Clinical trial NCT03391895: The Effect of the Inspiratory Muscle Training on Respiratory Parameters and Functional Capacity in Idiopathic Scoliosis
Official title: The Effect of the Inspiratory Muscle Training on Respiratory Muscle Strength, Respiratory Function and Functional Capacity in Adolescents With Idiopathic Scoliosis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Adolescent Idiopathic Scoliosis
Keywords: Adolescent Idiopathic Scoliosis
Scoliosis
Inspiratory Muscle Training
Exercise Training
Respiratory Exercise Training
Pulmonary Function Test
6-Minute Walk test
Respiratory Muscle Strength
Lead sponsor: Bezmialem Vakif University
Sponsor class: OTHER
First posted: 2018-01-05
Enrollment: 34
Sex: ALL
Minimum age (years): 10
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: Inclusion Criteria:

* Adolescent Idiopathic Scoliosis diagnosis

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Change from baseline Forced Vital Capacity (FVC) at 8 weeks
timeFrame: Eight weeks
measure: Change from baseline Forced Expiratory Volume in 1 second (FEV1) at 8 weeks
timeFrame: Eight weeks
measure: Change from baseline Peak Expiratory Flow (PEF) at 8 weeks
timeFrame: Eight weeks
measure: Change from baseline Maximum Inspiratory Pressure (MIP) at 8 weeks
timeFrame: Eight weeks
measure: Change from baseline Maximum Expiratory Pressure (MEP) at 8 weeks
timeFrame: Eight weeks
measure: Change from baseline distance covered in six-minute walk test at 8 weeks
timeFrame: Eight weeks
Secondary outcomes:
measure: Change from baseline thoracic axial trunk rotation (ATR)
timeFrame: Eight weeks
measure: Change from baseline thoracic-lumber junction axial trunk rotation (ATR)
timeFrame: Eight weeks
measure: Change from baseline lumber axial trunk rotation (ATR)
timeFrame: Eight weeks
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Bezmialem Vakif University
Study officials:
References: