Investigation of Dynamic Hyperinflation and Its Relationship With Functional Exercise Capacity in Children With Bronchiectasis
1 other identifier
observational
40
1 country
1
Brief Summary
Prevalence of dynamic hyperinflation and its relationship with functional exercise capacity will be evaluated in children with bronchiectasis.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Jun 2021
Shorter than P25 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 8, 2021
CompletedFirst Posted
Study publicly available on registry
May 13, 2021
CompletedStudy Start
First participant enrolled
June 1, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 10, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
August 10, 2021
CompletedOctober 25, 2021
October 1, 2021
2 months
May 8, 2021
October 21, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Dynamic hyperinflation
Dynamic hyperinflation will be defined as a decrease of \>100 mL in inspiratory capacity at the end of six-minute walk test determined by Spiropalm 6MWT device.
At baseline
Secondary Outcomes (9)
Six-minute walk distance
At baseline
Minute ventilation
At baseline
Breathing reserve
At baseline
Forced Vital Capacity (FVC)
At baseline
Forced Expiratory Volume in 1 second (FEV1)
At baseline
- +4 more secondary outcomes
Study Arms (1)
Bronchiectasis
Children with bronchiectasis
Interventions
"Spiropalm 6MWT" portable spirometry will be used during six-minute walk test for evaluation of dynamic hyperinflation and other related ventilatory parameters. The device will also be used as regular spirometry.
Functional exercise capacity of patients will be evaluated using six-minute walk test.
Handgrip strength and M. Quadriceps strength will be evaluated using hand-held dynamometer.
The Leicester Cough Questionnaire will be used for evaluating cough.
Eligibility Criteria
Children with bronchiectasis
You may qualify if:
- Diagnosis of bronchiectasis
You may not qualify if:
- Hospitalization history during past month
- Diagnosis of any other chronic childhood diseases such as cerebral palsy or neuromuscular diseases which may impede exercise tolerance
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Izmir Bakircay Universitylead
- Ege Universitycollaborator
Study Sites (1)
Ege University Faculty of Medicine, Department of Pediatrics, Division of Pediatric Pulmonology
Izmir, Turkey (Türkiye)
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- OTHER
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Assist. Prof. Dr.
Study Record Dates
First Submitted
May 8, 2021
First Posted
May 13, 2021
Study Start
June 1, 2021
Primary Completion
August 10, 2021
Study Completion
August 10, 2021
Last Updated
October 25, 2021
Record last verified: 2021-10