BronchiectasisNCT04885790
Investigation of Dynamic Hyperinflation and Its Relationship With Functional Exercise Capacity in Children With Bronchiectasis
An observational study of Bronchiectasis, run by Izmir Bakircay University at 1 site in Turkey (Türkiye).
Trial summary
Prevalence of dynamic hyperinflation and its relationship with functional exercise capacity will be evaluated in children with bronchiectasis. Read more about this study
- Who is it for?
- Ages 8 to 18 years
- Conditions the study is for
- Bronchiectasis
- What is being tested?
- Respiratory assessment using "Spiropalm 6MWT" portable spirometry, Evaluation of functional exercise capacity and Evaluation of peripheral muscle strength
- How many people
- 40 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jun 2021to 10 Aug 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 8 to 18 years
- All sexes
- Child, Adult
Study population: Children with bronchiectasis
Who may be able to join
- Diagnosis of bronchiectasis
Who cannot join
- Hospitalization history during past month
- Diagnosis of any other chronic childhood diseases such as cerebral palsy or neuromuscular diseases which may impede exercise tolerance
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Ege University Faculty of Medicine, Department of Pediatrics, Division of Pediatric Pulmonology
Izmir
About this study
Prevalence of dynamic hyperinflation and its relationship with functional exercise capacity will be evaluated in children with bronchiectasis.
Read the 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.
- Conditions
- Bronchiectasis
- Being tested
- Respiratory assessment using "Spiropalm 6MWT" portable spirometry, Evaluation of functional exercise capacity, Evaluation of peripheral muscle strength, Evaluation of chronic cough
- Keywords
- bronchiectasis, children, dynamic hyperinflation, exercise capacity, pulmonary function
- Medical subject headings
- Bronchiectasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Respiratory assessment using "Spiropalm 6MWT" portable spirometryOther
"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 capacityOther
Functional exercise capacity of patients will be evaluated using six-minute walk test.
Evaluation of peripheral muscle strengthOther
Handgrip strength and M. Quadriceps strength will be evaluated using hand-held dynamometer.
Evaluation of chronic coughOther
The Leicester Cough Questionnaire will be used for evaluating cough.
| Study group | Role | What they receive |
|---|---|---|
| Bronchiectasis | Children with bronchiectasis Receives: 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: At baseline
Secondary outcomes (9)
Six-minute walk distance
Distance walked in six minutes will be recorded. Test will be conducted according to the guideline of American Thoracic Society.
Measured: At baseline
Minute ventilation
Maximum minute ventilation during six-minute walk test will be measured via Spiropalm 6MWT device.
Measured: 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.
Measured: At baseline
Forced Vital Capacity (FVC)
FVC will be measured before six-minute walk test according to the guideline of European Respiratory Society.
Measured: 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.
Measured: At baseline
Peak Expiratory Flow (PEF)
PEF will be measured before six-minute walk test according to the guideline of European Respiratory Society.
Measured: At baseline
Handgrip strength
Handgrip strength will be measured using handgrip dynamometer.
Measured: At baseline
M. Quadriceps strength
- Quadriceps strength will be measured using hand-held dynamometer
Measured: 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.
Measured: At baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 May 2021
- Study start1 Jun 2021
- Primary completion10 Aug 2021
- Study completion10 Aug 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for BronchiectasisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Izmir Bakircay University
- Sponsor type
- University, hospital or other
- Collaborators
- Ege University
- Responsible party
- Principal investigator, Melih Zeren, Izmir Bakircay University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04885790
- Sponsor's protocol ID
- bakircaymzeren03
- Status last verified
- Oct 2021
- First submitted
- 8 May 2021
- Last updated
- 25 Oct 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of Dynamic Hyperinflation and Its Relationship With Functional Exercise Capacity in Children With Bronchiectasis
- ClinicalTrials.gov ID
- NCT04885790
- Acronym / sponsor ID
- bakircaymzeren03
- Conditions
- Bronchiectasis
- Keywords
- bronchiectasis, children, dynamic hyperinflation, exercise capacity, pulmonary function
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Izmir Bakircay UniversityUniversity, hospital or other
- Collaborators
- Ege University
- Study start
- 1 Jun 2021 (actual)
- Primary completion
- 10 Aug 2021 (actual)
- Study completion
- 10 Aug 2021 (actual)
- First posted
- 13 May 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Bronchiectasis | – | Other: Respiratory assessment using "Spiropalm 6MWT" portable spirometry, Other: Evaluation of functional exercise capacity, Other: Evaluation of peripheral muscle strength, Other: Evaluation of chronic coughChildren with bronchiectasis |
Who may qualify
- Ages
- 8 to 18 years
- Sex
- All
- Age groups
- Child, Adult
- Study population
- Children with bronchiectasis
Key inclusion criteria (1 listed)
- Diagnosis of bronchiectasis
Key exclusion criteria (2 listed)
- Hospitalization history during past month
- Diagnosis of any other chronic childhood diseases such as cerebral palsy or neuromuscular diseases which may impede exercise tolerance
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 | Bronchiectasis |
| Evaluation of functional exercise capacityFunctional exercise capacity of patients will be evaluated using six-minute walk test. | Other | Bronchiectasis |
| Evaluation of peripheral muscle strengthHandgrip strength and M. Quadriceps strength will be evaluated using hand-held dynamometer. | Other | Bronchiectasis |
| Evaluation of chronic coughThe Leicester Cough Questionnaire will be used for evaluating cough. | Other | Bronchiectasis |
Primary outcome
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.
9 secondary outcomes
Six-minute walk distance
Time frame: At baseline
Minute ventilation
Time frame: At baseline
Breathing reserve
Time frame: At baseline
Forced Vital Capacity (FVC)
Time frame: At baseline
Forced Expiratory Volume in 1 second (FEV1)
Time frame: At baseline
Peak Expiratory Flow (PEF)
Time frame: At baseline
Handgrip strength
Time frame: At baseline
M. Quadriceps strength
Time frame: At baseline
Leicester Cough Questionnaire
Time frame: At baseline
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Oct 2021.
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Bronchiectasis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Bronchiectasis, run by Izmir Bakircay University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Dynamic hyperinflation (time frame: At baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Oct 2021.