Clinical trial NCT03392129: Ai Chi Method for Children With Asthma
Official title: Ai Chi Method for Children With Asthma: A Single-blinded Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Asthma
Child
Respiratory Disease
Hydrotherapy
Respiratory Tract Diseases
Respiratory Hypersensitivity
Respiration Disorders
Keywords: Asthma
Child
respiratory exercises
Hydrotherapy
Physical Therapy Specialty
Sleep
Quality of life
Anxiety
Spirometry
Clinical trial
Lead sponsor: Universidade Federal do Rio Grande do Norte
Sponsor class: OTHER
First posted: 2018-01-05
Enrollment: 42
Sex: ALL
Minimum age (years): 7
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Change in Lung function (spirometry).
timeFrame: Baseline, six weeks later (endpoint) and one month since the initial of intervention (follow-up)
Secondary outcomes:
measure: Change in asthma control.
timeFrame: Baseline, six weeks later (endpoint) and one month since the initial of intervention (follow-up)
measure: Change in Quality of life
timeFrame: Baseline, six weeks later (endpoint) and one month since the initial of intervention (follow-up)
measure: Change in Anxiety symptoms.
timeFrame: Baseline, six weeks later (endpoint) and one month since the initial of intervention (follow-up)
measure: Change in Disturbed Sleep.
timeFrame: Baseline, six weeks later (endpoint) and one month since the initial of intervention (follow-up)
Other outcomes:
Locations:
city: Natal
country: Brazil
facility: Universidade Federal do Rio Grande do Norte (UFRN)
state: Rio Grande Do Norte
Study officials:
affiliation: Universidade Federal do Rio Grande do Norte
name: Karla Mendonça, PT, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Universidade Federal do Rio Grande do Norte
name: Renata Tomaz, PT, PhD's Student
role: PRINCIPAL_INVESTIGATOR
affiliation: Universidade Federal do Rio Grande do Norte
name: Ada Jácome, PT, PhD's student
role: PRINCIPAL_INVESTIGATOR
affiliation: Universidade Federal do Rio Grande do Norte
name: Thayla Amorim, PT, Ms
role: PRINCIPAL_INVESTIGATOR
References: