Adolescent Idiopathic Scoliosis (AIS)NCT06752993
Effects of Expiratory Muscle Strength Training in Adolescent Idiopathic Scoliosis
A study testing Expiratory Muscle Strength Training (EMST-150) in people with Adolescent Idiopathic Scoliosis (AIS) and Scoliosis; Adolescence, run by Gazi University at 1 site in Turkey (Türkiye).
Trial summary
Adolescent idiopathic scoliosis result in deterioration of core muscles and respiratory system. Core muscles provide trunk stabilization as well as responsible for respiratory system. Especially tr. Read more about this study
- Who is it for?
- Ages 10 to 19 years
- Conditions the study is for
- Adolescent Idiopathic Scoliosis (AIS), Scoliosis; Adolescence
- What is being tested?
- Expiratory Muscle Strength Training (EMST-150)
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 24 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 4 Jan 2025to 2 Jul 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 19 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Individuals diagnosed with idiopathic scoliosis,
- aged between 10 and 19 years,
- with a Cobb angle ranging from 10 to 45 degrees.
Who cannot join
- Individuals who have undergone spinal surgery,
- who have received conservative or surgical treatment for scoliosis,
- individuals with neurological, neuromuscular, systemic, rheumatological, or musculoskeletal disorders, or conditions affecting balance and walking,
- individuals with a history of cardiac or pulmonary diseases that could affect respiratory function and exercise capacity.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Muserrefe Nur Keles, Phd contact
Turkey (Türkiye)1 site
Gazi University, Faculty of Health Science, Department of Physiotherapy and Rehabilitation
Ankara, Yenimahalle
Naciye SEVİM, +90 (312) 586 80 00, naciye.sevim@gazi.edu.tr
Muserrefe Nur Keles, Phd, muserrefe@gazi.edu.tr
About this study
Official title: Effects of Expiratory Muscle Strength Training on Cobb Angle, Respiratory Muscle Strength, Core Stabilization, Functional Exercise Capacity and Quality of Life in Adolescent Idiopathic Scoliosis
Adolescent idiopathic scoliosis result in deterioration of core muscles and respiratory system. Core muscles provide trunk stabilization as well as responsible for respiratory system. Especially tr. abdominis, rectus abdominis, external oblic and internal oblic muscle, which are core muscles, highly active during forced expiration while diaphragm muscle also active during inspiration. Thus, expiratory muscle strength training has effect not only respiratory muscle strength but also trunk stabilization. While, effects of expiratory muscle strength training in adolesecent idiopathic scoliosis is a topic that needs to be investigated, this topic has not been investigated until today. Hence, this current study aimed to investigate the effects of expiratory muscle strength training on cobb angle, respiratory muscle strength, core stabilization, functional exercise capacity and quality of life.
Read the detailed description
A convenience of children with adolescent idiopathic scoliosis, 10-19 years, is going to recruited from Gazi University, Faculty of Health Sciences, Department of Physiotherapy and Rehabilitation. Patients will randomly allocate to either a treatment group or control group. The treatments group will receive expiratory muscle strength training at 50% maximal expiratory presssure while, the control group will receive sham expiratory muscle strength training without physiological load. Groups are going to train for a total of 25 breathe/day, 5 days/week, for 6 weeks. Before and after treatment, all of patients progression of scoliosis will be evaluated by calculating cobb angle, respiratory muscle strength using with electronic mouth pressure device, core stability using with Mc-Gill endurance test and the stabilizer biofeedback unit, functional exercise capacity using with six minute walk test (6MWT) and six minute pegboard and ring test (6MPBRT), quality of life using with scoliosis research society -22 questionnare (SRS-22) and daily living activity of upper extremity using with quick-DASH questionnare.
- Being tested
- Expiratory Muscle Strength Training (EMST-150), Sham Training
- Keywords
- Adolescent idiopathic scoliosis, Expiratory muscle strength training, Cobb angle, Core stability, Functional exercise capacity, Respiratory muscle stregth
- Medical subject headings
- Scoliosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Expiratory Muscle Strength Training (EMST-150)Device
Training is going to perform by using a pressure treshold-loading device (EMST-150, Aspire Products, LLC, Gainesville, FL) used to exhale against a same-pressure load every exhalation for strengthening primarily the core muscles. The device pressure is adjusted according to PEmax and reliability/reproducibility has been demonstrated.
Sham TrainingDevice
Training is going to perform by using a pressure treshold-loading device (EMST-150, Aspire Products, LLC, Gainesville, FL) without physiological load. The sham device closely resembled the EMST device, with the only difference being that the pressure release valve was rendered nonfunctional by removing the spring. As a result, it exerted minimal to no physiological load on the targeted muscles.
| Study group | Role | What they receive |
|---|---|---|
| Expiratory Muscle Strength Training Group | Active comparator | The treatment group will receive expiratory muscle strength training (EMST) at 50% maximal expiratory mouth pressure (PEmax) by using EMST-150 device and training load were adjusted to maintain 50% of the PEmax weekly. The PEmax will measured at supervised sessions each week and 50% of the measured value will determined as the new training work load. Receives: Device: Expiratory Muscle Strength Training (EMST-150) |
| Sham Group | Sham comparator | The control group will receive expiratory muscle strength training (EMST) without physiological load by using expiratory muscle strength training device. Receives: Device: Sham Training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cobb Angle
This is the gold standard method used to assess the lateral curvature of the spine. In this method, participants' anteroposterior radiographic images will be captured while they are in a standing position. The angle between a line drawn parallel to the upper edge of the highest vertebra involved in the scoliosis curve and a line drawn parallel to the lower edge of the lowest vertebra involved will be measured on the radiographic image. These measurements will be performed by an experienced orthopedic physician
Measured: 6 Weeks
Secondary outcomes (7)
Respiratory Muscle Strength
The measurement of maximal inspiratory pressures (MIP) and maximal expiratory pressures (MEP), which are voluntarily assessed to evaluate the participants' respiratory muscle strength, will be conducted using an electronic and portable mouth pressure measurement device (Micro Medical MicroRM, UK) in accordance with ATS/ERS criteria.
Measured: 6 Weeks
McGill Endurance Test
The participants' core stabilization will be assessed using the McGill Endurance Test.
Measured: 6 Weeks
'6 Minute Pegboard and Ring' Test
To assess the functional exercise capacity of the participants, the 'Pegboard and Ring' test will be performed for the upper extremities.
Measured: 6 Weeks
Scoliosis Research Society 22 Patient Questionnaire
The participants' quality of life will be assessed using the scoliosis research society 22 patient questionnaire. This questionnaire consists of 22 items and each item is scored between 0-5 point. While, the maximum score that obtained from the questionnaire is 110 point, the minimum score is 0 point. An increase scores on this questionnaire mean that quality of life has improved.
Measured: 6 Weeks
Quick Disabilities of the Arm, Shoulder and Hand Questionnaire
The functional impairments of the upper extremities in the participants' activities of daily living will be assessed using the quick disabilities of the arm, shoulder, and hand questionnaire. This questionnaire consists of 11 items and each item is scored between 1-5 point. While, the maximum score that obtained from the questionnaire is 55 point, the minimum score is 11 point. An increase scores on this questionnaire mean that upper extremities in the participants' activities of daily living have worsened.
Measured: 6 Weeks
The Stabilizer Pressure Biofeedback Unit
To assess the deep core muscle stabilization of the participants, the stabilizer pressure biofeedback unit will be performed.
Measured: 6 Weeks
6 Minute Walk Test
To evaluate functional exercise capacity of the participants, the '6-Minute Walk test will be conducted for the lower extremities
Measured: 6 Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Dec 2024
- Study start4 Jan 2025 (estimated)
- Primary completion2 May 2025 (estimated)
- Study completion2 Jul 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Adolescent Idiopathic Scoliosis (AIS)Studies of the same condition, open and under way.
- More trials run by Gazi 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Gazi University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Muserrefe Nur Keles, Gazi University
- Investigators
- Muserrefe Nur Keles, PhD, Study chair, Gazi University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06752993
- Sponsor's protocol ID
- 02112001
- Status last verified
- Dec 2024
- First submitted
- 6 Dec 2024
- Last updated
- 31 Dec 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Expiratory Muscle Strength Training on Cobb Angle, Respiratory Muscle Strength, Core Stabilization, Functional Exercise Capacity and Quality of Life in Adolescent Idiopathic Scoliosis
- ClinicalTrials.gov ID
- NCT06752993
- Acronym / sponsor ID
- 02112001
- Keywords
- Adolescent idiopathic scoliosis, Expiratory muscle strength training, Cobb angle, Core stability, Functional exercise capacity, Respiratory muscle stregth
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- Gazi UniversityUniversity, hospital or other
- Study start
- 4 Jan 2025 (estimated)
- Primary completion
- 2 May 2025 (estimated)
- Study completion
- 2 Jul 2025 (estimated)
- First posted
- 31 Dec 2024 (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.
Adolescent idiopathic scoliosis result in deterioration of core muscles and respiratory system. Core muscles provide trunk stabilization as well as responsible for respiratory system. Especially tr. abdominis, rectus abdominis, external oblic and internal oblic muscle, which are core muscles, highly active during forced expiration while diaphragm muscle also active during inspiration. Thus, expiratory muscle strength training has effect not only respiratory muscle strength but also trunk stabilization. While, effects of expiratory muscle strength training in adolesecent idiopathic scoliosis is a topic that needs to be investigated, this topic has not been investigated until today. Hence, this current study aimed to investigate the effects of expiratory muscle strength training on cobb angle, respiratory muscle strength, core stabilization, functional exercise capacity and quality of life.
Detailed description
A convenience of children with adolescent idiopathic scoliosis, 10-19 years, is going to recruited from Gazi University, Faculty of Health Sciences, Department of Physiotherapy and Rehabilitation. Patients will randomly allocate to either a treatment group or control group. The treatments group will receive expiratory muscle strength training at 50% maximal expiratory presssure while, the control group will receive sham expiratory muscle strength training without physiological load. Groups are going to train for a total of 25 breathe/day, 5 days/week, for 6 weeks. Before and after treatment, all of patients progression of scoliosis will be evaluated by calculating cobb angle, respiratory muscle strength using with electronic mouth pressure device, core stability using with Mc-Gill endurance test and the stabilizer biofeedback unit, functional exercise capacity using with six minute walk test (6MWT) and six minute pegboard and ring test (6MPBRT), quality of life using with scoliosis research society -22 questionnare (SRS-22) and daily living activity of upper extremity using with quick-DASH questionnare.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Expiratory Muscle Strength Training Group | Active comparator | Device: Expiratory Muscle Strength Training (EMST-150)The treatment group will receive expiratory muscle strength training (EMST) at 50% maximal expiratory mouth pressure (PEmax) by using EMST-150 device and training load were adjusted to maintain 50% of the PEmax weekly. The PEmax will measured at supervised sessions each week and 50% of the measured value will determined as the new training work load. |
| Sham Group | Sham comparator | Device: Sham TrainingThe control group will receive expiratory muscle strength training (EMST) without physiological load by using expiratory muscle strength training device. |
Who may qualify
- Ages
- 10 to 19 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- Individuals diagnosed with idiopathic scoliosis,
- aged between 10 and 19 years,
- with a Cobb angle ranging from 10 to 45 degrees.
Key exclusion criteria (4 listed)
- Individuals who have undergone spinal surgery,
- who have received conservative or surgical treatment for scoliosis,
- individuals with neurological, neuromuscular, systemic, rheumatological, or musculoskeletal disorders, or conditions affecting balance and walking,
- individuals with a history of cardiac or pulmonary diseases that could affect respiratory function and exercise capacity.
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 |
|---|---|---|
| Expiratory Muscle Strength Training (EMST-150)Training is going to perform by using a pressure treshold-loading device (EMST-150, Aspire Products, LLC, Gainesville, FL) used to exhale against a same-pressure load every exhalation for strengthening primarily the core muscles. The device pressure is adjusted according to PEmax and reliability/reproducibility has been demonstrated. | Device | Expiratory Muscle Strength Training Group |
| Sham TrainingTraining is going to perform by using a pressure treshold-loading device (EMST-150, Aspire Products, LLC, Gainesville, FL) without physiological load. The sham device closely resembled the EMST device, with the only difference being that the pressure release valve was rendered nonfunctional by removing the spring. As a result, it exerted minimal to no physiological load on the targeted muscles. | Device | Sham Group |
Primary outcome
Cobb Angle
Time frame: 6 Weeks
This is the gold standard method used to assess the lateral curvature of the spine. In this method, participants' anteroposterior radiographic images will be captured while they are in a standing position. The angle between a line drawn parallel to the upper edge of the highest vertebra involved in the scoliosis curve and a line drawn parallel to the lower edge of the lowest vertebra involved will be measured on the radiographic image. These measurements will be performed by an experienced orthopedic physician
7 secondary outcomes
Respiratory Muscle Strength
Time frame: 6 Weeks
McGill Endurance Test
Time frame: 6 Weeks
'6 Minute Pegboard and Ring' Test
Time frame: 6 Weeks
Scoliosis Research Society 22 Patient Questionnaire
Time frame: 6 Weeks
Quick Disabilities of the Arm, Shoulder and Hand Questionnaire
Time frame: 6 Weeks
The Stabilizer Pressure Biofeedback Unit
Time frame: 6 Weeks
6 Minute Walk Test
Time frame: 6 Weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Dec 2024.
- Individual participant dataSharing planned: No
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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.
Muserrefe Nur Keles, Phd contact
Muserrefe Nur Keles, PhD study chair
Gazi University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Expiratory Muscle Strength Training (EMST-150) in people with Adolescent Idiopathic Scoliosis (AIS) and Scoliosis; Adolescence, run by Gazi 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 3 inclusion and 4 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: opening soon, as of the sponsor's last update on 31 Dec 2024. 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. Some participants in this study may receive a placebo. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Naciye Sevim (+90 (312) 586 80 00, naciye.sevim@gazi.edu.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cobb Angle (time frame: 6 Weeks). 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 31 Dec 2024.