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

Not Applicable

Completed

• Conditions: Adolescent Idiopathic Scoliosis
• Interventions: Other: Home based exercise program; Other: Inspiratory Muscle Training

• Registration Number: NCT03391895
• Lead Sponsor: Bezmialem Vakif University

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-12-29
• Study First Submitted QC: 2017-12-29
• Study First Posted: 2018-01-05
• Study Start: 2018-02-23
• Status Verified: 2018-06
• Primary Completion: 2018-06-21
• Study Completion: 2018-06-26
• Last Update Submitted: 2018-06-27
• Last Update Posted: 2018-06-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 34

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control Group	Home based exercise program	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.
Training Group	Inspiratory Muscle Training	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.
Training Group	Home based exercise program	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.

Primary Outcome Measures

Name	Time	Method
Change from baseline Forced Expiratory Volume in 1 second (FEV1) at 8 weeks	Eight weeks
Change from baseline distance covered in six-minute walk test at 8 weeks	Eight weeks
Change from baseline Peak Expiratory Flow (PEF) at 8 weeks	Eight weeks
Change from baseline Maximum Inspiratory Pressure (MIP) at 8 weeks	Eight weeks
Change from baseline Maximum Expiratory Pressure (MEP) at 8 weeks	Eight weeks
Change from baseline Forced Vital Capacity (FVC) at 8 weeks	Eight weeks

Secondary Outcome Measures

Name	Time	Method
Change from baseline thoracic axial trunk rotation (ATR)	Eight weeks	Measurements will be applied with Bunnell Scoliometer by a qualified physiotherapist.
Change from baseline lumber axial trunk rotation (ATR)	Eight weeks	Measurements will be applied with Bunnell Scoliometer by a qualified physiotherapist.
Change from baseline thoracic-lumber junction axial trunk rotation (ATR)	Eight weeks	Measurements will be applied with Bunnell Scoliometer by a qualified physiotherapist.

Trial Locations

Locations (1)

Bezmialem Vakif University; 🇹🇷 Istanbul, Turkey