Идёт набор NCT07325305

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

Без фазы С лечением Sarcopenia Acute Lymphoblastic Leukemia

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают: В протоколе указаны: Exercise.
Кому может быть актуально: Состояния в реестре: Sarcopenia, Acute Lymphoblastic Leukemia. Базовые параметры: 5 лет — 17 лет · Все.
Что важно проверить: Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится: Австралия
Следующий шаг: Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Официальное название

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

Обзор

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.

Подробное описание

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.

Вмешательства

Поведенческое 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 assessm

Первичные конечные точки

Mean change in muscle mass of rectus femoris on muscle ultrasound [Срок оценки: Baseline, 16 weeks]
Mean change in grip strength with handheld dynamometry [Срок оценки: 5 weeks, 16 weeks]
Mean change in knee extension strength on handheld dynamometry [Срок оценки: 5 weeks, 16 weeks]
Mean change in lean muscle mass on Dual-Energy X-ray Absorptiometry (DEXA) scan [Срок оценки: 5 weeks and 24 weeks]
Qualitative acceptability [Срок оценки: 16 weeks]
Fidelity of the intervention [Срок оценки: Post-randomisation through to the final intervention session [anticipated at 15 weeks]]
Feasibility of the trial measured by recruitment rate [Срок оценки: through study recruitment completion, approximately 15 months]
Feasibility of the trial measured by lost recruitment opportunities [Срок оценки: through study recruitment completion, approximately 15 months]
Feasibility of the intervention measured by the attrition rate [Срок оценки: through study completion, approximately 17 months]
Trial safety is measured by the frequency and severity of recorded adverse events related to the trial [Срок оценки: through study completion, approximately 17 months]

Вторичные конечные точки (12)

Acceptability measured by Theoretical Framework of Acceptability (TFA) survey [Срок оценки: Baseline, mid intervention (4-7 weeks), 16 weeks (post intervention)]
Satisfaction of participants during the intervention [Срок оценки: Post-randomisation through to the final intervention session [anticipated at 15 weeks]]
Mean change in Lumbar spine bone mineral density measured by DEXA [Срок оценки: 5 weeks and 24 weeks]
Mean change of appendicular lean muscle mass on DEXA [Срок оценки: 5 weeks and 24 weeks]
Mean change in hip bone mineral density measured by DEXA [Срок оценки: 5 weeks and 24 weeks]
Mean change in grip strength with handheld dynamometry [Срок оценки: 5 weeks, 16 weeks and 24 weeks]
Mean change in knee extension strength with handheld dynamometry [Срок оценки: 5 weeks, 16 weeks and 24 weeks]
Mean change in tibialis anterior strength with handheld dynamometry [Срок оценки: 5 weeks, 16 weeks and 24 weeks]
Mean change in rectus femoris muscle measured on muscle ultrasound [Срок оценки: Baseline, 5 weeks, 16 weeks, 24 weeks]
Mean change in tibialis anterior muscle measured on muscle ultrasound [Срок оценки: Baseline, 5 weeks, 16 weeks, 24 weeks]
Mean change in vastus lateralis muscle measured on muscle ultrasound [Срок оценки: Baseline, 5 weeks, 16 weeks, 24 weeks]
Mean change in steps per day [Срок оценки: 5 weeks, 16 weeks, 24 weeks]

Критерии участия

Критерии включения

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)