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Clinical Trials/NCT05296707
NCT05296707CompletedNot Applicable

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

Ege University1 site in 1 country105 target enrollmentStarted: March 1, 2019Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
105
Locations
1
Primary Endpoint
Inflammatory marker

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
8 Years to 17 Years (Child)
Sex
All
Accepts Healthy Volunteers
Yes

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.

Arms & Interventions

Control Group

Active Comparator

Health children

Intervention: Control group (Other)

Used routine medicine group

Active Comparator

Followed 6 weeks

Intervention: Used routine medicine (Other)

Inspiratory muscle training group

Experimental

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

Intervention: Inspiratory muscle training (Other)

Inspiratory muscle training group

Experimental

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

Intervention: Used routine medicine (Other)

Outcomes

Primary Outcomes

Inflammatory marker

Time Frame: 6 weeks

We assessed C reaktive protein from Blood sample

Oxidative stress

Time Frame: 6 weeks

We assessed Total oxidative level.

Secondary Outcomes

  • functional capacity(6 weeks)
  • Quality life(6 weeks)
  • Pulmonary function test(6 weeks)
  • Respiratory muscle strength(6 weeks)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Ozden Gokcek

Principal Investigator

Ege University

Study Sites (1)

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