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

NCT07325305 | Recruiting

• 1 other identifier: 2025/ETH01569
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Sarcopenia; Acute Lymphoblastic Leukemia

Keywords

exercise; physical activity; behaviour change; paediatrics

Outcome Measures

Primary Outcomes (11)

• 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.

  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.

  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.

  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.

  5 weeks and 24 weeks

• Qualitative acceptability

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

  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.

  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.

  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.

  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

  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

  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.

  Through study completion, approximately 17 months

Secondary Outcomes (32)

• Acceptability measured by Theoretical Framework of Acceptability (TFA) survey

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

• Satisfaction of participants during the intervention

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

• Mean change in Lumbar spine bone mineral density measured by DEXA

  5 weeks and 24 weeks

• Mean change of appendicular lean muscle mass on DEXA

  5 weeks and 24 weeks

• Mean change in hip bone mineral density measured by DEXA

  5 weeks and 24 weeks

Study Arms (3)

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 (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.

Behavioral: Exercise

Interventions

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.

Also known as: physical activity, behaviour change, wearable device

Intervention group

Eligibility Criteria

• Age: 5 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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)

You may not qualify if:

• none

Sponsors & Collaborators

• Murdoch Childrens Research Institute: lead

Study Sites (1)

Royal Children's Hospital

Melbourne, Victoria, 3052, Australia

RECRUITING

MeSH Terms

Conditions

Sarcopenia; Precursor Cell Lymphoblastic Leukemia-Lymphoma; Motor Activity

Interventions

Exercise; Wearable Electronic Devices

Condition Hierarchy (Ancestors)

Muscular Atrophy; Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Atrophy; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Leukemia, Lymphoid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Behavior

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena; Electrical Equipment and Supplies; Equipment and Supplies

Study Officials

• Rachel Conyers, A/Prof Paediatric Oncologist

  Murdoch Children's Research Institute, Royal Children's Hospital (Melbourne), University of Melbourne

  STUDY DIRECTOR

Central Study Contacts

Sarah Grimshaw, PhD Physiotherapy

CONTACT

+61417162166; sarah.grimshaw@mcri.edu.au

Ella Thorburn, Bachelor of Physiotherapy(hon)

CONTACT

+61415066889; ella.thorburn@student.unimelb.edu.au

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Due to the nature of the intervention the provider of the intervention will not be blinded and nor will the participant. The investigator will be blinded where possible and any unblinding will be recorded and reported.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: December 18, 2025
• First Posted: January 8, 2026
• Study Start: February 24, 2026
• Primary Completion (Estimated): July 17, 2028
• Study Completion (Estimated): October 1, 2028
• Last Updated: April 13, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

AU (1)