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

February 28, 2023 updated by: Ayca Kiykim, Istanbul University - Cerrahpasa (IUC)

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

100

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Turkey
      • Istanbul, Turkey
        • Recruiting
        • Istanbul University-Cerrahpasa
        • Contact:
        • Sub-Investigator:
          • Betul Gemici Karaaslan

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

10 years to 18 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Active group
children older than 10 years with a diagnosis of allergic asthma respiratory and relaxation exercises
Other: respiratory exercises
respiratory exercises
Other: relaxation exercises
relaxation exercises
Placebo Comparator: Placebo group
children older than 10 years with a diagnosis of allergic asthma only relaxation exercises
Other: relaxation exercises
relaxation exercises

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in asthma attack frequency
Time Frame: at third and sixth months
asthma attack frequency by home PEF records and questionnaire, spirometric measurements and symptom and medication scoring charts
at third and sixth months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Quality of life questionnaire
Time Frame: at third and sixth months
increase quality of life
at third and sixth months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Istanbul University - Cerrahpasa (IUC)

Investigators

  • Principal Investigator: Ayca Kiykim, Istanbul University - Cerrahpasa (IUC)
  • Study Chair: Hilal Denizoglu, Atlas University
  • Study Chair: Hikmet Uçgun, Atlas University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 3, 2023

Primary Completion (Anticipated)

August 30, 2023

Study Completion (Anticipated)

August 30, 2023

Study Registration Dates

First Submitted

February 17, 2023

First Submitted That Met QC Criteria

February 28, 2023

First Posted (Actual)

March 1, 2023

Study Record Updates

Last Update Posted (Actual)

March 1, 2023

Last Update Submitted That Met QC Criteria

February 28, 2023

Last Verified

February 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Phaster

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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