Adolescent Idiopathic ScoliosisNCT03391895
The Effect of the Inspiratory Muscle Training on Respiratory Parameters and Functional Capacity in Idiopathic Scoliosis
A study testing Home based exercise program and Inspiratory Muscle Training in people with Adolescent Idiopathic Scoliosis, run by Bezmialem Vakif University at 1 site in Turkey (Türkiye).
Trial 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… Read more about this study
- Who is it for?
- Ages 10 to 18 years
- Conditions the study is for
- Adolescent Idiopathic Scoliosis
- What is being tested?
- Home based exercise program and Inspiratory Muscle Training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 23 Feb 2018to 26 Jun 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 10 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Adolescent Idiopathic Scoliosis diagnosis
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Adolescent Idiopathic Scoliosis
- Being tested
- Home based exercise program, Inspiratory Muscle Training
- Keywords
- Adolescent Idiopathic Scoliosis, Scoliosis, Inspiratory Muscle Training, Exercise Training, Respiratory Exercise Training, Pulmonary Function Test, 6-Minute Walk test, Respiratory Muscle Strength
- Medical subject headings
- Scoliosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Home based exercise programOther
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.
Inspiratory Muscle TrainingOther
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 group | Role | What they receive |
|---|---|---|
| Control Group | Active comparator | 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. Receives: Other: Home based exercise program |
| Training Group | Experimental | 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. Receives: Other: Home based exercise program; Other: Inspiratory Muscle Training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline Forced Vital Capacity (FVC) at 8 weeks
Measured: Eight weeks
Change from baseline Forced Expiratory Volume in 1 second (FEV1) at 8 weeks
Measured: Eight weeks
Change from baseline Peak Expiratory Flow (PEF) at 8 weeks
Measured: Eight weeks
Change from baseline Maximum Inspiratory Pressure (MIP) at 8 weeks
Measured: Eight weeks
Change from baseline Maximum Expiratory Pressure (MEP) at 8 weeks
Measured: Eight weeks
Change from baseline distance covered in six-minute walk test at 8 weeks
Measured: Eight weeks
Secondary outcomes (3)
Change from baseline thoracic axial trunk rotation (ATR)
Measurements will be applied with Bunnell Scoliometer by a qualified physiotherapist.
Measured: Eight weeks
Change from baseline thoracic-lumber junction axial trunk rotation (ATR)
Measurements will be applied with Bunnell Scoliometer by a qualified physiotherapist.
Measured: Eight weeks
Change from baseline lumber axial trunk rotation (ATR)
Measurements will be applied with Bunnell Scoliometer by a qualified physiotherapist.
Measured: Eight weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jan 2018
- Study start23 Feb 2018
- Primary completion21 Jun 2018
- Study completion26 Jun 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Adolescent Idiopathic ScoliosisStudies of the same condition, open and under way.
- More trials run by Bezmialem Vakif UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bezmialem Vakif University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gözde Başbuğ, Bezmialem Vakif University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03391895
- Sponsor's protocol ID
- BVUgbasbug01
- Status last verified
- Jun 2018
- First submitted
- 29 Dec 2017
- Last updated
- 28 Jun 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 28 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of the Inspiratory Muscle Training on Respiratory Muscle Strength, Respiratory Function and Functional Capacity in Adolescents With Idiopathic Scoliosis
- ClinicalTrials.gov ID
- NCT03391895
- Acronym / sponsor ID
- BVUgbasbug01
- Conditions
- 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
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- Bezmialem Vakif UniversityUniversity, hospital or other
- Study start
- 23 Feb 2018 (actual)
- Primary completion
- 21 Jun 2018 (actual)
- Study completion
- 26 Jun 2018 (actual)
- First posted
- 5 Jan 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control Group | Active comparator | Other: Home based exercise programPatients 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. |
| Training Group | Experimental | Other: Home based exercise program, Other: Inspiratory Muscle TrainingIn 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. |
Who may qualify
- Ages
- 10 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- Adolescent Idiopathic Scoliosis diagnosis
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Home based exercise programProgram 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 | Control Group, Training Group |
| Inspiratory Muscle TrainingThreshold 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. | Other | Training Group |
Primary outcome
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
3 secondary outcomes
Change from baseline thoracic axial trunk rotation (ATR)
Time frame: Eight weeks
Change from baseline thoracic-lumber junction axial trunk rotation (ATR)
Time frame: Eight weeks
Change from baseline lumber axial trunk rotation (ATR)
Time frame: Eight weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jun 2018.
- Individual participant dataSharing planned: Undecided
Related trials for Adolescent Idiopathic Scoliosis
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Turkish Adaptation and Validation of the Scoliosis Misconception Scale in Adolescents With Idiopathic Scoliosis
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Home based exercise program and Inspiratory Muscle Training in people with Adolescent Idiopathic Scoliosis, run by Bezmialem Vakif University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Jun 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline Forced Vital Capacity (FVC) at 8 weeks (time frame: Eight weeks). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jun 2018.