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Trial registered on ANZCTR


Registration number
ACTRN12619000841178
Ethics application status
Approved
Date submitted
23/05/2019
Date registered
12/06/2019
Date last updated
1/08/2019
Date data sharing statement initially provided
12/06/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Effects of exercise in childhood brain cancer survivors
Scientific title
Effects of a goal-directed therapeutic exercise program in paediatric survivors of childhood posterior fossa brain tumours: a randomised controlled trial
Secondary ID [1] 298246 0
CCABCR010
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Childhood brain cancer (childhood posterior fossa brain tumours) 312951 0
Condition category
Condition code
Cancer 311438 311438 0 0
Brain
Physical Medicine / Rehabilitation 311439 311439 0 0
Physiotherapy
Physical Medicine / Rehabilitation 311440 311440 0 0
Other physical medicine / rehabilitation

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Brief name: Goal-directed therapeutic exercise program

Study treatments:
Arm 1 = Exercise intervention: participants will receive one weekly 30-60 minute individualised, goal-directed therapeutic exercise session for 12 weeks, delivered face-to-face by a trained exercise physiologist or physiotherapist at the research facility, and an accompanying parent-led, home exercise program to be completed for 30 minutes three times per week. The intervention will be based on accepted exercise prescription guidelines for children and adolescents, with the aim of one hour of physical activity most days and three strengthening sessions per week, and comprise of a combination of moderate intensity physical exercise training (aerobic capacity, muscle strength or functional performance) as well as goal-directed task specific practice. Examples of exercise prescribed in the therapeutic exercise session and in the home exercise program include: bike riding, ball games, skipping and sport-specific skills such as soccer or netball. The intervention will be tailored according to participant age, e.g. game-based activities for younger children, and may include peers or siblings to promote adherence to the home-based component. Adherence to the intervention will be assessed by the physiotherapist or exercise physiologist who will complete a study logbook to record details about the exercises prescribed and the exercises completed.
Intervention code [1] 314547 0
Rehabilitation
Intervention code [2] 314548 0
Lifestyle
Intervention code [3] 314549 0
Behaviour
Comparator / control treatment
Participants randomised to the control group will receive care as usual. Care as usual includes any therapies (for example, occupational therapy and physiotherapy) usually provided by the public or private services and visits to their treating medical practitioner.
Control group
Active

Outcomes
Primary outcome [1] 320158 0
Cardiorespiratory fitness (VO2 peak) as assessed by an electronically-braked paediatric cycle ergometer
Timepoint [1] 320158 0
All primary outcomes are assessed at baseline, 12 weeks after intervention commencement (primary time point), 6 months following the 12 week assessment, and at 12-months following the 12 week intervention
Primary outcome [2] 320159 0
Submaximal endurance using the Modified Shuttle Test (MST)
Timepoint [2] 320159 0
All primary outcomes are assessed at baseline, 12 weeks after intervention commencement (primary time point), 6 months following the 12 week assessment, and at 12-months following the 12 week intervention
Primary outcome [3] 320160 0
Goal attainment using the Canadian Occupational Performance Measure (COPM)
Timepoint [3] 320160 0
All primary outcomes are assessed at baseline, 12 weeks after intervention commencement (primary time point), 6 months following the 12 week assessment, and at 12-months following the 12 week intervention.
Secondary outcome [1] 370739 0
Muscle strength as assessed by the 30-second repetition maximum of functional strength exercises (sit-to-stand, lateral step-up and half-kneel to stand)
Timepoint [1] 370739 0
All secondary outcomes are assessed at baseline, 12 weeks after intervention commencement, 6 months following the 12 week assessment, and at 12-months following the 12 week intervention
Secondary outcome [2] 370740 0
Cognitive ability as assessed by the Cognitive Assessment System 2nd Edition
Timepoint [2] 370740 0
All secondary outcomes are assessed at baseline, 12 weeks after intervention commencement, 6 months following the 12 week assessment, and at 12-months following the 12 week intervention.
Secondary outcome [3] 370741 0
High-level mobility skills as assessed by the High-level Mobility Assessment Tool (HiMAT)
Timepoint [3] 370741 0
All secondary outcomes are assessed at baseline, 12 weeks after intervention commencement, 6 months following the 12 week assessment, and at 12-months following the 12 week intervention.
Secondary outcome [4] 370742 0
Fatigue as assessed by the Paediatric Quality of Life Inventory (PedsQL) Multidimensional Fatigue Scale
Timepoint [4] 370742 0
All secondary outcomes are assessed at baseline, 12 weeks after intervention commencement, 6 months following the 12 week assessment, and at 12-months following the 12 week intervention.
Secondary outcome [5] 370743 0
Quality of life as assessed by the Paediatric Quality of Life Inventory (PedsQL) Generic Core Scales and Brain Tumor Module
Timepoint [5] 370743 0
All secondary outcomes are assessed at baseline, 12 weeks after intervention commencement, 6 months following the 12 week assessment, and at 12-months following the 12 week intervention.
Secondary outcome [6] 370744 0
Habitual Physical Activity: daily moderate-to-vigorous physical activity (MVPA) will be objectively measured using the ActiGraph GT3X+ accelerometer
Timepoint [6] 370744 0
All secondary outcomes are assessed at baseline, 12 weeks after intervention commencement, 6 months following the 12 week assessment, and at 12-months following the 12 week intervention.
Secondary outcome [7] 370745 0
Participation as assessed by the Participation and Environment Measure for children and youth (PEM-CY)
Timepoint [7] 370745 0
All secondary outcomes are assessed at baseline, 12 weeks after intervention commencement, 6 months following the 12 week assessment, and at 12-months following the 12 week intervention.

Eligibility
Key inclusion criteria
Eligibility criteria: (1) Children (5 to 17 years); (2) diagnosis of a PFBT that required surgery at least 12 months earlier, with no maximum time since surgery as long as the participant meets the age eligibility criterion; (3) no chemotherapy or radiation therapy received in the last 6 months; (4) no evidence of progressive disease; and (5) medically able to complete an exercise program.
Minimum age
5 Years
Maximum age
17 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Exclusion criteria: (1) insufficient English to complete study assessments or participate in the exercise intervention; (2) the study is not suitable as assessed by the treating oncologist; (3) concurrent medical condition that would prohibit exercise testing or may jeopardise the ability of the patient to undergo the exercise intervention with reasonable safety; (4) participants is unable to travel to research facility for intervention sessions and there are no participating physiotherapists in their local area who can deliver the intervention or to the research facility to complete study assessments.

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)
Yes. Allocation involved contacting the holder of the allocation schedule who was “off-site” or at central administration site.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Permuted block randomisation.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint(s)
Efficacy
Statistical methods / analysis
To detect the clinically important between-group differences of 5 ml/kg/min for peak VO2 with 80% power, a sample of 20 participants per group is required (N=40). This calculation assumes a two-tailed alpha level of 0.05 and standard deviations of 5.5 ml/kg/min for peak VO2. To offset a projected attrition rate of up to 20%, we will recruit and enrol 24 participants per group, providing an overall sample size of N=48.

Analyses will follow standard principles for RCTs using 2 group comparisons including all participants on an intention-to-treat basis. Between-group differences on the primary and secondary study outcomes will be tested immediately post intervention, 6-month follow-up, and 12-month follow-up using linear regression with treatment group (exercise vs. usual care control) as the main effect and baseline measures of the respective outcome, along with other potential confounders (e.g., age, sex), as covariates.

Characteristics of those with missing data (drop outs) and those with complete data as well as group allocation and reason for drop out will be assessed to determine whether data are missing completely at random (MCAR), missing at random (MAR) or missing not at random (MNAR). Depending on the mechanism of missing data (MCAR, MAR, MNAR) an appropriate analytic choice will be made (e.g. completers analysis, multiple imputation or selection models) taking into consideration both bias and preservation of variance.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 13818 0
Queensland Children's Hospital - South Brisbane
Recruitment postcode(s) [1] 26571 0
4101 - South Brisbane

Funding & Sponsors
Funding source category [1] 302788 0
Charities/Societies/Foundations
Name [1] 302788 0
Children's Hospital Foundation
Address [1] 302788 0
PO Box 8009 Woolloongabba, QLD 4102
Country [1] 302788 0
Australia
Primary sponsor type
Individual
Name
Prof Stewart Trost
Address
Queensland University of Technology. Level 6, 62 Graham Street, South Brisbane QLD 4101,
Country
Australia
Secondary sponsor category [1] 302808 0
None
Name [1] 302808 0
Address [1] 302808 0
Country [1] 302808 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 303380 0
Children’s Health Queensland Hospital and Health Service – Children’s Health Queensland Hospital and Health Service Human Research Ethics Committee
Ethics committee address [1] 303380 0
Human Research Ethics Committee Centre for Children’s Health Research
Queensland Children’s Hospital Precinct
Level 7, 62 Graham Street
South Brisbane QLD 4101
Ethics committee country [1] 303380 0
Australia
Date submitted for ethics approval [1] 303380 0
07/06/2019
Approval date [1] 303380 0
25/07/2019
Ethics approval number [1] 303380 0
HREC/19/QCHQ/50464

Summary
Brief summary
This randomised control trial will evaluate the immediate and long terms impacts of a 12 week exercise program in pediatric survivors of childhood posterior fossa brain tumours (PFBTs)

Who is it for?
The study is for children aged between 5 to 17 years with a diagnosis of a PFBT that required surgery at least 12 months earlier.

Study details
Participants will be randomly assigned to either the intervention or the control group. All participants in the intervention group will be required to attend a research facility once a week for a 30-60 minute individualized, goal-directed exercise session for 12 weeks. The study will also involve a parent-led, home exercise program to be completed for 30 minutes, 3 times per week. The control will receive standard care.

Participants will be assessed on immediate (at 12 weeks) and long-term (at 6 month and 12 month follow-up) effects on their cardiorespiratory fitness, goal attainment, muscular strength, habitual physical activity, and quality of life.

If found to be effective, the therapeutic exercise program may improve the quality of survivorship, and will have strong potential for translation to clinical practice and paediatric rehabilitation services.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 93470 0
Prof Stewart Trost
Address 93470 0
Queensland University of Technology. Level 6, 62 Graham Street, South Brisbane QLD 4101,
Country 93470 0
Australia
Phone 93470 0
+61 7 3069 7301
Fax 93470 0
Email 93470 0
s.trost@qut.edu.au
Contact person for public queries
Name 93471 0
Prof Stewart Trost
Address 93471 0
Queensland University of Technology. Level 6, 62 Graham Street, South Brisbane QLD 4101,
Country 93471 0
Australia
Phone 93471 0
+61 7 3069 7301
Fax 93471 0
Email 93471 0
s.trost@qut.edu.au
Contact person for scientific queries
Name 93472 0
Prof Stewart Trost
Address 93472 0
Queensland University of Technology. Level 6, 62 Graham Street, South Brisbane QLD 4101,
Country 93472 0
Australia
Phone 93472 0
+61 7 3069 7301
Fax 93472 0
Email 93472 0
s.trost@qut.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?
Researchers will be able to contact the Principle Investigator for access to data. Data will be maintained in a csv format to enable open re-use of the data. Data available will be all of the individual participant data collected during the trial, after de-identification.
When will data be available (start and end dates)?
Immediately following main results publication; no end date determined.
Available to whom?
Case-by-case basis at the discretion of Principle Investigator
Available for what types of analyses?
Any purpose
How or where can data be obtained?
Access subject to approvals by Principal Investigator
What supporting documents are/will be available?
No other documents available
Summary results
No Results