novel questionnaire created by the research team adapted from previous surveys in mental health and diet used in Australia. Part 1, the Healthy Diet Score contains 9 items enquiring to unhealthy diet habits related to unhealthy food and drink consumption.
Timepoint [27] 427909 0
Intervention Midpoint (study week 7)
Post 12-week intervention (study week 14)
Post 12-week follow-up (study week 27)
Secondary outcome [28] 427910 0
Quality of life assessed using the 35-item Assessment of Quality of Life - Eight Dimensions survey that examines Quality of Life related to Independent Living, Relationships, Mental Health, Coping, Pain, Senses, Self-Worth, and Happiness. (composite outcomes)
Timepoint [28] 427910 0
Intervention Midpoint (study week 7)
Post 12-week intervention (study week 14)
Post 12-week follow-up (study week 27)

Eligibility
Key inclusion criteria
Adult (18-65) mental health consumers, engaged with an outpatient, hospital mental health team and referred to exercise services.
Diagnosed with at least one mental health disorder (e.g., psychotic, bipolar, personality, depressive, or anxiety disorder) and be deemed to have sufficient capacity to provide informed consent.
Minimum age
18 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Exclusion criteria includes any circumstances that may impact on capacity to provide informed consent, when increasing physical activity does not align with treatment goals, or in which the exercise interventions are a safety risk for participants, including:
• a substantial cognitive disorder/deficit (consent),
• an involuntary community treatment order (consent),
• compulsive exercise behaviours (treatment goals),
• a diagnosis of a feeding or eating disorder (treatment goals),
• unstable or untreated cardiovascular disease (safety), or
• physical disability that will limit safety in exercise participation (safety).

Informal exercise history will not impact a consumer’s recruitment into this study; however, participants will be excluded if they have had a previous successful engagement with the community Exercise Physiology program provided at the mental health services within the previous 12 months (success defined by an engagement of a minimum 12-weeks with successful exercise discharge plan).

Participants will be excluded from participation in this trial if they have any reported history, or any clinical indication of compulsive exercise behaviours, or feeding-and eating disorders, as the goals of exercise therapy for these participants are different to the goals of exercise therapies provided in this research trial. These two exclusion criteria will be determined by information obtained from the participant referrer and intake assessment.

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
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis
Statistical analyses to be conducted on implementation outcomes includes reporting mean, medians, and modes where appropriate (e.g., reported minutes of physical activity, number of drop out, and number lost to follow up), and reporting on demographic information with comparisons made between either intervention arm.

Effectiveness outcomes will be examined by utilising one-way analysis of variance on change scores, and analysis of covariance to determine the impacts of the interventions on participant health data. Additional to analysis of the effect of the individual interventions, between group comparisons will be made between intervention styles using Cohen’s D effect sizes.

Qualitative interviews will be analysed using a reflexive thematic methodology, allowing for description and coding of themes related to participant perceptions of the exercise interventions. An exploratory, inductive thematic analysis will be utilised for the purpose of understanding the participant perceptions and allowing themes to be created based on their own insight, rather than being guided by a pre-established theory of the participants expected perceptions. Through analysis of transcription data meaning units will be identified and recorded, within an overarching theme structure, with the research team employing a “critical friends” approach to validate and challenge the thematic structure to finalise outcomes.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
14/03/2024
Actual
29/04/2024
Date of last participant enrolment
Anticipated
14/03/2025
Actual
Date of last data collection
Anticipated
30/06/2025
Actual
Sample size
Target
50
Accrual to date
7
Final
Recruitment in Australia
Recruitment state(s)
WA
Recruitment hospital [1] 25479 0
Fremantle Hospital and Health Service - Fremantle
Recruitment postcode(s) [1] 41291 0
6160 - Fremantle

Funding & Sponsors
Funding source category [1] 314724 0
University
Name [1] 314724 0
The University of Western Australia
Country [1] 314724 0
Australia
Funding source category [2] 314927 0
Hospital
Name [2] 314927 0
Fremantle Hospital Mental Health Service
Country [2] 314927 0
Australia
Primary sponsor type
University
Name
The University of Western Australia
Address
35 Stirling Highway, Crawley 6009, Western Australia,
Country
Australia
Secondary sponsor category [1] 316696 0
None
Name [1] 316696 0
Address [1] 316696 0
Country [1] 316696 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 313734 0
South Metropolitan Health Service Human Research Ethics Committee
Ethics committee address [1] 313734 0
Ethics committee country [1] 313734 0
Australia
Date submitted for ethics approval [1] 313734 0
27/09/2023
Approval date [1] 313734 0
14/12/2023
Ethics approval number [1] 313734 0

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

Contacts
Principal investigator
Name 129178 0
A/Prof Bonnie Furzer
Address 129178 0
The University of Western Australia, 35 Stirling Highway, Crawley 6009, Western Australia
Country 129178 0
Australia
Phone 129178 0
+61 08 6488 3510
Fax 129178 0
Email 129178 0
[email protected]
Contact person for public queries
Name 129179 0
Caleb McMahen
Address 129179 0
The University of Western Australia, 35 Stirling Highway, Crawley 6009, Western Australia
Country 129179 0
Australia
Phone 129179 0
+61 08 6488 3510
Fax 129179 0
Email 129179 0
[email protected]
Contact person for scientific queries
Name 129180 0
Caleb McMahen
Address 129180 0
The University of Western Australia, 35 Stirling Highway, Crawley 6009, Western Australia
Country 129180 0
Australia
Phone 129180 0
+61 08 6488 3510
Fax 129180 0
Email 129180 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?

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20206Study protocol    The study protocol will be available via publicati... [More Details]



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