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Ai Chi Method for Children With Asthma

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ClinicalTrials.gov Identifier: NCT03392129
Recruitment Status : Recruiting
First Posted : January 5, 2018
Last Update Posted : February 19, 2019
Sponsor:
Information provided by (Responsible Party):
Karla Morganna Pereira Pinto de Mendonça, Universidade Federal do Rio Grande do Norte

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.

Condition or disease Intervention/treatment Phase
Asthma Child Respiratory Disease Hydrotherapy Respiratory Tract Diseases Respiratory Hypersensitivity Respiration Disorders Other: Ai Chi Other: Asthma education Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 42 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Ai Chi Method for Children With Asthma: A Single-blinded Randomized Controlled Trial
Actual Study Start Date : December 20, 2017
Estimated Primary Completion Date : June 20, 2019
Estimated Study Completion Date : July 20, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Asthma

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.




Primary Outcome Measures :
  1. Change in pulmonary function (spirometry). [ Time Frame: Baseline, six weeks later (endpoint) and one month since the initial of intervention (follow-up) ]
    Measured parameters of Forced expiratory volume in one second (FEV1)

  2. Change in pulmonary function (spirometry). [ Time Frame: Baseline, six weeks later (endpoint) and one month since the initial of intervention (follow-up) ]
    Measured parameters of Forced vital capacity (FVC)

  3. Change in pulmonary function (spirometry). [ Time Frame: Baseline, six weeks later (endpoint) and one month since the initial of intervention (follow-up) ]
    Measured parameters of Tiffeneau index - FEV1/FVC ratio

  4. Change in pulmonary function (spirometry). [ Time Frame: Baseline, six weeks later (endpoint) and one month since the initial of intervention (follow-up) ]
    Measured parameters of Mean forced expiratory flow between 25% and 75% of FVC (FEF25-75%)

  5. Change in pulmonary function (spirometry). [ Time Frame: Baseline, six weeks later (endpoint) and one month since the initial of intervention (follow-up) ]
    Measured parameters of Peak expiratory flow (PEF)


Secondary Outcome Measures :
  1. Change in asthma control. [ Time Frame: Baseline, six weeks later (endpoint) and one month since the initial of intervention (follow-up) ]
    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 .

  2. Change in Quality of life [ Time Frame: Baseline, six weeks later (endpoint) and one month since the initial of intervention (follow-up) ]
    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.

  3. Change in Anxiety symptoms. [ Time Frame: Baseline, six weeks later (endpoint) and one month since the initial of intervention (follow-up) ]
    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.

  4. Change in Disturbed Sleep. [ Time Frame: Baseline, six weeks later (endpoint) and one month since the initial of intervention (follow-up) ]
    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.



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Ages Eligible for Study:   7 Years to 12 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03392129


Contacts
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Contact: Karla Morganna P.P Mendonça, PT, PHD +55 84 3342-2020 karla-morganna@hotmail.com

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

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Responsible Party: Karla Morganna Pereira Pinto de Mendonça, Principal Investigator, Universidade Federal do Rio Grande do Norte
ClinicalTrials.gov Identifier: NCT03392129     History of Changes
Other Study ID Numbers: 67253617.4.0000.5537
First Posted: January 5, 2018    Key Record Dates
Last Update Posted: February 19, 2019
Last Verified: February 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Karla Morganna Pereira Pinto de Mendonça, Universidade Federal do Rio Grande do Norte:
Asthma
Child
respiratory exercises
Hydrotherapy
Physical Therapy Specialty
Sleep
Quality of life
Anxiety
Spirometry
Clinical trial

Additional relevant MeSH terms:
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Asthma
Hypersensitivity
Respiration Disorders
Respiratory Tract Diseases
Respiratory Hypersensitivity
Bronchial Diseases
Lung Diseases, Obstructive
Lung Diseases
Hypersensitivity, Immediate
Immune System Diseases