Ai Chi Method for Children With Asthma: A Single-blinded Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 入组人数
- 42
- 试验地点
- 1
- 主要终点
- Change in Lung function (spirometry).
研究概览
简要总结
This study has the aim to assess the effectiveness of the Ai Chi method as an adjunct therapy in the treatment of children with asthma.
详细描述
Children from 7 to 12 years old with asthma diagnosis will be included. Children assigned to the control group will receive, along with their parents, educational interventions in relation to asthma, based on guidelines of Global Strategy for Asthma Management and Prevention Revised 2017.Children in the intervention group will perform 12 sessions (twice a week) of treatment with the Ai Chi Method and educational interventions similiar to the control group. The investigators will assess pulmonary function (spirometry), asthma control by the Childhood Asthma Control Test (c-ACT Questionnaire), quality of life by the PAQLQ (Paediatric Asthma Quality of Life Questionnaire), anxiety symptoms by the SCAS (Spence Children's Anxiety Scale) and Disturbed Sleep by the Sleep Disorders Scale in Children. In addition, information will be collected on the numbers of hospitalizations, occurence of absence in school due to exacerbation of the disease, asthma symptoms and Beta2-agonists usage.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 7 Years 至 12 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Children from 7 up to 12 years old with asthma diagnose;
- •Regular inhaled corticosteroids with no change in dose in the preceding 4 weeks;
- •Children cannot present: other respiratory disease (such as cystic fibrosis, bronchiectasis, tuberculosis), obesity, retinal detachment, hypertensive crisis, congenital heart defect, pulmonary edema, history of lobectomy or lung segmentectomy, respiratory infections 15 days prior to the evaluations.
排除标准
- •Children that are not able to perform some of the necessary procedures;
- •Give up participating in the research and present acute symptoms of respiratory tract during the assessments.
研究组 & 干预措施
Ai Chi
Children in the intervention group will perform 12 sessions (twice a week, 40 minutes each session) of treatment with the Ai Chi Method and educational interventions in relation to asthma.
干预措施: Ai Chi (Other)
Asthma education
Children assigned to the control group will receive, along with their parents, educational interventions in relation to asthma.
干预措施: Asthma education (Other)
结局指标
主要结局
Change in Lung function (spirometry).
时间窗: Baseline, six weeks later (endpoint) and one month since the initial of intervention (follow-up)
Forced expiratory volume in one second (FEV1), forced vital capacity (FVC), FEV1/FVC ratio, forced expiratory flow between 25-75% of the pulmonary volume (FEF25-75).
次要结局
- Change in asthma control.(Baseline, six weeks later (endpoint) and one month since the initial of intervention (follow-up))
- Change in Quality of life(Baseline, six weeks later (endpoint) and one month since the initial of intervention (follow-up))
- Change in Anxiety symptoms.(Baseline, six weeks later (endpoint) and one month since the initial of intervention (follow-up))
- Change in Disturbed Sleep.(Baseline, six weeks later (endpoint) and one month since the initial of intervention (follow-up))
研究者
Karla Morganna Pereira Pinto de Mendonça
Principal Investigator
Universidade Federal do Rio Grande do Norte