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Completed

NCT Number: NCT03391895

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

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.

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Key information

Age range

10 year–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Bezmialem Vakif University

Istanbul, Turkey (Türkiye)

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Home based exercise program

Other

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

Other

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.

Primary outcomes

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

    Time frame: Eight weeks

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

    Time frame: Eight weeks

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

    Time frame: Eight weeks

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

    Time frame: Eight weeks

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

    Time frame: Eight weeks

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

    Time frame: Eight weeks

Secondary outcomes

  1. Change from baseline thoracic axial trunk rotation (ATR)

    Time frame: Eight weeks

    Measurements will be applied with Bunnell Scoliometer by a qualified physiotherapist.

  2. Change from baseline thoracic-lumber junction axial trunk rotation (ATR)

    Time frame: Eight weeks

    Measurements will be applied with Bunnell Scoliometer by a qualified physiotherapist.

  3. Change from baseline lumber axial trunk rotation (ATR)

    Time frame: Eight weeks

    Measurements will be applied with Bunnell Scoliometer by a qualified physiotherapist.

Sponsors and collaborators

Lead sponsor

Bezmialem Vakif University

Other

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2018
Study completion
2018
First posted
Jan 5, 2018
Registry last updated
Jun 28, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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