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

Completed

• Conditions: Bronchiectasis
• Interventions: Other: Respiratory assessment using "Spiropalm 6MWT" portable spirometry; Other: Evaluation of functional exercise capacity; Other: Evaluation of peripheral muscle strength; Other: Evaluation of chronic cough

• Registration Number: NCT04885790
• Lead Sponsor: Izmir Bakircay University

Brief Summary

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

Detailed 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.

Study Timeline

• Study First Submitted: 2021-05-08
• Study First Submitted QC: 2021-05-08
• Study First Posted: 2021-05-13
• Study Start: 2021-06-01
• Primary Completion: 2021-08-10
• Study Completion: 2021-08-10
• Status Verified: 2021-10
• Last Update Submitted: 2021-10-21
• Last Update Posted: 2021-10-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Bronchiectasis	Evaluation of peripheral muscle strength	Children with bronchiectasis
Bronchiectasis	Respiratory assessment using "Spiropalm 6MWT" portable spirometry	Children with bronchiectasis
Bronchiectasis	Evaluation of chronic cough	Children with bronchiectasis
Bronchiectasis	Evaluation of functional exercise capacity	Children with bronchiectasis

Primary Outcome Measures

Name	Time	Method
Dynamic hyperinflation	At baseline	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.

Secondary Outcome Measures

Name	Time	Method
M. Quadriceps strength	At baseline	M. Quadriceps strength will be measured using hand-held dynamometer
Peak Expiratory Flow (PEF)	At baseline	PEF will be measured before six-minute walk test according to the guideline of European Respiratory Society.
Six-minute walk distance	At baseline	Distance walked in six minutes will be recorded. Test will be conducted according to the guideline of American Thoracic Society.
Breathing reserve	At baseline	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.
Leicester Cough Questionnaire	At baseline	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.
Handgrip strength	At baseline	Handgrip strength will be measured using handgrip dynamometer.
Forced Expiratory Volume in 1 second (FEV1)	At baseline	FEV1 will be measured before six-minute walk test according to the guideline of European Respiratory Society.
Minute ventilation	At baseline	Maximum minute ventilation during six-minute walk test will be measured via Spiropalm 6MWT device.
Forced Vital Capacity (FVC)	At baseline	FVC will be measured before six-minute walk test according to the guideline of European Respiratory Society.

Trial Locations

Locations (1)

Ege University Faculty of Medicine, Department of Pediatrics, Division of Pediatric Pulmonology; 🇹🇷 İzmir, Turkey