The Effect of Inspiratory Muscle Training on Respiratory Function, Exercise Tolerance and Core Stability in Children and Adolescents With Idiopathic Scoliosis Undergoing Schroth Therapy.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 56
- 试验地点
- 4
- 主要终点
- Pulmonary function test
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Double (Participant, Care Provider)
入排标准
- 年龄范围
- 11 Years 至 16 Years(Child)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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;
排除标准
- •chronic respiratory diseases,
- •inhalant allergies,
- •limited contact with the patient, preventing the examination from being performed;
研究组 & 干预措施
Sham Group
IMT (Sham) and Schroth therapy
干预措施: Inspiratory Muscle Training (Sham) (Device)
IMT Group
IMT and Schroth therapy
干预措施: Inspiratory Muscle Training (Device)
结局指标
主要结局
Pulmonary function test
时间窗: Baseline and after 8 weeks (post-intervention)
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))
时间窗: Baseline and after 8 weeks (post-intervention)
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)
时间窗: Baseline and after 8 weeks (post-intervention)
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
时间窗: Baseline and after 8 weeks (post-intervention)
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.
Forced oscillation technique (FOT)
时间窗: Baseline and after 8 weeks (post-intervention)
To provide information on the mechanical and elastic properties of the respiratory system, the forced oscillation technique (FOT) will be performed. For this purpose, the Resmon Pro V3 device (MGC Diagnostics®) will be used, employing the built-in pediatric mode that applies an 8 Hz signal frequency. The main parameters analyzed will be resistance (Rrs) and reactance (Xrs).
Six-minute walk test (6MWT)
时间窗: Baseline and after 8 weeks (post-intervention)
This test will be used to assess cardiorespiratory fitness. The examination will be conducted in accordance with the American Thoracic Society guidelines for this test. The parameter analyzed will be the distance covered by the participants.
Isokinetic dynamometry (Peak torque)
时间窗: Baseline and after 8 weeks (post-intervention)
Isokinetic dynamometry using the Biodex Multi-Joint System will be employed to assess the participants' ability to maintain postural stability in different planes under static and isokinetic conditions. Assessed muscle groups responsible for trunk stabilization: trunk flexors (abdominal muscles) and trunk extensors (back muscles). The evaluated parameter, peak torque, represents the maximum recorded torque produced by the analyzed muscle group at a specified angular velocity, expressed in newton-meters (N·m). Measurements will consist of performing trunk flexion and extension as quickly as possible with maximal force at two angular velocities. A warm-up will be conducted prior to testing. Five maximal trials will be performed, with rest periods between trials. During the trials, participants will be verbally encouraged to exert maximal effort.
Isokinetic dynamometry (Total work)
时间窗: Baseline and after 8 weeks (post-intervention)
Isokinetic dynamometry using the Biodex Multi-Joint System will be employed to assess the participants' ability to maintain postural stability in different planes under static and isokinetic conditions. Assessed muscle groups responsible for trunk stabilization: trunk flexors (abdominal muscles) and trunk extensors (back muscles). Total work is the work performed by the muscles throughout all movements executed during the task. It also allows for the assessment of muscle endurance. This parameter is expressed in joules (J). Measurements will consist of performing trunk flexion and extension as quickly as possible with maximal force at two angular velocities. A warm-up will be conducted prior to testing. Five maximal trials will be performed, with rest periods between trials. During the trials, participants will be verbally encouraged to exert maximal effort.
Isokinetic dynamometry (Average power)
时间窗: Baseline and after 8 weeks (post-intervention)
Isokinetic dynamometry using the Biodex Multi-Joint System will be employed to assess the participants' ability to maintain postural stability in different planes under static and isokinetic conditions. Assessed muscle groups responsible for trunk stabilization: trunk flexors (abdominal muscles) and trunk extensors (back muscles). Average power is a parameter calculated by dividing the work performed during a single repetition by the duration of the movement. Its values are expressed in watts (W). Measurements will consist of performing trunk flexion and extension as quickly as possible with maximal force at two angular velocities. A warm-up will be conducted prior to testing. Five maximal trials will be performed, with rest periods between trials. During the trials, participants will be verbally encouraged to exert maximal effort.
次要结局
- Physical activity(Before intervention)
研究者
Aleksandra Grudzińska
MSc
Wroclaw University of Health and Sport Sciences
