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.
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
none
Parallel
Exercise
BehavioralThese 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 (with activity tracking via Fitbit for continuous feedback) as well as concurrent 8 weeks of 3x45-60 minute structured exercise sessions weekly. These are individualised based on their 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 individuals development stage, age, interests and enjoyment.
Mean change in muscle mass of rectus femoris on muscle ultrasound
Muscle mass is measured via ultrasound by cross-sectional area and thickness of rectus femoris at enrolment/diagnosis compared with pre-delayed intensification (post-intervention). This will be used to determine the sample size required for a future randomised controlled trial.
Mean change in grip strength with handheld dynamometry
Grip strength is measured by handheld dynamometry at post-induction (pre-intervention) compared with pre-delayed intensification (post-intervention). This will be used to determine the sample size required for a future randomised controlled trial.
Mean change in knee extension strength on handheld dynamometry
Knee extension strength is measured by using handheld dynamometry at post-induction (pre-intervention) and pre-delayed intensification (post-intervention). This will be used to determine the sample size required for a future randomised controlled trial.
Mean change in lean muscle mass on Dual-Energy X-ray Absorptiometry (DEXA) scan
Quantity of lean muscle mass as measured on DEXA scan. This will be used to determine the sample size required for a future randomised controlled trial.
Acceptability measured by Theoretical Framework of Acceptability (TFA) survey
The TFA is a generic survey specifically altered for the PROTECT study with 9 questions scoring 1-5. A score of 36 or higher is considered acceptable.
Satisfaction of participants during the intervention
Using a Smiley face likert scale (5-point scale) of enjoyment, the children will be asked to rate their satisfaction following the completion of the intervention. A score of 4 or more is considered 'enjoyed'.
Mean change in Lumbar spine bone mineral density measured by DEXA
Change over time to Lumbar spine bone mineral density on DEXA scan
Mean change of appendicular lean muscle mass on DEXA
Change over time to appendicular lean mass measured by DEXA.
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