An interventional study of Ai Chi and Asthma education in Asthma, Child and Respiratory Disease, sponsored by Universidade Federal do Rio Grande do Norte. Status unknown at 1 site in Brazil. Open to participants aged 7 Years to 12 Years. Per ClinicalTrials.gov, last updated 2019-08-12.
Sponsored by Universidade Federal do Rio Grande do Norte · Not applicable, Interventional, and Treatment
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.
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.
4,841 studies on the registry are indexed under Asthma; 600 are open to participants now.
This study's planned enrollment of 42 is below the median of 78 across 3,341 interventional studies indexed under Asthma.
Browse Asthma studies →Universidade Federal do Rio Grande do Norte is the lead sponsor of 86 studies on the registry; 13 are open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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 assigned to the control group will receive, along with their parents, educational interventions in relation to asthma.
Other: Asthma education
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.
Children assigned to the control group will receive, along with their parents, educational interventions in relation to asthma.
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).
Time frame: Baseline, six weeks later (endpoint) and one month since the initial of intervention (follow-up)
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 .
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Baseline, six weeks later (endpoint) and one month since the initial of intervention (follow-up)
Plan to share: No
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This study is status unknown, as verified in Aug 2019. You cannot join it, but the record below documents what was studied.
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Universidade Federal do Rio Grande do Norte