None listed
Conditions
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.
Interventions
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 prescript
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.
Sponsors
Prof Stewart Trost
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Prevention
Masking
Blinded (masking used) (Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
5 Years to 17 Years
Healthy volunteers
No
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.
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.
Outcome results
None listed