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

NCT05296707 | Completed

• 1 other identifier: 2019/16
• Study Type: interventional
• Target: 105
• Locations: 1 country
• Sites: 1

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.

Conditions

Asthma in Children; Children, Adult

Keywords

Childhood Asthma; Inspiratory Muscle Training; Inflammation

Outcome Measures

Primary Outcomes (6)

• 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 Outcomes (4)

• Pulmonary function test

  6 weeks

• Respiratory muscle strength

  6 weeks

• functional capacity

  6 weeks

• Quality life

  6 weeks

Study Arms (3)

Inspiratory muscle training group

EXPERIMENTAL

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

Other: Inspiratory muscle training; Other: Used routine medicine

Used routine medicine group

ACTIVE COMPARATOR

Followed 6 weeks

Other: Used routine medicine

Control Group

ACTIVE COMPARATOR

Health children

Other: Control group

Interventions

Inspiratory muscle training OTHER

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.

Inspiratory muscle training group

Used routine medicine OTHER

After the first evaluation was made, a second evaluation was made after 6 weeks of follow-up.

Inspiratory muscle training group; Used routine medicine group

Control group OTHER

A healthy child compatible with the age and sex of the patient group was evaluated once.

Control Group

Eligibility Criteria

• Age: 8 Years - 17 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ege University: lead
• Mustafa Kemal University: collaborator

Study Sites (1)

Ege University

Izmir, Karsıyaka, Turkey (Türkiye)

Location

Related Publications (1)

• Gokcek O, Yurdalan U, Tugay BU, El C, Dogan S. Evaluation of the possible effect of inspiratory muscle training on inflammation markers and oxidative stress in childhood asthma. Eur J Pediatr. 2023 Aug;182(8):3713-3722. doi: 10.1007/s00431-023-05047-4. Epub 2023 Jun 7.

  PMID: 37285069 DERIVED

MeSH Terms

Conditions

Inflammation

Interventions

Control Groups

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Randomized clinical trial

Study Record Dates

• First Submitted: March 3, 2022
• First Posted: March 25, 2022
• Study Start: March 1, 2019
• Primary Completion: June 30, 2020
• Study Completion: June 30, 2020
• Last Updated: February 20, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)