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OpenTrials
Completed

NCT Number: NCT05963919

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.

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Key information

Conditions

Asthma in Children

Age range

6 year–17 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Istanbul Atlas University

Istanbul, Turkey (Türkiye)

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

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.

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.

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.

Primary outcomes

  1. 6-minute walk test

    Time frame: 15-20 minutes

  2. Forced expiratory volume in 1 second (FEV1)

    Time frame: 10-15 minutes

  3. Peak expiratory flow (PEF)

    Time frame: 10-15 minutes

  4. Maximal inspiratory pressure (MIP)

    Time frame: 15-20 minutes

  5. Maximal expiratory pressure (MEP)

    Time frame: 15-20 minutes

  6. Lower extremity muscle strength

    Time frame: 5-10 minutes

Sponsors and collaborators

Lead sponsor

Atlas University

Other

Registry information

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Jul 27, 2023
Registry last updated
Jul 27, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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