Asthma in ChildrenNCT05963919
Determinants of Functional Capacity in Children With Asthma
An observational study of Asthma in Children, run by Atlas University at 1 site in Turkey (Türkiye).
Trial summary
The primary aim of this study is to compare the respiratory function, respiratory muscle strength, functional capacity, and lower extremity strength of children with asthma and healthy children in the same age group. Read more about this study
- Who is it for?
- Ages 6 to 17 yearsHealthy volunteers can take part
- Conditions the study is for
- Asthma in Children
- What is being tested?
- 6-minute walk test, Pulmonary function test and Respiratory muscle strength test
- How many people
- 100 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jan 2023to 30 Jun 2023
- Phase
- Observational
- 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 6 to 17 years
- All sexes
- Healthy volunteers accepted
- Child
Study population: Children with asthma aged between 6-17 years and healthy children aged between 6-17 years will be included in the study. Informed consent forms for the study prepared for both the asthma group and the control group will be carefully explained and the participants will be included in the study after they and their parents have read, understood, and accepted.
Asthma Group Inclusion Criteria:
- Being between the ages of 6-17
- Being diagnosed with asthma
- Able to walk, cooperate and clinically stable
- Being a volunteer to participate in the study
- To be able to speak, read, understand, and cooperate in Turkish
Asthma Group Exclusion Criteria:
- History of previous lung or liver transplant
- Having an acute exacerbation and/or a history of hospitalization in the last 1 month
- Having diagnosed orthopedic problems affecting mobility or a history of musculoskeletal surgery
Control Group Inclusion Criteria:
- Being between the ages of 6-17
- To be able to speak, read, understand, and cooperate in Turkish
- Being a volunteer to participate in the study
Control Group Exclusion Criteria:
- Having a diagnosed vision, hearing, or neurological disease that may affect balance
- Having any other neurological, orthopedic, cardiovascular, thoracic, or metabolic disease or pathological condition that would affect assessments
- Resting saturation below 90% during exercise tests
Trial locations and contacts
1 site in 1 country.
About this study
The primary aim of this study is to compare the respiratory function, respiratory muscle strength, functional capacity, and lower extremity strength of children with asthma and healthy children in the same age group. The secondary aim of our study is to determine the determinants of functional capacity in children with asthma.
- Conditions
- Asthma in Children
- Being tested
- 6-minute walk test, Pulmonary function test, Respiratory muscle strength test, Lower extremity muscle strength test
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
6-minute walk testOther
Functional capacity will be assessed with the 6-minute walk test (6MWT). 6MWT will be performed in accordance with the criteria of the American Thoracic Society. The 6MWT distance will be recorded in meters.
Pulmonary function testOther
Pulmonary function test will be performed with a spirometer ("COSMED Pony FX" (COSMED; Italy) by ATS/ERS criteria. Forced expiratory volume in 1 second (FEV1) and peak expiratory volume (PEF) parameters will be measured. The results will be recorded both as a percentage of measured values and expected values.
Respiratory muscle strength testOther
Respiratory muscle strength will be measured in accordance with ATS/ERS criteria using an electronic, mobile, (MicroRPM, Micro Medical; UK) intraoral pressure measuring device. Maximal inspiratory pressure (MIP) and maximal expiratory pressure (MEP) values will be recorded. Three measurements will be repeated for each maneuver and the highest value recorded as cmH2O.
Lower extremity muscle strength testOther
The 30-Second Chair Test is administered using a folding chair without arms, with a seat height of 17 inches (43.2 cm). The chair, with rubber tips on the legs, is placed against a wall to prevent it from moving. The participant is seated in the middle of the chair, back straight; feet approximately a shoulder width apart, and placed on the floor at an angle slightly back from the knees, with one foot slightly in front of the other to help maintain balance. Arms are crossed at the wrists and held against the chest. The participant is encouraged to complete as many full stands as possible within 30 seconds. The participant is instructed to fully sit between each stand.
| Study group | Role | What they receive |
|---|---|---|
| Asthma Group | 6 minute walk test, Pulmonary function test, Respiratory muscle strength test, Lower extremity muscle strength test Receives: Other: 6-minute walk test; Other: Pulmonary function test; Other: Respiratory muscle strength test; Other: Lower extremity muscle strength test | |
| Control Group | 6 minute walk test, Pulmonary function test, Respiratory muscle strength test, Lower extremity muscle strength test Receives: Other: 6-minute walk test; Other: Pulmonary function test; Other: Respiratory muscle strength test; Other: Lower extremity muscle strength test |
What is being measured
The primary outcome is the main question the study is designed to answer.
6-minute walk test
Measured: 15-20 minutes
Forced expiratory volume in 1 second (FEV1)
Measured: 10-15 minutes
Peak expiratory flow (PEF)
Measured: 10-15 minutes
Maximal inspiratory pressure (MIP)
Measured: 15-20 minutes
Maximal expiratory pressure (MEP)
Measured: 15-20 minutes
Lower extremity muscle strength
Measured: 5-10 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jul 2023
- Study start1 Jan 2023
- Primary completion30 Jun 2023
- Study completion30 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Asthma in ChildrenStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Atlas University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05963919
- Sponsor's protocol ID
- Atlasumkaya01
- Status last verified
- Jul 2023
- First submitted
- 18 Jul 2023
- Last updated
- 27 Jul 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Determinants of Functional Capacity in Children With Asthma
- ClinicalTrials.gov ID
- NCT05963919
- Acronym / sponsor ID
- Atlasumkaya01
- Conditions
- Asthma in Children
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Atlas UniversityUniversity, hospital or other
- Study start
- 1 Jan 2023 (actual)
- Primary completion
- 30 Jun 2023 (actual)
- Study completion
- 30 Jun 2023 (actual)
- First posted
- 27 Jul 2023 (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.
The primary aim of this study is to compare the respiratory function, respiratory muscle strength, functional capacity, and lower extremity strength of children with asthma and healthy children in the same age group. The secondary aim of our study is to determine the determinants of functional capacity in children with asthma.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Asthma Group | – | Other: 6-minute walk test, Other: Pulmonary function test, Other: Respiratory muscle strength test, Other: Lower extremity muscle strength test6 minute walk test, Pulmonary function test, Respiratory muscle strength test, Lower extremity muscle strength test |
| Control Group | – | Other: 6-minute walk test, Other: Pulmonary function test, Other: Respiratory muscle strength test, Other: Lower extremity muscle strength test6 minute walk test, Pulmonary function test, Respiratory muscle strength test, Lower extremity muscle strength test |
Who may qualify
- Ages
- 6 to 17 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- Children with asthma aged between 6-17 years and healthy children aged between 6-17 years will be included in the study. Informed consent forms for the study prepared for both the asthma group and the control group will be carefully explained and the participants will be included in the study after they and their parents have read, understood, and accepted.
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 |
|---|---|---|
| 6-minute walk testFunctional capacity will be assessed with the 6-minute walk test (6MWT). 6MWT will be performed in accordance with the criteria of the American Thoracic Society. The 6MWT distance will be recorded in meters. | Other | Asthma Group, Control Group |
| Pulmonary function testPulmonary function test will be performed with a spirometer ("COSMED Pony FX" (COSMED; Italy) by ATS/ERS criteria. Forced expiratory volume in 1 second (FEV1) and peak expiratory volume (PEF) parameters will be measured. The results will be recorded both as a percentage of measured values and expected values. | Other | Asthma Group, Control Group |
| Respiratory muscle strength testRespiratory muscle strength will be measured in accordance with ATS/ERS criteria using an electronic, mobile, (MicroRPM, Micro Medical; UK) intraoral pressure measuring device. Maximal inspiratory pressure (MIP) and maximal expiratory pressure (MEP) values will be recorded. Three measurements will be repeated for each maneuver and the highest value recorded as cmH2O. | Other | Asthma Group, Control Group |
| Lower extremity muscle strength testThe 30-Second Chair Test is administered using a folding chair without arms, with a seat height of 17 inches (43.2 cm). The chair, with rubber tips on the legs, is placed against a wall to prevent it from moving. The participant is seated in the middle of the chair, back straight; feet approximately a shoulder width apart, and placed on the floor at an angle slightly back from the knees, with one foot slightly in front of the other to help maintain balance. Arms are crossed at the wrists and held against the chest. The participant is encouraged to complete as many full stands as possible within 30 seconds. The participant is instructed to fully sit between each stand. | Other | Asthma Group, Control Group |
Primary outcome
6-minute walk test
Time frame: 15-20 minutes
Forced expiratory volume in 1 second (FEV1)
Time frame: 10-15 minutes
Peak expiratory flow (PEF)
Time frame: 10-15 minutes
Maximal inspiratory pressure (MIP)
Time frame: 15-20 minutes
Maximal expiratory pressure (MEP)
Time frame: 15-20 minutes
Lower extremity muscle strength
Time frame: 5-10 minutes
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 27 Jul 2023.
- 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?
An observational study of Asthma in Children, run by Atlas 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?
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 27 Jul 2023. 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?
6-minute walk test (time frame: 15-20 minutes). 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?
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 27 Jul 2023.