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

Sponsor

Istanbul University - Cerrahpasa (IUC) (Other)

Overall Status

Recruiting

CT.gov ID

NCT05749237

Collaborator

(none)

100

Enrollment

Location

Arms

6.8

Anticipated Duration (Months)

14.6

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Allergic Asthma	Other: respiratory exercises Other: relaxation exercises	N/A

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 Design

Study Type:

Interventional

Anticipated Enrollment :

100 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

Randomized placebo controlledRandomized placebo controlled

Masking:

Single (Participant)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Feb 3, 2023

Anticipated Primary Completion Date :

Aug 30, 2023

Anticipated Study Completion Date :

Aug 30, 2023

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

Change in asthma attack frequency [at third and sixth months]
asthma attack frequency by home PEF records and questionnaire, spirometric measurements and symptom and medication scoring charts

Secondary Outcome Measures

Quality of life questionnaire [at third and sixth months]
increase quality of life

Eligibility Criteria

Criteria

Ages Eligible for Study:

10 Years to 18 Years

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Istanbul University-Cerrahpasa	Istanbul		Turkey

Sponsors and Collaborators

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 Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Ayca Kiykim, Associate Professor, Istanbul University - Cerrahpasa (IUC)

ClinicalTrials.gov Identifier:

NCT05749237

Other Study ID Numbers:

Phaster

First Posted:

Mar 1, 2023

Last Update Posted:

Mar 1, 2023

Last Verified:

Feb 1, 2023

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Ayca Kiykim, Associate Professor, Istanbul University - Cerrahpasa (IUC)

allergy, asthma, respiratory exercises, children

Additional relevant MeSH terms:

Asthma

Study Results

No Results Posted as of Mar 1, 2023