Determinants of Functional Capacity in Children With Asthma

Sponsor
Atlas University (Other)
Overall Status
Completed
CT.gov ID
NCT05963919
Collaborator
(none)
100
1
5.9
16.9

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: 6-minute walk test
  • Other: Pulmonary function test
  • Other: Respiratory muscle strength test
  • Other: Lower extremity muscle strength test

Study Design

Study Type:
Observational
Actual Enrollment :
100 participants
Observational Model:
Case-Control
Time Perspective:
Prospective
Official Title:
Determinants of Functional Capacity in Children With Asthma
Actual Study Start Date :
Jan 1, 2023
Actual Primary Completion Date :
Jun 30, 2023
Actual Study Completion Date :
Jun 30, 2023

Arms and Interventions

Arm Intervention/Treatment
Asthma Group

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

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: 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: 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: 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: 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: 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.

Outcome Measures

Primary Outcome Measures

  1. 6-minute walk test [15-20 minutes]

  2. Forced expiratory volume in 1 second (FEV1) [10-15 minutes]

  3. Peak expiratory flow (PEF) [10-15 minutes]

  4. Maximal inspiratory pressure (MIP) [15-20 minutes]

  5. Maximal expiratory pressure (MEP) [15-20 minutes]

  6. Lower extremity muscle strength [5-10 minutes]

Eligibility Criteria

Criteria

Ages Eligible for Study:
6 Years to 17 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Istanbul Atlas University Istanbul Turkey

Sponsors and Collaborators

  • Atlas University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Atlas University
ClinicalTrials.gov Identifier:
NCT05963919
Other Study ID Numbers:
  • Atlasumkaya01
First Posted:
Jul 27, 2023
Last Update Posted:
Jul 27, 2023
Last Verified:
Jul 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jul 27, 2023