Effect of Inspiratory Muscle Training in Operated Adolescent Idiopathic Scoliosis

NCT06229314 | Completed

• 1 other identifier: 2023/165
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (1)

• Pulmonary function

  A spirometer (Cosmed Pony FX Spirometer, Milan, Italy) was used to measure forced vital capacity (FVC), forced expiratory volume in one second (FEV1), FEV1/FVC, peak expiratory flow rate (PEF), and forced expiratory volume from 25-75% (FEF25-75%), based on the European Respiratory Society/American Thoracic Society (ERS/ATS) criteria. The test was performed in the sitting position. At least three technically acceptable measurements were obtained between the two best-measured FEV1 values, with no more than a 5% difference, and the best FEV1 value was selected for analysis.

  Six week

Secondary Outcomes (5)

• Dyspnea

  Six week

• Respiratory muscle strength

  Six week

• Peripheral muscle strength

  Six week

• Functional capacity

  Six week

• Quality of Health

  Six week

Study Arms (2)

IMT Group

EXPERIMENTAL

The IMT group received IMT at 60% of the measured MIP value. IMT was administered using the Powerbreathe device (Powerbreathe Plus, Warwickshire, England) 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.

Device: Inspiratory muscle training

Control Group

SHAM COMPARATOR

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.

Device: Inspiratory muscle training

Interventions

Inspiratory muscle training DEVICE

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.

Control Group; IMT Group

Eligibility Criteria

• Age: Up to 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• did not have any orthopedic, cardiac, pulmonary, vestibular or neurological diseases other than scoliosis.

You may not qualify if:

• had experienced acute infections within the last 15 days were excluded

Sponsors & Collaborators

• Nuh Naci Yazgan University: lead

Study Sites (1)

Nuh Naci Yazgan University

Kayseri, Turkey (Türkiye)

Location

Study Officials

• Ukbe ŞIRAYDER, Dr.

  Nuh Naci Yazgan University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: 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.

Study Record Dates

• First Submitted: January 10, 2024
• First Posted: January 29, 2024
• Study Start: March 1, 2023
• Primary Completion: July 15, 2023
• Study Completion: December 15, 2023
• Last Updated: January 30, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)