- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05505695
The Effect of Schroth Exercises on Pulmonary Function in Adolescent Idiopathic Scoliosis
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
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Istanbul, Turkey
- Halic University
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
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
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: NON_RANDOMIZED
- Interventional Model: PARALLEL
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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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.
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Schroth exercises, which are a specific exercise method for scoliosis, were given to the experimental group for 8 weeks, different from the control group.
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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.
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Among the patients included in the study, those who wore braces but did not agree to exercise constituted the ''Brace Group'' of the study.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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FVC - Respiratory Functions
Time Frame: 8 Weeks
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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.
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8 Weeks
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FEV1 - Respiratory Functions
Time Frame: 8 Weeks
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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.
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8 Weeks
|
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PEF - Respiratory Functions
Time Frame: 8 Weeks
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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.
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8 Weeks
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Collaborators and Investigators
Collaborators
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- schroth exercises
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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