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

Not Applicable

Completed

• Conditions: Children, Adult; Asthma in Children
• Interventions: Other: Control group; Other: Inspiratory muscle training; Other: Used routine medicine

• Registration Number: NCT05296707
• Lead Sponsor: Ege University

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2019-03-01
• Primary Completion: 2020-06-30
• Study Completion: 2020-06-30
• Study First Submitted: 2022-03-03
• Study First Submitted QC: 2022-03-16
• Study First Posted: 2022-03-25
• Status Verified: 2024-02
• Last Update Submitted: 2024-02-15
• Last Update Posted: 2024-02-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 105

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Inspiratory muscle training group	Used routine medicine	Threshold IMT was given this group. Applied for 7 days 6 weeks.
Used routine medicine group	Used routine medicine	Followed 6 weeks
Control Group	Control group	Health children
Inspiratory muscle training group	Inspiratory muscle training	Threshold IMT was given this group. Applied for 7 days 6 weeks.

Primary Outcome Measures

Name	Time	Method
Inflammatory marker	6 weeks	We assessed Periostin from Blood sample
Oxidative stress	6 weeks	We assessed oxidative status index

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Ege University; 🇹🇷 İzmir, Karsıyaka, Turkey