The Effect of Schroth Exercises on Pulmonary Function in Adolescent Idiopathic Scoliosis
1 other identifier
interventional
24
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Dec 2019
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 2, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 11, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
September 11, 2020
CompletedFirst Submitted
Initial submission to the registry
July 30, 2022
CompletedFirst Posted
Study publicly available on registry
August 18, 2022
CompletedAugust 22, 2022
July 1, 2022
9 months
July 30, 2022
August 19, 2022
Conditions
Outcome Measures
Primary Outcomes (3)
FVC - Respiratory Functions
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
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
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
Study Arms (2)
"Brace&Exercise Group"
EXPERIMENTALThe 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.
"Brace Group"
ACTIVE COMPARATORThe 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.
Interventions
Schroth exercises, which are a specific exercise method for scoliosis, were given to the experimental group for 8 weeks, different from the control group.
Among the patients included in the study, those who wore braces but did not agree to exercise constituted the ''Brace Group'' of the study.
Eligibility Criteria
You may qualify if:
- years,
- Cobb degree,
- Brace and exercise treatment prescribed by the physician
- Participation in the study was approved by the family/caregiver
You may not qualify if:
- Chronic respiratory diseases,
- Professional athletes,
- Did not perform the exercises regularly
- Did not compliance the brace
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Istanbul Medipol University Hospitallead
- Halic Universitycollaborator
Study Sites (1)
Halic University
Istanbul, Turkey (Türkiye)
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 30, 2022
First Posted
August 18, 2022
Study Start
December 2, 2019
Primary Completion
September 11, 2020
Study Completion
September 11, 2020
Last Updated
August 22, 2022
Record last verified: 2022-07
Data Sharing
- IPD Sharing
- Will not share