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

Tracking Information

• First Submitted Date: December 29, 2017
• First Posted Date: January 5, 2018
• Last Update Posted Date: June 28, 2018
• Actual Study Start Date: February 23, 2018
• Actual Primary Completion Date: June 21, 2018 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: December 29, 2017)

• 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 ]

• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: January 5, 2018)

• 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.

Original Secondary Outcome Measures (submitted: December 29, 2017)

• 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 thoraco-lumber 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.

• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: The Effect of the Inspiratory Muscle Training on Respiratory Parameters and Functional Capacity in Idiopathic Scoliosis
• Official Title: The Effect of the Inspiratory Muscle Training on Respiratory Muscle Strength, Respiratory Function and Functional Capacity in Adolescents With Idiopathic Scoliosis

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.

• Detailed Description: Not Provided
• Study Type: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Double (Participant, Outcomes Assessor); Primary Purpose: Treatment
• Condition: Adolescent Idiopathic Scoliosis

Intervention

• 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.

Study Arms

• 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.
  Intervention: Other: Home based exercise program
• 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.
  Interventions:

  • Other: Home based exercise program
  • Other: Inspiratory Muscle Training

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: June 27, 2018): 34
• Original Estimated Enrollment (submitted: December 29, 2017): 30
• Actual Study Completion Date: June 26, 2018
• Actual Primary Completion Date: June 21, 2018 (Final data collection date for primary outcome measure)

Eligibility 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.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 10 Years to 18 Years (Child, Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Turkey

Administrative Information

• NCT Number: NCT03391895
• Other Study ID Numbers: BVUgbasbug01
• Has Data Monitoring Committee: No

U.S. FDA-regulated Product

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

IPD Sharing Statement

• Plan to Share IPD: Undecided

• Current Responsible Party: Gözde Başbuğ, Bezmialem Vakif University
• Original Responsible Party: Same as current
• Current Study Sponsor: Bezmialem Vakif University
• Original Study Sponsor: Same as current
• Collaborators: Not Provided
• Investigators: Not Provided
• PRS Account: Bezmialem Vakif University
• Verification Date: June 2018