Evaluation of the Possible Effect of Inspiratory Muscle Training on Inflammation Markers and Oxidative Stress in Childhood Asthma

Asthma in Children Clinical Trial

Official title:

Evaluation of the Possible Effect of Inspiratory Muscle Training on Inflammation Markers and Oxidative Stress in Childhood Asthma

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05296707
• Other study ID #: 2019/16
• Status: Completed
• Phase: N/A
• Start date: March 1, 2019
• Est. completion date: June 30, 2020

Study information

• Verified date: February 2024
• Source: Ege University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 105
• Est. completion date: June 30, 2020
• Est. primary completion date: June 30, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 8 Years to 17 Years

Eligibility

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.

Related Conditions & MeSH terms

• Asthma
• Asthma in Children
• Children, Adult
• Inflammation
• Respiratory Aspiration

Intervention

Other:
• Inspiratory muscle training
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.
• Used routine medicine
After the first evaluation was made, a second evaluation was made after 6 weeks of follow-up.
• Control group
A healthy child compatible with the age and sex of the patient group was evaluated once.

Locations

Country	Name	City	State
Turkey	Ege University	Izmir	Karsiyaka

Sponsors (2)

Lead Sponsor	Collaborator
Ege University	Mustafa Kemal University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Inflammatory marker	We assessed C reaktive protein from Blood sample	6 weeks
Primary	Inflammatory marker	We assessed TGF-B from Blood sample	6 weeks
Primary	Inflammatory marker	We assessed Periostin from Blood sample	6 weeks
Primary	Oxidative stress	We assessed Total oxidative level.	6 weeks
Primary	Oxidative stress	We assessed total antioxidative level	6 weeks
Primary	Oxidative stress	We assessed oxidative status index	6 weeks
Secondary	Pulmonary function test	Pulmonary function test was measured with a portable MiniSpirobank device	6 weeks
Secondary	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
Secondary	functional capacity	functional capacity was assessed 6 MWT	6 weeks
Secondary	Quality life	Quality life was assessed PedsQl	6 weeks