Ai Chi Method for Children With Asthma

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

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.

Study Overview

• Status: Unknown
• Conditions: Respiratory Tract Diseases; Respiration Disorders; Child; Asthma; Respiratory Hypersensitivity; Hydrotherapy; Respiratory Disease
• Intervention / Treatment: Other: Ai Chi; Other: Asthma education

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 Type: Interventional
• Enrollment (Anticipated): 42
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Brazil
  • Rio Grande Do Norte
    • Natal, Rio Grande Do Norte, Brazil, 59078-970
      • Recruiting
      • Universidade Federal do Rio Grande do Norte (UFRN)
      • Contact: Karla Mendonça, Phd; Phone Number: +55 84 3342-2020; Email: karla-morganna@hotmail.com
      • Contact: Renata Tomaz, Phd; Phone Number: +55 83 999351535; Email: renatinha_sud@hotmail.com
      • Principal Investigator: Karla Mendonça, Phd
      • Principal Investigator: Renata Tomaz, Phd
      • Sub-Investigator: Ada Jacome, Phd
      • Sub-Investigator: Thayla Amorim, Ms

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 7 years to 12 years (CHILD)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: 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.	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.
ACTIVE_COMPARATOR: Asthma education; Children assigned to the control group will receive, along with their parents, educational interventions in relation to asthma.	Other: Asthma education; Children assigned to the control group will receive, along with their parents, educational interventions in relation to asthma.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)
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)
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)
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)

Collaborators and Investigators

• Sponsor: Universidade Federal do Rio Grande do Norte
• Investigators: Principal Investigator: Karla Mendonça, PT, PhD, Universidade Federal do Rio Grande do Norte; Principal Investigator: Renata Tomaz, PT, PhD's Student, Universidade Federal do Rio Grande do Norte; Principal Investigator: Ada Jácome, PT, PhD's student, Universidade Federal do Rio Grande do Norte; Principal Investigator: Thayla Amorim, PT, Ms, Universidade Federal do Rio Grande do Norte

Study record dates

Study Major Dates

• Study Start (ACTUAL): December 20, 2017
• Primary Completion (ANTICIPATED): July 20, 2020
• Study Completion (ANTICIPATED): July 20, 2020

Study Registration Dates

• First Submitted: December 28, 2017
• First Submitted That Met QC Criteria: January 4, 2018
• First Posted (ACTUAL): January 5, 2018

Study Record Updates

• Last Update Posted (ACTUAL): August 12, 2019
• Last Update Submitted That Met QC Criteria: August 8, 2019
• Last Verified: August 1, 2019

More Information

Terms related to this study

• Keywords: Child; Asthma; Anxiety; Quality of life; Sleep; Physical Therapy Specialty; Clinical trial; Spirometry; Hydrotherapy; respiratory exercises
• Additional Relevant MeSH Terms: Immune System Diseases; Lung Diseases; Hypersensitivity, Immediate; Bronchial Diseases; Lung Diseases, Obstructive; Hypersensitivity; Asthma; Respiration Disorders; Respiratory Tract Diseases; Respiratory Hypersensitivity
• Other Study ID Numbers: 67253617.4.0000.5537

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No