Effect of Inspiratory Muscle Training on Respiratory Function, Exercise Capacity, and Quality of Life in Operated Adolescent Idiopathic Scoliosis: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- Pulmonary function
研究概览
简要总结
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.
详细描述
There are very few studies in the literature that have investigated the effects of Inspiratory Muscle Training (IMT) to individuals with scoliosis. In a study conducted by Kim et al. in 2005, individuals with scoliosis and spinal cord injuries were given IMT, and after treatment, a decrease in Cobb angles, a significant increase in lung volumes, and respiratory muscle strengths were observed. In a study by Basbug et al. in 2023, the impact of IMT on pulmonary function and functional capacity in individuals with AIS was investigated. There is no study in the literature on providing IMT after surgery in scoliosis patients. It has been shown that surgical treatment alone in scoliosis patients is insufficient to improve respiratory capacity in the short term. Therefore, in this study, we aimed to investigate the effects of postoperative IMT on pulmonary function, functional capacity, and quality of life in AIS patients.
Methods Trial design
This study was planned as a single-blind, randomized, parallel group clinical trial. Participants did not know which group they were in.
Participants
Patients admitted to Kayseri System Hospital between February 2023 and December 2023 and diagnosed with idiopathic scoliosis were included in the study. Data were collected at Nuh Naci Yazgan University Department of Physiotherapy and Rehabilitation Laboratories. We calculated (G*Power Version 3.1.9.4, Franz Faul, Universitat Kiel, Düsseldorf, Germany) a power of 80% with 0.05 significance, a difference to be detected of 0.84 liter, and a standard deviation of 0.59 liter in FVC value, generating a sample of 10 individuals per group. It was planned to take a total of 24 individuals, 12 individuals in each group, by calculating a minimum 20% drop-out rate. A total of 24 individuals, 12 in the IMT group and 12 in the sham group were included in the study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- — 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •did not have any orthopedic, cardiac, pulmonary, vestibular or neurological diseases other than scoliosis.
排除标准
- •had experienced acute infections within the last 15 days were excluded
研究组 & 干预措施
IMT Group
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.
干预措施: Inspiratory muscle training (Device)
Control Group
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.
干预措施: Inspiratory muscle training (Device)
结局指标
主要结局
Pulmonary function
时间窗: Six week
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.
次要结局
- Respiratory muscle strength(Six week)
- Dyspnea(Six week)
- Functional capacity(Six week)
- Peripheral muscle strength(Six week)
- Quality of Health(Six week)
研究者
Ukbe Sirayder
Principal Investigator
Nuh Naci Yazgan University