Clinical trial NCT05220488: Fear of COVID-19 and Physical Activity in Children With Asthma During the Covid Period
Official title: Fear of COVID-19 and Physical Activity Level of Children With Asthma
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Asthma in Children
Keywords: Asthma
COVID-19
Physical Activity
Lead sponsor: Bartın Unıversity
Sponsor class: OTHER
First posted: 2022-02-02
Enrollment: 80
Sex: ALL
Minimum age (years): 6
Maximum age (years): 18
Standard ages: CHILD
ADULT
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Asthmatic and healthy children and adolescents

Brief 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. 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

Eligibility criteria: Inclusion Criteria:

* 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,

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,

Exclusion Criteria:

* 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,

Primary outcomes:
measure: Physical Activity Questionnaire
timeFrame: 10 minutes
Secondary outcomes:
measure: Asthma Control Test
timeFrame: 5 minutes
measure: Fear of COVID-19
timeFrame: 5 minutes
measure: Social Isolation
timeFrame: 4 weeks
Other outcomes:
Locations:
city: Bartın
country: Turkey
facility: Bartın University
Study officials:
affiliation: Bartın Unıversity
name: Şeyma Nur Önal
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: Skevaki 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.
citation: Lovinsky-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.
citation: Barsoum 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.
citation: Papadopoulos 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.