Ai Chi Method for Children With Asthma: A Single-blinded Randomized Controlled Trial
| Registry | NCT03392129 |
|---|---|
| Status | Unknown |
| Phase | Not applicable |
| Study type | Interventional; randomized, parallel, masking: single, treatment |
| Enrollment | 42 (Estimated) |
| Sponsor | Universidade Federal do Rio Grande do Norte (Other) |
| Conditions | Asthma, Child, Respiratory Disease, Hydrotherapy, Respiratory Tract Diseases, Respiratory Hypersensitivity, Respiration Disorders |
| Interventions | Ai Chi, Asthma education (Other) |
| Dates | start 2017-12-20, primary completion 2020-07-20 (estimated), completion 2020-07-20 (estimated), first posted 2018-01-05, last updated 2019-08-12 |
| Locations | 1 site in Brazil |
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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.
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.
| Arm | Type | Interventions | Description |
|---|---|---|---|
| Ai Chi | Experimental | Other: 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. |
| Asthma education | Active comparator | Other: Asthma education | Children assigned to the control group will receive, along with their parents, educational interventions in relation to asthma. |
Sex: All, ages: 7 Years to 12 Years
Inclusion Criteria: * 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. Exclusion Criteria: * 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.
| Facility | City | Country | Status |
|---|---|---|---|
| Universidade Federal do Rio Grande do Norte (UFRN) | Natal, Rio Grande do Norte | Brazil | Recruiting |