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

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

Study Overview

• Status: Completed
• Conditions: Bronchiectasis
• Intervention / Treatment: 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

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 Type: Observational
• Enrollment (Actual): 40

Contacts and Locations

Study Locations

• Turkey
  • İzmir, Turkey
    • Ege University Faculty of Medicine, Department of Pediatrics, Division of Pediatric Pulmonology

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 8 years to 18 years (Child, Adult)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Children with bronchiectasis

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

Bronchiectasis; Children with bronchiectasis

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.; Other: Evaluation of functional exercise capacity; Functional exercise capacity of patients will be evaluated using six-minute walk test.; Other: Evaluation of peripheral muscle strength; Handgrip strength and M. Quadriceps strength will be evaluated using hand-held dynamometer.; Other: Evaluation of chronic cough; The Leicester Cough Questionnaire will be used for evaluating cough.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
Minute ventilation	Maximum minute ventilation during six-minute walk test will be measured via Spiropalm 6MWT device.	At baseline
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
Forced Vital Capacity (FVC)	FVC will be measured before six-minute walk test according to the guideline of European Respiratory Society.	At baseline
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
Peak Expiratory Flow (PEF)	PEF will be measured before six-minute walk test according to the guideline of European Respiratory Society.	At baseline
Handgrip strength	Handgrip strength will be measured using handgrip dynamometer.	At baseline
M. Quadriceps strength	M. Quadriceps strength will be measured using hand-held dynamometer	At baseline
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

Collaborators and Investigators

• Sponsor: Izmir Bakircay University
• Collaborators: Ege University

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2021
• Primary Completion (Actual): August 10, 2021
• Study Completion (Actual): August 10, 2021

Study Registration Dates

• First Submitted: May 8, 2021
• First Submitted That Met QC Criteria: May 8, 2021
• First Posted (Actual): May 13, 2021

Study Record Updates

• Last Update Posted (Actual): October 25, 2021
• Last Update Submitted That Met QC Criteria: October 21, 2021
• Last Verified: October 1, 2021

More Information

Terms related to this study

• Keywords: children; exercise capacity; pulmonary function; bronchiectasis; dynamic hyperinflation
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Bronchial Diseases; Bronchiectasis
• Other Study ID Numbers: bakircaymzeren03

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No