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
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Qualitative acceptability
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Outcomes Assessor)
盲法说明
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.
入排标准
- 年龄范围
- 5 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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)
排除标准
- 未提供
研究组 & 干预措施
Usual care control group
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
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.
干预措施: Exercise (Behavioral)
Observation cohort
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.
结局指标
主要结局
Qualitative acceptability
时间窗: 16 weeks
Measured by a semi-structured interview designed with Theoretical Domains Framework (TDF) and TFA theory
Fidelity of the intervention
时间窗: 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 intervention measured by the attrition rate
时间窗: through study completion, approximately 17 months
Rate and reasons for attrition of participants from the trial
Mean change in muscle mass of rectus femoris on muscle ultrasound
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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.
Feasibility of the trial measured by recruitment rate
时间窗: 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
时间窗: 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.
Trial safety is measured by the frequency and severity of recorded adverse events related to the trial
时间窗: 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
时间窗: 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.
次要结局
- Mean change in vastus lateralis muscle measured on muscle ultrasound(Baseline, 5 weeks, 16 weeks, 24 weeks)
- Mean change in lower limb endurance as measured by the 30 second chair stand(5 weeks, 16 weeks and 24 weeks)
- Mean change in upper limb endurance as measured by the 30 second timed push ups(5 weeks, 16 weeks and 24 weeks)
- mean change in mobility as assessed by the 10 meter walk run test(5 weeks, 16 weeks and 24 weeks)
- Mean change in subjective fatigue evaluated by the PROMIS-Fatigue module questionnaire(5 weeks, 16 weeks, 24 weeks)
- Mean change in subjective pain experience evaluated by the PROMIS-pain interference and behaviour module questionnaire(5 weeks, 16 weeks and 24 weeks)
- Mean change in subjective sleep impairment evaluated by the PROMIS-sleep disturbance and impairment module questionnaire(5 weeks, 16 weeks and 24 weeks)
- Mean change in subjective strength evaluated by the PROMIS-Strength impact questionnaire(5 weeks, 16 weeks, 24 weeks)
- Mean change in subjective stress evaluated by the PROMIS-psychological stress questionnaire(5 weeks, 16 weeks and 24 weeks)
- Mean change for ability to climb stairs as measured by the Timed Up and Down Stairs (TUDS)(5 weeks, 16 weeks and 24 weeks)
- 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)
- Mean change in grip strength with handheld dynamometry(5 weeks, 16 weeks and 24 weeks)
- Mean change in knee extension strength with handheld dynamometry(5 weeks, 16 weeks and 24 weeks)
- Mean change in tibialis anterior strength with handheld dynamometry(5 weeks, 16 weeks and 24 weeks)
- Mean change in rectus femoris muscle measured on muscle ultrasound(Baseline, 5 weeks, 16 weeks, 24 weeks)
- Mean change in tibialis anterior muscle measured on muscle ultrasound(Baseline, 5 weeks, 16 weeks, 24 weeks)
- Mean change in steps per day(5 weeks, 16 weeks, 24 weeks)
- Mean change in sedentary time per day(5 weeks, 16 weeks, 24 weeks)
- Mean change in malnutrition measured by Malnutrition Score(5 weeks, 16 weeks and 24 weeks)
- Mean change in lower limb power evaluated by Jump Forward(5 weeks, 16 weeks and 24 weeks)
- Mean change in mobility endurance evaluated by the 100-meter Timed Test (100mTT)(5 weeks, 16 weeks, 24 weeks)
- Mean change in ability to rise from the floor as measured by the Time Rise from Floor - quality assessment (TRF)(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)(5 weeks, 16 weeks, 24 weeks)
- Mean change in endurance as evaluated by the 6-Minute Walk Test (6MWT)(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)(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(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(5 weeks, 16 weeks and 24 weeks)
- Mean change in subjective upper limb function evaluated by the PROMIS-Upper Limb Function questionnaire(5 weeks, 16 weeks and 24 weeks)