Skip to main content
OpenTrials
Completed

NCT Number: NCT04885790

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Bronchiectasis Bronchial Diseases Respiratory Tract Diseases

Age range

8 year–18 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Ege University Faculty of Medicine, Department of Pediatrics, Division of Pediatric Pulmonology

Izmir, Turkey (Türkiye)

About this study

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.

Who can participate

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Respiratory assessment using "Spiropalm 6MWT" portable spirometry

Other

"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

Other

Functional exercise capacity of patients will be evaluated using six-minute walk test.

Evaluation of peripheral muscle strength

Other

Handgrip strength and M. Quadriceps strength will be evaluated using hand-held dynamometer.

Evaluation of chronic cough

Other

The Leicester Cough Questionnaire will be used for evaluating cough.

Primary outcomes

  1. Dynamic hyperinflation

    Time frame: 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 outcomes

  1. Six-minute walk distance

    Time frame: At baseline

    Distance walked in six minutes will be recorded. Test will be conducted according to the guideline of American Thoracic Society.

  2. Minute ventilation

    Time frame: At baseline

    Maximum minute ventilation during six-minute walk test will be measured via Spiropalm 6MWT device.

  3. Breathing reserve

    Time frame: 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.

  4. Forced Vital Capacity (FVC)

    Time frame: At baseline

    FVC will be measured before six-minute walk test according to the guideline of European Respiratory Society.

  5. Forced Expiratory Volume in 1 second (FEV1)

    Time frame: At baseline

    FEV1 will be measured before six-minute walk test according to the guideline of European Respiratory Society.

  6. Peak Expiratory Flow (PEF)

    Time frame: At baseline

    PEF will be measured before six-minute walk test according to the guideline of European Respiratory Society.

  7. Handgrip strength

    Time frame: At baseline

    Handgrip strength will be measured using handgrip dynamometer.

  8. M. Quadriceps strength

    Time frame: At baseline

    M. Quadriceps strength will be measured using hand-held dynamometer

  9. Leicester Cough Questionnaire

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Izmir Bakircay University

Other

Collaborators

  • Ege University

Registry information

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
May 13, 2021
Registry last updated
Oct 25, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.