Evaluation of the Possible Effect of Inspiratory Muscle Training on Inflammation Markers and Oxidative Stress in Childhood Asthma
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.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Karsıyaka
-
İzmir, Karsıyaka, Turkey
- Ege University
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: Used routine medicine group
Followed 6 weeks
|
After the first evaluation was made, a second evaluation was made after 6 weeks of follow-up.
|
|
Active Comparator: Control Group
Health children
|
A healthy child compatible with the age and sex of the patient group was evaluated once.
|
|
Experimental: Inspiratory muscle training group
Threshold IMT was given this group.
Applied for 7 days 6 weeks.
|
After the first evaluation was made, a second evaluation was made after 6 weeks of follow-up.
The MIP/MEP value of the group that will receive inspiratory muscle training was determined and Threshold 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. |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Inflammatory marker
Time Frame: 6 weeks
|
We assessed C reaktive protein from Blood sample
|
6 weeks
|
|
Inflammatory marker
Time Frame: 6 weeks
|
We assessed TGF-B from Blood sample
|
6 weeks
|
|
Inflammatory marker
Time Frame: 6 weeks
|
We assessed Periostin from Blood sample
|
6 weeks
|
|
Oxidative stress
Time Frame: 6 weeks
|
We assessed Total oxidative level.
|
6 weeks
|
|
Oxidative stress
Time Frame: 6 weeks
|
We assessed total antioxidative level
|
6 weeks
|
|
Oxidative stress
Time Frame: 6 weeks
|
We assessed oxidative status index
|
6 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Pulmonary function test
Time Frame: 6 weeks
|
Pulmonary function test was measured with a portable MiniSpirobank device
|
6 weeks
|
|
Respiratory muscle strength
Time Frame: 6 weeks
|
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
Time Frame: 6 weeks
|
functional capacity was assessed 6 MWT
|
6 weeks
|
|
Quality life
Time Frame: 6 weeks
|
Quality life was assessed PedsQl
|
6 weeks
|
Collaborators and Investigators
Sponsor
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
- 2019/16
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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