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: Completed
• Conditions: Asthma in Children; Children, Adult
• Intervention / Treatment: Other: Used routine medicine; Other: Control group; Other: Inspiratory muscle training

• Study Type: Interventional
• Enrollment (Actual): 105
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • Karsıyaka
    • İzmir, Karsıyaka, Turkey
      • Ege University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 8 years to 17 years (Child)
• Accepts Healthy Volunteers: Yes

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)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Used routine medicine group; Followed 6 weeks	Other: Used routine medicine; After the first evaluation was made, a second evaluation was made after 6 weeks of follow-up.
Active Comparator: Control Group; Health children	Other: Control group; 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.	Other: Used routine medicine; After the first evaluation was made, a second evaluation was made after 6 weeks of follow-up.; 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.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Ege University
• Collaborators: Mustafa Kemal University

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2019
• Primary Completion (Actual): June 30, 2020
• Study Completion (Actual): June 30, 2020

Study Registration Dates

• First Submitted: March 3, 2022
• First Submitted That Met QC Criteria: March 16, 2022
• First Posted (Actual): March 25, 2022

Study Record Updates

• Last Update Posted (Actual): February 20, 2024
• Last Update Submitted That Met QC Criteria: February 15, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Keywords: Inflammation; Childhood Asthma; Inspiratory Muscle Training
• Additional Relevant MeSH Terms: Pathologic Processes; Respiratory Tract Diseases; Immune System Diseases; Respiration Disorders; Lung Diseases; Hypersensitivity, Immediate; Bronchial Diseases; Lung Diseases, Obstructive; Respiratory Hypersensitivity; Hypersensitivity; Inflammation; Respiratory Aspiration; Asthma
• Other Study ID Numbers: 2019/16

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No