Adolescent, child Asthma
Conditions
Interventions
This is a randomized, double-blind, controlled clinical trial with three study arms. Sixty-three children and adolescents with asthma of both sexes, aged between 6 and 17 years, will participate and w
Sponsors
Programa de Pós-Graduação em Fisioterapia da Universidade Federal de São Carlos
Fundação de Amparo à Pesquisa do estado de São Paulo
Eligibility
Age
6 Years to 18 Years
Inclusion criteria
Inclusion criteria: Children and adolescents of both sexes; aged between 6 years and 17 years and 11 months; previous diagnosis of asthma; regular medical follow-up; well-controlled or partially controlled asthma according to GINA (2023) criteria; pulmonary function assessment by spirometry and plethysmography showing parameters compatible with disease control; absence of recent exacerbations; evaluation of daytime and nighttime symptoms during the previous four weeks; appropriate use of inhaled medication; responsiveness to pharmacological treatment; absence of significant limitations in daily activities due to asthma; absence of frequent nocturnal awakenings related to the disease; controlled associated multimorbidities; body mass index (BMI) lower than 25 kg/m² for eutrophic asthma groups; children and adolescents with obesity associated with asthma eligible exclusively for the IMT Plus group; scores compatible with disease control in the c-ACT or ACT questionnaires according to age group.
Exclusion criteria
Exclusion criteria: Children younger than 6 years old; adolescents older than 17 years and 11 months; presence of uncontrolled neurological, musculoskeletal, metabolic, cardiovascular, or genetic diseases; history of thoracic surgery; cognitive or behavioral impairments preventing the performance of the proposed assessments and interventions; low tolerance to the assessments or intervention protocol; asthma exacerbation during participation in the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| An improvement in respiratory muscle strength is expected after the inspiratory muscle training protocol, assessed through maximal inspiratory pressure (MIP) and maximal expiratory pressure (MEP) obtained by manovacuometry, as well as improvement in functional capacity assessed by the 3-minute step test. Improvement in pulmonary function assessed by spirometry and whole-body plethysmography is also expected, including variables such as forced expiratory volume in the first second (FEV1), forced vital capacity (FVC), and forced expiratory volume in the first second/forced vital capacity ratio (FEV1/FVC). Data will be collected before and after the 8-week intervention. | — |
Secondary
| Measure | Time frame |
|---|---|
| Improvement in endothelial function assessed by flow-mediated dilation of the brachial artery using ultrasonography is expected; improvement in cardiac autonomic control assessed through heart rate variability (HRV); improvement in peripheral and respiratory muscle oxygenation assessed by near-infrared spectroscopy (NIRS); reduction in salivary inflammatory biomarkers and fractional exhaled nitric oxide (FeNO); improvement in quality of life assessed by the Pediatric Asthma Quality of Life Questionnaire (PAQLQ); improvement in sleep quality assessed by the Sleep Disturbance Scale for Children (SDSC); improvement in asthma control assessed by the Childhood Asthma Control Test (c-ACT) and Asthma Control Test (ACT) questionnaires; reduction in dyspnea and fatigue perception assessed by the Borg scale. Data will be collected before and after the 8-week intervention. | — |
Countries
BR
Contacts
Public ContactAdriana de Araújo
Universidade Federal de São Carlos
Outcome results
None listed