Evaluatıon Of The Possible Effect Of Inspıratory Muscle Training On Inflammation Markers And Oxıdatıve Stress In Childhood Asthma

Study Overview
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Brief Summary
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As inflammation and oxidative stress increase in asthma patients, the severity of symptoms and clinical findings increase. Therefore, this study was planned to evaluate the possible effect of inspiratory muscle training (IMT) on inflammation markers and oxidative stress in childhood asthma. The study included asthma patient; 35 routine medication, 35 drug therapy and inspiratory muscle training (IMT), and 35 healthy total 105 children aged 8-17 years. Demographic information and hemogram values were recorded. Functional capacity was evaluated with the 6-minute walking test, quality of life PedsQL, respiratory muscle strength oral pressure measuring device, respiratory function test, dyspnea severity with Modified Borg Scale. C-Reactive Protein (CRP), Periostin, Transforming Growth Factor-βeta (TGF-β), Total Antioxidant Status (TAS), Total Oxidant Status (TOS), Oxidative Stress Index (OSI) were analyzed. IMT was given with a Threshold IMT device for 7 days/6 weeks at 30% of maximal inspiratory pressure, and then a second evaluation was made.

Official Title
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Evaluatıon Of The Possible Effect Of Inspıratory Muscle Training On Inflammation Markers And Oxıdatıve Stress In Childhood Asthma

Conditions
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Asthma in Children, Children, Adult

Intervention / Treatment
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* Other: Inspıratory muscle training
* Other: Used routine medicine
* Other: Control group


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Have been diagnosed with asthma, Between the ages of 8-17, No asthma attack, Cooperating with the study, Without cerebral palsy, mental retardation or any other major neurological diagnosis, Agreeing to participate in the study, Cases whose medication has not been changed for at least three weeks. Exclusion Criteria: Presence of kyphoscoliosis that may affect respiration, Having advanced postural alignment problem, Having mental problems, Having neuromuscular disease, Making changes in the medications used in the last three weeks, Presence of inflammatory diseases such as juvenile idiopathic arthritis.

Ages Eligible for Study
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Minimum Age: 8 Years
Maximum Age: 17 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Randomized clinical trial
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Inspiratory muscle training group<br>Thershold IMT was given this group. Applied for 7 days 6 weeks. | Other: Inspıratory muscle training<br>* The MIP/MEP value of the group that will receive inspiratory muscle training was determined and Thershold IMT training was given with 30%. In the training, the subjects were asked to sit in a relaxed position with their upper chest and shoulders relaxed. After the nose clip was attached, the children were asked to inhale and exhale by tightly closing the mouthpiece of the instrument with their lips. A 30-minute training session was carried out for 6 weeks, with 10-15 repetitive breathing apparatus and 5-10 seconds rest breaks every day.<br>Other: Used routine medicine<br>* After the first evaluation was made, a second evaluation was made after 6 weeks of follow-up.<br>|
| Active Comparator: Used routine medicine group<br>Followed 6 weeks | Other: Used routine medicine<br>* After the first evaluation was made, a second evaluation was made after 6 weeks of follow-up.<br>|
| Active Comparator: Control Group<br>Health children | Other: Control group<br>* A healthy child compatible with the age and sex of the patient group was evaluated once.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Inflammatory marker | We assessed C reaktive protein from Blood sample | 6 weeks | 
| Inflammatory marker | We assessed TGF-B from Blood sample | 6 weeks | 
| Inflammatory marker | We assessed Periostin from Blood sample | 6 weeks | 
| Oxidative stress | We assessed Total oxidative level. | 6 weeks | 
| Oxidative stress | We assessed total antioxidative level | 6 weeks | 
| Oxidative stress | We assessed oxidative status index | 6 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pulmonary function test | Pulmonary function test was measured with a portable MiniSpirobank device | 6 weeks | 
| Respiratory muscle strength | Respiratory muscle strength was measured using a portable (micro RPM brand) electronic mouth pressure measuring device according to ATS/ERS criteria | 6 weeks | 
| functional capacity | functional capacity was assessed 6 MWT | 6 weeks | 
| Quality life | Quality life was assessed PedsQl | 6 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Childhood Asthma, Inspiratory Muscle Training, Inflammation