The Impact of Breath Exercises by Telemedicine in Patients Aged 8-18 Years With a Diagnosis of Asthma

NCT ID: NCT05749237

Last Updated: 2023-03-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-02-03

Study Completion Date

2023-08-30

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Allergic Asthma

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Randomized placebo controlled
Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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Active group

children older than 10 years with a diagnosis of allergic asthma respiratory and relaxation exercises

Group Type ACTIVE_COMPARATOR

respiratory exercises

Intervention Type OTHER

respiratory exercises

relaxation exercises

Intervention Type OTHER

relaxation exercises

Placebo group

children older than 10 years with a diagnosis of allergic asthma only relaxation exercises

Group Type PLACEBO_COMPARATOR

relaxation exercises

Intervention Type OTHER

relaxation exercises

Interventions

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respiratory exercises

respiratory exercises

Intervention Type OTHER

relaxation exercises

relaxation exercises

Intervention Type OTHER

Eligibility Criteria

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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

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Minimum Eligible Age

10 Years

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Istanbul University - Cerrahpasa

OTHER

Sponsor Role lead

Responsible Party

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Ayca Kiykim

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Ayca Kiykim

Role: PRINCIPAL_INVESTIGATOR

Istanbul University - Cerrahpasa

Hilal Denizoglu

Role: STUDY_CHAIR

Atlas University

Hikmet Uçgun

Role: STUDY_CHAIR

Atlas University

Locations

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Istanbul University-Cerrahpasa

Istanbul, , Turkey (Türkiye)

Site Status RECRUITING

Countries

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Turkey (Türkiye)

Central Contacts

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Ayca Kiykim

Role: CONTACT

+905423432245

Facility Contacts

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Ayca Kiykim

Role: primary

+905423432245

Other Identifiers

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Phaster

Identifier Type: -

Identifier Source: org_study_id

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