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

• ClinicalTrials.gov Identifier: NCT03391895
• Recruitment Status: Completed
• First Posted: January 5, 2018
• Last Update Posted: June 28, 2018
• Sponsor: Bezmialem Vakif University
• Information provided by (Responsible Party): Gözde Başbuğ, Bezmialem Vakif University

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Adolescent Idiopathic Scoliosis	Other: Home based exercise program; Other: Inspiratory Muscle Training	Not Applicable

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 34 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: The Effect of the Inspiratory Muscle Training on Respiratory Muscle Strength, Respiratory Function and Functional Capacity in Adolescents With Idiopathic Scoliosis
• Actual Study Start Date: February 23, 2018
• Actual Primary Completion Date: June 21, 2018
• Actual Study Completion Date: June 26, 2018

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures :

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 Outcome Measures :

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.

Eligibility Criteria

• Ages Eligible for Study: 10 Years to 18 Years (Child, Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

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.

Contacts and Locations

Locations

Turkey

Bezmialem Vakif University

Istanbul, Turkey

Sponsors and Collaborators

Bezmialem Vakif University

More Information

• Responsible Party: Gözde Başbuğ, Lecturer, PT, MSc, Bezmialem Vakif University
• ClinicalTrials.gov Identifier: NCT03391895
• Other Study ID Numbers: BVUgbasbug01
• First Posted: January 5, 2018
• Last Update Posted: June 28, 2018
• Last Verified: June 2018

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: Undecided

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Gözde Başbuğ, Bezmialem Vakif University:

Adolescent Idiopathic Scoliosis; Scoliosis; Inspiratory Muscle Training; Exercise Training; Respiratory Exercise Training; Pulmonary Function Test; 6-Minute Walk test; Respiratory Muscle Strength

Additional relevant MeSH terms:

Scoliosis; Respiratory Aspiration; Spinal Curvatures; Spinal Diseases; Bone Diseases; Musculoskeletal Diseases; Respiration Disorders; Respiratory Tract Diseases; Pathologic Processes