Ai Chi Method for Children With Asthma

Asthma Clinical Trial

Official title:

Ai Chi Method for Children With Asthma: A Single-blinded Randomized Controlled Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03392129
• Other study ID #: 67253617.4.0000.5537
• Status: Recruiting
• Phase: N/A
• Start date: December 20, 2017
• Est. completion date: July 20, 2020

Study information

• Verified date: August 2019
• Source: Universidade Federal do Rio Grande do Norte
• Contact: Karla Morganna P.P Mendonça, PT, PHD
• Phone: +55 84 3342-2020
• Email: karla-morganna[@]hotmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 42
• Est. completion date: July 20, 2020
• Est. primary completion date: July 20, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 7 Years to 12 Years

Eligibility

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.

Related Conditions & MeSH terms

• Asthma
• Child
• Hydrotherapy
• Hypersensitivity
• Respiration Disorders
• Respiratory Disease
• Respiratory Hypersensitivity
• Respiratory Tract Diseases

Intervention

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 intervention in relation to asthma.
• Asthma education
Children assigned to the control group will receive, along with their parents, educational interventions in relation to asthma.

Locations

Country	Name	City	State
Brazil	Universidade Federal do Rio Grande do Norte (UFRN)	Natal	Rio Grande Do Norte

Sponsors (1)

Lead Sponsor	Collaborator
Universidade Federal do Rio Grande do Norte

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Lung function (spirometry).	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).	Baseline, six weeks later (endpoint) and one month since the initial of intervention (follow-up)
Secondary	Change in asthma control.	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 .	Baseline, six weeks later (endpoint) and one month since the initial of intervention (follow-up)
Secondary	Change in Quality of life	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.	Baseline, six weeks later (endpoint) and one month since the initial of intervention (follow-up)
Secondary	Change in Anxiety symptoms.	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.	Baseline, six weeks later (endpoint) and one month since the initial of intervention (follow-up)
Secondary	Change in Disturbed Sleep.	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.	Baseline, six weeks later (endpoint) and one month since the initial of intervention (follow-up)