About this trial
This study evaluates the effectiveness of inspiratory muscle training in children and adolescents with idiopathic scoliosis undergoing therapy with the Schroth method.
The intervention- inspiratory muscle training- aims to improve respiratory function, increase exercise tolerance, and strengthen core stability in the participants.
The proposed training may enhance the effectiveness of therapy conducted using the Schroth method and improve participants' performance in activities of daily living.
The project aims to assess the impact of inspiratory muscle training in children and adolescents with idiopathic scoliosis on respiratory system function, exercise tolerance, and core stability.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
diagnosed idiopathic scoliosis,
age: 11-16 years (girls after their first period, boys after voice mutation),
spinal curvature angle > 20° according to Cobb,
guardian's consent to participate in the study;
Disqualifiers
chronic respiratory diseases,
inhalant allergies,
limited contact with the patient, preventing the examination from being performed;
Trial design
Parallel
Treatments tested in this trial
Inspiratory Muscle Training
DeviceParticipants will perform inspiratory muscle training using a respiratory muscle trainer. The initial training load will be set at 30% of PImax. The intervention will last for 8 weeks and will be carried out 5 days per week, twice daily, in 3 sets of 10 repetitions. The training load will be increased in the 2nd, 4th, and 6th week of the program, each time by an additional 10% relative to the initial PImax.
Inspiratory Muscle Training (Sham)
DeviceThe training intervention in the Sham Group will differ from the experimental group only in terms of training load. This load will remain constant at 15% PImax, which does not cause any changes in the functioning of the inspiratory muscles. All other training parameters will be identical to those in the IMT group.
Treatment groups
Trial outcomes
Primary outcomes
Pulmonary function test
Assessment of pulmonary ventilation will be performed using pulmonary function testing with a MasterScreen Pneumo spirometer (Jaeger). This examination is non-invasive and performed in accordance with ATS and ERS criteria. The data collected for analysis will include the following parameters: vital capacity (VC), forced vital capacity (FVC), forced expiratory volume in one second (FEV1), peak expiratory flow (PEF), maximal expiratory flow at 50% of forced vital capacity (MEF50). Unite of measurements: all measurements are taken as a percentage from predicted.
Pulmonary function test (Maximal inspiratory flow at 50% of FVC (MIF50))
Pulmonary function test will be performed using a MasterScreen Pneumo spirometer (Jaeger). This examination is non-invasive and performed in accordance with ATS and ERS criteria. Maximal inspiratory flow at 50% of FVC (MIF50) is expressed in litres per second (l/s).
Pulmonary function test (MEF50/MIF50 ratio)
Pulmonary function test will be performed using a MasterScreen Pneumo spirometer (Jaeger). This examination is non-invasive and performed in accordance with ATS and ERS criteria. The MEF50/MIF50 ratio is a dimensionless value (because in this case the MEF50 value is expressed in l/s, similarly to MIF50). This indicator assesses airway patency. It is mainly used for the diagnosis and differentiation of upper airway stenosis.
Measurement of maximal inspiratory and expiratory pressure
Respiratory muscle strength will be assessed by measuring maximal inspiratory and expiratory pressure. The test is non-invasive and will be performed using a pneumatic adapter connected to the tachometer of the device used for pulmonary function testing. The assessment will be conducted in accordance with ATS/ERS guidelines; following the recommended procedure, 5 to 10 measurements will be taken, from which the three highest values will be selected. Based on the results of this test, the training parameters for the planned intervention will be determined.
Secondary outcomes
Physical activity
Physical activity levels will be assessed using the PAQ-C (Physical Activity Questionnaire for Children) or PAQ-A (Physical Activity Questionnaire for Adolescents). This questionnaire gathers information on the frequency and intensity of physical activities, including sports, outdoor play, and other forms of exercise. Higher scores indicate greater levels of physical activity.
Sponsors and contacts
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