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
Sponsored by
About this trial
This is an interventional treatment trial for Allergic Asthma focused on measuring allergy, asthma, respiratory exercises, children
Eligibility Criteria
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
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
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
No
Eligibility Criteria
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
-
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ayca Kiykim
Phone
+905423432245
Email
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
Email
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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