The Effect of the Inspiratory Muscle Training on Respiratory Parameters and Functional Capacity in Idiopathic Scoliosis

Adolescent Idiopathic Scoliosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03391895
• Other study ID #: BVUgbasbug01
• Status: Completed
• Phase: N/A
• Start date: February 23, 2018
• Est. completion date: June 26, 2018

Study information

• Verified date: June 2018
• Source: Bezmialem Vakif University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 34
• Est. completion date: June 26, 2018
• Est. primary completion date: June 21, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 10 Years to 18 Years

Eligibility

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.

Related Conditions & MeSH terms

• Adolescent Idiopathic Scoliosis
• Respiratory Aspiration
• Scoliosis

Intervention

Other:
• Home based exercise program
Program will include deep diaphragmatic breathing exercises, local expansion exercise on the collapsed areas in scoliosis concave sides with elastic exercise bands, dynamic lumber stabilization exercises for core stabilisation, strengthening of interscapular muscles with elastic bands and stretching exercises for lumbar extensor, hip flexor and hamstring muscles. Exercises will be applied 2 sets of 10 repetitions and once a day.
• Inspiratory Muscle Training
Threshold IMT device will be used for the training. Training intensity will set at 30% of the maximum inspiratory pressure after assessment of respiratory muscle strength for each patient every week.

Locations

Country	Name	City	State
Turkey	Bezmialem Vakif University	Istanbul

Sponsors (1)

Lead Sponsor	Collaborator
Bezmialem Vakif University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from baseline Forced Vital Capacity (FVC) at 8 weeks		Eight weeks
Primary	Change from baseline Forced Expiratory Volume in 1 second (FEV1) at 8 weeks		Eight weeks
Primary	Change from baseline Peak Expiratory Flow (PEF) at 8 weeks		Eight weeks
Primary	Change from baseline Maximum Inspiratory Pressure (MIP) at 8 weeks		Eight weeks
Primary	Change from baseline Maximum Expiratory Pressure (MEP) at 8 weeks		Eight weeks
Primary	Change from baseline distance covered in six-minute walk test at 8 weeks		Eight weeks
Secondary	Change from baseline thoracic axial trunk rotation (ATR)	Measurements will be applied with Bunnell Scoliometer by a qualified physiotherapist.	Eight weeks
Secondary	Change from baseline thoracic-lumber junction axial trunk rotation (ATR)	Measurements will be applied with Bunnell Scoliometer by a qualified physiotherapist.	Eight weeks
Secondary	Change from baseline lumber axial trunk rotation (ATR)	Measurements will be applied with Bunnell Scoliometer by a qualified physiotherapist.	Eight weeks