NCT05220488

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
80

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Feb 2022

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 29, 2022

Completed
4 days until next milestone

First Posted

Study publicly available on registry

February 2, 2022

Completed
1 day until next milestone

Study Start

First participant enrolled

February 3, 2022

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 20, 2022

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 12, 2022

Completed
Last Updated

December 13, 2022

Status Verified

December 1, 2022

Enrollment Period

2 months

First QC Date

January 29, 2022

Last Update Submit

December 11, 2022

Conditions

Keywords

AsthmaCOVID-19Physical Activity

Outcome Measures

Primary Outcomes (1)

  • 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.

    10 minutes

Secondary Outcomes (3)

  • Asthma Control Test

    5 minutes

  • Fear of COVID-19

    5 minutes

  • Social Isolation

    4 weeks

Study Arms (2)

Asthma Group

Asthma Group

Other: Assessment

Healthy Group

Healthy Group

Other: Assessment

Interventions

Parameters such as physical activity and fear of covid will be evaluated in asthmatic and healthy children and adolescents.

Asthma GroupHealthy Group

Eligibility Criteria

Age6 Years - 18 Years
Sexall
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodProbability Sample
Study Population

Asthmatic and healthy children and adolescents

You may qualify if:

  • 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,
  • 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,

You may not qualify if:

  • 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,
  • 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,

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Bartın University

Bartın, Turkey (Türkiye)

Location

Related Publications (5)

  • 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.

MeSH Terms

Conditions

AsthmaCOVID-19Motor Activity

Interventions

Restraint, Physical

Condition Hierarchy (Ancestors)

Bronchial DiseasesRespiratory Tract DiseasesLung Diseases, ObstructiveLung DiseasesRespiratory HypersensitivityHypersensitivity, ImmediateHypersensitivityImmune System DiseasesPneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsBehavior

Intervention Hierarchy (Ancestors)

Behavior ControlTherapeuticsImmobilizationInvestigative Techniques

Study Officials

  • Şeyma Nur Önal

    Bartın Unıversity

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Lecturer

Study Record Dates

First Submitted

January 29, 2022

First Posted

February 2, 2022

Study Start

February 3, 2022

Primary Completion

March 20, 2022

Study Completion

December 12, 2022

Last Updated

December 13, 2022

Record last verified: 2022-12

Data Sharing

IPD Sharing
Will not share

Locations