NCT06053905

Brief Summary

Peak inspiratory flow (PIF) may be due to respiratory muscle strength, especially in those with severe airflow obstruction. PIF appears to be lower in children and adolescents with asthma than in non-asthmatics and correlates positively with age, height, weight, and respiratory muscle strength. Although physical activity and fitness are also believed to be important in lung health, the relationship between lung function and physical fitness is unclear. It measures dynamic lung volumes, s-index and PIF and provides information on dynamic lung function in children and adolescents. In this study, the dynamic components of the lung will be compared between asthmatic and healthy children, and the relationship between respiratory parameters and physical assessment, such as physical fitness, activity and functional capacity, will be investigated in children with asthma.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
40

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Mar 2023

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 13, 2023

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

August 9, 2023

Completed
2 months until next milestone

First Posted

Study publicly available on registry

September 26, 2023

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 13, 2023

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 10, 2024

Completed
Last Updated

August 9, 2024

Status Verified

August 1, 2024

Enrollment Period

9 months

First QC Date

August 9, 2023

Last Update Submit

August 7, 2024

Conditions

Keywords

Asthma ChildhoodRespiratory MusclePhysical ActivityFitness

Outcome Measures

Primary Outcomes (2)

  • Dynamic Respiratory Muscle Strength and Endurance

    POWERbreathe K-Series, K5, intelligent digital breathing trainers, The first 2 breaths should be taken as quickly and deeply as possible. During these breaths, the maximum respiratory capacity is measured. The index of the power indicator ranges from 10 to 240 cm H2O. Higher values are better. For hygiene reasons, the test is done with a disposable mouthpiece.

    Day 1

  • Pulmonary Function Test

    It is evaluated with the Pulmonary Function Test. After a deep, full inspiration, a forced expiratory maneuver is performed. Used with disposable antiviral filter. The patient's height and body weight are measured and recorded with age. It is done 3 times, there should be no more than 10% difference between the values. The highest value is accepted.

    Day 1

Secondary Outcomes (7)

  • 6 Minutes Walking Test

    Day 1

  • Physical Activity Questionnaire

    Day 1

  • FITNESSGRAM (a) Sit and lie down test with back support:

    Day 1

  • FITNESSGRAM (b) Trunk Extension-extension test:

    Day 1

  • FITNESSGRAM (c) Trunk Flexion flexion test:

    Day 1

  • +2 more secondary outcomes

Study Arms (2)

Asthmatic Child

Children with asthma between 6-11 years old

Healthy Controls Group

Healthy children between 6-11 years old

Eligibility Criteria

Age6 Years - 11 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)
Sampling MethodProbability Sample
Study Population

asthmatic child and healthly peers

You may qualify if:

  • Hacettepe University Faculty of Medicine, Department of Pediatrics, Allergy and Asthma Unit patients referred for Cardiopulmonary Rehabilitation,
  • Those who have been diagnosed with asthma,
  • Clinically stable and not in active asthma attack,
  • Between the ages of 6-11,
  • Giving consent on a voluntary basis,
  • cooperative,

You may not qualify if:

  • Those whose clinical status is not stable and who are in active asthma attack,
  • Having serious diseases such as cancers, heart failure and acute respiratory infections,
  • Having chronic lung disease other than asthma,
  • Severe neuromuscular and musculoskeletal problems,
  • Uncooperative to do the tests,
  • For safety reasons, patients admitted or hospitalized in the last 3 months due to an asthma attack will not be included in the study.
  • Not having any chronic disease for healthy individuals,
  • be between the ages of 6-11,
  • Volunteering to participate in the study,
  • Not having speech and hearing problems,
  • Being cooperative,
  • Not having a mental, neurological, orthopedic, cardiovascular or pulmonary problem that would prevent physical activity,
  • The presence of a medical indication that requires complete restriction of physical activity,
  • Having symptoms of any chronic or acute illness involving the lungs
  • Existence of cooperation and communication problems

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ebru Çalik Kütükcü

Ankara, Altındağ, 06100, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Motor Activity

Condition Hierarchy (Ancestors)

Behavior

Study Officials

  • Ebru Calik Kutukcu, PhD

    Hacettepe University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Lecturer

Study Record Dates

First Submitted

August 9, 2023

First Posted

September 26, 2023

Study Start

March 13, 2023

Primary Completion

December 13, 2023

Study Completion

March 10, 2024

Last Updated

August 9, 2024

Record last verified: 2024-08

Data Sharing

IPD Sharing
Will not share

Locations