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

Primary Purpose

Asthma in Children, Children, Adult

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Inspıratory muscle training
Used routine medicine
Control group
Sponsored by
Ege University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Asthma in Children focused on measuring Childhood Asthma, Inspiratory Muscle Training, Inflammation

Eligibility Criteria

8 Years - 17 Years (Child)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Ege University

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Active Comparator

Arm Label

Inspiratory muscle training group

Used routine medicine group

Control Group

Arm Description

Thershold IMT was given this group. Applied for 7 days 6 weeks.

Followed 6 weeks

Health children

Outcomes

Primary Outcome Measures

Inflammatory marker
We assessed C reaktive protein from Blood sample
Inflammatory marker
We assessed TGF-B from Blood sample
Inflammatory marker
We assessed Periostin from Blood sample
Oxidative stress
We assessed Total oxidative level.
Oxidative stress
We assessed total antioxidative level
Oxidative stress
We assessed oxidative status index

Secondary Outcome Measures

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

Full Information

First Posted
March 3, 2022
Last Updated
March 16, 2022
Sponsor
Ege University
Collaborators
Mustafa Kemal University
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1. Study Identification

Unique Protocol Identification Number
NCT05296707
Brief Title
Evaluatıon Of The Possible Effect Of Inspıratory Muscle Training On Inflammation Markers And Oxıdatıve Stress In Childhood Asthma
Official Title
Evaluatıon Of The Possible Effect Of Inspıratory Muscle Training On Inflammation Markers And Oxıdatıve Stress In Childhood Asthma
Study Type
Interventional

2. Study Status

Record Verification Date
March 2022
Overall Recruitment Status
Completed
Study Start Date
March 1, 2019 (Actual)
Primary Completion Date
June 30, 2020 (Actual)
Study Completion Date
June 30, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ege University
Collaborators
Mustafa Kemal University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Asthma in Children, Children, Adult
Keywords
Childhood Asthma, Inspiratory Muscle Training, Inflammation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Randomized clinical trial
Masking
None (Open Label)
Allocation
Randomized
Enrollment
105 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Inspiratory muscle training group
Arm Type
Experimental
Arm Description
Thershold IMT was given this group. Applied for 7 days 6 weeks.
Arm Title
Used routine medicine group
Arm Type
Active Comparator
Arm Description
Followed 6 weeks
Arm Title
Control Group
Arm Type
Active Comparator
Arm Description
Health children
Intervention Type
Other
Intervention Name(s)
Inspıratory muscle training
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Used routine medicine
Intervention Description
After the first evaluation was made, a second evaluation was made after 6 weeks of follow-up.
Intervention Type
Other
Intervention Name(s)
Control group
Intervention Description
A healthy child compatible with the age and sex of the patient group was evaluated once.
Primary Outcome Measure Information:
Title
Inflammatory marker
Description
We assessed C reaktive protein from Blood sample
Time Frame
6 weeks
Title
Inflammatory marker
Description
We assessed TGF-B from Blood sample
Time Frame
6 weeks
Title
Inflammatory marker
Description
We assessed Periostin from Blood sample
Time Frame
6 weeks
Title
Oxidative stress
Description
We assessed Total oxidative level.
Time Frame
6 weeks
Title
Oxidative stress
Description
We assessed total antioxidative level
Time Frame
6 weeks
Title
Oxidative stress
Description
We assessed oxidative status index
Time Frame
6 weeks
Secondary Outcome Measure Information:
Title
Pulmonary function test
Description
Pulmonary function test was measured with a portable MiniSpirobank device
Time Frame
6 weeks
Title
Respiratory muscle strength
Description
Respiratory muscle strength was measured using a portable (micro RPM brand) electronic mouth pressure measuring device according to ATS/ERS criteria
Time Frame
6 weeks
Title
functional capacity
Description
functional capacity was assessed 6 MWT
Time Frame
6 weeks
Title
Quality life
Description
Quality life was assessed PedsQl
Time Frame
6 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
8 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Facility Information:
Facility Name
Ege University
City
İzmir
State/Province
Karsıyaka
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
No

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

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