Determinants of Functional Capacity in Children With Asthma

Asthma in Children Clinical Trial

Official title:

Determinants of Functional Capacity in Children With Asthma

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05963919
• Other study ID #: Atlasumkaya01
• Status: Completed
• Start date: January 1, 2023
• Est. completion date: June 30, 2023

Study information

• Verified date: July 2023
• Source: Atlas University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The primary aim of this study is to compare the respiratory function, respiratory muscle strength, functional capacity, and lower extremity strength of children with asthma and healthy children in the same age group. The secondary aim of our study is to determine the determinants of functional capacity in children with asthma.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: June 30, 2023
• Est. primary completion date: June 30, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 6 Years to 17 Years

Eligibility

Asthma Group Inclusion Criteria:

• Being between the ages of 6-17

• Being diagnosed with asthma

• Able to walk, cooperate and clinically stable

• Being a volunteer to participate in the study

• To be able to speak, read, understand, and cooperate in Turkish

Asthma Group Exclusion Criteria:

• History of previous lung or liver transplant

• Having an acute exacerbation and/or a history of hospitalization in the last 1 month

• Having diagnosed orthopedic problems affecting mobility or a history of musculoskeletal surgery

Control Group Inclusion Criteria:

• Being between the ages of 6-17

• To be able to speak, read, understand, and cooperate in Turkish

• Being a volunteer to participate in the study

Control Group Exclusion Criteria:

• Having a diagnosed vision, hearing, or neurological disease that may affect balance

• Having any other neurological, orthopedic, cardiovascular, thoracic, or metabolic disease or pathological condition that would affect assessments

• Resting saturation below 90% during exercise tests

Related Conditions & MeSH terms

• Asthma
• Asthma in Children

Intervention

Other:
• 6-minute walk test
Functional capacity will be assessed with the 6-minute walk test (6MWT). 6MWT will be performed in accordance with the criteria of the American Thoracic Society. The 6MWT distance will be recorded in meters.
• Pulmonary function test
Pulmonary function test will be performed with a spirometer ("COSMED Pony FX" (COSMED; Italy) by ATS/ERS criteria. Forced expiratory volume in 1 second (FEV1) and peak expiratory volume (PEF) parameters will be measured. The results will be recorded both as a percentage of measured values and expected values.
• Respiratory muscle strength test
Respiratory muscle strength will be measured in accordance with ATS/ERS criteria using an electronic, mobile, (MicroRPM, Micro Medical; UK) intraoral pressure measuring device. Maximal inspiratory pressure (MIP) and maximal expiratory pressure (MEP) values will be recorded. Three measurements will be repeated for each maneuver and the highest value recorded as cmH2O.
• Lower extremity muscle strength test
The 30-Second Chair Test is administered using a folding chair without arms, with a seat height of 17 inches (43.2 cm). The chair, with rubber tips on the legs, is placed against a wall to prevent it from moving. The participant is seated in the middle of the chair, back straight; feet approximately a shoulder width apart, and placed on the floor at an angle slightly back from the knees, with one foot slightly in front of the other to help maintain balance. Arms are crossed at the wrists and held against the chest. The participant is encouraged to complete as many full stands as possible within 30 seconds. The participant is instructed to fully sit between each stand.

Locations

Country	Name	City	State
Turkey	Istanbul Atlas University	Istanbul

Sponsors (1)

Lead Sponsor	Collaborator
Atlas University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	6-minute walk test		15-20 minutes
Primary	Forced expiratory volume in 1 second (FEV1)		10-15 minutes
Primary	Peak expiratory flow (PEF)		10-15 minutes
Primary	Maximal inspiratory pressure (MIP)		15-20 minutes
Primary	Maximal expiratory pressure (MEP)		15-20 minutes
Primary	Lower extremity muscle strength		5-10 minutes