Inspiratory Muscle Training in Children and Adolescents With Idiopathic Scoliosis Undergoing Schroth Therapy.

Официальное название

The Effect of Inspiratory Muscle Training on Respiratory Function, Exercise Tolerance and Core Stability in Children and Adolescents With Idiopathic Scoliosis Undergoing Schroth Therapy.

Обзор

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.

Вмешательства

• Устройство Inspiratory Muscle Training
  Participants 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.
• Устройство Inspiratory Muscle Training (Sham)
  The 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.

Первичные конечные точки

• Pulmonary function test [Срок оценки: Baseline and after 8 weeks (post-intervention)]
• Pulmonary function test (Maximal inspiratory flow at 50% of FVC (MIF50)) [Срок оценки: Baseline and after 8 weeks (post-intervention)]
• Pulmonary function test (MEF50/MIF50 ratio) [Срок оценки: Baseline and after 8 weeks (post-intervention)]
• Measurement of maximal inspiratory and expiratory pressure [Срок оценки: Baseline and after 8 weeks (post-intervention)]
• Forced oscillation technique (FOT) [Срок оценки: Baseline and after 8 weeks (post-intervention)]
• Six-minute walk test (6MWT) [Срок оценки: Baseline and after 8 weeks (post-intervention)]
• Isokinetic dynamometry (Peak torque) [Срок оценки: Baseline and after 8 weeks (post-intervention)]
• Isokinetic dynamometry (Total work) [Срок оценки: Baseline and after 8 weeks (post-intervention)]
• Isokinetic dynamometry (Average power) [Срок оценки: Baseline and after 8 weeks (post-intervention)]

Вторичные конечные точки (1)

• Physical activity [Срок оценки: Before intervention]

Критерии участия

Критерии включения

• 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;

Критерии исключения

• chronic respiratory diseases,
• inhalant allergies,
• limited contact with the patient, preventing the examination from being performed;

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Двойное слепое

Основная цель

Поддерживающая терапия

Центры проведения

Польша · 2 центра

• Centrum Skolioz- Centrum Diagnostyczno-Rehabilitacyjne Promyk Słońca — Wroclaw
• Wroclaw University of Health and Sport Sciences — Wroclaw

Идентификаторы

NCT: NCT07177430 · WroclawUHSS Ethics (22/2025)

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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