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

Primary Purpose

Allergic Asthma

Status

Recruiting

Phase

Not Applicable

Locations

Turkey

Study Type

Interventional

Intervention

respiratory exercises

relaxation exercises

About this trial

This is an interventional treatment trial for Allergic Asthma focused on measuring allergy, asthma, respiratory exercises, children

Eligibility Criteria

10 Years - 18 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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 -

Sites / Locations

Istanbul University-CerrahpasaRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Active group

Placebo group

Arm Description

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

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

Outcomes

Primary Outcome Measures

Change in asthma attack frequency

asthma attack frequency by home PEF records and questionnaire, spirometric measurements and symptom and medication scoring charts

Secondary Outcome Measures

Quality of life questionnaire

increase quality of life

Full Information

NCT ID

NCT05749237

First Posted

February 17, 2023

Last Updated

February 28, 2023

Sponsor

Istanbul University - Cerrahpasa (IUC)

1. Study Identification

Unique Protocol Identification Number

NCT05749237

Brief Title

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

Acronym

PHASTER

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

February 2023

Overall Recruitment Status

Recruiting

Study Start Date

February 3, 2023 (Actual)

Primary Completion Date

August 30, 2023 (Anticipated)

Study Completion Date

August 30, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Istanbul University - Cerrahpasa (IUC)

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief 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.

Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Allergic Asthma

Keywords

allergy, asthma, respiratory exercises, children

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Model Description

Randomized placebo controlled

Masking

Participant

Allocation

Randomized

Enrollment

100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Active group

Arm Type

Active Comparator

Arm Description

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

Arm Title

Placebo group

Arm Type

Placebo Comparator

Arm Description

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

Intervention Type

Other

Intervention Name(s)

respiratory exercises

Intervention Description

respiratory exercises

Intervention Type

Other

Intervention Name(s)

relaxation exercises

Intervention Description

relaxation exercises

Primary Outcome Measure Information:

Title

Change in asthma attack frequency

Description

asthma attack frequency by home PEF records and questionnaire, spirometric measurements and symptom and medication scoring charts

Time Frame

at third and sixth months

Secondary Outcome Measure Information:

Title

Quality of life questionnaire

Description

increase quality of life

Time Frame

at third and sixth months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

10 Years

Maximum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Ayca Kiykim

Phone

+905423432245

ayca.kiykim@iuc.edu.tr

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Ayca Kiykim

Organizational Affiliation

Istanbul University - Cerrahpasa (IUC)

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Hilal Denizoglu

Organizational Affiliation

Atlas University

Official's Role

Study Chair

First Name & Middle Initial & Last Name & Degree

Hikmet Uçgun

Organizational Affiliation

Atlas University

Official's Role

Study Chair

Facility Information:

Facility Name

Istanbul University-Cerrahpasa

City

Istanbul

Country

Turkey

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Ayca Kiykim

Phone

+905423432245

ayca.kiykim@iuc.edu.tr

First Name & Middle Initial & Last Name & Degree

Betul Gemici Karaaslan

12. IPD Sharing Statement

Learn more about this trial

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

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