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NCT Number: NCT07325305

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

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.

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Key information

Conditions

Sarcopenia Acute Lymphoblastic Leukemia Atrophy Behavior Hematologic Diseases Hemic and Lymphatic Diseases Immune System Diseases Immunoproliferative Disorders Leukemia Leukemia, Lymphoid Lymphatic Diseases Lymphoproliferative Disorders Motor Activity Muscular Atrophy Neoplasms Neoplasms by Histologic Type Nervous System Diseases Neurologic Manifestations Neuromuscular Manifestations Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Precursor Cell Lymphoblastic Leukemia-Lymphoma Signs and Symptoms

Age range

5 year–17 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Royal Children's Hospital

Melbourne, Victoria, 3052, Australia

Location status: Recruiting

Location contact

Ella Thorburn, Bachelor of Physiotherapy(hon)

CONTACT

[email protected]

+61415066889

Sarah Grimshaw, PhD Physiotherapy

CONTACT

[email protected]

+61417162166

Sarah Grimshaw, PhD Physiotherapy

PRINCIPAL_INVESTIGATOR

About this study

This is a pilot randomised controlled trial with a hybrid implementation design. In this pilot study, we are exploring a range of outcome measures to assess feasibility, acceptability, and preliminary variability. Data from these measures will inform the selection of the most appropriate primary and secondary outcomes, and estimate sample size for a future definitive trial. 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, there is optional consent for participants to have their blood samples biobanked for future studies. There are no standardised diagnostic criteria, assessment tools or treatments for sarcopenia or frailty. Often studies limit diagnosis to imaging modalities alone, omitting functional assessment. We will use a standardised criteria incorporating muscle mass and functional measurements (such as hand grip strength). This study aims to explore factor that contribute the frailty including sarcopenia assessment ("muscle strength" and muscle mass "loss of muscle") as well as "slowness", "poor endurance", "low physical activity" The intervention aims to reduce the risk of 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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Exercise

Behavioral

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 (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.

Other names: physical activity, behaviour change, wearable device

Primary outcomes

  1. Mean change in muscle mass of rectus femoris on muscle ultrasound

    Time frame: Baseline, 16 weeks

    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.

  2. Mean change in grip strength with handheld dynamometry

    Time frame: 5 weeks, 16 weeks

    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.

  3. Mean change in knee extension strength on handheld dynamometry

    Time frame: 5 weeks, 16 weeks

    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.

  4. Mean change in lean muscle mass on Dual-Energy X-ray Absorptiometry (DEXA) scan

    Time frame: 5 weeks and 24 weeks

    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.

  5. Qualitative acceptability

    Time frame: 16 weeks

    Measured by a semi-structured interview designed with Theoretical Domains Framework (TDF) and TFA theory

  6. Fidelity of the intervention

    Time frame: Post-randomisation through to the final intervention session [anticipated at 15 weeks]

    Measured using the National Institutes of Health Behavior Change Consortium (NIH BCC) framework for fidelity of delivery, receipt and enactment.

  7. Feasibility of the trial measured by recruitment rate

    Time frame: through study recruitment completion, approximately 15 months

    Number of participants recruited compared with those given the study brief, and reasons for refusal.

  8. Feasibility of the trial measured by lost recruitment opportunities

    Time frame: through study recruitment completion, approximately 15 months

    the number of participants screened by the research team compared to number of eligible children admitted to ward across the study period.

  9. Feasibility of the intervention measured by the attrition rate

    Time frame: through study completion, approximately 17 months

    Rate and reasons for attrition of participants from the trial

  10. Trial safety is measured by the frequency and severity of recorded adverse events related to the trial

    Time frame: through study completion, approximately 17 months

    Adverse events will be assessed using the Common Terminology Criteria for Adverse Events (CTCAE) version 3.0

  11. Feasibility of assessments is measured by the number of completed assessments

    Time frame: Through study completion, approximately 17 months

    Percentage of data recorded for each individual outcome measure compared to the number of planned outcome measures, and reasons for non-completed data.

Secondary outcomes

  1. Acceptability measured by Theoretical Framework of Acceptability (TFA) survey

    Time frame: Baseline, mid intervention (4-7 weeks), 16 weeks (post intervention)

    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.

  2. Satisfaction of participants during the intervention

    Time frame: Post-randomisation through to the final intervention session [anticipated at 15 weeks]

    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'.

  3. Mean change in Lumbar spine bone mineral density measured by DEXA

    Time frame: 5 weeks and 24 weeks

    Change over time to Lumbar spine bone mineral density on DEXA scan

  4. Mean change of appendicular lean muscle mass on DEXA

    Time frame: 5 weeks and 24 weeks

    Change over time to appendicular lean mass measured by DEXA.

  5. Mean change in hip bone mineral density measured by DEXA

    Time frame: 5 weeks and 24 weeks

    Change over time to hip bone mineral density measured by DEXA.

  6. Mean change in grip strength with handheld dynamometry

    Time frame: 5 weeks, 16 weeks and 24 weeks

    Grip strength assessed with handheld dynamometry at post-induction (pre-intervention), compared to pre-delayed intensification (post-intervention), and post-delayed intensification

  7. Mean change in knee extension strength with handheld dynamometry

    Time frame: 5 weeks, 16 weeks and 24 weeks

    Knee extension strength assessed with handheld dynamometry at post-induction (pre-intervention), compared to pre-delayed intensification (post-intervention), and post-delayed intensification

  8. Mean change in tibialis anterior strength with handheld dynamometry

    Time frame: 5 weeks, 16 weeks and 24 weeks

    Tibialis anterior strength assessed with handheld dynamometry at post-induction (pre-intervention), compared to pre-delayed intensification (post-intervention), and post-delayed intensification

  9. Mean change in rectus femoris muscle measured on muscle ultrasound

    Time frame: Baseline, 5 weeks, 16 weeks, 24 weeks

    Muscle changes measured on ultrasound via the cross-sectional area, thickness and echogenicity of rectus femoris at enrolment/diagnosis compared with post-induction (pre-intervention) and pre delayed intensification (post-intervention), and post-delayed intensification.

  10. Mean change in tibialis anterior muscle measured on muscle ultrasound

    Time frame: Baseline, 5 weeks, 16 weeks, 24 weeks

    Muscle changes measured on ultrasound via the cross-sectional area, thickness and echogenicity of tibialis anterior at enrolment/diagnosis compared with post-induction (pre-intervention) and pre delayed intensification (post-intervention), and post-delayed intensification.

  11. Mean change in vastus lateralis muscle measured on muscle ultrasound

    Time frame: Baseline, 5 weeks, 16 weeks, 24 weeks

    Muscle changes measured on ultrasound via the thickness, pennation angle, fascicle length, and echogenicity of vastus lateralis at enrolment/diagnosis compared with ultrasound at enrolment/diagnosis compared with post-induction (pre-intervention) and pre delayed intensification (post-intervention), and post-delayed intensification.

  12. Mean change in steps per day

    Time frame: 5 weeks, 16 weeks, 24 weeks

    Measured using the Fitbit Inspire 3 for a 7 day period at post-induction (pre-intervention), compared to pre-delayed intensification (post-intervention), and post-delayed intensification.

  13. Mean change in sedentary time per day

    Time frame: 5 weeks, 16 weeks, 24 weeks

    Measured using the Fitbit Inspire 3 for a 7 day period at post-induction (pre-intervention), compared to pre-delayed intensification (post-intervention), and post-delayed intensification.

  14. Mean change in malnutrition measured by Malnutrition Score

    Time frame: 5 weeks, 16 weeks and 24 weeks

    The Malnutrition Score identifies the presence and severity of malnutrition based on changes in age-related z scores for BMI.

  15. Mean change in lower limb power evaluated by Jump Forward

    Time frame: 5 weeks, 16 weeks and 24 weeks

    Long jump measures the furthest horizontal distance (cm) jumped from a standing start. The assessment will be completed in line with standardised procedures.

  16. Mean change in lower limb endurance as measured by the 30 second chair stand

    Time frame: 5 weeks, 16 weeks and 24 weeks

    Lower limb endurance is measured by the number of stands (established as full hip and knee extension) achieved in 30 seconds. The assessment will be completed in line with the standardised procedures. Change will be measured over time.

  17. Mean change in upper limb endurance as measured by the 30 second timed push ups

    Time frame: 5 weeks, 16 weeks and 24 weeks

    Upper limb endurance is measured by the number of knee push ups a participant can complete in 30 seconds. This assessment will be carried out in-line with the standardised sub-section of the Bruininks-Oseretsky Test of Motor Proficiency, 2nd Edition (BOT-2).

  18. mean change in mobility as assessed by the 10 meter walk run test

    Time frame: 5 weeks, 16 weeks and 24 weeks

    Mobility is assessed using the 10-meter walk/run test (10MWRT). This is a timed test that measures walking or running speed over a 10m distance. It's used to assess mobility, gait, and balance. The assessment will be completed in line with the standardised procedures.

  19. Mean change in mobility endurance evaluated by the 100-meter Timed Test (100mTT)

    Time frame: 5 weeks, 16 weeks, 24 weeks

    Mobility endurance is assessed using the 100mTT. This is a timed test that measures walking or running speed over a 100m distance. It's used to assess mobility, gait, and balance. The assessment will be completed in line with the standardised procedures.

  20. Mean change for ability to climb stairs as measured by the Timed Up and Down Stairs (TUDS)

    Time frame: 5 weeks, 16 weeks and 24 weeks

    Ability to climb stairs will be measured using the TUDS conducted on a set of 13 stairs with handrails. The time taken to walk up the stairs, turn around, and walk back down as quickly as possible was recorded. The assessment will be completed in line with the standardised procedures.

  21. Mean change in ability to rise from the floor as measured by the Time Rise from Floor - quality assessment (TRF)

    Time frame: 5 weeks, 16 weeks and 24 weeks

    Ability to rise from floor is measured by the TRF which starts in supine and the participant rises from the floor. A graded quality assessment is conducted. The test will be conducted in line with standardised procedures.

  22. Mean change in ability to rise from the floor and walk 6m and sit back down evaluated by the Timed Floor To Stand - Natural (TFTS-N)

    Time frame: 5 weeks, 16 weeks, 24 weeks

    TFTS-N is a timed test conducted from sitting to standing, walking around a cone placed 3m away, and returning to sitting. The test will be conducted in line with standardised procedures.

  23. Mean change in endurance as evaluated by the 6-Minute Walk Test (6MWT)

    Time frame: 5 weeks, 16 weeks and 24 weeks

    Measured by the total distance (m) walked in 6 minutes. The assessment will be completed in line with standardised procedures. Assessed at post-induction (pre-intervention), compared to pre-delayed intensification (post-intervention), and post-delayed intensification

  24. Mean change in chemotherapy-induced peripheral neuropathy as measured by the Paediatric modified Total Neuropathy Score (Ped m-TNS)

    Time frame: 5 weeks, 16 weeks and 24 weeks

    Chemotherapy-induced peripheral neuropathy will be assessed using the Ped m-TNS. This is a standardised assessment that combines subjective and objective components, yielding a score indicating the severity of neuropathy. Assessment will be carried out in accordance with standard procedures. Assessed at post-induction (pre-intervention), compared to pre-delayed intensification (post-intervention), and post-delayed intensification.

  25. Mean change in subjective physical activity evaluated by the Patient-Reported Outcomes Measurement Information System (PROMIS)-Physical Activity questionnaire

    Time frame: 5 weeks, 16 weeks and 24 weeks

    PROMIS is a set of person-centred measures that evaluates and monitors physical, mental, and social health in children. The PROMIS measures several health domains. Each domain takes ~ 3 min to complete. Within PROTECT, we will use the parent proxy (age 5-17) and the Paediatric (age 8-17) questionnaires. Assessed at post-induction (pre-intervention), compared to pre-delayed intensification (post-intervention), and post-delayed intensification.

  26. Mean change in subjective sarcopenia measured via the Ped-SARC-F (Paediatric, Strength, Assistance with walking, Rising from a chair, Climbing stairs, and Falls): subjective sarcopenia questionnaire

    Time frame: 5 weeks, 16 weeks and 24 weeks

    The PED-SARC-F is a screening tool used to identify sarcopenia in pediatric patients, particularly those undergoing haemato-oncology treatment. The PED-SARC-F is a child-specific version of the standard SARC-F questionnaire used to assess sarcopenia in adults.

  27. Mean change in subjective fatigue evaluated by the PROMIS-Fatigue module questionnaire

    Time frame: 5 weeks, 16 weeks, 24 weeks

    PROMIS is a set of person-centred measures that evaluates and monitors physical, mental, and social health in children. The PROMIS measures across several health domains. Each domain takes ~ 3 min to complete. Within PROTECT we will use the parent proxy (age 5-17) and Pediatric (age 8-17

  28. Mean change in subjective pain experience evaluated by the PROMIS-pain interference and behaviour module questionnaire

    Time frame: 5 weeks, 16 weeks and 24 weeks

    PROMIS is a set of person-centred measures that evaluates and monitors physical, mental, and social health in children. The PROMIS measures across several health domains. Each domain takes ~ 3 min to complete. Within PROTECT we will use the parent proxy (age 5-17) and Pediatric (age 8-17

  29. Mean change in subjective sleep impairment evaluated by the PROMIS-sleep disturbance and impairment module questionnaire

    Time frame: 5 weeks, 16 weeks and 24 weeks

    PROMIS is a set of person-centred measures that evaluates and monitors physical, mental, and social health in children. The PROMIS measures across several health domains. Each domain takes ~ 3 min to complete. Within PROTECT we will use the parent proxy (age 5-17) and Pediatric (age 8-17

  30. Mean change in subjective strength evaluated by the PROMIS-Strength impact questionnaire

    Time frame: 5 weeks, 16 weeks, 24 weeks

    PROMIS is a set of person-centred measures that evaluates and monitors physical, mental, and social health in children. The PROMIS measures across several health domains. Each domain takes ~ 3 min to complete. Within PROTECT we will use the parent proxy (age 5-17) and Pediatric (age 8-17

  31. Mean change in subjective stress evaluated by the PROMIS-psychological stress questionnaire

    Time frame: 5 weeks, 16 weeks and 24 weeks

    PROMIS is a set of person-centred measures that evaluates and monitors physical, mental, and social health in children. The PROMIS measures across several health domains. Each domain takes ~ 3 min to complete. Within PROTECT we will use the parent proxy (age 5-17) and Pediatric (age 8-17

  32. Mean change in subjective upper limb function evaluated by the PROMIS-Upper Limb Function questionnaire

    Time frame: 5 weeks, 16 weeks and 24 weeks

    PROMIS is a set of person-centred measures that evaluates and monitors physical, mental, and social health in children. The PROMIS measures several health domains. Each domain takes ~ 3 min to complete. Within PROTECT, we will use the parent proxy (age 5-17) and the Paediatric (age 8-17) questionnaires. Assessed at post-induction (pre-intervention), compared to pre-delayed intensification (post-intervention), and post-delayed intensification.

Study contacts

Contact information is provided by the study sponsor or research team.

Ella Thorburn, Bachelor of Physiotherapy(hon)

CONTACT

[email protected]

+61415066889

Sarah Grimshaw, PhD Physiotherapy

CONTACT

[email protected]

+61417162166

Sponsors and collaborators

Lead sponsor

Murdoch Childrens Research Institute

Other

Registry information

Official study title

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

Acronym: PROTECT

Important dates

Study start
2026
Primary completion
2028
Study completion
2028
First posted
Jan 8, 2026
Registry last updated
Jul 6, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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