Physical Activity and Exercise During Early Treatment Phases for Childhood Acute Lymphoblastic Leukaemia to Protect Against Muscle Loss and Improve Frailty Outcomes (PROTECT)

Murdoch Childrens Research Institute

Status: Not yet enrolling

Conditions: Acute Lymphoblastic Leukemia; Sarcopenia

Treatments: Behavioral: Exercise

Study type: Interventional

Funder types: Other

Identifiers

NCT07325305

2025/ETH01569

Details and patient eligibility

About

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.

Full description

This is a pilot randomised controlled trial with a hybrid implementation design. At 5 weeks following an acute lymphoblastic leukaemia diagnosis children/adolescents (5-17 years) will be assessed for frailty using a novel frailty framework, to evaluate their frailty risk and identify those with signs of sarcopenia.

Children with signs of sarcopenia will be randomised to one of two groups:

1. Standard care only, or,
2. Physical activity and strengthening intervention plus activity tracking with a Fitbit (A wearable electronic activity tracker) This study will evaluate if the implementability of this intervention as well as the limited efficacy and investigate the framework for frailty used in this study.

It is known that children undergoing acute treatment for ALL experience signs of frailty from as early as 6 weeks post diagnosis. It is known that physical activity and exercise is safe and effective for children though it is most commonly conducted as a reactive therapy when children have already significantly deteriorated.

Very little is known regarding the pathophysiology that drives sarcopenia in children with cancer and there are no standardised diagnostic criteria, assessment tools or treatments. Often studies limit diagnosis to muscle ultrasound alone, omitting functional assessment. It has been recommended that a standardised criteria incorporating muscle mass (by ultrasound) and functional measurements (such as hand grip strength), should be established. This study aims to create a frailty framework including sarcopenia assessment ("muscle strength" and muscle mass "loss of muscle") as well as "slowness", "poor endurance", "low physical activity" as described in the outcome measurement section. This should contribute to a standardised criteria for sarcopenia as well as a criteria for identifying early signs of frailty with cut-offs.

The intervention aims to prevent frailty for participants with early signs of sarcopenia and currently there are no interventions that target frailty directly in children with cancer nor has frailty been investigated in the acute treatment phases of treatment.

Enrollment: 60 estimated patients

Sex: All

Ages: 5 to 17 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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)

Exclusion criteria

• none

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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60 participants in 3 patient groups

Observation cohort

No Intervention group

Description:

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.

Usual care control group

No Intervention group

Description:

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.

Intervention group

Experimental group

Description:

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.

Treatment:

Behavioral: Exercise