Determinants of Functional Capacity in Children With Asthma

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.

Study Overview

• Status: Completed
• Conditions: Asthma in Children
• Intervention / Treatment: Other: Respiratory muscle strength test; Other: 6-minute walk test; Other: Pulmonary function test; Other: Lower extremity muscle strength test

• Study Type: Observational
• Enrollment (Actual): 100

Contacts and Locations

Study Locations

• Turkey
  • Istanbul, Turkey
    • Istanbul Atlas University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

Children with asthma aged between 6-17 years and healthy children aged between 6-17 years will be included in the study. Informed consent forms for the study prepared for both the asthma group and the control group will be carefully explained and the participants will be included in the study after they and their parents have read, understood, and accepted.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Asthma Group; 6 minute walk test, Pulmonary function test, Respiratory muscle strength test, Lower extremity muscle strength test	Other: 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.; 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.; Other: 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.; Other: 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.
Control Group; 6 minute walk test, Pulmonary function test, Respiratory muscle strength test, Lower extremity muscle strength test	Other: 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.; 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.; Other: 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.; Other: 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.

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Atlas University

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2023
• Primary Completion (Actual): June 30, 2023
• Study Completion (Actual): June 30, 2023

Study Registration Dates

• First Submitted: July 18, 2023
• First Submitted That Met QC Criteria: July 18, 2023
• First Posted (Actual): July 27, 2023

Study Record Updates

• Last Update Posted (Actual): July 27, 2023
• Last Update Submitted That Met QC Criteria: July 18, 2023
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Immune System Diseases; Lung Diseases; Hypersensitivity, Immediate; Bronchial Diseases; Lung Diseases, Obstructive; Respiratory Hypersensitivity; Hypersensitivity; Asthma
• Other Study ID Numbers: Atlasumkaya01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No