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

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

Study Overview

• Status: Completed
• Conditions: Adolescent Idiopathic Scoliosis
• Intervention / Treatment: Other: Home based exercise program; Other: Inspiratory Muscle Training

• Study Type: Interventional
• Enrollment (Actual): 34
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • Istanbul, Turkey
    • Bezmialem Vakif University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 10 years to 18 years (ADULT, CHILD)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.	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.
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.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Change from baseline Forced Vital Capacity (FVC) at 8 weeks	Eight weeks
Change from baseline Forced Expiratory Volume in 1 second (FEV1) 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 distance covered in six-minute walk test at 8 weeks	Eight weeks

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Bezmialem Vakif University

Study record dates

Study Major Dates

• Study Start (Actual): February 23, 2018
• Primary Completion (Actual): June 21, 2018
• Study Completion (Actual): June 26, 2018

Study Registration Dates

• First Submitted: December 29, 2017
• First Submitted That Met QC Criteria: December 29, 2017
• First Posted (Actual): January 5, 2018

Study Record Updates

• Last Update Posted (Actual): June 28, 2018
• Last Update Submitted That Met QC Criteria: June 27, 2018
• Last Verified: June 1, 2018

More Information

Terms related to this study

• Keywords: Scoliosis; Exercise Training; Inspiratory Muscle Training; Pulmonary Function Test; Adolescent Idiopathic Scoliosis; Respiratory Muscle Strength; Respiratory Exercise Training; 6-Minute Walk test
• Additional Relevant MeSH Terms: Pathologic Processes; Respiratory Tract Diseases; Respiration Disorders; Musculoskeletal Diseases; Spinal Diseases; Bone Diseases; Spinal Curvatures; Respiratory Aspiration; Scoliosis
• Other Study ID Numbers: BVUgbasbug01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No