Effects of Expiratory Muscle Strength Training in Adolescent Idiopathic Scoliosis

NCT06752993 | Not Yet Recruiting DMC

• 1 other identifier: 02112001
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (1)

• 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

  6 Weeks

Secondary Outcomes (7)

• Respiratory Muscle Strength

  6 Weeks

• McGill Endurance Test

  6 Weeks

• '6 Minute Pegboard and Ring' Test

  6 Weeks

• Scoliosis Research Society 22 Patient Questionnaire

  6 Weeks

• Quick Disabilities of the Arm, Shoulder and Hand Questionnaire

  6 Weeks

Study Arms (2)

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.

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.

Device: Sham Training

Interventions

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.

Expiratory Muscle Strength Training Group

Sham Training 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.

Sham Group

Eligibility Criteria

• Age: 10 Years - 19 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Gazi University: lead

Study Sites (1)

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

Ankara, Yenimahalle, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Scoliosis

Condition Hierarchy (Ancestors)

Spinal Curvatures; Spinal Diseases; Bone Diseases; Musculoskeletal Diseases

Study Officials

• Muserrefe Nur Keles, PhD

  Gazi University

  STUDY CHAIR

Central Study Contacts

Naciye Sevim

CONTACT

+90 (312) 586 80 00; naciye.sevim@gazi.edu.tr

Muserrefe Nur Keles, Phd

CONTACT

muserrefe@gazi.edu.tr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: December 6, 2024
• First Posted: December 31, 2024
• Study Start: January 4, 2025
• Primary Completion: May 2, 2025
• Study Completion: July 2, 2025
• Last Updated: December 31, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)