NCT05749237

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Feb 2023

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 3, 2023

Completed
14 days until next milestone

First Submitted

Initial submission to the registry

February 17, 2023

Completed
12 days until next milestone

First Posted

Study publicly available on registry

March 1, 2023

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 30, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 30, 2023

Completed
Last Updated

March 1, 2023

Status Verified

February 1, 2023

Enrollment Period

7 months

First QC Date

February 17, 2023

Last Update Submit

February 28, 2023

Conditions

Allergic Asthma

Keywords

allergy, asthma, respiratory exercises, children

Outcome Measures

Primary Outcomes (1)

  • Change in asthma attack frequency

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

    at third and sixth months

Secondary Outcomes (1)

  • Quality of life questionnaire

    at third and sixth months

Study Arms (2)

Active group

ACTIVE COMPARATOR

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

Other: respiratory exercisesOther: relaxation exercises

Placebo group

PLACEBO COMPARATOR

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

Other: relaxation exercises

Interventions

respiratory exercisesOTHER

respiratory exercises

Active group
relaxation exercisesOTHER

relaxation exercises

Active groupPlacebo group

Eligibility Criteria

Age10 Years - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • clinical diagnosis of allergic asthma allergic asthma severity step 1 or step 2 -

You may not qualify if:

  • asthmatic children more severe than step 2 other comorbid disorders involving respiratory system or neuromusculatory disorders

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Istanbul University-Cerrahpasa

Istanbul, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

HypersensitivityAsthma

Interventions

Breathing Exercises

Condition Hierarchy (Ancestors)

Immune System DiseasesBronchial DiseasesRespiratory Tract DiseasesLung Diseases, ObstructiveLung DiseasesRespiratory HypersensitivityHypersensitivity, Immediate

Intervention Hierarchy (Ancestors)

Mind-Body TherapiesComplementary TherapiesTherapeuticsExercise Movement TechniquesPhysical Therapy Modalities

Study Officials

  • Ayca Kiykim

    Istanbul University - Cerrahpasa

    PRINCIPAL INVESTIGATOR

  • Hilal Denizoglu

    Atlas University

    STUDY CHAIR

  • Hikmet Uçgun

    Atlas University

    STUDY CHAIR

Central Study Contacts

Ayca Kiykim

CONTACT

+905423432245ayca.kiykim@iuc.edu.tr

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Randomized placebo controlled
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

February 17, 2023

First Posted

March 1, 2023

Study Start

February 3, 2023

Primary Completion

August 30, 2023

Study Completion

August 30, 2023

Last Updated

March 1, 2023

Record last verified: 2023-02

Locations

TU(1)