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临床试验/NCT03391895
NCT03391895已完成不适用

The Effect of the Inspiratory Muscle Training on Respiratory Muscle Strength, Respiratory Function and Functional Capacity in Adolescents With Idiopathic Scoliosis

Bezmialem Vakif University1 个研究点 分布在 1 个国家目标入组 34 人开始时间: 2018年2月23日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
34
试验地点
1
主要终点
Change from baseline Maximum Expiratory Pressure (MEP) at 8 weeks

研究概览

简要总结

Scoliosis is the abnormality of the spine with direct effects on the shape and mechanics of the thoracic cage. Adolescent Idiopathic Scoliosis (AIS) is the most common 3-dimensional deformity of the spine which can potentially affect respiratory function, exercise capacity as well as the performance of inspiratory and expiratory muscles. During growth morphological changes of thoracic cage affects the pulmonary tissues and functions. Respiratory functions shows negative changes due to Cobb angle, curve localization, number of vertebra and onset age in patient with scoliosis.

Exercise approaches include respiratory training program and aim to improve respiratory functions.It is reported that respiratory muscle weakness is a potent contributor to pulmonary impairment in mild, moderate, and severe forms of scoliosis. Studies showed that exercise training and respiratory exercises may improve respiratory function and exercise capacity in patients with AIS. Thus the aim of this study was to investigate the effect of inspiratory muscle training on respiratory muscle strength, respiratory function and functional capacity in adolescents with idiopathic scoliosis.

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
Double (Participant, Outcomes Assessor)

入排标准

年龄范围
10 Years 至 18 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • Adolescent Idiopathic Scoliosis diagnosis

排除标准

  • Documented diagnosis any of cardiopulmonary, neurological, orthopedic or mental disorders which may affect the assessment results.
  • Subjects previously involved in exercise training or physiotherapy programs
  • Subjects previously undertaken any of spinal surgeries.

研究组 & 干预措施

Control Group

Active Comparator

Patients in this group will receive a home based exercise program. Home based exercise program includes deep diaphragmatic breathing exercises, resistive local expansion exercise on the collapsed areas in scoliosis concave sides, dynamic lumber stabilization, strengthening of inter scapular muscles, posture and stretching exercises once a day for 8 weeks. One of the exercise sessions was supervised by physiotherapist each week.

干预措施: Home based exercise program (Other)

Training Group

Experimental

In addition to home based exercise program, patients in this group will also receive inspiratory muscle training for 15 minutes, twice a day, 7 days a week for 8 weeks. One exercise session will be supervised in our clinic per week, other sessions will be performed at home.

干预措施: Home based exercise program (Other)

Training Group

Experimental

In addition to home based exercise program, patients in this group will also receive inspiratory muscle training for 15 minutes, twice a day, 7 days a week for 8 weeks. One exercise session will be supervised in our clinic per week, other sessions will be performed at home.

干预措施: Inspiratory Muscle Training (Other)

结局指标

主要结局

Change from baseline Maximum Expiratory Pressure (MEP) at 8 weeks

时间窗: Eight weeks

Change from baseline Forced Vital Capacity (FVC) at 8 weeks

时间窗: Eight weeks

Change from baseline Forced Expiratory Volume in 1 second (FEV1) at 8 weeks

时间窗: Eight weeks

Change from baseline distance covered in six-minute walk test at 8 weeks

时间窗: Eight weeks

Change from baseline Peak Expiratory Flow (PEF) at 8 weeks

时间窗: Eight weeks

Change from baseline Maximum Inspiratory Pressure (MIP) at 8 weeks

时间窗: Eight weeks

次要结局

  • Change from baseline thoracic-lumber junction axial trunk rotation (ATR)(Eight weeks)
  • Change from baseline thoracic axial trunk rotation (ATR)(Eight weeks)
  • Change from baseline lumber axial trunk rotation (ATR)(Eight weeks)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Gözde Başbuğ

Lecturer, PT, MSc

Bezmialem Vakif University

研究点 (1)

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