SarcopeniaPROTECTNCT07325305
Physical Activity and Exercise During Early Treatment Phases for Childhood Acute Lymphoblastic Leukaemia to Protect Against Muscle Loss and Improve Frailty Outcomes
A study testing Exercise in people with Sarcopenia and Acute Lymphoblastic Leukemia, run by Murdoch Childrens Research Institute at 1 site in Australia.
Trial 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… Read more about this study
- Who is it for?
- Ages 5 to 17 years
- Conditions the study is for
- Sarcopenia, Acute Lymphoblastic Leukemia
- What is being tested?
- Exercise
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteAustralia
- Study dates
- 24 Feb 2026to Oct 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 5 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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)
Who cannot join
- none
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Ella Thorburn, Bachelor of Physiotherapy(hon) contact
Australia1 site, 1 recruiting
- Recruiting
Royal Children's Hospital
Melbourne, Victoria, 3052
Sarah Grimshaw, PhD Physiotherapy, +61417162166, sarah.grimshaw@mcri.edu.au
Ella Thorburn, Bachelor of Physiotherapy(hon), +61415066889, ella.thorburn@student.unimelb.edu.au
About this study
Official 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
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.
Read more
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.
Read the detailed description
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.
- Conditions
- Sarcopenia, Acute Lymphoblastic Leukemia
- Being tested
- Exercise
- Keywords
- exercise, physical activity, behaviour change, paediatrics
- Medical subject headings
- Sarcopenia, Precursor Cell Lymphoblastic Leukemia-Lymphoma, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ExerciseBehavioural
Also called physical activity, behaviour change, wearable device
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.
| Study group | Role | What they receive |
|---|---|---|
| Observation cohort | No intervention | 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 | 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 | 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 (~40 minute sessions 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. A second component will be delivered throughout the trial via staff driven solutions which address commonly identifed environmental and organisational barriers to physical activity for children throughout the trial. Receives: Behavioral: Exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline, 16 weeks
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.
Measured: 5 weeks, 16 weeks
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.
Measured: 5 weeks, 16 weeks
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.
Measured: 5 weeks and 24 weeks
Qualitative acceptability
Measured by a semi-structured interview designed with Theoretical Domains Framework (TDF) and TFA theory
Measured: 16 weeks
Fidelity of the intervention
Measured using the National Institutes of Health Behavior Change Consortium (NIH BCC) framework for fidelity of delivery, receipt and enactment.
Measured: Post-randomisation through to the final intervention session [anticipated at 15 weeks]
Feasibility of the trial measured by recruitment rate
Number of participants recruited compared with those given the study brief, and reasons for refusal.
Measured: through study recruitment completion, approximately 15 months
Feasibility of the trial measured by lost recruitment opportunities
the number of participants screened by the research team compared to number of eligible children admitted to ward across the study period.
Measured: through study recruitment completion, approximately 15 months
Feasibility of the intervention measured by the attrition rate
Rate and reasons for attrition of participants from the trial
Measured: through study completion, approximately 17 months
Trial safety is measured by the frequency and severity of recorded adverse events related to the trial
Adverse events will be assessed using the Common Terminology Criteria for Adverse Events (CTCAE) version 3.0
Measured: through study completion, approximately 17 months
Feasibility of assessments is measured by the number of completed assessments
Percentage of data recorded for each individual outcome measure compared to the number of planned outcome measures, and reasons for non-completed data.
Measured: Through study completion, approximately 17 months
Secondary outcomes (32)
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.
Measured: Baseline, mid intervention (4-7 weeks), 16 weeks (post intervention)
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'.
Measured: Post-randomisation through to the final intervention session [anticipated at 15 weeks]
Mean change in Lumbar spine bone mineral density measured by DEXA
Change over time to Lumbar spine bone mineral density on DEXA scan
Measured: 5 weeks and 24 weeks
Mean change of appendicular lean muscle mass on DEXA
Change over time to appendicular lean mass measured by DEXA.
Measured: 5 weeks and 24 weeks
Mean change in hip bone mineral density measured by DEXA
Change over time to hip bone mineral density measured by DEXA.
Measured: 5 weeks and 24 weeks
Mean change in grip strength with handheld dynamometry
Grip strength assessed with handheld dynamometry at post-induction (pre-intervention), compared to pre-delayed intensification (post-intervention), and post-delayed intensification
Measured: 5 weeks, 16 weeks and 24 weeks
Mean change in knee extension strength with handheld dynamometry
Knee extension strength assessed with handheld dynamometry at post-induction (pre-intervention), compared to pre-delayed intensification (post-intervention), and post-delayed intensification
Measured: 5 weeks, 16 weeks and 24 weeks
Mean change in tibialis anterior strength with handheld dynamometry
Tibialis anterior strength assessed with handheld dynamometry at post-induction (pre-intervention), compared to pre-delayed intensification (post-intervention), and post-delayed intensification
Measured: 5 weeks, 16 weeks and 24 weeks
Mean change in rectus femoris muscle measured on muscle ultrasound
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.
Measured: Baseline, 5 weeks, 16 weeks, 24 weeks
Mean change in tibialis anterior muscle measured on muscle ultrasound
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.
Measured: Baseline, 5 weeks, 16 weeks, 24 weeks
Mean change in vastus lateralis muscle measured on muscle ultrasound
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.
Measured: Baseline, 5 weeks, 16 weeks, 24 weeks
Mean change in steps per day
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.
Measured: 5 weeks, 16 weeks, 24 weeks
Mean change in sedentary time per day
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.
Measured: 5 weeks, 16 weeks, 24 weeks
Mean change in malnutrition measured by Malnutrition Score
The Malnutrition Score identifies the presence and severity of malnutrition based on changes in age-related z scores for BMI.
Measured: 5 weeks, 16 weeks and 24 weeks
Mean change in lower limb power evaluated by Jump Forward
Long jump measures the furthest horizontal distance (cm) jumped from a standing start. The assessment will be completed in line with standardised procedures.
Measured: 5 weeks, 16 weeks and 24 weeks
Mean change in lower limb endurance as measured by the 30 second chair stand
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.
Measured: 5 weeks, 16 weeks and 24 weeks
Mean change in upper limb endurance as measured by the 30 second timed push ups
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).
Measured: 5 weeks, 16 weeks and 24 weeks
mean change in mobility as assessed by the 10 meter walk run test
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.
Measured: 5 weeks, 16 weeks and 24 weeks
Mean change in mobility endurance evaluated by the 100-meter Timed Test (100mTT)
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.
Measured: 5 weeks, 16 weeks, 24 weeks
Mean change for ability to climb stairs as measured by the Timed Up and Down Stairs (TUDS)
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.
Measured: 5 weeks, 16 weeks and 24 weeks
Mean change in ability to rise from the floor as measured by the Time Rise from Floor - quality assessment (TRF)
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.
Measured: 5 weeks, 16 weeks and 24 weeks
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)
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.
Measured: 5 weeks, 16 weeks, 24 weeks
Mean change in endurance as evaluated by the 6-Minute Walk Test (6MWT)
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
Measured: 5 weeks, 16 weeks and 24 weeks
Mean change in chemotherapy-induced peripheral neuropathy as measured by the Paediatric modified Total Neuropathy Score (Ped m-TNS)
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.
Measured: 5 weeks, 16 weeks and 24 weeks
Mean change in subjective physical activity evaluated by the Patient-Reported Outcomes Measurement Information System (PROMIS)-Physical Activity questionnaire
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.
Measured: 5 weeks, 16 weeks and 24 weeks
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
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.
Measured: 5 weeks, 16 weeks and 24 weeks
Mean change in subjective fatigue evaluated by the PROMIS-Fatigue module questionnaire
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
Measured: 5 weeks, 16 weeks, 24 weeks
Mean change in subjective pain experience evaluated by the PROMIS-pain interference and behaviour module questionnaire
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
Measured: 5 weeks, 16 weeks and 24 weeks
Mean change in subjective sleep impairment evaluated by the PROMIS-sleep disturbance and impairment module questionnaire
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
Measured: 5 weeks, 16 weeks and 24 weeks
Mean change in subjective strength evaluated by the PROMIS-Strength impact questionnaire
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
Measured: 5 weeks, 16 weeks, 24 weeks
Mean change in subjective stress evaluated by the PROMIS-psychological stress questionnaire
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
Measured: 5 weeks, 16 weeks and 24 weeks
Mean change in subjective upper limb function evaluated by the PROMIS-Upper Limb Function questionnaire
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.
Measured: 5 weeks, 16 weeks and 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jan 2026
- Study start24 Feb 2026
- Primary completion17 Jul 2028 (estimated)
- Study completionOct 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SarcopeniaStudies of the same condition, open and under way.
- More trials run by Murdoch Childrens Research InstituteThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Cohort observational study with embedded randomised control trial with randomisation 1:1 ratio to intervention and control group for those identified with sarcopenia after induction phase of treatment for acute lymphoblastic leukaemia.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Murdoch Childrens Research Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Rachel Conyers, A/Prof Paediatric Oncologist, Study director, Murdoch Children's Research Institute, Royal Children's Hospital (Melbourne), University of Melbourne
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07325305
- Sponsor's protocol ID
- 2025/ETH01569
- Acronym
- PROTECT
- Status last verified
- Jan 2026
- First submitted
- 18 Dec 2025
- Last updated
- 6 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: There is an optional consent for the data collected to be used in future studies however, there are no data sharing agreements in place and therefore future studies would be using data under the original data agreements and protocols. A protocol publication is planned and will be linked to the registration when it is complete.
Study at a glance
From the registry record, last updated by the sponsor on 6 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT07325305
- Acronym / sponsor ID
- PROTECT / 2025/ETH01569
- Conditions
- Sarcopenia, Acute Lymphoblastic Leukemia
- Keywords
- exercise, physical activity, behaviour change, paediatrics
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Murdoch Childrens Research InstituteUniversity, hospital or other
- Study start
- 24 Feb 2026 (actual)
- Primary completion
- 17 Jul 2028 (estimated)
- Study completion
- Oct 2028 (estimated)
- First posted
- 8 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
- Model description
- Cohort observational study with embedded randomised control trial with randomisation 1:1 ratio to intervention and control group for those identified with sarcopenia after induction phase of treatment for acute lymphoblastic leukaemia.
| Arm | Type | Receives |
|---|---|---|
| Observation cohort | No intervention | –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 | –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 | Behavioral: ExerciseThese 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 (~40 minute sessions 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. A second component will be delivered throughout the trial via staff driven solutions which address commonly identifed environmental and organisational barriers to physical activity for children throughout the trial. |
Who may qualify
- Ages
- 5 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- 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)
Key exclusion criteria (1 listed)
- none
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ExerciseAlso: physical activity, behaviour change, wearable deviceThese 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. | Behavioural | Intervention group |
Primary outcome
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.
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.
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.
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.
Qualitative acceptability
Time frame: 16 weeks
Measured by a semi-structured interview designed with Theoretical Domains Framework (TDF) and TFA theory
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.
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.
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.
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
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
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.
32 secondary outcomes
Acceptability measured by Theoretical Framework of Acceptability (TFA) survey
Time frame: Baseline, mid intervention (4-7 weeks), 16 weeks (post intervention)
Satisfaction of participants during the intervention
Time frame: Post-randomisation through to the final intervention session [anticipated at 15 weeks]
Mean change in Lumbar spine bone mineral density measured by DEXA
Time frame: 5 weeks and 24 weeks
Mean change of appendicular lean muscle mass on DEXA
Time frame: 5 weeks and 24 weeks
Mean change in hip bone mineral density measured by DEXA
Time frame: 5 weeks and 24 weeks
Mean change in grip strength with handheld dynamometry
Time frame: 5 weeks, 16 weeks and 24 weeks
Mean change in knee extension strength with handheld dynamometry
Time frame: 5 weeks, 16 weeks and 24 weeks
Mean change in tibialis anterior strength with handheld dynamometry
Time frame: 5 weeks, 16 weeks and 24 weeks
Mean change in rectus femoris muscle measured on muscle ultrasound
Time frame: Baseline, 5 weeks, 16 weeks, 24 weeks
Mean change in tibialis anterior muscle measured on muscle ultrasound
Time frame: Baseline, 5 weeks, 16 weeks, 24 weeks
Mean change in vastus lateralis muscle measured on muscle ultrasound
Time frame: Baseline, 5 weeks, 16 weeks, 24 weeks
Mean change in steps per day
Time frame: 5 weeks, 16 weeks, 24 weeks
Mean change in sedentary time per day
Time frame: 5 weeks, 16 weeks, 24 weeks
Mean change in malnutrition measured by Malnutrition Score
Time frame: 5 weeks, 16 weeks and 24 weeks
Mean change in lower limb power evaluated by Jump Forward
Time frame: 5 weeks, 16 weeks and 24 weeks
Mean change in lower limb endurance as measured by the 30 second chair stand
Time frame: 5 weeks, 16 weeks and 24 weeks
Mean change in upper limb endurance as measured by the 30 second timed push ups
Time frame: 5 weeks, 16 weeks and 24 weeks
mean change in mobility as assessed by the 10 meter walk run test
Time frame: 5 weeks, 16 weeks and 24 weeks
Mean change in mobility endurance evaluated by the 100-meter Timed Test (100mTT)
Time frame: 5 weeks, 16 weeks, 24 weeks
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
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
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
Mean change in endurance as evaluated by the 6-Minute Walk Test (6MWT)
Time frame: 5 weeks, 16 weeks and 24 weeks
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
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
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
Mean change in subjective fatigue evaluated by the PROMIS-Fatigue module questionnaire
Time frame: 5 weeks, 16 weeks, 24 weeks
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
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
Mean change in subjective strength evaluated by the PROMIS-Strength impact questionnaire
Time frame: 5 weeks, 16 weeks, 24 weeks
Mean change in subjective stress evaluated by the PROMIS-psychological stress questionnaire
Time frame: 5 weeks, 16 weeks and 24 weeks
Mean change in subjective upper limb function evaluated by the PROMIS-Upper Limb Function questionnaire
Time frame: 5 weeks, 16 weeks and 24 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jul 2026.
- Individual participant dataSharing planned: No. There is an optional consent for the data collected to be used in future studies however, there are no data sharing agreements in place and therefore future studies would be using data under the original data agreements and protocols. A protocol publication is planned and will be linked to the registration when it is complete.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Ella Thorburn, Bachelor of Physiotherapy(hon) contact
Rachel Conyers, A/Prof Paediatric Oncologist study director
Murdoch Children's Research Institute, Royal Children's Hospital (Melbourne), University of Melbourne
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exercise in people with Sarcopenia and Acute Lymphoblastic Leukemia, run by Murdoch Childrens Research Institute at 1 site in Australia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 6 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Sarah Grimshaw, PhD Physiotherapy (+61417162166, sarah.grimshaw@mcri.edu.au), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean change in muscle mass of rectus femoris on muscle ultrasound (time frame: Baseline, 16 weeks). The study lists 11 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jul 2026.