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Ai Chi Method for Children With Asthma

Primary Purpose

Asthma, Child, Respiratory Disease

Status
Unknown status
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Ai Chi
Asthma education
Sponsored by
Universidade Federal do Rio Grande do Norte
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Asthma focused on measuring Asthma, Child, respiratory exercises, Hydrotherapy, Physical Therapy Specialty, Sleep, Quality of life, Anxiety, Spirometry, Clinical trial

Eligibility Criteria

7 Years - 12 Years (Child)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Universidade Federal do Rio Grande do Norte (UFRN)Recruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Ai Chi

Asthma education

Arm Description

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.

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

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

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 .
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.
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.
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.

Full Information

First Posted
December 28, 2017
Last Updated
August 8, 2019
Sponsor
Universidade Federal do Rio Grande do Norte
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1. Study Identification

Unique Protocol Identification Number
NCT03392129
Brief Title
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

2. Study Status

Record Verification Date
August 2019
Overall Recruitment Status
Unknown status
Study Start Date
December 20, 2017 (Actual)
Primary Completion Date
July 20, 2020 (Anticipated)
Study Completion Date
July 20, 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universidade Federal do Rio Grande do Norte

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
42 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Ai Chi
Arm Type
Experimental
Arm Description
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.
Arm Title
Asthma education
Arm Type
Active Comparator
Arm Description
Children assigned to the control group will receive, along with their parents, educational interventions in relation to asthma.
Intervention Type
Other
Intervention Name(s)
Ai Chi
Intervention Description
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
Intervention Name(s)
Asthma education
Intervention Description
Children assigned to the control group will receive, along with their parents, educational interventions in relation to asthma.
Primary Outcome Measure Information:
Title
Change in Lung function (spirometry).
Description
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).
Time Frame
Baseline, six weeks later (endpoint) and one month since the initial of intervention (follow-up)
Secondary Outcome Measure Information:
Title
Change in asthma control.
Description
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 .
Time Frame
Baseline, six weeks later (endpoint) and one month since the initial of intervention (follow-up)
Title
Change in Quality of life
Description
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.
Time Frame
Baseline, six weeks later (endpoint) and one month since the initial of intervention (follow-up)
Title
Change in Anxiety symptoms.
Description
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.
Time Frame
Baseline, six weeks later (endpoint) and one month since the initial of intervention (follow-up)
Title
Change in Disturbed Sleep.
Description
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.
Time Frame
Baseline, six weeks later (endpoint) and one month since the initial of intervention (follow-up)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
7 Years
Maximum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Karla Morganna P.P Mendonça, PT, PHD
Phone
+55 84 3342-2020
Email
karla-morganna@hotmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Karla Mendonça, PT, PhD
Organizational Affiliation
Universidade Federal do Rio Grande do Norte
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Renata Tomaz, PT, PhD's Student
Organizational Affiliation
Universidade Federal do Rio Grande do Norte
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Ada Jácome, PT, PhD's student
Organizational Affiliation
Universidade Federal do Rio Grande do Norte
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Thayla Amorim, PT, Ms
Organizational Affiliation
Universidade Federal do Rio Grande do Norte
Official's Role
Principal Investigator
Facility Information:
Facility Name
Universidade Federal do Rio Grande do Norte (UFRN)
City
Natal
State/Province
Rio Grande Do Norte
ZIP/Postal Code
59078-970
Country
Brazil
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Karla Mendonça, Phd
Phone
+55 84 3342-2020
Email
karla-morganna@hotmail.com
First Name & Middle Initial & Last Name & Degree
Renata Tomaz, Phd
Phone
+55 83 999351535
Email
renatinha_sud@hotmail.com
First Name & Middle Initial & Last Name & Degree
Karla Mendonça, Phd
First Name & Middle Initial & Last Name & Degree
Renata Tomaz, Phd
First Name & Middle Initial & Last Name & Degree
Ada Jacome, Phd
First Name & Middle Initial & Last Name & Degree
Thayla Amorim, Ms

12. IPD Sharing Statement

Plan to Share IPD
No

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Ai Chi Method for Children With Asthma

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