Asthma in ChildrenNCT05220488
Fear of COVID-19 and Physical Activity in Children With Asthma During the Covid Period
An observational study of Asthma in Children, run by Bartın Unıversity at 1 site in Turkey (Türkiye).
Trial summary
Social isolation rules applied to prevent and control COVID-19 disease reduce cross-infection, exposure to more allergens in the home environment, reducing hospital admissions by avoiding contamination, asthma control, fear of COVID-19 and physical activity for reasons such as increased anxiety and lack of exercise. Read more about this study
- Who is it for?
- Ages 6 to 18 years
- Conditions the study is for
- Asthma in Children
- What is being tested?
- Assessment
- How many people
- 80 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 3 Feb 2022to 12 Dec 2022
- 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 18 years
- All sexes
- Child, Adult
Study population: Asthmatic and healthy children and adolescents
Who may be able to join
- Asthma Group Inclusion Criteria:
- Having been diagnosed with asthma,
- In addition, not having any chronic disease,
- Volunteering to participate in the study,
- Not having speech and hearing problems,
- Being cooperative,
Show all 13Show fewer
- Not having mental, neurological, orthopedic, cardiovascular or pulmonary problems that would prevent physical activity,
- Healthy Group Inclusion Criteria
- Not having any chronic disease for healthy individuals,
- Volunteering to participate in the study,
- Not having speech and hearing problems,
- Being cooperative,
- Not having a mental, neurological, orthopedic, cardiovascular or pulmonary problem that would prevent physical activity,
Who cannot join
- Asthma Group Exclusion Criteria:
- The presence of a medical indication that requires complete restriction of physical activity,
- To have had COVID-19 in the last 1 month or to be newly diagnosed with COVID-19,
- Having symptoms of COVID-19 and suspected illness,
- Existence of cooperation and communication problems. Healthy Group Inclusion Criteria
- Not having any chronic disease for healthy individuals,
Show all 10Show fewer
- Volunteering to participate in the study,
- Not having speech and hearing problems,
- Being cooperative,
- Not having a mental, neurological, orthopedic, cardiovascular or pulmonary problem that would prevent physical activity,
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Fear of COVID-19 and Physical Activity Level of Children With Asthma
Social isolation rules applied to prevent and control COVID-19 disease reduce cross-infection, exposure to more allergens in the home environment, reducing hospital admissions by avoiding contamination, asthma control, fear of COVID-19 and physical activity for reasons such as increased anxiety and lack of exercise. How it will affect is unclear. Considering all these, positive or negative changes in asthma-related risk factors, changes in physical activity level, asthma attacks and control, fear of COVID-19 will be examined and contribute to the literature in children with asthma.
Read the detailed description
Social isolation rules applied to prevent and control COVID-19 disease reduce cross-infection, exposure to more allergens in the home environment, reducing hospital admissions by avoiding contamination, asthma control, fear of COVID-19 and physical activity for reasons such as increased anxiety and lack of exercise. How it will affect is unclear. Considering all these, positive or negative changes in asthma-related risk factors, changes in physical activity level, asthma attacks and control, fear of COVID-19 will be examined and contribute to the literature in children with asthma. Therefore, our primary aim in our study is; The aim of this study is to examine the asthma control and COVID-19 fear levels of asthmatic children who were in social isolation during the COVID-19 pandemic in children with asthma and compare their effects compared to healthy children. Our secondary aim in our study; The aim of this study is to examine the physical activity levels of children in social isolation during the COVID-19 pandemic in children with asthma.
Asthma Group Inclusion Criteria:
- Having been diagnosed with asthma,
- In addition, not having any chronic disease,
- Volunteering to participate in the study,
- Not having speech and hearing problems,
- Being cooperative,
- Not having mental, neurological, orthopedic, cardiovascular or pulmonary problems that would prevent physical activity,
Asthma Group Exclusion Criteria:
- The presence of a medical indication that requires complete restriction of physical activity,
- To have had COVID-19 in the last 1 month or to be newly diagnosed with COVID-19,
- Having symptoms of COVID-19 and suspected illness,
- Existence of cooperation and communication problems.
Healthy Group Inclusion Criteria
- Not having any chronic disease for healthy individuals,
- Volunteering to participate in the study,
- Not having speech and hearing problems,
- Being cooperative,
- Not having a mental, neurological, orthopedic, cardiovascular or pulmonary problem that would prevent physical activity,
Healthy Group Exclusion Criteria
- The presence of a medical indication that requires complete restriction of physical activity,
- To have had COVID-19 in the last 1 month or to be newly diagnosed with COVID-19,
- Having symptoms of COVID-19 and suspected illness,
- Existence of cooperation and communication problems
- Conditions
- Asthma in Children
- Being tested
- Assessment
- Keywords
- Asthma, COVID-19, Physical Activity
- Medical subject headings
- Asthma, COVID-19, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AssessmentOther
Parameters such as physical activity and fear of covid will be evaluated in asthmatic and healthy children and adolescents.
| Study group | Role | What they receive |
|---|---|---|
| Asthma Group | Asthma Group Receives: Other: Assessment | |
| Healthy Group | Healthy Group Receives: Other: Assessment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Physical Activity Questionnaire
It will be evaluated by Physical Activity Questionnaire-Child and Physical Activity Questionnaire-Adolescent. The scale consists of 10 questions and item 10 questions the presence of an illness or an acute condition that limits physical activity. Frequent activities (hopping, walking, football, gymnastics, dance, etc.), level of participation in physical education class, and frequency of activities during break time, lunch time, after school, evening hours and weekends, during leisure time in the last seven days The frequency of the activities performed and the frequency of sports, dance, games and other similar physical activities seven days a week are questioned.
Measured: 10 minutes
Secondary outcomes (3)
Asthma Control Test
Asthma Control Test: The Asthma Control Test (AKT) was developed to evaluate people's asthma control. It consists of 5 questions. It is applied to children over 12 years old. Questions are scored between 1-5. A minimum of 5 points and a maximum of 25 points are taken. If the total score is 25, it is considered as complete control, 24-20 as partial control, and ≤19 as not under control (17). In the 2020 Asthma Guide update, the total score is defined as 5-15 uncontrolled asthma, 16-19 insufficient control, 20-25 good control. Uysal et al. The Cronbach's alpha value of the scale, whose validity and reliability in Turkish was made by Dr., was found to be 0.84 (18). It will be used in the form to be applied to adolescents.
Measured: 5 minutes
Fear of COVID-19
Qualitative Questions on Examining the Fear of COVID-19:
- I am very afraid of the coronavirus (Covid-19).
- I am afraid of dying from coronavirus.
- I can't sleep because of the fear of catching the coronavirus.
- I am afraid of catching coronavirus and being hospitalized.
Measured: 5 minutes
Social Isolation
Social Isolation
- In the last 4 weeks, how many days have participants been out of the house outdoors? (park, nature, field, garden, etc.)
- In the last 4 weeks, how many days have participants been out of the house indoors? (shopping mall, workplace, market, home visit etc.)
- In the last 4 weeks, how many days has an outsider come to participants r home? (Guest, relative, etc.)
- In the last 4 weeks, how many days has someone from the house outside of participants went out of the house? (park, nature, field, garden, etc.)
- In the last 4 weeks, how many days has someone other than participants gone out of the house indoors? (shopping mall, workplace, market, home visit etc.)
- In the last 4 weeks, I have warned family members who have come from outside to wash their hands and faces before removing their masks.
Questions; Never, 1-3 days, 4-7 days, 7-15 days, 16-22 days, 23-30 days will be answered. The questions were created by the researchers.
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Feb 2022
- Study start3 Feb 2022
- Primary completion20 Mar 2022
- Study completion12 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- 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
- Retrospective
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bartın Unıversity
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Şeyma Nur Önal, Bartın Unıversity
- Investigators
- Şeyma Nur Önal, Principal investigator, Bartın Unıversity
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05220488
- Sponsor's protocol ID
- COVID-19asthmachildphysicalact
- Status last verified
- Dec 2022
- First submitted
- 29 Jan 2022
- Last updated
- 13 Dec 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Rothan HA, Byrareddy SN. The epidemiology and pathogenesis of coronavirus disease (COVID-19) outbreak. J Autoimmun. 2020 May;109:102433. doi: 10.1016/j.jaut.2020.102433. Epub 2020 Feb 26.
PubMed 32113704Skevaki C, Karsonova A, Karaulov A, Xie M, Renz H. Asthma-associated risk for COVID-19 development. J Allergy Clin Immunol. 2020 Dec;146(6):1295-1301. doi: 10.1016/j.jaci.2020.09.017. Epub 2020 Sep 28.
PubMed 33002516Lovinsky-Desir S, Deshpande DR, De A, Murray L, Stingone JA, Chan A, Patel N, Rai N, DiMango E, Milner J, Kattan M. Asthma among hospitalized patients with COVID-19 and related outcomes. J Allergy Clin Immunol. 2020 Nov;146(5):1027-1034.e4. doi: 10.1016/j.jaci.2020.07.026. Epub 2020 Aug 6.
PubMed 32771560Barsoum Z. Pediatric Asthma & Coronavirus (COVID-19)-Clinical Presentation in an Asthmatic Child-Case Report. SN Compr Clin Med. 2020;2(6):700-702. doi: 10.1007/s42399-020-00310-3. Epub 2020 May 19.
PubMed 32838131Papadopoulos NG, Custovic A, Deschildre A, Mathioudakis AG, Phipatanakul W, Wong G, Xepapadaki P, Agache I, Bacharier L, Bonini M, Castro-Rodriguez JA, Chen Z, Craig T, Ducharme FM, El-Sayed ZA, Feleszko W, Fiocchi A, Garcia-Marcos L, Gern JE, Goh A, Gomez RM, Hamelmann EH, Hedlin G, Hossny EM, Jartti T, Kalayci O, Kaplan A, Konradsen J, Kuna P, Lau S, Le Souef P, Lemanske RF, Makela MJ, Morais-Almeida M, Murray C, Nagaraju K, Namazova-Baranova L, Garcia AN, Yusuf OM, Pitrez PMC, Pohunek P, Pozo Beltran CF, Roberts GC, Valiulis A, Zar HJ; Pediatric Asthma in Real Life Collaborators. Impact of COVID-19 on Pediatric Asthma: Practice Adjustments and Disease Burden. J Allergy Clin Immunol Pract. 2020 Sep;8(8):2592-2599.e3. doi: 10.1016/j.jaip.2020.06.001. Epub 2020 Jun 17.
PubMed 32561497
Study at a glance
From the registry record, last updated by the sponsor on 13 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Fear of COVID-19 and Physical Activity Level of Children With Asthma
- ClinicalTrials.gov ID
- NCT05220488
- Acronym / sponsor ID
- COVID-19asthmachildphysicalact
- Conditions
- Asthma in Children
- Keywords
- Asthma, COVID-19, Physical Activity
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Bartın UnıversityUniversity, hospital or other
- Study start
- 3 Feb 2022 (actual)
- Primary completion
- 20 Mar 2022 (actual)
- Study completion
- 12 Dec 2022 (actual)
- First posted
- 2 Feb 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.
Social isolation rules applied to prevent and control COVID-19 disease reduce cross-infection, exposure to more allergens in the home environment, reducing hospital admissions by avoiding contamination, asthma control, fear of COVID-19 and physical activity for reasons such as increased anxiety and lack of exercise. How it will affect is unclear. Considering all these, positive or negative changes in asthma-related risk factors, changes in physical activity level, asthma attacks and control, fear of COVID-19 will be examined and contribute to the literature in children with asthma.
Detailed description
Social isolation rules applied to prevent and control COVID-19 disease reduce cross-infection, exposure to more allergens in the home environment, reducing hospital admissions by avoiding contamination, asthma control, fear of COVID-19 and physical activity for reasons such as increased anxiety and lack of exercise. How it will affect is unclear. Considering all these, positive or negative changes in asthma-related risk factors, changes in physical activity level, asthma attacks and control, fear of COVID-19 will be examined and contribute to the literature in children with asthma. Therefore, our primary aim in our study is; The aim of this study is to examine the asthma control and COVID-19 fear levels of asthmatic children who were in social isolation during the COVID-19 pandemic in children with asthma and compare their effects compared to healthy children. Our secondary aim in our study; The aim of this study is to examine the physical activity levels of children in social isolation during the COVID-19 pandemic in children with asthma.
Asthma Group Inclusion Criteria:
- Having been diagnosed with asthma,
- In addition, not having any chronic disease,
- Volunteering to participate in the study,
- Not having speech and hearing problems,
- Being cooperative,
- Not having mental, neurological, orthopedic, cardiovascular or pulmonary problems that would prevent physical activity,
Asthma Group Exclusion Criteria:
- The presence of a medical indication that requires complete restriction of physical activity,
- To have had COVID-19 in the last 1 month or to be newly diagnosed with COVID-19,
- Having symptoms of COVID-19 and suspected illness,
- Existence of cooperation and communication problems.
Healthy Group Inclusion Criteria
- Not having any chronic disease for healthy individuals,
- Volunteering to participate in the study,
- Not having speech and hearing problems,
- Being cooperative,
- Not having a mental, neurological, orthopedic, cardiovascular or pulmonary problem that would prevent physical activity,
Healthy Group Exclusion Criteria
- The presence of a medical indication that requires complete restriction of physical activity,
- To have had COVID-19 in the last 1 month or to be newly diagnosed with COVID-19,
- Having symptoms of COVID-19 and suspected illness,
- Existence of cooperation and communication problems
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Asthma Group | – | Other: AssessmentAsthma Group |
| Healthy Group | – | Other: AssessmentHealthy Group |
Who may qualify
- Ages
- 6 to 18 years
- Sex
- All
- Age groups
- Child, Adult
- Study population
- Asthmatic and healthy children and adolescents
Key inclusion criteria (13 listed)
- Asthma Group Inclusion Criteria:
- Having been diagnosed with asthma,
- In addition, not having any chronic disease,
- Volunteering to participate in the study,
- Not having speech and hearing problems,
Key exclusion criteria (10 listed)
- Asthma Group Exclusion Criteria:
- The presence of a medical indication that requires complete restriction of physical activity,
- To have had COVID-19 in the last 1 month or to be newly diagnosed with COVID-19,
- Having symptoms of COVID-19 and suspected illness,
- Existence of cooperation and communication problems. Healthy Group Inclusion Criteria
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 |
|---|---|---|
| AssessmentParameters such as physical activity and fear of covid will be evaluated in asthmatic and healthy children and adolescents. | Other | Asthma Group, Healthy Group |
Primary outcome
Physical Activity Questionnaire
Time frame: 10 minutes
It will be evaluated by Physical Activity Questionnaire-Child and Physical Activity Questionnaire-Adolescent. The scale consists of 10 questions and item 10 questions the presence of an illness or an acute condition that limits physical activity. Frequent activities (hopping, walking, football, gymnastics, dance, etc.), level of participation in physical education class, and frequency of activities during break time, lunch time, after school, evening hours and weekends, during leisure time in the last seven days The frequency of the activities performed and the frequency of sports, dance, games and other similar physical activities seven days a week are questioned.
3 secondary outcomes
Asthma Control Test
Time frame: 5 minutes
Fear of COVID-19
Time frame: 5 minutes
Social Isolation
Time frame: 4 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 13 Dec 2022.
- Results publication: PubMed 32113704Rothan HA, Byrareddy SN. The epidemiology and pathogenesis of coronavirus disease (COVID-19) outbreak. J Autoimmun. 2020 May;109:102433. doi: 10.1016/j.jaut.2020.102433. Epub 2020 Feb 26.
- Results publication: PubMed 33002516Skevaki C, Karsonova A, Karaulov A, Xie M, Renz H. Asthma-associated risk for COVID-19 development. J Allergy Clin Immunol. 2020 Dec;146(6):1295-1301. doi: 10.1016/j.jaci.2020.09.017. Epub 2020 Sep 28.
- Results publication: PubMed 32771560Lovinsky-Desir S, Deshpande DR, De A, Murray L, Stingone JA, Chan A, Patel N, Rai N, DiMango E, Milner J, Kattan M. Asthma among hospitalized patients with COVID-19 and related outcomes. J Allergy Clin Immunol. 2020 Nov;146(5):1027-1034.e4. doi: 10.1016/j.jaci.2020.07.026. Epub 2020 Aug 6.
- Results publication: PubMed 32838131Barsoum Z. Pediatric Asthma & Coronavirus (COVID-19)-Clinical Presentation in an Asthmatic Child-Case Report. SN Compr Clin Med. 2020;2(6):700-702. doi: 10.1007/s42399-020-00310-3. Epub 2020 May 19.
- Results publication: PubMed 32561497Papadopoulos NG, Custovic A, Deschildre A, Mathioudakis AG, Phipatanakul W, Wong G, Xepapadaki P, Agache I, Bacharier L, Bonini M, Castro-Rodriguez JA, Chen Z, Craig T, Ducharme FM, El-Sayed ZA, Feleszko W, Fiocchi A, Garcia-Marcos L, Gern JE, Goh A, Gomez RM, Hamelmann EH, Hedlin G, Hossny EM, Jartti T, Kalayci O, Kaplan A, Konradsen J, Kuna P, Lau S, Le Souef P, Lemanske RF, Makela MJ, Morais-Almeida M, Murray C, Nagaraju K, Namazova-Baranova L, Garcia AN, Yusuf OM, Pitrez PMC, Pohunek P, Pozo Beltran CF, Roberts GC, Valiulis A, Zar HJ; Pediatric Asthma in Real Life Collaborators. Impact of COVID-19 on Pediatric Asthma: Practice Adjustments and Disease Burden. J Allergy Clin Immunol Pract. 2020 Sep;8(8):2592-2599.e3. doi: 10.1016/j.jaip.2020.06.001. Epub 2020 Jun 17.
- 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.
Şeyma Nur Önal principal investigator
Bartın Unıversity
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 Bartın Unıversity 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 13 inclusion and 10 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 13 Dec 2022. 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?
Physical Activity Questionnaire (time frame: 10 minutes). 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 NCT05220488, which also lists 5 linked publications.
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 13 Dec 2022.