Effects of Expiratory Muscle Strength Training in Adolescent Idiopathic Scoliosis

NCT ID: NCT06752993

Last Updated: 2024-12-31

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 24 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-01-04
• Study Completion Date: 2025-07-02

Brief 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. 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.

Conditions

Adolescent Idiopathic Scoliosis (AIS); Scoliosis; Adolescence

Keywords

Adolescent idiopathic scoliosis; Expiratory muscle strength training; Cobb angle; Core stability; Functional exercise capacity; Respiratory muscle stregth

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Expiratory Muscle Strength Training Group

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.

Group Type: ACTIVE_COMPARATOR

Expiratory Muscle Strength Training (EMST-150)

Intervention Type: 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 Group

The control group will receive expiratory muscle strength training (EMST) without physiological load by using expiratory muscle strength training device.

Group Type: SHAM_COMPARATOR

Sham Training

Intervention Type: DEVICE

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.

Interventions

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.

Intervention Type: DEVICE

Sham Training

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.

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• Individuals diagnosed with idiopathic scoliosis,
• aged between 10 and 19 years,
• with a Cobb angle ranging from 10 to 45 degrees.

Exclusion Criteria

• 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.

• Minimum Eligible Age: 10 Years
• Maximum Eligible Age: 19 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Gazi University

OTHER

Sponsor Role: lead

Responsible Party

Muserrefe Nur Keles

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Muserrefe Nur Keles, PhD

Role: STUDY_CHAIR

Gazi University

Locations

Gazi University, Faculty of Health Science, Department of Physiotherapy and Rehabilitation

Ankara, Yenimahalle, Turkey (Türkiye)

Countries

Turkey (Türkiye)

Central Contacts

Naciye Sevim

Role: CONTACT

Phone: +90 (312) 586 80 00

Email: naciye.sevim@gazi.edu.tr

Muserrefe Nur Keles, Phd

Role: CONTACT

Email: muserrefe@gazi.edu.tr

Facility Contacts

Naciye SEVİM

Role: primary

Muserrefe Nur Keles, Phd

Role: backup

Other Identifiers

02112001

Identifier Type: -

Identifier Source: org_study_id