- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05220488
Fear of COVID-19 and Physical Activity in Children With Asthma During the Covid Period
Fear of COVID-19 and Physical Activity Level of Children With Asthma
Study Overview
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 Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
-
Bartın, Turkey
- Bartın University
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
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,
Study Plan
How is the study designed?
Design Details
- Observational Models: Case-Control
- Time Perspectives: Retrospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Asthma Group
|
Parameters such as physical activity and fear of covid will be evaluated in asthmatic and healthy children and adolescents.
|
|
Healthy Group
|
Parameters such as physical activity and fear of covid will be evaluated in asthmatic and healthy children and adolescents.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
10 minutes
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Asthma Control Test
Time Frame: 5 minutes
|
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.
|
5 minutes
|
|
Fear of COVID-19
Time Frame: 5 minutes
|
Qualitative Questions on Examining the Fear of COVID-19:
10. I am afraid of catching coronavirus and being hospitalized. |
5 minutes
|
|
Social Isolation
Time Frame: 4 weeks
|
Social Isolation
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. |
4 weeks
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Şeyma Nur Önal, Bartın Unıversity
Publications and helpful links
General 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.
- 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.
- 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.
- 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.
- 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.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Coronavirus Infections
- Coronaviridae Infections
- Nidovirales Infections
- RNA Virus Infections
- Virus Diseases
- Infections
- Respiratory Tract Infections
- Respiratory Tract Diseases
- Immune System Diseases
- Pneumonia, Viral
- Pneumonia
- Lung Diseases
- Hypersensitivity, Immediate
- Bronchial Diseases
- Lung Diseases, Obstructive
- Respiratory Hypersensitivity
- Hypersensitivity
- COVID-19
- Asthma
Other Study ID Numbers
- COVID-19asthmachildphysicalact
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Asthma in Children
-
Basque Health ServiceBasque Government Department of Public HealthNot yet recruiting
-
Montefiore Medical CenterNational Heart, Lung, and Blood Institute (NHLBI)RecruitingAsthma in ChildrenUnited States
-
Meyer Children's Hospital IRCCSRecruitingAsthma in Children | Asthma Acute | Asthma Crisis | Asthma ChildhoodItaly
-
University of MiamiCompletedAsthma in Children | Artificial IntelligenceUnited States
-
Istituto di Farmacologia Traslazionale - sede di...Not yet recruitingAsthma in Children | Children, Only | Serious Game
-
Children's Hospital of PhiladelphiaNational Heart, Lung, and Blood Institute (NHLBI)Recruiting
-
University of FloridaNational Heart, Lung, and Blood Institute (NHLBI)CompletedAsthma in ChildrenUnited States
-
ResMedCompletedAsthma in ChildrenUnited States
-
University of WashingtonNational Institute of Environmental Health Sciences (NIEHS); National Institute... and other collaboratorsCompleted
Clinical Trials on Assessment
-
Istanbul University - CerrahpasaCompletedHealthy | Physical InactivityTurkey
-
Gazi UniversityUnknownPhysical Functional Performance | Postural Balance | Complete Tear, Ankle, Lateral LigamentTurkey
-
Saglik Bilimleri UniversitesiNot yet recruitingPain Management | Anxiety Depression | Patient Satisfaction | Voice Quality | Laryngeal Carcinoma | Swallowing Function | Quality of Life (QOL)
-
Çankırı Karatekin UniversityHacettepe UniversityCompleted
-
Assistance Publique - Hôpitaux de ParisURC Necker Cochin, FranceCompletedShock | Cerebral Lesion | Arterial HypotensionFrance
-
McGill UniversityCompletedCommunication | Gait | Emotions | MusicCanada
-
Hacettepe UniversityNot yet recruitingAnxiety | Pain, Chronic | Grip | Muscle Disorder
-
Vanderbilt University Medical CenterNational Institute of Mental Health (NIMH)Active, not recruitingAutism Spectrum DisorderUnited States
-
Çankırı Karatekin UniversityCompletedCognitive Dysfunction | Aging | Motor Skills DisordersTurkey
-
University Hospital, ToursRecruitingNeurophysiological Study of Sensory and Cognitive Processes in Healthy Children and Adults (PROSCEA)Healthy VolunteerFrance