Asthma in Children Clinical Trial
Official title:
Evaluation of the Possible Effect of Inspiratory Muscle Training on Inflammation Markers and Oxidative Stress in Childhood Asthma
NCT number | NCT05296707 |
Other study ID # | 2019/16 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | March 1, 2019 |
Est. completion date | June 30, 2020 |
Verified date | February 2024 |
Source | Ege University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 105 |
Est. completion date | June 30, 2020 |
Est. primary completion date | June 30, 2020 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 8 Years to 17 Years |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
Turkey | Ege University | Izmir | Karsiyaka |
Lead Sponsor | Collaborator |
---|---|
Ege University | Mustafa Kemal University |
Turkey,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Inflammatory marker | We assessed C reaktive protein from Blood sample | 6 weeks | |
Primary | Inflammatory marker | We assessed TGF-B from Blood sample | 6 weeks | |
Primary | Inflammatory marker | We assessed Periostin from Blood sample | 6 weeks | |
Primary | Oxidative stress | We assessed Total oxidative level. | 6 weeks | |
Primary | Oxidative stress | We assessed total antioxidative level | 6 weeks | |
Primary | Oxidative stress | We assessed oxidative status index | 6 weeks | |
Secondary | Pulmonary function test | Pulmonary function test was measured with a portable MiniSpirobank device | 6 weeks | |
Secondary | 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 | |
Secondary | functional capacity | functional capacity was assessed 6 MWT | 6 weeks | |
Secondary | Quality life | Quality life was assessed PedsQl | 6 weeks |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT04450108 -
Vivatmo Pro™ for Fractional Exhaled Nitric Oxide (FeNO) Monitoring in U.S. Asthmatic Patients
|
N/A | |
Recruiting |
NCT05734261 -
Forced Oscillations Technique During a Metacholine Test in Children
|
N/A | |
Recruiting |
NCT06044051 -
Dynamics of the Upper and Lower Airway Respiratory Microbiomes Associated With Severe Infant Asthma
|
N/A | |
Completed |
NCT04896502 -
Effectiveness of Telemedicine Home Assessments for Identification and Reduction of Asthma Triggers
|
N/A | |
Completed |
NCT03503812 -
Mitigating the Health Effects of Desert Dust Storms Using Exposure-Reduction Approaches
|
N/A | |
Recruiting |
NCT06003569 -
Reducing Asthma Attacks in Disadvantaged School Children With Asthma
|
N/A | |
Not yet recruiting |
NCT05902702 -
Isotonic Saline for Children With Bronchiolitis
|
N/A | |
Not yet recruiting |
NCT05547477 -
Continuous EMG Measurements in Children With Asthma During Sleep
|
||
Completed |
NCT04388098 -
Oral Health Status of Asthmatic Children
|
||
Terminated |
NCT03586544 -
Reducing Exercise-induced Bronchoconstriction in Children With Asthma and Obesity
|
Phase 4 | |
Recruiting |
NCT04821908 -
Consequences of COVID 19 Pandemic on Childhood Asthma
|
||
Not yet recruiting |
NCT03277170 -
Pragmatic RCT of High-dose Oral Montelukast for Moderate and Severe Pediatric Acute Asthma Exacerbations
|
Phase 2 | |
Enrolling by invitation |
NCT06239844 -
Navigating Together for Equitable Asthma Management for Children in Families Who Communicate in Language Other Than English
|
N/A | |
Not yet recruiting |
NCT05997784 -
Study of Indoor Air Pollutants and Their Impact in Childhood Health and Wellbeing
|
||
Not yet recruiting |
NCT05974917 -
Serious gaMes as Emerging E-health Interventions for Young People With neurologicaL or rEspiratory disoRders
|
||
Recruiting |
NCT05366309 -
Performance and Adherence in Children Using Spacers
|
N/A | |
Completed |
NCT05684926 -
COVID-19 Pandemic Asthma Child Telerehabilitation Yoga
|
N/A | |
Recruiting |
NCT04166344 -
A mHealth Intervention to Improve Symptom Control in Children and Adolescents With Difficult-to-control Asthma
|
N/A | |
Completed |
NCT03673618 -
Soluble Corn Fiber Supplementation for Asthma
|
Phase 2 | |
Completed |
NCT05576142 -
Oral Findings in Pediatric Patients With Allergic Rhinitis and/or Asthma
|