Application Construction and Effect Evaluation of Family-empowered Pulmonary Rehabilitation in School-age Children With Asthma

Обзор

Study Purpose: To develop a pulmonary rehabilitation intervention program suitable for school-age children with asthma, and to evaluate its effectiveness in improving asthma control in children through a prospective randomized controlled trial. Study Methods: This is a single-center, prospective, randomized, open-label, parallel-controlled trial. Eligible subjects who meet all inclusion criteria and none of the exclusion criteria, together with their families, will be randomly assigned in a 1:1 ratio to either the intervention group (family-empowered pulmonary rehabilitation intervention) or the control group (conventional pulmonary rehabilitation care) after signing the informed consent form. Both groups will receive a 12-week core intervention period, with follow-up assessments conducted at baseline, end of intervention (12 weeks), and at 24 and 48 weeks after intervention.

Вмешательства

• Поведенческое Family-empowered pulmonary rehabilitation
  Family-empowered pulmonary rehabilitation intervention, including education, skills training, and home-based rehabilitation guidance.
• Поведенческое Conventional pulmonary rehabilitation care
  Routine pulmonary rehabilitation care and regular follow-up as per clinical practice.

Первичные конечные точки

• Asthma control level [Срок оценки: Baseline]

Вторичные конечные точки (1)

• Pulmonary function [Срок оценки: Baseline]

Критерии участия

Inclusion Criteria:(All must be met)

• School-aged children aged 6 to 12 years.
• Meet the diagnostic criteria for asthma according to the Guidelines for the Diagnosis and Prevention of Bronchial Asthma in Children (2025 Edition).
• Received regular inhaled asthma medications for at least 3 months, with moderate or better medication adherence (score ≥6 on the Morisky Medication Adherence Scale).
• Pulmonary function test shows obstructive ventilatory dysfunction or small airway dysfunction.
• The primary caregiver has good communication and literacy skills, can use smartphone applications (e.g., WeChat) proficiently, and is willing to participate in the study.
• Written informed consent has been obtained from the participant and their legal guardian.

Exclusion Criteria:(Any one leads to exclusion)

• Children in acute asthma exacerbation.
• Presence of other severe chronic diseases (e.g., congenital heart disease, neuromuscular disease, immunodeficiency disease, etc.).
• Children with mental or psychological disorders who cannot cooperate.
• Other conditions judged by the investigator to be unsuitable for participation in this study.

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

Открытое

Основная цель

Лечение

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT07558954 · 2026-IRB-0029

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗