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

Overview

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.

Full Title of Study: “The Effect of the Inspiratory Muscle Training on Respiratory Muscle Strength, Respiratory Function and Functional Capacity in Adolescents With Idiopathic Scoliosis”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Double (Participant, Outcomes Assessor)
  • Study Primary Completion Date: June 21, 2018

Interventions

  • 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.
  • Other: 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.

Arms, Groups and Cohorts

  • Active Comparator: Control Group
    • 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.
  • Experimental: Training Group
    • 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.

Clinical Trial Outcome Measures

Primary Measures

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

Secondary Measures

  • Change from baseline thoracic axial trunk rotation (ATR)
    • Time Frame: Eight weeks
    • Measurements will be applied with Bunnell Scoliometer by a qualified physiotherapist.
  • 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.
  • Change from baseline lumber axial trunk rotation (ATR)
    • Time Frame: Eight weeks
    • Measurements will be applied with Bunnell Scoliometer by a qualified physiotherapist.

Participating in This Clinical Trial

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.

Gender Eligibility: All

Minimum Age: 10 Years

Maximum Age: 18 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Bezmialem Vakif University
  • Provider of Information About this Clinical Study
    • Principal Investigator: Gözde Başbuğ, Lecturer, PT, MSc – Bezmialem Vakif University

Clinical trials entries are delivered from the US National Institutes of Health and are not reviewed separately by this site. Please see the identifier information above for retrieving further details from the government database.

At TrialBulletin.com, we keep tabs on over 200,000 clinical trials in the US and abroad, using medical data supplied directly by the US National Institutes of Health. Please see the About and Contact page for details.