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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05749237
Other study ID # Phaster
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date February 3, 2023
Est. completion date August 30, 2023

Study information

Verified date February 2023
Source Istanbul University - Cerrahpasa (IUC)
Contact Ayca Kiykim
Phone +905423432245
Email ayca.kiykim@iuc.edu.tr
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The goal of this randomized, placebo controlled study is to evaluate the effect of respiratory exercises on asthma attack frequency, symptom and medication scores and quality of life of children with a diagnosis of asthma. Participants will be asked to perform respiratory exercises described at once in hospital at home regularly. Control group will comprised children with asthma without respiratory exercises.


Description:

At the beginning of the study anthropometric measurements, basal respiratory function assessment, drugs, demographic information, allergen sensitivity, asthma control levels and quality of life scales will be documented. Patients will be randomly divided into two groups; one group following respiratory exercises and relaxation exercises and the other following only relaxation exercises. Both groups will be called regularly to remind the exercises. The spirometric tests and asthma control forms will be reevaluated at the 3rd and 6th month at hospital. Peak flow meters will be given to patients to document PEF values during study.


Recruitment information / eligibility

Status Recruiting
Enrollment 100
Est. completion date August 30, 2023
Est. primary completion date August 30, 2023
Accepts healthy volunteers No
Gender All
Age group 10 Years to 18 Years
Eligibility Inclusion Criteria: clinical diagnosis of allergic asthma allergic asthma severity step 1 or step 2 - Exclusion Criteria: asthmatic children more severe than step 2 other comorbid disorders involving respiratory system or neuromusculatory disorders -

Study Design


Related Conditions & MeSH terms


Intervention

Other:
respiratory exercises
respiratory exercises
relaxation exercises
relaxation exercises

Locations

Country Name City State
Turkey Istanbul University-Cerrahpasa Istanbul

Sponsors (1)

Lead Sponsor Collaborator
Istanbul University - Cerrahpasa (IUC)

Country where clinical trial is conducted

Turkey, 

Outcome

Type Measure Description Time frame Safety issue
Primary Change in asthma attack frequency asthma attack frequency by home PEF records and questionnaire, spirometric measurements and symptom and medication scoring charts at third and sixth months
Secondary Quality of life questionnaire increase quality of life at third and sixth months
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