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

Primary Purpose

Adolescent Idiopathic Scoliosis

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Home based exercise program
Inspiratory Muscle Training
Sponsored by
Bezmialem Vakif University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Adolescent Idiopathic Scoliosis focused on measuring Adolescent Idiopathic Scoliosis, Scoliosis, Inspiratory Muscle Training, Exercise Training, Respiratory Exercise Training, Pulmonary Function Test, 6-Minute Walk test, Respiratory Muscle Strength

Eligibility Criteria

10 Years - 18 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Bezmialem Vakif University

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Control Group

Training Group

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Change from baseline thoracic axial trunk rotation (ATR)
Measurements will be applied with Bunnell Scoliometer by a qualified physiotherapist.
Change from baseline thoracic-lumber junction axial trunk rotation (ATR)
Measurements will be applied with Bunnell Scoliometer by a qualified physiotherapist.
Change from baseline lumber axial trunk rotation (ATR)
Measurements will be applied with Bunnell Scoliometer by a qualified physiotherapist.

Full Information

First Posted
December 29, 2017
Last Updated
June 27, 2018
Sponsor
Bezmialem Vakif University
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1. Study Identification

Unique Protocol Identification Number
NCT03391895
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
Study Type
Interventional

2. Study Status

Record Verification Date
June 2018
Overall Recruitment Status
Completed
Study Start Date
February 23, 2018 (Actual)
Primary Completion Date
June 21, 2018 (Actual)
Study Completion Date
June 26, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Bezmialem Vakif University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Adolescent Idiopathic Scoliosis
Keywords
Adolescent Idiopathic Scoliosis, Scoliosis, Inspiratory Muscle Training, Exercise Training, Respiratory Exercise Training, Pulmonary Function Test, 6-Minute Walk test, Respiratory Muscle Strength

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
34 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Control Group
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Training Group
Arm Type
Experimental
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Home based exercise program
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Inspiratory Muscle Training
Intervention Description
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 Measure Information:
Title
Change from baseline Forced Vital Capacity (FVC) at 8 weeks
Time Frame
Eight weeks
Title
Change from baseline Forced Expiratory Volume in 1 second (FEV1) at 8 weeks
Time Frame
Eight weeks
Title
Change from baseline Peak Expiratory Flow (PEF) at 8 weeks
Time Frame
Eight weeks
Title
Change from baseline Maximum Inspiratory Pressure (MIP) at 8 weeks
Time Frame
Eight weeks
Title
Change from baseline Maximum Expiratory Pressure (MEP) at 8 weeks
Time Frame
Eight weeks
Title
Change from baseline distance covered in six-minute walk test at 8 weeks
Time Frame
Eight weeks
Secondary Outcome Measure Information:
Title
Change from baseline thoracic axial trunk rotation (ATR)
Description
Measurements will be applied with Bunnell Scoliometer by a qualified physiotherapist.
Time Frame
Eight weeks
Title
Change from baseline thoracic-lumber junction axial trunk rotation (ATR)
Description
Measurements will be applied with Bunnell Scoliometer by a qualified physiotherapist.
Time Frame
Eight weeks
Title
Change from baseline lumber axial trunk rotation (ATR)
Description
Measurements will be applied with Bunnell Scoliometer by a qualified physiotherapist.
Time Frame
Eight weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
10 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Facility Information:
Facility Name
Bezmialem Vakif University
City
Istanbul
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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

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