Ai Chi Method for Children With Asthma

NCT ID: NCT03392129

Last Updated: 2019-08-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

42 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-12-20

Study Completion Date

2020-07-20

Brief Summary

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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.

Detailed Description

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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.

Conditions

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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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.

Group Type EXPERIMENTAL

Ai Chi

Intervention Type OTHER

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.

Group Type ACTIVE_COMPARATOR

Asthma education

Intervention Type OTHER

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

Interventions

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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.

Intervention Type OTHER

Asthma education

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

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

7 Years

Maximum Eligible Age

12 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Universidade Federal do Rio Grande do Norte

OTHER

Sponsor Role lead

Responsible Party

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Karla Morganna Pereira Pinto de Mendonça

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Karla Mendonça, PT, PhD

Role: PRINCIPAL_INVESTIGATOR

Universidade Federal do Rio Grande do Norte

Renata Tomaz, PT, PhD's Student

Role: PRINCIPAL_INVESTIGATOR

Universidade Federal do Rio Grande do Norte

Ada Jácome, PT, PhD's student

Role: PRINCIPAL_INVESTIGATOR

Universidade Federal do Rio Grande do Norte

Thayla Amorim, PT, Ms

Role: PRINCIPAL_INVESTIGATOR

Universidade Federal do Rio Grande do Norte

Locations

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Universidade Federal do Rio Grande do Norte (UFRN)

Natal, Rio Grande do Norte, Brazil

Site Status RECRUITING

Countries

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Brazil

Central Contacts

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Karla Morganna P.P Mendonça, PT, PHD

Role: CONTACT

+55 84 3342-2020

Facility Contacts

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Karla Mendonça, Phd

Role: primary

+55 84 3342-2020

Renata Tomaz, Phd

Role: backup

+55 83 999351535

Other Identifiers

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67253617.4.0000.5537

Identifier Type: -

Identifier Source: org_study_id

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