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Набор скоро начнётся NCT07643753

Active Airways for Children and Young People With Asthma

Без фазы С лечением Asthma Childhood Exercise Children

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 TRAINING WITH OR WITHOUT MEDICATION, education.
Кому может быть актуально
Состояния в реестре: Asthma Childhood, Exercise, Children. Базовые параметры: 10 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
Великобритания
Следующий шаг
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Официальное название

The Feasibility of an Exercise and Asthma Educational Programme 'Active Airways' on Health Outcomes in Children and Young People With Asthma With All Severities

Обзор

What is this study about? The investigators want to see if exercise and education sessions can help children and young people (aged 10-17) with asthma, manage the participants asthma better. The investigators will place participants that are recruited to this study into one of three groups by a computer (randomly): Group 1: Usual Care: Continue with normal asthma treatment. Group 2: Education: Usual care + a 45-minute online asthma education class once a week. Group 3: Exercise \& Education: Usual care + 3 exercise sessions a week and asthma education classes.

Подробное описание

This research aims to identify if an exercise and/or asthma education programme, called 'Active Airways', is feasible and acceptable in the paediatric asthma patient. Feasibility, the primary outcome of this study, will be evaluated by calculating the percentage of people approached who participate in the intervention (recruitment) and the percentage who complete the intervention (retention and adherence). The investigators also want to see if the Active Airways programme could improve cardiorespiratory fitness, quality of life and lung function, reduce asthma attacks and reduce healthcare use.

Вмешательства

  • Другое EXERCISE TRAINING WITH OR WITHOUT MEDICATION
    12 week interval exercise training programme and 12 week education on exercise with asthma
  • Другое education
    education on exercise and asthma

Первичные конечные точки

  • Recruitment [Срок оценки: 12 weeks]
  • Retention [Срок оценки: 12 weeks]
Вторичные конечные точки (10)
  • Adherence to programme [Срок оценки: 12 weeks]
  • Wrist worn accelerometers [Срок оценки: 12 weeks]
  • Focus groups on patients experience to barriers to an exercise programme [Срок оценки: 12 weeks]
  • Health beliefs [Срок оценки: 12 weeks]
  • Respiratory (throat) samples [Срок оценки: Baseline, 12 weeks, 6 months and 1 year.]
  • Quality of life of participants using the paeditric quality of life inventory (asthma module) [Срок оценки: Baseline, 12 weeks, 6 months and 1 year]
  • Effectiveness of the programme [Срок оценки: Baseline, 12 weeks, 6 months and 1 year.]
  • Respiratory (nasal) samples [Срок оценки: Baseline, 12 weeks, 6 months and 1 year.]
  • Gut samples [Срок оценки: Baseline, 12 weeks, 6 months and 1 year.]
  • Focus groups on motivators for an exercise programme [Срок оценки: 12 weeks]

Критерии участия

Критерии включения

Willing and able to consent to participate in the trial

Able to understand written and spoken English

A diagnosis of Mild to Moderate Asthma or Severe Asthma based on the European Respiratory Society (ERS)/ American Thoracic Society (ATS) consensus statement on Severe Asthma

Able to participate in a formal exercise programme

Aged 10-17 years

Able to engage in focus groups

Approximately 130cm tall (to be able to complete cardiopulmonary exercise testing (CPET))

Критерии исключения

Self-reported uncontrolled severe exercise-induced breathlessness

Required a course of antibiotics or oral corticosteroids within the 4 weeks prior to the study commencing

Children with severe co-morbidities that will not allow them to participate in an exercise programme e.g. Severe neuromuscular disorders, recent fractures or surgeries, cognitive or behavioural conditions.

Participant is unable or unwilling, in the opinion of the investigator, to give informed consent

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Рандомизированное
Модель
Параллельные группы
Маскирование
Простое слепое
Основная цель
Профилактика

Центры проведения

Великобритания · 1 центр
  • University of Leicester — Leicester

Идентификаторы

NCT: NCT07643753 · 1068

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗