Determinants of Functional Capacity in Children With Asthma

NCT05963919 | Completed

• 1 other identifier: Atlasumkaya01
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Asthma in Children

Outcome Measures

Primary Outcomes (6)

• 6-minute walk test

  15-20 minutes

• 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

• Lower extremity muscle strength

  5-10 minutes

Study Arms (2)

Asthma Group

6 minute walk test, Pulmonary function test, Respiratory muscle strength test, Lower extremity muscle strength test

Other: 6-minute walk test; Other: Pulmonary function test; Other: Respiratory muscle strength test; Other: Lower extremity muscle strength test

Control Group

6 minute walk test, Pulmonary function test, Respiratory muscle strength test, Lower extremity muscle strength test

Other: 6-minute walk test; Other: Pulmonary function test; Other: Respiratory muscle strength test; Other: Lower extremity muscle strength test

Interventions

6-minute walk test OTHER

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.

Asthma Group; Control Group

Pulmonary function test OTHER

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.

Asthma Group; Control Group

Respiratory muscle strength test OTHER

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.

Asthma Group; Control Group

Lower extremity muscle strength test OTHER

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.

Asthma Group; Control Group

Eligibility Criteria

• Age: 6 Years - 17 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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
• 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
• 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

Sponsors & Collaborators

• Atlas University: lead

Study Sites (1)

Istanbul Atlas University

Istanbul, Turkey (Türkiye)

Location

MeSH Terms

Interventions

Respiratory Physiological Phenomena

Intervention Hierarchy (Ancestors)

Circulatory and Respiratory Physiological Phenomena

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 18, 2023
• First Posted: July 27, 2023
• Study Start: January 1, 2023
• Primary Completion: June 30, 2023
• Study Completion: June 30, 2023
• Last Updated: July 27, 2023

Record last verified: 2023-07

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)