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Completed

NCT Number: NCT05296707

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.

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Key information

Conditions

Asthma in Children Children, Adult Inflammation Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

8 year–17 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Ege University

Izmir, Karsıyaka, Turkey (Türkiye)

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Used routine medicine

Other

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

Control Group

Other

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

Primary outcomes

  1. Inflammatory marker

    Time frame: 6 weeks

    We assessed C reaktive protein from Blood sample

  2. Inflammatory marker

    Time frame: 6 weeks

    We assessed TGF-B from Blood sample

  3. Inflammatory marker

    Time frame: 6 weeks

    We assessed Periostin from Blood sample

  4. Oxidative stress

    Time frame: 6 weeks

    We assessed Total oxidative level.

  5. Oxidative stress

    Time frame: 6 weeks

    We assessed total antioxidative level

  6. Oxidative stress

    Time frame: 6 weeks

    We assessed oxidative status index

Secondary outcomes

  1. Pulmonary function test

    Time frame: 6 weeks

    Pulmonary function test was measured with a portable MiniSpirobank device

  2. Respiratory muscle strength

    Time frame: 6 weeks

    Respiratory muscle strength was measured using a portable (micro RPM brand) electronic mouth pressure measuring device according to ATS/ERS criteria

  3. functional capacity

    Time frame: 6 weeks

    functional capacity was assessed 6 MWT

  4. Quality life

    Time frame: 6 weeks

    Quality life was assessed PedsQl

Sponsors and collaborators

Lead sponsor

Ege University

Other

Collaborators

  • Mustafa Kemal University

Registry information

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Mar 25, 2022
Registry last updated
Feb 20, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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