The Effect of Schroth Exercises on Pulmonary Function in Adolescent Idiopathic Scoliosis
Primary Purpose
Adolescent Idiopathic Scoliosis, Pulmonary Function
Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Brace and Exercise Treatment
Brace Treatment
Sponsored by
About this trial
This is an interventional treatment trial for Adolescent Idiopathic Scoliosis
Eligibility Criteria
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
Sites / Locations
- Halic University
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
"Brace&Exercise Group"
"Brace Group"
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
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.
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.
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT05505695
First Posted
July 30, 2022
Last Updated
August 19, 2022
Sponsor
Istanbul Medipol University Hospital
Collaborators
Halic University
1. Study Identification
Unique Protocol Identification Number
NCT05505695
Brief Title
The Effect of Schroth Exercises on Pulmonary Function in Adolescent Idiopathic Scoliosis
Official Title
The Effect of Schroth Exercises on Pulmonary Function in Adolescent Idiopathic Scoliosis
Study Type
Interventional
2. Study Status
Record Verification Date
July 2022
Overall Recruitment Status
Completed
Study Start Date
December 2, 2019 (Actual)
Primary Completion Date
September 11, 2020 (Actual)
Study Completion Date
September 11, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Istanbul Medipol University Hospital
Collaborators
Halic University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Adolescent Idiopathic Scoliosis, Pulmonary Function
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
24 (Actual)
8. Arms, Groups, and Interventions
Arm Title
"Brace&Exercise Group"
Arm Type
Experimental
Arm Description
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.
Arm Title
"Brace Group"
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Brace and Exercise Treatment
Intervention Description
Schroth exercises, which are a specific exercise method for scoliosis, were given to the experimental group for 8 weeks, different from the control group.
Intervention Type
Other
Intervention Name(s)
Brace Treatment
Intervention Description
Among the patients included in the study, those who wore braces but did not agree to exercise constituted the ''Brace Group'' of the study.
Primary Outcome Measure Information:
Title
FVC - Respiratory Functions
Description
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.
Time Frame
8 Weeks
Title
FEV1 - Respiratory Functions
Description
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.
Time Frame
8 Weeks
Title
PEF - Respiratory Functions
Description
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.
Time Frame
8 Weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
10 Years
Maximum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Halic University
City
Istanbul
Country
Turkey
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
The Effect of Schroth Exercises on Pulmonary Function in Adolescent Idiopathic Scoliosis
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