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

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ClinicalTrials.gov Identifier: NCT03391895
Recruitment Status : Recruiting
First Posted : January 5, 2018
Last Update Posted : February 26, 2018
Sponsor:
Information provided by (Responsible Party):
Gözde Başbuğ, 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.


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

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 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
Estimated Primary Completion Date : May 2018
Estimated Study Completion Date : June 2018

Resource links provided by the National Library of Medicine


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.




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.



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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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03391895


Contacts
Contact: Gözde Basbug, PT, MSc +905355588909 gozde.basbug@gmail.com
Contact: Gözde Başbuğ, PT, MSc +902124012600 ext 4648 gbasbug@bezmialem.edu.tr

Locations
Turkey
Bezmialem Vakif University Recruiting
Istanbul, Turkey
Contact: Ayhan Dalak    +902125232288    adalak@bezmialem.edu.tr   
Sponsors and Collaborators
Bezmialem Vakif University

Responsible Party: Gözde Başbuğ, Lecturer, PT, MSc, Bezmialem Vakif University
ClinicalTrials.gov Identifier: NCT03391895     History of Changes
Other Study ID Numbers: BVUgbasbug01
First Posted: January 5, 2018    Key Record Dates
Last Update Posted: February 26, 2018
Last Verified: February 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