Asthma in ChildrenNCT03985956
Pediatric Glittre ADL-test in Children With Asthma
An observational study of Asthma in Children, run by Gazi University at 1 site in Turkey (Türkiye).
Trial summary
The aim of the study is to investigate reliability, validity, of the Glittre ADL Test in children with Asthma. Read more about this study
- Who is it for?
- Ages 6 to 14 years
- Conditions the study is for
- Asthma in Children
- How many people
- 34 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jun 2019to 10 Jul 2020
- 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 14 years
- All sexes
- No healthy volunteers
- Child
Study population: Children with asthma who apply to Gazi University, Department of Physiotherapy and Rehabilitation will be invited to this study.
Who may be able to join
- Children and adolescents aged 6-14 years with a diagnosis of Asthma
- Task-oriented and co-operative patients without any musculoskeletal, rheumatic, neurological, hearing and visual diseases and without pulmonary exacerbation at the time of data collection will be included in this study.
Who cannot join
- -
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Gazi University, Faculty of Health and Sciences, Department of Physiotherapy and Rehabilitation
Ankara, 06500
About this study
Official title: The Validity and Reliability of the ADL-Glittre Test as a Measure of Functional Capacity in Children With Asthma
The aim of the study is to investigate reliability, validity, of the Glittre ADL Test in children with Asthma.
Read the detailed description
The TGlittre-P is an adaptation of the TGlittre test for pediatric patients. It consists of completing a circuit while carrying a backpack with a variable weight of 0.5 kg to 2.5 kg, according to the child´s age and sex. This weight range follows the guidelines of the World Health Organization, which states that the younger the female child is, the lighter the backpack should be, in order to assure the school children´s health condition. The following tasks should be carried out; from a sitting position, the child stands up and walks along a 10m-long flat course, going up and down a 2-step rise (17 cm high x 27 cm wide) about halfway along that distance, to reach a bookshelf with three 0.5 kg objects (i.e. colorful plastic bowling pins filled with sand). The objects are placed on the top shelf at eye level, which should be removed, one by one, to the lower shelf at the level of the umbilicus, and then to the ground. Next, the objects should be placed on the lower shelf and then back to the top shelf. The child walks back along the same route. (S)he sits down, stands up and immediately starts the next lap. The following verbal instructions are given during the test: "sit" and "stand." The time required to walk five laps is registered; the less the time spent, the better the performance is. The test performance was evaluated by comparing the patient´s data with the data predicted by the equation, in his study with healthy children. The equation for girls is "time in TGlittre-P = 3.781-0.083 x AGE"; and boys, "time in TGlittre-P = 4.025-0.123 x AGE".
- Conditions
- Asthma in Children
- Keywords
- Daily Living Activities, Exercise
- Medical subject headings
- Motor Activity
What is being measured
The primary outcome is the main question the study is designed to answer.
Glittre ADL test
Functional test
Measured: 15 minutes
Secondary outcomes (1)
Six Minute Walk Test
Exercise Test
Measured: 10 mimutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jun 2019
- Study start1 Jun 2019
- Primary completion30 Jun 2019
- Study completion10 Jul 2020
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.
- More trials run by Gazi 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
- Observational
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gazi University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Muserrefe Nur Keles, Gazi University
- Investigators
- Müşerrefe N Keleş, Principal investigator, Gazi University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03985956
- Sponsor's protocol ID
- 13579
- Status last verified
- Oct 2021
- First submitted
- 11 Jun 2019
- Last updated
- 15 Oct 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Validity and Reliability of the ADL-Glittre Test as a Measure of Functional Capacity in Children With Asthma
- ClinicalTrials.gov ID
- NCT03985956
- Acronym / sponsor ID
- 13579
- Conditions
- Asthma in Children
- Keywords
- Daily Living Activities, Exercise
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- Gazi UniversityUniversity, hospital or other
- Study start
- 1 Jun 2019 (actual)
- Primary completion
- 30 Jun 2019 (actual)
- Study completion
- 10 Jul 2020 (actual)
- First posted
- 14 Jun 2019 (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 aim of the study is to investigate reliability, validity, of the Glittre ADL Test in children with Asthma.
Detailed description
The TGlittre-P is an adaptation of the TGlittre test for pediatric patients. It consists of completing a circuit while carrying a backpack with a variable weight of 0.5 kg to 2.5 kg, according to the child´s age and sex. This weight range follows the guidelines of the World Health Organization, which states that the younger the female child is, the lighter the backpack should be, in order to assure the school children´s health condition. The following tasks should be carried out; from a sitting position, the child stands up and walks along a 10m-long flat course, going up and down a 2-step rise (17 cm high x 27 cm wide) about halfway along that distance, to reach a bookshelf with three 0.5 kg objects (i.e. colorful plastic bowling pins filled with sand). The objects are placed on the top shelf at eye level, which should be removed, one by one, to the lower shelf at the level of the umbilicus, and then to the ground. Next, the objects should be placed on the lower shelf and then back to the top shelf. The child walks back along the same route. (S)he sits down, stands up and immediately starts the next lap. The following verbal instructions are given during the test: "sit" and "stand." The time required to walk five laps is registered; the less the time spent, the better the performance is. The test performance was evaluated by comparing the patient´s data with the data predicted by the equation, in his study with healthy children. The equation for girls is "time in TGlittre-P = 3.781-0.083 x AGE"; and boys, "time in TGlittre-P = 4.025-0.123 x AGE".
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 6 to 14 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Children with asthma who apply to Gazi University, Department of Physiotherapy and Rehabilitation will be invited to this study.
Key inclusion criteria (2 listed)
- Children and adolescents aged 6-14 years with a diagnosis of Asthma
- Task-oriented and co-operative patients without any musculoskeletal, rheumatic, neurological, hearing and visual diseases and without pulmonary exacerbation at the time of data collection will be included in this study.
Key exclusion criteria (1 listed)
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Glittre ADL test
Time frame: 15 minutes
Functional test
1 secondary outcome
Six Minute Walk Test
Time frame: 10 mimutes
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 15 Oct 2021.
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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.
Müşerrefe N Keleş principal investigator
Gazi University
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 Gazi 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 2 inclusion and 1 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 15 Oct 2021. 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?
Glittre ADL test (time frame: 15 minutes). 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 15 Oct 2021.