Asthma in ChildrenNCT05296707
Evaluation of the Possible Effect of Inspiratory Muscle Training on Inflammation Markers and Oxidative Stress in Childhood Asthma
A study testing Inspiratory muscle training and Used routine medicine in people with Asthma in Children and Children, Adult, run by Ege University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 8 to 17 yearsHealthy volunteers can take part
- Conditions the study is for
- Asthma in Children, Children, Adult
- What is being tested?
- Inspiratory muscle training and Used routine medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 105 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Mar 2019to 30 Jun 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 8 to 17 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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
- Being tested
- Inspiratory muscle training, Used routine medicine, Control group
- Keywords
- Childhood Asthma, Inspiratory Muscle Training, Inflammation
- Medical subject headings
- Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Inspiratory muscle trainingOther
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 medicineOther
After the first evaluation was made, a second evaluation was made after 6 weeks of follow-up.
Control groupOther
A healthy child compatible with the age and sex of the patient group was evaluated once.
| Study group | Role | What they receive |
|---|---|---|
| Inspiratory muscle training group | Experimental | Threshold IMT was given this group. Applied for 7 days 6 weeks. Receives: Other: Inspiratory muscle training; Other: Used routine medicine |
| Used routine medicine group | Active comparator | Followed 6 weeks Receives: Other: Used routine medicine |
| Control Group | Active comparator | Health children Receives: Other: Control group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Inflammatory marker
We assessed C reaktive protein from Blood sample
Measured: 6 weeks
Inflammatory marker
We assessed TGF-B from Blood sample
Measured: 6 weeks
Inflammatory marker
We assessed Periostin from Blood sample
Measured: 6 weeks
Oxidative stress
We assessed Total oxidative level.
Measured: 6 weeks
Oxidative stress
We assessed total antioxidative level
Measured: 6 weeks
Oxidative stress
We assessed oxidative status index
Measured: 6 weeks
Secondary outcomes (4)
Pulmonary function test
Pulmonary function test was measured with a portable MiniSpirobank device
Measured: 6 weeks
Respiratory muscle strength
Respiratory muscle strength was measured using a portable (micro RPM brand) electronic mouth pressure measuring device according to ATS/ERS criteria
Measured: 6 weeks
functional capacity
functional capacity was assessed 6 MWT
Measured: 6 weeks
Quality life
Quality life was assessed PedsQl
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Mar 2022
- Study start1 Mar 2019
- Primary completion30 Jun 2020
- Study completion30 Jun 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Asthma in ChildrenStudies of the same condition, open and under way.
- More trials run by Ege UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized clinical trial
- Masking
- None (open label)
- Enrolment
- 105 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ege University
- Sponsor type
- University, hospital or other
- Collaborators
- Mustafa Kemal University
- Responsible party
- Principal investigator, Ozden Gokcek, Ege University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05296707
- Sponsor's protocol ID
- 2019/16
- Status last verified
- Feb 2024
- First submitted
- 3 Mar 2022
- Last updated
- 20 Feb 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 37285069
Study at a glance
From the registry record, last updated by the sponsor on 20 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Possible Effect of Inspiratory Muscle Training on Inflammation Markers and Oxidative Stress in Childhood Asthma
- ClinicalTrials.gov ID
- NCT05296707
- Acronym / sponsor ID
- 2019/16
- Conditions
- Asthma in Children, Children, Adult
- Keywords
- Childhood Asthma, Inspiratory Muscle Training, Inflammation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 105 participants (actual)
- Lead sponsor
- Ege UniversityUniversity, hospital or other
- Collaborators
- Mustafa Kemal University
- Study start
- 1 Mar 2019 (actual)
- Primary completion
- 30 Jun 2020 (actual)
- Study completion
- 30 Jun 2020 (actual)
- First posted
- 25 Mar 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- Randomized clinical trial
| Arm | Type | Receives |
|---|---|---|
| Inspiratory muscle training group | Experimental | Other: Inspiratory muscle training, Other: Used routine medicineThreshold IMT was given this group. Applied for 7 days 6 weeks. |
| Used routine medicine group | Active comparator | Other: Used routine medicineFollowed 6 weeks |
| Control Group | Active comparator | Other: Control groupHealth children |
Who may qualify
- Ages
- 8 to 17 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (7 listed)
- 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,
Key exclusion criteria (6 listed)
- 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,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Inspiratory muscle trainingThe 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. | Other | Inspiratory muscle training group |
| Used routine medicineAfter the first evaluation was made, a second evaluation was made after 6 weeks of follow-up. | Other | Inspiratory muscle training group, Used routine medicine group |
| Control groupA healthy child compatible with the age and sex of the patient group was evaluated once. | Other | Control Group |
Primary outcome
Inflammatory marker
Time frame: 6 weeks
We assessed C reaktive protein from Blood sample
Inflammatory marker
Time frame: 6 weeks
We assessed TGF-B from Blood sample
Inflammatory marker
Time frame: 6 weeks
We assessed Periostin from Blood sample
Oxidative stress
Time frame: 6 weeks
We assessed Total oxidative level.
Oxidative stress
Time frame: 6 weeks
We assessed total antioxidative level
Oxidative stress
Time frame: 6 weeks
We assessed oxidative status index
4 secondary outcomes
Pulmonary function test
Time frame: 6 weeks
Respiratory muscle strength
Time frame: 6 weeks
functional capacity
Time frame: 6 weeks
Quality life
Time frame: 6 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Feb 2024.
- Derived from this study: PubMed 37285069Gokcek 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Inspiratory muscle training and Used routine medicine in people with Asthma in Children and Children, Adult, run by Ege University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Inflammatory marker (time frame: 6 weeks). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05296707, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Feb 2024.