Ai Chi Method for Children With Asthma

Not Applicable

• Conditions: Hydrotherapy; Respiratory Tract Diseases; Respiration Disorders; Asthma; Respiratory Hypersensitivity; Respiratory Disease; Child
• Interventions: Other: Asthma education; Other: Ai Chi

• Registration Number: NCT03392129
• Lead Sponsor: Universidade Federal do Rio Grande do Norte

Brief Summary

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.

Detailed Description

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.

Study Timeline

• Study Start: 2017-12-20
• Study First Submitted: 2017-12-28
• Study First Submitted QC: 2018-01-04
• Study First Posted: 2018-01-05
• Status Verified: 2019-08
• Last Update Submitted: 2019-08-08
• Last Update Posted: 2019-08-12
• Primary Completion: 2020-07-20
• Study Completion: 2020-07-20

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 42

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Asthma education	Asthma education	Children assigned to the control group will receive, along with their parents, educational interventions in relation to asthma.
Ai Chi	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.

Primary Outcome Measures

Name	Time	Method
Change in Lung function (spirometry).	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).

Secondary Outcome Measures

Name	Time	Method
Change in asthma control.	Baseline, six weeks later (endpoint) and one month since the initial of intervention (follow-up)	Asthma control will be assessed by the Childhood Asthma Control Test - c-ACT Questionnaire Mean c-ACT score. Do higher values of 19 points represent a better outcome .
Change in Quality of life	Baseline, six weeks later (endpoint) and one month since the initial of intervention (follow-up)	Quality of life of childhood asthma as assessed by the Standardized Pediatric Asthma Quality of Life Questionnaire (PAQLQ). 7 point rating scale Do higher values represent a better outcome.
Change in Anxiety symptoms.	Baseline, six weeks later (endpoint) and one month since the initial of intervention (follow-up)	Change in Spence Children's Anxiety Scale following intervention. Self-reported (child and parent version) child anxiety symptoms, 38 items questionnaire, rated at a 4-point scale. Do higher values represent a worse outcome.
Change in Disturbed Sleep.	Baseline, six weeks later (endpoint) and one month since the initial of intervention (follow-up)	Disturbed Sleep will be assessed by the Sleep Disorders Scale in Children. 26 items questionnaire, rated at a 5-point scale. Do higher values represent a worse outcome.

Trial Locations

Locations (1)

Universidade Federal do Rio Grande do Norte (UFRN); 🇧🇷 Natal, Rio Grande Do Norte, Brazil