Clinical trial NCT05296707: Evaluation of the Possible Effect of Inspiratory Muscle Training on Inflammation Markers and Oxidative Stress in Childhood Asthma
Official title: Evaluation of the Possible Effect of Inspiratory Muscle Training on Inflammation Markers and Oxidative Stress in Childhood Asthma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Asthma in Children
Children, Adult
Keywords: Childhood Asthma
Inspiratory Muscle Training
Inflammation
Lead sponsor: Ege University
Sponsor class: OTHER
Collaborators: name: Mustafa Kemal University
First posted: 2022-03-25
Enrollment: 105
Sex: ALL
Minimum age (years): 8
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized clinical trial
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Inflammatory marker
timeFrame: 6 weeks
measure: Inflammatory marker
timeFrame: 6 weeks
measure: Inflammatory marker
timeFrame: 6 weeks
measure: Oxidative stress
timeFrame: 6 weeks
measure: Oxidative stress
timeFrame: 6 weeks
measure: Oxidative stress
timeFrame: 6 weeks
Secondary outcomes:
measure: Pulmonary function test
timeFrame: 6 weeks
measure: Respiratory muscle strength
timeFrame: 6 weeks
measure: functional capacity
timeFrame: 6 weeks
measure: Quality life
timeFrame: 6 weeks
Other outcomes:
Locations:
city: İzmir
country: Turkey
facility: Ege University
state: Karsıyaka
Study officials:
References: