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The PROTECT Trial Physical Activity and Exercise During Early Treatment for Children With Acute Lymphoblastic Leukaemia to Protect Against Sarcopenia and Improve Frailty Outcomes: a Pilot Randomised Controlled Trial

Status: Recruiting
Location: See location...
Intervention Type: Behavioral
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

This is a small trial testing out a new approach before doing a bigger study. Researchers are observing a group of children/adolescents (ages 5-17) with acute lymphoblastic leukemia (ALL) and testing a physical activity and exercise program on a group of them who after 5 weeks of treatment show signs of weakness or frailty. Kids who are NOT losing muscle aren't part of the exercise trial - they're just monitored over time to see how they do. The goal: To see if an exercise program helps kids who are getting weaker from acute lymphoblastic leukemia treatment build back/maintain their strength, compared to kids who don't do the extra intervention. The study will also look at if this way of measuring muscle weakness works well for kids with cancer.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 5
Maximum Age: 17
Healthy Volunteers: f
View:

• Aged 5-17 years at the time of consent

• New diagnosis of acute lymphoblastic leukaemia \<7 days

• Is planned to receive management for their cancer treatment at the trial site for the duration of the trial period

• Has a legally acceptable representative capable of understanding the informed consent document in English and providing consent on the participant's behalf

• Have a family electronic device that can be linked with the tool to be used (Fitbit)

Locations
Other Locations
Australia
Royal Children's Hospital
RECRUITING
Melbourne
Contact Information
Primary
Sarah Grimshaw, PhD Physiotherapy
sarah.grimshaw@mcri.edu.au
+61417162166
Backup
Ella Thorburn, Bachelor of Physiotherapy(hon)
ella.thorburn@student.unimelb.edu.au
+61415066889
Time Frame
Start Date: 2026-02-24
Estimated Completion Date: 2028-10
Participants
Target number of participants: 60
Treatments
No_intervention: Observation cohort
These participants did not have early signs of sarcopenia at the post induction therapy assessment point, but will be followed up at all timepoints to better understand the natural progression of acute lymphoblastic leukaemia.~Usual care is a ward based physiotherapist service which is reactive and referral based only.
No_intervention: Usual care control group
These participants demonstrated early signs of sarcopenia at the post induction phase of treatment assessment point and were randomised to the control group. Usual care is a ward based physiotherapist service which is reactive and referral based only.
Experimental: Intervention group
These participants demonstrated early signs of sarcopenia at the post induction phase of treatment assessment point and were randomised to the intervention group. The intervention group receives 9 weeks of goal setting and physical activity behaviour change coaching, as well as concurrently receiving 8 weeks of structured exercise sessions weekly (45-60 minutes per session x 3/week). These sessions are individualised based on the participant's functional performance outcomes from the assessment prior to randomisation, with a resistance strength training and progressive overload principles. The delivery of the specific exercises will be based on a pragmatic, participation based focus and will incorporate the individual's development stage, age, interests and enjoyment.
Sponsors
Leads: Murdoch Childrens Research Institute

This content was sourced from clinicaltrials.gov

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