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

Condition(s) studied

Investigational drug(s) / intervention(s)

Exercise: 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 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.

Eligibility

Primary outcome measure(s)

• Mean change in muscle mass of rectus femoris on muscle ultrasound — 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 — 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 — 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 — 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 — 16 weeks
  Measured by a semi-structured interview designed with Theoretical Domains Framework (TDF) and TFA theory
• Fidelity of the intervention — 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 — 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 — 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 — 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 — 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 — 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.

Trial sites (1)

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