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Effect of Inspiratory Muscle Training in Operated Adolescent Idiopathic Scoliosis

NCT06229314 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2024-01-30

No results posted yet for this study

Summary

In adolescent idiopathic scoliosis (AIS), if the appropriate treatment approach is not applied, the patient's general health condition is negatively affected by the deterioration of pulmonary function. Although studies in the literature evaluate individuals with AIS and investigate the effects of exercise training on their functional capacity, no study has been found examining the effectiveness of post-surgical respiratory muscle strength training (IMT). Therefore, this study was designed as a randomized controlled study with the aim of investigating the effectiveness of IMT in the early post-surgical period in individuals with AIS. Participants included individuals diagnosed with AIS, for whom a surgical decision was made by an orthopedic surgeon, and who could cooperate in the tests to be conducted. Twelve patients were in the IMT group, and 12 were in the sham group. Pulmonary function and respiratory and peripheral muscle strength were measured. Functional capacities were assessed using the Six-Minute Walk Test (6MWT). Disease-specific quality of life (QoL) was evaluated through the Scoliosis Research Society-22 (SRS-22) and Oswestry Low Back Pain Questionnaire, while dyspnea was assessed using the Modified Medical Research Council (mMRC) scale. In the IMT group, IMT was provided at 60% of the Maximum Inspiratory Pressure (MIP), while in the Sham group, IMT was provided at 5% of MIP.

Conditions

  • Scoliosis Idiopathic Adolescent

Interventions

DEVICE

Inspiratory muscle training

In this study, the preoperative pulmonary function, respiratory and peripheral muscle strengths, functional capacities, and QoL of AIS patients who were eligible for surgery by the physician were evaluated. Subsequently, individuals underwent surgery. Pulmonary function tests and respiratory muscle strength measurements were performed on the patients approximately two days after surgery. Inspiratory Muscle Training was initiated at 60% of the MIP value. IMT was administered using the Powerbreathe device twice a day with 30x2 breaths. The device was adjusted weekly based on the patient\'s current MIP value, and training continued at 60% of the MIP value . The sham group received IMT at 5% of the measured MIP value, with adjustments made weekly, similar to the IMT group. Patients were asked to keep a daily record of their sessions. IMT was administered for a total of 6 weeks. At the end of the sixth week, initial tests and questionnaires were repeated for individuals in both groups.

Sponsors & Collaborators

  • Nuh Naci Yazgan University

    lead OTHER

Principal Investigators

  • Ukbe ŞIRAYDER, Dr. · Nuh Naci Yazgan University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Max Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-03-01
Primary Completion
2023-07-15
Completion
2023-12-15

Countries

  • Turkey (Türkiye)

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06229314 on ClinicalTrials.gov