Medulloblastoma Online Video-based Exercise Pilot Study
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: Medulloblastoma, Childhood. Базовые параметры: 3 лет — 18 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
- Германия, Швеция
- 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
Medulloblastoma Online Video-based Exercise Pilot Study (MOVE)
Обзор
In this study, the investigators test whether it is possible to deliver an exercise intervention via video meetings to children and adolescents who have completed therapy for medulloblastoma. The exercise sessions will be individualized and offered three times weekly during 12 weeks.
Подробное описание
Tumors of the central nervous system (CNS) represent 25-30% of all cases of pediatric cancer in Sweden. The survival for children with a brain tumor has improved over the last years. The 5-year overall survival rate is now 70%, resulting in a growing number or survivors every year. Malignant brain tumors typically have a poor prognosis, and curative treatment usually requires a combination of neurosurgery, chemotherapy and/or radiotherapy. For the survivors, the cure often comes at the cost of long-term side effects. Finding effective ways to mitigate the long-term side effects after childhood brain tumor is important, since they can severely impact the survivors´ daily life.
There is growing evidence that physical exercise is beneficial to cognition and improves cardiorespiratory fitness and motor function. It appears to be important that interventions start early, within 1-2 years after radiotherapy. For this to be feasible in international multicenter trials, the intervention and outcome assessments will need to be delivered remotely. Whether this is feasible in children treated for medulloblastoma is not known.
The investigators will perform a pilot study to provide pivotal information on whether exercise training can be remotely delivered in the home environment in children treated for medulloblastoma. This will take exercise training from an interesting research concept into a scalable intervention that can be offered regardless of geographic location of the patient. The study will further define the validity and feasibility of in-home outcome assessments of cardiorespiratory, muscular fitness and motor function in children treated for medulloblastoma. If shown feasible, this will work as a proof-of-concept and lead the way for including physical activity intervention in other childhood cancer treatment protocols as well. The results from this study will also enable the researchers to proceed in the planning of the first exercise intervention to be included upfront in an international childhood cancer treatment protocol, the upcoming Pan-European treatment protocol for standard-risk medulloblastoma in children (SIOP-MB6).
Вмешательства
- Поведенческое Exercise
Moderate-high intensity exercise, with three sessions per week during 12 weeks. Includes both aerobic and resistance training and will also include exercises that strengthen coordination and balance.
Первичные конечные точки
- Feasibility of the remote assessment and a digitally delivered exercise intervention [Срок оценки: From enrollment to the end of exercise at 12 weeks and then for prolonged support for another 12 weeks.]
Вторичные конечные точки (9)
- Handgrip strength [Срок оценки: Change from baseline, until 3 and 12 months.]
- Physical activity [Срок оценки: Change from baseline, until 1.5, 3, 6, and 12 months.]
- Patient-reported quality of life [Срок оценки: Change from baseline, until 3 and 12 months.]
- Motor function [Срок оценки: Change from baseline, until 3 and 12 months.]
- Cardiorespiratory fitness [Срок оценки: Change from baseline, until 3 and 12 months.]
- Epigenetic age acceleration [Срок оценки: Change from baseline, until 3 and 12 months.]
- Feasibility of the outcome measures [Срок оценки: 12 weeks]
- Cognitive function [Срок оценки: Change from baseline to 12 weeks and 12 months.]
- Lower limb strength [Срок оценки: Change from baseline until 3 and 12 months.]
Критерии участия
Inclusion Criteria: Completed therapy for medulloblastoma, including craniospinal radiation therapy, within 36 months before study entry.
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Exclusion Criteria: Inability to walk without support. Progressive disease.
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Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.
Здоровые добровольцы: Нет
Дизайн исследования
- Распределение
- Не применимо
- Модель
- Одна группа
- Маскирование
- Открытое
- Основная цель
- Поддерживающая терапия
Центры проведения
Германия · 1 центр
- Technical University Munich — München
Швеция · 1 центр
- Queen Silvia C hildren´s Hospital — Gothenburg
Идентификаторы
NCT: NCT06898684 · MOVE pilot