The Effect of Schroth Exercises on Pulmonary Function in Adolescent Idiopathic Scoliosis

August 19, 2022 updated by: Istanbul Medipol University Hospital

Background: In the present study, we aimed to evaluate the effect of regular Schroth exercises on pulmonary functions in adolescent idiopathic scoliosis (AIS) patients who use rigid braces and perform Schroth exercises regularly.

Objective: The main purpose of this study, is to investigate the effects of Schroth exercises on pulmonary functions in adolescents who use rigid braces and perform Schroth exercises regularly.

Methods: Twenty-four patients with AIS were included in the study. The patients who wore rigid braces and performed the SSE therapy constituted the "Brace&Exercise" (N=12), and the patients who wore full-time rigid braces but did not perform exercise constituted the "Brace Group" (N=12) of the study. The effects of Schroth exercises on pulmonary functions were measured at the beginning of treatment and the 8th week of the treatment.

Keywords: Adolescent, idiopathic scoliosis, conservative treatment, brace, respiratory function, Schroth exercises.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
24

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
      • Istanbul, Turkey
        • Halic University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

10 years to 16 years (CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 10-16 years,
  • 25-45 Cobb degree,
  • Brace and exercise treatment prescribed by the physician
  • Participation in the study was approved by the family/caregiver

Exclusion Criteria:

  • Chronic respiratory diseases,
  • Professional athletes,
  • Did not perform the exercises regularly
  • Did not compliance the brace

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NON_RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
EXPERIMENTAL: "Brace&Exercise Group"
The patients who were the rigid brace and performed the SSE therapy in the specified constituted the Brace & Exercise. Experimental group patients wore full-time rigid brace and Schroth exercises for 60 minutes 5 days a week by the physician.
Other: Brace and Exercise Treatment
Schroth exercises, which are a specific exercise method for scoliosis, were given to the experimental group for 8 weeks, different from the control group.
ACTIVE_COMPARATOR: "Brace Group"
The patients who wore full-time rigid braces but did not perform exercise constituted the Brace group. Comparator group patients wore full-time brace only, did not perform Schroth exercises.
Other: Brace Treatment
Among the patients included in the study, those who wore braces but did not agree to exercise constituted the ''Brace Group'' of the study.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
FVC - Respiratory Functions
Time Frame: 8 Weeks
Forced vital capacity (FVC), is the maximum amount of air that can be exhaled when blowing out as fast as possible. The pulmonary function test was evaluated with two different measurements, both at the beginning of the treatment (T0) and at the 8th week of the treatment (T1). The data obtained was determined as the primary outcome of the study, and the patients in both groups were administered by the research physiotherapist. For respiratory function tests were used a handheld type spirometer (SP10W, Contec). For the spirometric measurement, the patient was seated on the chair and a clip was placed on the patient nose to keep the nostril closed. Afterward, the device was placed in the patient's mouth, they were asked to take a deep breath and exhale into the device with maximum force. This process was repeated three times and the highest value among the measurements was recorded as respiratory function data.
8 Weeks
FEV1 - Respiratory Functions
Time Frame: 8 Weeks
Forced expiratory volume in 1 second (FEV1) is the volume of air exhaled in the first second during forced exhalation after maximum inspiration. The pulmonary function test was evaluated with two different measurements, both at the beginning of the treatment (T0) and at the 8th (T1) week of the treatment. The obtained data were determined as the primary outcome of the study and the patients in both groups were administered the same procedure by the researcher physiotherapist.
8 Weeks
PEF - Respiratory Functions
Time Frame: 8 Weeks
Peak expiratory flow (PEF), the maximal flow that can be exhaled when blowing out at a steady rate. The pulmonary function test was evaluated with two different measurements, both at the beginning of the treatment (T0) and at the 8th (T1) week of the treatment. The obtained data were determined as the primary outcome of the study and the patients in both groups were administered the same procedure by the researcher physiotherapist.
8 Weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Istanbul Medipol University Hospital

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Halic University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 2, 2019

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 11, 2020

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 11, 2020

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 30, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 15, 2022

First Posted (ACTUAL)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 18, 2022

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 22, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 19, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • schroth exercises

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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