Investigation of Dynamic Hyperinflation and Its Relationship With Functional Exercise Capacity in Children With Bronchiectasis

Bronchiectasis Clinical Trial

Official title:

Investigation of Dynamic Hyperinflation and Its Relationship With Functional Exercise Capacity in Children With Bronchiectasis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04885790
• Other study ID #: bakircaymzeren03
• Status: Completed
• Start date: June 1, 2021
• Est. completion date: August 10, 2021

Study information

• Verified date: October 2021
• Source: Izmir Bakircay University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Prevalence of dynamic hyperinflation and its relationship with functional exercise capacity will be evaluated in children with bronchiectasis.

Description:

Exercise or hyperpnea-induced air trapping is referred to as dynamic hyperinflation. In the presence of high resistance to expiratory flows and short expiratory times, the respiratory system is unable to return to its resting volume at the end of exhalation. The positive pressure within regions of hyperinflated lung raises the mean intrathoracic pressure and causes the inspiratory muscles to operate at a higher than resting lung volume. Thus, dynamic hyperinflation places the respiratory muscles at a considerable mechanical disadvantage and further impairs respiratory function. Dynamic hyperinflation is considered to be a key determinant of exercise capacity in patients with obstructive lung diseases. Although bronchiectasis is one of the obstructive lung diseases, the presence of dynamic hyperinflation in these patients has not been adequately investigated. Management guidelines of bronchiectasis state that imaging methods or pulmonary function tests alone is not sufficient to determine the disease burden and prognosis in these patients, so they recommend including detailed evaluation of exercise tolerance in the management of bronchiectasis. Aim of this study is to investigate the prevalence of dynamic hyperinflation and its relationship with functional exercise capacity in children with bronchiectasis.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: August 10, 2021
• Est. primary completion date: August 10, 2021
• Gender: All
• Age group: 8 Years to 18 Years

Eligibility

Inclusion Criteria:

• Diagnosis of bronchiectasis

Exclusion Criteria:

• Hospitalization history during past month
• Diagnosis of any other chronic childhood diseases such as cerebral palsy or neuromuscular diseases which may impede exercise tolerance

Related Conditions & MeSH terms

• Bronchiectasis

Intervention

Other:
• Respiratory assessment using "Spiropalm 6MWT" portable spirometry
"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.
• Evaluation of functional exercise capacity
Functional exercise capacity of patients will be evaluated using six-minute walk test.
• Evaluation of peripheral muscle strength
Handgrip strength and M. Quadriceps strength will be evaluated using hand-held dynamometer.
• Evaluation of chronic cough
The Leicester Cough Questionnaire will be used for evaluating cough.

Locations

Country	Name	City	State
Turkey	Ege University Faculty of Medicine, Department of Pediatrics, Division of Pediatric Pulmonology	Izmir

Sponsors (2)

Lead Sponsor	Collaborator
Izmir Bakircay University	Ege University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Six-minute walk distance	Distance walked in six minutes will be recorded. Test will be conducted according to the guideline of American Thoracic Society.	At baseline
Secondary	Minute ventilation	Maximum minute ventilation during six-minute walk test will be measured via Spiropalm 6MWT device.	At baseline
Secondary	Breathing reserve	Breathing reserve (BR) will be calculated as the difference between the maximal voluntary ventilation (MVV) and the maximum minute ventilation (VE) as a fraction of the MVV using Spiropalm 6MWT during six-minute walk test.	At baseline
Secondary	Forced Vital Capacity (FVC)	FVC will be measured before six-minute walk test according to the guideline of European Respiratory Society.	At baseline
Secondary	Forced Expiratory Volume in 1 second (FEV1)	FEV1 will be measured before six-minute walk test according to the guideline of European Respiratory Society.	At baseline
Secondary	Peak Expiratory Flow (PEF)	PEF will be measured before six-minute walk test according to the guideline of European Respiratory Society.	At baseline
Secondary	Handgrip strength	Handgrip strength will be measured using handgrip dynamometer.	At baseline
Secondary	M. Quadriceps strength	M. Quadriceps strength will be measured using hand-held dynamometer	At baseline
Secondary	Leicester Cough Questionnaire	Chronic cough will be evaluated using Leicester Cough Questionnaire. Questionnaire consists of 19 items covering physical, psychological and social domains with a 7 point likert response scale (range from 1 to 7). Higher score indicates better quality of life.	At baseline