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Recruiting NCT07177430

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

No phase Interventional Scoliosis Idiopathic

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Inspiratory Muscle Training, Inspiratory Muscle Training (Sham).
Who it may be relevant to
Registry conditions: Scoliosis Idiopathic. Basic parameters: 11 years — 16 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Poland
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

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

Overview

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.

Interventions

  • Device 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.
  • Device 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.

Primary outcome measures

  • Pulmonary function test [Time frame: Baseline and after 8 weeks (post-intervention)]
  • Pulmonary function test (Maximal inspiratory flow at 50% of FVC (MIF50)) [Time frame: Baseline and after 8 weeks (post-intervention)]
  • Pulmonary function test (MEF50/MIF50 ratio) [Time frame: Baseline and after 8 weeks (post-intervention)]
  • Measurement of maximal inspiratory and expiratory pressure [Time frame: Baseline and after 8 weeks (post-intervention)]
  • Forced oscillation technique (FOT) [Time frame: Baseline and after 8 weeks (post-intervention)]
  • Six-minute walk test (6MWT) [Time frame: Baseline and after 8 weeks (post-intervention)]
  • Isokinetic dynamometry (Peak torque) [Time frame: Baseline and after 8 weeks (post-intervention)]
  • Isokinetic dynamometry (Total work) [Time frame: Baseline and after 8 weeks (post-intervention)]
  • Isokinetic dynamometry (Average power) [Time frame: Baseline and after 8 weeks (post-intervention)]
Secondary outcome measures (1)
  • Physical activity [Time frame: Before intervention]

Eligibility criteria

Inclusion criteria

  • 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;

Exclusion criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Double blind
Primary purpose
Supportive care

Study locations

Poland · 2 centers
  • Centrum Skolioz- Centrum Diagnostyczno-Rehabilitacyjne Promyk Słońca — Wroclaw
  • Wroclaw University of Health and Sport Sciences — Wroclaw

Identifiers

NCT: NCT07177430 · WroclawUHSS Ethics (22/2025)

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗